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Common Stock - Schedule of Exercise of Both Outstanding and Available for Grant Stock Options (Details)	Dec. 31, 2024 shares
Class of Stock [Line Items]
Convertible preferred stock	19,827,003
Common stock options granted and outstanding	5,667,555
Total common stock reserved for future issuance	27,094,929
2016 Stock Incentive Plan
Class of Stock [Line Items]
Shares available for issuance	1,600,371

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2024	Mar. 01, 2025	Jun. 30, 2024
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Trading Symbol	BBNX
Current Fiscal Year End Date	--12-31
Document Annual Report	true
Document Transition Report	false
Entity File Number	001-42491
Entity Registrant Name	BETA BIONICS, INC.
Entity Central Index Key	0001674632
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-5386878
Entity Address, Address Line One	11 Hughes
Entity Address, City or Town	Irvine
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92618
City Area Code	949
Local Phone Number	427-7785
Entity Well-known Seasoned Issuer	No
Entity Current Reporting Status	No
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		43,348,840
Entity Public Float			$ 0
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Security Exchange Name	NASDAQ
ICFR Auditor Attestation Flag	false
Entity Voluntary Filers	No
Document Financial Statement Error Correction [Flag]	false
Auditor Firm ID	42
Auditor Name	Ernst & Young LLP
Auditor Location	San Diego, California
Auditor Opinion [Text Block]	Opinion on the Financial Statements We have audited the accompanying balance sheets of Beta Bionics, Inc. (the Company) as of December 31, 2024 and 2023, the related statements of operations and comprehensive loss, convertible preferred stock and stockholders' deficit and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.

Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Nov. 30, 2024	Dec. 31, 2024	May 31, 2024
Commitments and Contingencies Disclosure [Abstract]
One-time payment			$ 0.5
One-time milestone payment			$ 3.0
Milestone achieved and payment made	$ 3.0
Clinical material ordered for phase 2		$ 0.9
Percentage of deposit equal to estimated clinical material costs		30.00%

Organization and Basis of Presentation

12 Months Ended

Dec. 31, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Basis of Presentation

The Company

Beta Bionics, Inc. (the “Company”) is a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (“PWD”) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. The Company was incorporated as a Massachusetts benefit corporation in October 2015, and converted to a Delaware corporation in August 2024.

The Company’s product, the iLet Bionic Pancreas (“iLet”), was cleared by the U.S. Food and Drug Administration (“FDA”) for the treatment of type 1 diabetes (“T1D”) in adults and children six years of age and older in May 2023, and it began commercializing the iLet in the United States in May 2023. The iLet is the first adaptive closed-loop algorithm insulin dosing system that does not require T1D users to keep a daily tabulation of their carbohydrate intake or perform calculations to determine the correct dose of insulin to take.

From its inception to December 31, 2024, the Company has devoted substantially all of its resources to organizing and staffing the Company, business planning, capital raising, establishing and engaging in collaborations, performing research and development, advancing and scaling up manufacturing capabilities, commercializing its products, establishing a sales infrastructure and providing general and administrative support for these activities. The Company’s operations to date have been funded primarily through the issuance and sale of convertible preferred stock and sales of the iLet and single-use products.

Reverse Stock Split

On January 21, 2025, the Company effectuated a 1-for-1.970 reverse stock split of the Company’s issued and outstanding shares of Class A, Class B and Class C common stock, Series A convertible preferred stock (the “Series A Preferred Stock”), Series A-2 convertible preferred stock (the “Series A-2 Preferred Stock”), Series B convertible preferred stock (the “Series B Preferred Stock”), Series B-2 convertible preferred stock (the “Series B-2 Preferred Stock”), Series C convertible preferred stock (the “Series C Preferred Stock”), Series D convertible preferred stock (the “Series D Preferred Stock”), and Series E convertible preferred stock (the “Series E Preferred Stock”) , as well as stock option awards to purchase shares of Class B common stock and warrants to purchase shares of Class B common stock and Series C preferred stock. Consequently, all issued and outstanding shares of stock, stock option awards, warrants, and per share data have been retroactively adjusted in these financial statements to reflect the reverse stock split for all periods presented. The authorized shares and par value of the common stock and preferred stock remain unchanged. As the number and issuance price of all outstanding preferred stock were adjusted, the conversion ratios for each series of the Company’s preferred stock were unchanged. Stockholders entitled to fractional shares as a result of the reverse stock split received cash payment in lieu of receiving fractional shares.

Initial Public Offering

On January 31, 2025, the Company completed its initial public offering (“IPO”) pursuant to which the Company issued 13,800,000 shares of its common stock, including 1,800,000 additional shares pursuant to the exercise in full of the underwriters of their option to purchase shares of common stock from the Company and other selling stockholders (consisting of 475,000 shares from the Company and 1,325,000 shares from the selling stockholders), at a public offering price of $17.00 per share (the “IPO Price”). The aggregate net proceeds from the offering, after deducting underwriting discounts, commissions, and other offering expenses, were approximately $190.4 million. In addition, upon the closing of the IPO, all 6,671,174 shares of Class A, Class B, and Class C Common Stock were converted into an equal number of shares of common stock, all 17,228,954 outstanding shares of convertible preferred stock were converted into 19,827,003 shares of common

stock, and all 3,196,025 outstanding warrants to purchase shares of Series C Preferred Stock and Class B Common Stock were converted into 3,373,409 shares of common stock.

Private Placement Offering

On January 21, 2025, the Company entered into a Common Stock Purchase Agreement (the “Private Placement Offering”) with an existing accredited investor pursuant to which the Company sold 1,000,000 shares of its common stock at a per share price equal to the IPO Price. The Private Placement Offering closed concurrently with the IPO on January 31, 2025. The aggregate net proceeds from the Private Placement Offering, after deducting underwriting discounts, commissions, and other offering expenses, were approximately $15.6 million.

Basis of Presentation

The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as found in the Accounting Standards Codification (“ASC”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).

On August 30, 2024, the Company converted from a Massachusetts benefit corporation to a Delaware corporation. All outstanding shares of preferred stock, common stock, options and warrants of the Massachusetts benefit corporation were converted into an equivalent share, option or warrant of the Delaware corporation and the par value of the Company’s preferred stock and common stock was adjusted to $0.0001. The impact of the change has been given retroactive effect in the financial statements and the accompanying notes as it relates to the year ended December 31, 2023.

The Reverse Stock Split became effective on January 21, 2025. Accordingly, all share and per share data included in these financial statements and the accompanying notes have been adjusted retroactively to reflect the impact of the Reverse Stock Split.

Emerging Growth Company Status

The Company is an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”), enacted in 2012. Under the JOBS Act, EGCs can delay adopting new or revised accounting standards issued after the enactment of the JOBS Act until those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an EGC or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

Accrued Expenses and Other Current Liabilities

12 Months Ended

Dec. 31, 2024

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

10.

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Accrued employee compensation and benefits	$	9,942	$	5,475
Accrued professional fees		2,119		963
Accrued sales returns, rebates and patient assistance		1,502		592
Accrued inventory in transit		530		342
Accrued royalties		741		294
Other current liabilities		994		462
Accrued expenses and other current liabilities	$	15,828	$	8,128

Reconciliations of the changes in the Company’s product warranty liability, which is included in other current liabilities, were as follows:


	Year Ended December 31,
	2024			2023
	(in thousands)
Product warranty liability at beginning of year	$	22		$	—
Warranty expense		1,689			84
Warranty fulfillment		(1,054	)		(62	)
Product warranty liability at end of year	$	657		$	22

Convertible Preferred Stock and Warrants (Tables)

12 Months Ended

Dec. 31, 2024

Equity [Abstract]

Summary of Preferred Stock

At the balance sheet dates, Preferred Stock consisted of the following:


	December 31, 2024
	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value (in thousands)		Liquidation Preference (in thousands)		Common Stock Issuable Upon Conversion
Series A Preferred Stock		500,000		253,807	$	6,589	$	5,000		317,040
Series A-2 Preferred Stock		500,000		253,807		6,626		5,000		317,040
Series B Preferred Stock		4,197,930		2,130,910		61,606		63,053		3,010,683
Series B-2 Preferred Stock		3,960,000		2,010,144		63,228		63,360		2,892,318
Series C Preferred Stock		5,127,250		2,082,153		44,985		57,049		2,791,789
Series D Preferred Stock		12,107,140		6,145,740		78,679		101,700		6,145,740
Series E Preferred Stock		8,574,227		4,352,393		59,660		60,000		4,352,393
		34,966,547		17,228,954	$	321,373	$	355,162		19,827,003


	December 31, 2023
	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value (in thousands)		Liquidation Preference (in thousands)		Common Stock Issuable Upon Conversion
Series A Preferred Stock		500,000		253,807	$	6,589	$	5,000		317,040
Series A-2 Preferred Stock		500,000		253,807		6,626		5,000		317,040
Series B Preferred Stock		4,200,000		2,130,910		61,606		63,053		3,010,683
Series B-2 Preferred Stock		4,000,000		2,010,144		63,228		63,360		2,892,318
Series C Preferred Stock		5,127,250		2,082,153		44,985		57,049		2,791,789
Series D Preferred Stock		12,107,140		6,145,740		78,679		101,700		6,145,740
		26,434,390		12,876,561	$	261,713	$	295,162		15,474,610

- Definition

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

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+ Details

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2024

Prepaid Expense and Other Assets, Current [Abstract]

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Prepaid expenses	$	2,982	$	908
Other current assets		1,050		275
Prepaid expenses and other current assets	$	4,032	$	1,183

Property and Equipment, Net (Tables)

12 Months Ended

Dec. 31, 2024

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment, Net

Property and equipment, net consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Manufacturing equipment	$	6,252		$	4,386
Leasehold improvements		810			951
Furniture		924			924
Computer equipment		308			468
Construction in progress		1,735			167
Total cost		10,029			6,896
Less: Accumulated depreciation		(5,253	)		(4,420	)
Property and equipment, net	$	4,776		$	2,476

Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2024

Accounting Policies [Abstract]

Schedule of Customers Accounted for 10% or More

The following table summarizes the percentages of total sales and accounts receivable, net for customers who accounted for 10% or more of the respective amounts for the periods presented:


	Net Sales						Accounts Receivable, net
	Year Ended December 31,						December 31,
	2024			2023			2024			2023
Distributor A		12.8	%		20.6	%		13.7	%		28.9	%
Distributor B		18.3	%		19.0	%		13.3	%		24.5	%
Distributor C		11.6	%		16.3	%		10.6	%		12.3	%
Distributor D		16.3	%		14.2	%		13.0	%	*
Distributor E	*			*				14.8	%	*

* Amount related to the respective customer represented less than 10% for the period presented.

Accounts Receivable, Net (Tables)

12 Months Ended

Dec. 31, 2024

Receivables [Abstract]

Schedule of Accounts Receivable, Net

Accounts receivable, net consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Accounts receivable	$	12,112		$	4,494
Less: allowance for credit losses		(116	)		(46	)
Accounts receivable, net	$	11,996		$	4,448

Schedule of Change in Allowance for Estimated Credit Losses

The following table provides a reconciliation of the changes in the allowance for estimated credit losses for the years ended December 31, 2024 and 2023:


	Year Ended December 31,
	2024		2023
	(in thousands)
Balance at beginning of year	$	46	$	—
Provision for expected credit losses		70		46
Balance at end of year	$	116	$	46

Net Loss Per Share

12 Months Ended

Dec. 31, 2024

Earnings Per Share [Abstract]

Net Loss Per Share

16.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities.

Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding, including all potentially dilutive common shares. The impact of all potentially dilutive shares which are anti-dilutive are excluded from the calculation of net loss per share. Potentially dilutive common stock equivalents are comprised of convertible preferred stock, calculated using the if-converted method, stock options to purchase Class B common stock, warrants to purchase Series C Preferred Stock and warrants to purchase Class B common stock, each calculated using the treasury stock method. Potentially dilutive securities not included in the calculation of diluted net loss per share, are as follows (in common stock equivalent shares):


	Year Ended December 31,
	2024		2023
Convertible preferred stock (as converted into shares of Class B common stock)		19,827,003		15,474,597
Stock options to purchase Class B common stock		5,667,555		5,202,905
Warrants to purchase Series C convertible preferred stock		697,874		697,885
Warrants to purchase Class B common stock		2,675,535		3,310,052
Total		28,867,967		24,685,439

The following table sets forth the computation of basic and diluted net loss per share attributable to Class A, Class B, and Class C common stockholders:


	Year Ended December 31,
	2024			2023
	(in thousands, except share and per share data)
Numerator:
Net loss attributable to Class A, Class B and Class C common stockholders, basic and diluted	$	(54,756	)	$	(44,099	)
Denominator:
Weighted-average Class A common stock outstanding, basic and diluted		2,952,123			2,989,847
Weighted-average Class B common stock outstanding, basic and diluted		3,364,023			2,264,919
Weighted-average Class C common stock outstanding, basic and diluted		48,918			48,918
Weighted-average Class A, Class B, Class C common stock outstanding, basic and diluted		6,365,064			5,303,684

Net loss per share attributable to Class A, Class B and Class C common stockholders, basic and diluted	$	(8.60	)	$	(8.31	)

Short-Term Investments (Tables)

12 Months Ended

Dec. 31, 2024

Investments, Debt and Equity Securities [Abstract]

Summary of Estimated Fair Value of Short-term Investments

The following represents a summary of the estimated fair value of short-term investments at December 31, 2024 and 2023:


	At December 31, 2024
	Amortized		Unrealized		Unrealized		Estimated
	Cost		Gains		Losses		Fair Value
	(in thousands)
Short-term investments
U.S. Treasury bills	$	73,078	$	65	$	—	$	73,143
Total	$	73,078	$	65	$	—	$	73,143


	As of December 31, 2023
	Amortized		Unrealized		Unrealized		Estimated
	Cost		Gains		Losses		Fair Value
	(in thousands)
Short-term investments
U.S. Treasury bills	$	70,042	$	137	$	—	$	70,179
Total	$	70,042	$	137	$	—	$	70,179

Significant Accounting Policies - Summary of Percentage of Total Sales and Accounts Receivable (Details) - Customer Concentration Risk	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Net Sales \| Distributor A
Concentration Risk [Line Items]
Customers accounted for 10% or more	12.80%	20.60%
Net Sales \| Distributor B
Concentration Risk [Line Items]
Customers accounted for 10% or more	18.30%	19.00%
Net Sales \| Distributor C
Concentration Risk [Line Items]
Customers accounted for 10% or more	11.60%	16.30%
Net Sales \| Distributor D
Concentration Risk [Line Items]
Customers accounted for 10% or more	16.30%	14.20%
Accounts Receivable, net \| Distributor A
Concentration Risk [Line Items]
Customers accounted for 10% or more	13.70%	28.90%
Accounts Receivable, net \| Distributor B
Concentration Risk [Line Items]
Customers accounted for 10% or more	13.30%	24.50%
Accounts Receivable, net \| Distributor C
Concentration Risk [Line Items]
Customers accounted for 10% or more	10.60%	12.30%
Accounts Receivable, net \| Distributor D
Concentration Risk [Line Items]
Customers accounted for 10% or more	13.00%
Accounts Receivable, net \| Distributor E
Concentration Risk [Line Items]
Customers accounted for 10% or more	14.80%

Financial Instruments and Fair Value Measurements - Additional Information (Details)	12 Months Ended
	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value transfers between levels \| $	$ 0	$ 0
Expected Dividend Yield
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants and rights outstanding measurement input	0
Class B
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants exercise price	$ 0.02
Class B \| Expected Dividend Yield
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants and rights outstanding measurement input	0	0
Class B \| August 2023 Series D Preferred Stock Financing
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants to purchase common stock \| shares	4,302,009
Series D Preferred Stock \| August 2023 Series D Preferred Stock Financing
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Percentage of preferred stock purchased	70.00%
Warrants exercise price	$ 0.02
Expiration date	Aug. 28, 2033
Series C Preferred Stock
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants exercise price	$ 0.02
Series C Preferred Stock \| Expected Dividend Yield
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants and rights outstanding measurement input	0	0
Series C Preferred Stock \| February 2022 Series C Preferred Stock Financing
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrants to purchase common stock \| shares	520,490
Warrants exercise price	$ 0.02
Expiration date	Feb. 16, 2032

Commitments and Contingencies

12 Months Ended

Dec. 31, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

18. Commitments and Contingencies

Legal Proceedings

From time to time, the Company may become involved in various legal proceedings, including those that may arise in the ordinary course of business.

The Company believes there is no litigation pending that could have, individually, or in the aggregate, have a material adverse effect on the results of its operations, financial condition or cash flows.

Xeris Agreements

In May 2024, the Company and Xeris Pharmaceuticals, Inc. (“Xeris”) entered into a collaboration and license agreement (“Collaboration and License Agreement”). Under the Collaboration and License Agreement, the Company received a worldwide, exclusive, royalty-bearing, sublicensable license under certain patent rights and know-how related to Xeris’ proprietary non-aqueous formulation technology and technology developed during the collaboration (“Xeris Technology”) to develop and commercialize glucagon products that are reformulated using the Xeris Technology and developed by Xeris under a development plan under the Collaboration and License Agreement for use in a pump product or system for glycemic control (“Glucagon Products”) in the field of chronic glycemic control in diabetes mellitus, excluding single-dose, one-time use form for treatment of severe hypoglycemia and diagnostic uses (“Field”). The Company also received a worldwide, exclusive, sublicensable manufacturing license under the Xeris Technology to manufacture Glucagon Products in the Field following a future manufacturing transfer date to be agreed with Xeris and subject to a separate commercial supply agreement.

In consideration for the licenses and other rights granted to the Company under the Collaboration and License Agreement, the Company paid Xeris a one-time payment of $0.5 million, which was included as a component of research and development expenses in the Company’s unaudited condensed statements of operations and comprehensive loss and the Company will pay Xeris a one-time milestone payment of $3.0 million upon its achievement of a certain development milestone event. The milestone was achieved and the payment of $3.0 million was made in November 2024. In addition, the Company is required to pay Xeris tiered royalties of low double-digit percentages based on net sales of Glucagon Products by the Company or its sublicensees, subject to certain customary reductions. The Company’s obligation to pay Xeris royalties will commence, on a Glucagon Product-by-Glucagon Product and country-by-country basis, on the first commercial sale of such Glucagon Product in such country and expire on the later of (i) ten years after the first commercial sale of such Glucagon Product in such applicable country; (ii) expiration of the last valid claim of a specified patent right licensed by Xeris covering such Glucagon Product in such country; and (iii) expiration or termination or regulatory exclusivity for such Glucagon Product in the applicable country.

In connection with entering into phase 2 of the collaboration, during the twelve months ended December 31, 2024, under its clinical supply arrangement the Company ordered clinical material totaling $0.9 million for phase 2 clinical trials and has paid a deposit equal to 30% of the estimated clinical material costs, which is recognized in prepaid expense and other current assets in the unaudited condensed balance sheets.

Stock-Based Compensation

12 Months Ended

Dec. 31, 2024

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

13.

Stock-Based Compensation

2016 Stock Incentive Plan

The Company’s 2016 Stock Incentive Plan, as amended (the “2016 Plan”), provides for the Company to grant stock options and restricted stock awards to employees, officers, directors and consultants of the Company. The 2016 Plan is administered by the Board or, at the discretion of the Board, by a committee of the Board. The exercise prices, vesting and other restrictions are determined at the discretion of the Board, or its committee if so delegated.

The Company grants equity classified stock options for the purchase of Class B common stock. Stock options granted under the 2016 Plan with service-based vesting conditions typically vest over four years based on continuous service and expire after ten years. The total number of shares of Class B common stock that may be issued under the 2016 Plan was 7,267,926 shares as of December 31, 2024, of which 1,577,469 shares remained available for future issuance as of December 31, 2024. Shares that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future grant under the 2016 Plan.

The exercise price for stock options granted may not be less than the fair value of Class B common stock as determined by the Board as of the date of grant. The Board values the Company’s Class B common stock taking into consideration the most recent sales of the Company’s preferred stock, results obtained from contemporaneous third-party valuations and additional factors the Company deems relevant and which may have changed since the date of the most recent valuation through the date of grant.

Stock Option Cancellation and Regrant

On March 2, 2023, and in accordance with the terms of the Company’s 2016 Plan, the Board approved a stock option cancel and regrant (the “2023 Cancel and Regrant”), wherein 2,273,054 previously granted stock options to acquire shares of the Company’s common stock that were issued from December 2019 through December 2022 to 85 grantees were canceled and regranted at the price of the Company’s common stock valuation on March 2, 2023. As of that date, the Company’s common stock fair value was $7.50 per share.

Aside from the reduced strike price, all regranted options kept the same terms and conditions of the canceled stock options, including vested amounts and vesting schedules. Upon the cancel and regrant, the Company recognized additional stock-based compensation from vested options of $0.4 million and a total of $0.4 million as unvested options continued to vest during the year ended December 31, 2023. The Company will recognize an additional $1.1 million stock-based compensation expense from the date of the modification through the third quarter of 2027, based on the requisite service period, as the remaining unvested options continue to vest.

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option pricing model to determine the grant-date fair value of stock options granted:


	Year Ended December 31,
	2024			2023
Fair value of common stock	$	13.08		$	8.51
Risk-free interest rate		4.09	%		3.06	%
Expected term (in years)		6.02			5.39
Expected volatility		86.80	%		75.12	%
Expected dividend yield		0	%		0	%


						Weighted-
				Weighted- Average		Average Remaining		Aggregate
	Number of Options			Exercise Price		Contractual Term		Intrinsic Value
						(in years)		(in thousands)
Outstanding at December 31, 2023		5,202,905		$	6.30		8.1	$	535
Granted		935,105		$	9.27
Exercised		(11,953	)	$	7.42
Forfeited or cancelled		(415,087	)	$	8.96
Expired		(43,415	)	$	7.58
Outstanding at December 31, 2024		5,667,555		$	6.98		7.6	$	22,962
Vested and expected to vest at December 31, 2024		5,667,555		$	6.98		7.6	$	22,962
Options exercisable at December 31, 2024		2,887,678		$	6.88		6.6	$	12,174

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s Class B common stock for those stock options that had exercise prices lower than the fair value of the Company’s Class B common stock. The total intrinsic value of options exercised during the twelve months ended December 31, 2024 and 2023 were not significant.

The weighted-average grant-date fair value of stock options granted during the years ended December 31, 2024 and 2023 was $6.92 per share and $4.26 per share, respectively. The total fair value of shares vested during the years ended December 31, 2024 and 2023 was $3.1 million and $2.5 million, respectively.

The following table summarizes the non-vested stock options that were outstanding as of December 31, 2024 and 2023:


			Weighted- Average
	Number of Options		Exercise Price
Non-vested options, December 31, 2024		2,779,877	$	7.07
Non-vested options, December 31, 2023		3,124,193	$	6.06

Stock-Based Compensation Expense

Stock-based compensation expense related to the stock options was included in the Company’s statements of operations and comprehensive loss as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Cost of sales	$	275	$	239
Research and development		1,144		1,781
Sales and marketing		1,661		610
General and administrative		3,304		3,028
Total stock-based compensation expense	$	6,384	$	5,658

As of December 31, 2024, total unrecognized stock-based compensation expense related to the unvested stock-based awards was $13.7 million, which is expected to be recognized over a weighted-average period of 8.6 years.

Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued employee compensation and benefits	$ 9,942	$ 5,475
Accrued professional fees	2,119	963
Accrued sales returns, rebates and patient assistance	1,502	592
Accrued inventory in transit	530	342
Accrued royalties	741	294
Other current liabilities	994	462
Accrued expenses and other current liabilities	$ 15,828	$ 8,128

STATEMENTS OF BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Convertible preferred stock, par value	$ 0.0001	$ 0.0001
Convertible preferred stock, shares authorized	34,966,547	26,434,390
Convertible preferred stock, shares issued	17,228,954	12,876,561
Convertible preferred stock, shares outstanding	17,228,954	12,876,561
Convertible preferred stock, liquidation preference	$ 355,162	$ 295,162
Class A Common Stock
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	5,790,000	6,000,000
Common stock, shares issued	2,939,085	2,989,847
Common stock, shares outstanding	2,939,085	2,989,847
Class B Common Stock
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	70,000,000	65,000,000
Common stock, shares issued	3,679,790	2,982,562
Common stock, shares outstanding	3,679,790	2,982,562
Class C Common Stock
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	96,910	100,000
Common stock, shares issued	48,918	48,918
Common stock, shares outstanding	48,918	48,918

Leases - Additional Information (Details) $ in Thousands	1 Months Ended				12 Months Ended
Leases - Additional Information (Details) $ in Thousands	Oct. 31, 2024 USD ($)	Sep. 30, 2024 USD ($) Employee	Nov. 30, 2023	May 31, 2023	Dec. 31, 2024 USD ($) ft² Lease	Dec. 31, 2023 USD ($)
Leases [Line Items]
Operating lease payments					$ 1,300	$ 1,100
Operating leases, option to extend					true
Operating lease right-of-use asset					$ 6,645	$ 3,722
Operating lease liability					$ 7,255
California
Leases [Line Items]
Lease description					the Company entered into two separate lease agreements for a total of approximately 8,500 square feet of office space in San Diego, California. These leases will expire in July 2025 and February 2027.
Number of lease agreements \| Lease					2
Area of real estate \| ft²					8,500
Lease expiration period	2027-03		2027-02	2025-07
Operating leases, option to extend					true
Operating lease, additional lease term					5 years
Operating leases, option to extend					The larger of the two leases has one option to extend the lease term for an additional five years.
Number of renewal options \| Employee		2
Operating lease lease term period		2027-05
Operating lease extending lease term period		2032-06
Operating lease right-of-use asset	$ 200	$ 3,800
Operating lease liability	$ 200	$ 3,800

Revenue

12 Months Ended

Dec. 31, 2024

Revenue from Contract with Customer [Abstract]

Revenue

The Company disaggregates net sales by product category and reimbursement channel, which the Company believes provides a meaningful depiction of how the nature, timing and uncertainty of net sales are affected by economic factors.

During the year ended December 31, 2024 and 2023, the Company’s revenues were predominantly generated from sales of the iLet. The iLet requires the use of separately purchased single-use products which include cartridges for storing and delivering insulin, and infusion sets that connect the iLet to the user’s body. These single-use products generate recurring revenue for the Company, as these are typically replaced by the end-user every 2-3 days or as directed by a healthcare provider.

The Company’s customers are distributors and pharmacies who sell these products to insulin-requiring PWD, through the durable medical equipment (“DME”) and the pharmacy benefit plan (“PBP”) reimbursement channels, which entail differing payment outlays. For the year ended December 31, 2024 and 2023, the majority of the Company’s sales were through the DME channel.

The following table summarizes the Company’s disaggregated revenues:


	Year Ended December 31,
	2024		2023
	(in thousands)
DME channel
iLet(1)	$	46,617	$	10,169
Single-use products		12,189		1,091
Total DME channel		58,806		11,260

PBP channel
iLet(1)		2,099		535
Single-use products		4,219		200
Total PBP channel		6,318		735
Total net sales	$	65,124	$	11,995

(2)

iLet includes the over-time recognition software updates and mobile app access.

The Company recognizes revenue at a point in time once control has transferred to the customer, as well as over time for performance obligation to provide ongoing services such as unspecified software updates. Revenue recognized during the year ended December 31, 2024 that was included in the deferred revenue balance as of December 31, 2023 was approximately $0.1 million.

At December 31, 2024 and 2023, $2.8 million and $0.3 million, respectively, was allocated to performance obligations that were not yet satisfied and is recorded in deferred revenue on the balance sheet. At December 31, 2024 and 2023, of the performance obligations not yet satisfied, $0.9 million and $0.1 million, respectively, is expected to be recognized as revenue in the next 12 months, with the remainder expected to be recognized thereafter. At December 31, 2024 and 2023, the $2.8 million and $0.3 million, respectively, relates to amounts deferred associated with the unspecified software updates promised to users and the user’s access to the mobile application.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-13

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org/606/tableOfContent

+ Details

Stock-Based Compensation - Additional Information (Details)		12 Months Ended		55 Months Ended
	Mar. 02, 2023 Grantee $ / shares shares	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares	Sep. 30, 2027 USD ($)
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock reserved for future issuance \| shares		27,094,929
Stock options granted \| shares		935,105
Total intrinsic value of options exercised		$ 0	$ 0
Weighted average grant date fair value \| $ / shares		$ 6.92	$ 4.26
Stock-based compensation		$ 6,384,000	$ 5,658,000
Fair value of shares vested		3,100,000	2,500,000
Unrecognized stock-based compensation expense		$ 13,700,000
Unrecognized stock-based compensation expense period for recognition		8 years 7 months 6 days
Class B Common Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares authorized \| shares		65,000,000
2016 Plan \| Class B Common Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period		4 years
Expiration period		10 years
Number of shares authorized \| shares		7,267,926
Common stock reserved for future issuance \| shares		1,577,469
2023 Cancel and Regrant
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock options granted \| shares	2,273,054
Number of grantees \| Grantee	85
Weighted average grant date fair value \| $ / shares	$ 7.5
2023 Cancel and Regrant \| Vested Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation			400,000
2023 Cancel and Regrant \| Unvested Options Continued To Vest
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation			$ 400,000
2023 Cancel and Regrant \| Unvested Options Continued To Vest \| Scenario forecast
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation				$ 1,100,000

Employee Benefit Plan	12 Months Ended
Employee Benefit Plan	Dec. 31, 2024
Retirement Benefits [Abstract]
Employee Benefit Plan	14. Employee Benefit Plan The Company maintains a 401(k) retirement plan (the “401(k) Plan”) for the benefit of eligible employees. Each participant may elect to contribute up to 100% of his or her compensation to the 401(k) Plan each year, subject to certain Internal Revenue Service limitations. Under the terms of the Plan, the Company matches 100% of the first 6% of employee contributions. During the years ended December 31, 2024 and 2023, the Company contributed $2.2 million and $1.2 million, respectively, to the 401(k) Plan.

Net Loss Per Share (Tables)

12 Months Ended

Dec. 31, 2024

Earnings Per Share [Abstract]

Summary of potential dilutive securities, not included in the calculation of diluted net loss per share

Potentially dilutive securities not included in the calculation of diluted net loss per share, are as follows (in common stock equivalent shares):


	Year Ended December 31,
	2024		2023
Convertible preferred stock (as converted into shares of Class B common stock)		19,827,003		15,474,597
Stock options to purchase Class B common stock		5,667,555		5,202,905
Warrants to purchase Series C convertible preferred stock		697,874		697,885
Warrants to purchase Class B common stock		2,675,535		3,310,052
Total		28,867,967		24,685,439

Summary of computation of basic and diluted net loss per share

The following table sets forth the computation of basic and diluted net loss per share attributable to Class A, Class B, and Class C common stockholders:


	Year Ended December 31,
	2024			2023
	(in thousands, except share and per share data)
Numerator:
Net loss attributable to Class A, Class B and Class C common stockholders, basic and diluted	$	(54,756	)	$	(44,099	)
Denominator:
Weighted-average Class A common stock outstanding, basic and diluted		2,952,123			2,989,847
Weighted-average Class B common stock outstanding, basic and diluted		3,364,023			2,264,919
Weighted-average Class C common stock outstanding, basic and diluted		48,918			48,918
Weighted-average Class A, Class B, Class C common stock outstanding, basic and diluted		6,365,064			5,303,684

Net loss per share attributable to Class A, Class B and Class C common stockholders, basic and diluted	$	(8.60	)	$	(8.31	)

STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT (Parenthetical) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Series D Preferred Stock
Stock issuance costs		$ 700
Warrant liabilities		$ 22,321
Series E Preferred Stock [Member]
Stock issuance costs	$ 340

Financial Instruments and Fair Value Measurements

12 Months Ended

Dec. 31, 2024

Fair Value Disclosures [Abstract]

Financial Instruments and Fair Value Measurements

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis:


	Fair Value Measurements at December 31, 2024
Assets	Level 1		Level 2		Level 3		Total
	(in thousands)
Cash equivalents:
Money market fund	$	27,107	$	—	$	—	$	27,107
Restricted cash:
Money market fund		100		—		—		100
Short-term investments
U.S. Treasury bills		73,143		—		—		73,143
Total assets	$	100,350	$	—	$	—	$	100,350
Liabilities
Series C warrant liabilities	$	—	$	—	$	9,935	$	9,935
Common B warrant liabilities		—		—		34,963		34,963
Total liabilities	$	—	$	—	$	44,898	$	44,898


	Fair Value Measurements at December 31, 2023
Assets	Level 1		Level 2		Level 3		Total
	(in thousands)
Cash equivalents:
Money market fund	$	24,414	$	—	$	—	$	24,414
Restricted cash:
Money market fund		100		—		—		100
Short-term investments
U.S. Treasury bills		70,179		—		—		70,179
Total assets	$	94,693	$	—	$	—	$	94,693
Liabilities
Series C warrant liabilities	$	—	$	—	$	9,447	$	9,447
Common B warrant liabilities		—		—		28,126		28,126
Total liabilities	$	—	$	—	$	37,573	$	37,573

Money market funds and U.S. Treasury bills were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were no changes to the valuation methods during the years ended December 31, 2024 and 2023. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between Level 1 or Level 2 during the years ended December 31, 2024 and 2023.

Warrant Liabilities

In connection with the August 2023 Series D Preferred Stock financing (see Note 11), the Company granted warrants to purchase up to 4,302,009 shares of Common B common stock equal to 70% of the shares of Series D Preferred Stock purchased by the purchaser at an exercise price of $0.02 per share and expire on the earliest to occur of (i) August 28, 2033, (ii) immediately prior to the sale of the Company or a transaction that qualifies as a Deemed Liquidation Event (as defined in the Company’s certificate of incorporation) or (iii) immediately prior to the consummation of a qualifying initial public offering or a SPAC Transaction (as defined in the Company’s certificate of incorporation). The Common B warrants have been recorded as a liability as they represent freestanding financial instruments that are not indexed to the Company’s common stock and are required to be remeasured to fair value at each reporting date. Additionally, the Common B warrants do not meet the definition of a derivative.

In connection with the February 2022 Series C Preferred Stock financing (see Note 11), the Company granted warrants to purchase up to 520,490 shares of Series C Preferred Stock at a price per share equal to $0.02 and with a term ending on the earliest to occur of (i) February 16, 2032, (ii) immediately prior to the sale of the Company or a transaction that qualifies as a Deemed Liquidation Event or (iii) immediately prior to the consummation of a qualifying initial public offering or a SPAC Transaction. As the warrants are exercisable for preferred stock that is contingently redeemable outside of the Company’s control, the warrants have been recorded as a liability and are required to be remeasured to fair value at each reporting date.

As there are significant inputs that are not observable in the market, the warrant valuations represent a Level 3 measurement within the fair value hierarchy. The Company’s valuations of the preferred stock and Common B warrants utilized the Black-Scholes option pricing model, which incorporates assumptions and estimates to value the preferred stock and Common B warrant.

The quantitative elements associated with the Company’s Level 3 inputs impacting the fair value measurement of the preferred stock and common stock warrant liabilities include the fair value per share of the underlying stock, expected volatility of the price of the underlying stock, the remaining contractual term of the warrant, risk-free interest rate, and expected dividend yield. The most significant assumption in the Black-Scholes option pricing model impacting the fair value of the preferred stock and common stock warrant

liabilities is the fair value of the Company’s Series C Preferred Stock and Class B common stock as of each remeasurement date. The Company determines the fair value per share of the underlying preferred stock by taking into consideration its most recent sales of its convertible preferred stock. Further, the Board values the Company’s Class B common stock taking into consideration the most recent sales of the Company’s preferred stock, results obtained from third-party valuations and additional factors the Company deems relevant and which may have changed since the date of the most recent valuation through the effective date of the warrant. The Company historically has been a private company and lacks company-specific historical and implied volatility information of its stock. Therefore, it estimates the expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrant. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrant. The Company has estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends.

The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of the preferred stock warrant liabilities as of December 31, 2024 and 2023:


	December 31,
	2024			2023
Fair value of Series C Preferred Stock	$	19.11		$	18.16
Strike price	$	0.02		$	0.02
Risk-free interest rate		4.39	%		4.69	%
Expected term (in years)		0.38			1.30
Expected volatility		65.00	%		78.00	%
Expected dividend yield		0	%		0	%

The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of the common stock warrant liabilities as of the date of issuance and as of December 31, 2024 and 2023:


	December 31,
	2024			2023
Fair value of Class B common stock	$	13.08		$	8.51
Strike price	$	0.02		$	0.02
Risk-free interest rate		4.53	%		3.88	%
Expected term (in years)		8.70			9.70
Expected volatility		75.77	%		74.64	%
Expected dividend yield		0	%		0	%

The Company recognizes changes in the fair value of the warrant liabilities as a component of other income (expense) in its statements of operations and comprehensive loss. The Company will continue to recognize changes in the fair value of the warrant liabilities until the warrants are exercised, expire, or qualify for equity classification.

A reconciliation of the Level 3 warrant liabilities is as follows:


	Series C Warrant Liability
	(in thousands)
Balance at December 31, 2022	$	10,497
Change in fair value		(1,050	)
Balance at December 31, 2023		9,447
Change in fair value		488
Balance at December 31, 2024	$	9,935


	Common B Warrant Liability
	(in thousands)
Balance at December 31, 2022	$	—
Issuance of Common B warrants in connection with Series D preferred stock		22,321
Common B warrant exercises		(5,203	)
Change in fair value		11,008
Balance at December 31, 2023		28,126
Change in fair value		6,837
Balance at December 31, 2024	$	34,963

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

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-Paragraph 107
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+ Details

Subsequent Event - Additional Information (Details)	Jan. 21, 2025 shares
Subsequent Event \| 2025 Equity Incentive Plan
Subsequent Event [Line Items]
Number of shares available for issuance under awards granted	12,016,744

Inventories, Net (Tables)

12 Months Ended

Dec. 31, 2024

Inventory Disclosure [Abstract]

Schedule of Inventories

Inventories consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Raw materials	$	6,737	$	803
Work in process		637		34
Finished goods		5,946		408
Inventories	$	13,320	$	1,245

Stock-Based Compensation - Summary of Stock Options Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]
Number of options outstanding, Balance	5,202,905
Number of options, Granted	935,105
Number of options, Exercised	(11,953)
Number of options, Forfeited or cancelled	(415,087)
Number of options, Expired	(43,415)
Number of options outstanding, Balance	5,667,555	5,202,905
Number of options, Vested and expected to vest at December 31, 2024	5,667,555
Number of options, Exercisable at December 31, 2024	2,887,678
Weighted-average exercise price outstanding, Balance	$ 6.3
Weighted-average exercise price , Granted	9.27
Weighted-average exercise price , Exercised	7.42
Weighted-average exercise price , Forfeited or cancelled	8.96
Weighted-average exercise price , Expired	7.58
Weighted-average exercise price outstanding, Balance	6.98	$ 6.3
Weighted-average exercise price , Vested and expected to vest at December 31, 2024	6.98
Weighted-average exercise price , Exercisable at December 31, 2024	$ 6.88
Weighted-average remaining contractual term outstanding, Balance	7 years 7 months 6 days	8 years 1 month 6 days
Weighted-average remaining contractual term, Vested and expected to vest at December 31, 2024	7 years 7 months 6 days
Weighted-average remaining contractual term, Options exercisable at December 31, 2024	6 years 7 months 6 days
Aggregate intrinsic value outstanding, Balance	$ 535
Aggregate intrinsic value outstanding, Balance	22,962	$ 535
Aggregate intrinsic value, Vested and expected to vest at December 31, 2024	22,962
Aggregate intrinsic value, Options exercisable at December 31, 2024	$ 12,174

Leases

12 Months Ended

Dec. 31, 2024

Leases [Abstract]

Leases

17.

Leases

In May and November 2023, the Company entered into two separate lease agreements for a total of approximately 8,500 square feet of office space in San Diego, California. These leases will expire in July 2025 and February 2027. The larger of the two leases has one option to extend the lease term for an additional five years. The option to extend the lease term was not included in the right-of-use asset and lease liability as it was not reasonably certain of being exercised.

In September 2024, the Company amended its lease for office space and a manufacturing facility in Irvine, California to include two renewal options. The Company is reasonably certain it will exercise one of these options, extending the lease term from May 2027 to June 2032, which has been factored into the lease liability. As the amendment only resulted in the extension of the lease term, it did not meet the criteria to be accounted for as a separate contract. Accordingly, the right-of-use asset and lease liability were remeasured as

of the effective date of the amendment, resulting in the recording of an additional right-of-use asset and lease liability of $3.8 million.

In October 2024, the Company entered into a lease agreement for an additional office suite to expand its office space in San Diego, California, which expires in March 2027. As a result, the Company recognized operating lease right-of-use asset and associated operating lease liability of $0.2 million on the balance sheets in 2024.

The components of lease expense were as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Operating lease cost–fixed	$	1,375	$	1,008
Operating lease cost–variable		209		138
Short-term lease expense		17		13
Total lease expense	$	1,601	$	1,159

Cash paid for amounts included in the measurement of operating lease liabilities was $1.3 million and $1.1 million, respectively, for the years ended December 31, 2024 and 2023.

The weighted-average remaining lease term and discount rate were as follows:


	December 31, 2024
Weighted-average remaining lease term	6.29 years
Weighted-average discount rate		6.69	%

Future lease payments under non-cancellable leases as of December 31, 2024 were as follows:


(in thousands)
Year Ending December 31,
2025	$	1,581
2026		1,532
2027		929
2028		1,050
2029 and thereafter		4,010
Total future lease payments		9,102
Less: imputed interest		(1,847	)
Total lease liabilities	$	7,255

Short-Term Investments - Summary of Estimated Fair Value of Short-term Investments (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost	$ 73,078	$ 70,042
Unrealized Gains	65	137
Estimated Fair Value	73,143	70,179
U.S. Treasury bills
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost	73,078	70,042
Unrealized Gains	65	137
Estimated Fair Value	$ 73,143	$ 70,179

- Definition

Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

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- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Income Taxes - Schedule of Changes in Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Income Tax Disclosure [Abstract]
Beginning balance	$ 1,053	$ 0
Increases related to prior year tax positions	0	854
Increases related to current year tax positions	348	199
Ending balance	$ 1,401	$ 1,053

Stock-Based Compensation - Schedule of Assumptions Used to Determine Grant-date Fair Value of Stock Options Granted (Details) - $ / shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]
Fair value of common stock	$ 13.08	$ 8.51
Risk-free interest rate	4.09%	3.06%
Expected term (in years)	6 years 7 days	5 years 4 months 20 days
Expected volatility	86.80%	75.12%
Expected dividend yield	0.00%	0.00%

Organization and Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Millions			12 Months Ended
	Jan. 31, 2025 USD ($) $ / shares shares	Jan. 21, 2025 USD ($) shares	Dec. 31, 2024 shares	Aug. 30, 2024 $ / shares	Dec. 31, 2023 shares	Dec. 31, 2022 shares
Class of Stock [Line Items]
Stockholders' Equity, Reverse Stock Split			On January 21, 2025, the Company effectuated a 1-for-1.970 reverse stock split of the Company’s issued and outstanding shares of Class A, Class B and Class C common stock, Series A convertible preferred stock (the “Series A Preferred Stock”), Series A-2 convertible preferred stock (the “Series A-2 Preferred Stock”), Series B convertible preferred stock (the “Series B Preferred Stock”), Series B-2 convertible preferred stock (the “Series B-2 Preferred Stock”), Series C convertible preferred stock (the “Series C Preferred Stock”), Series D convertible preferred stock (the “Series D Preferred Stock”), and Series E convertible preferred stock (the “Series E Preferred Stock”) , as well as stock option awards to purchase shares of Class B common stock and warrants to purchase shares of Class B common stock and Series C preferred stock.
Convertible preferred stock converted to common stock			19,827,003
Common stock, par value \| $ / shares				$ 0.0001
Preferred stock, par value \| $ / shares				$ 0.0001
Subsequent Event
Class of Stock [Line Items]
Reverse stock split		0.5076
Common Stock
Class of Stock [Line Items]
Shares outstanding			6,667,793		6,021,327	5,028,148
Initial Public Offering \| Subsequent Event
Class of Stock [Line Items]
Common stock, shares issued	13,800,000
Common stock, additional shares issued	1,800,000
Common stock shares purchased from company	475,000
Common stock shares purchased from other selling stockholders	1,325,000
Net proceeds from offering \| $	$ 190.4
Preferred stock outstanding	17,228,954
Initial Public Offering \| Common Stock \| Subsequent Event
Class of Stock [Line Items]
Sale of stock, price per share \| $ / shares	$ 17
Convertible preferred stock converted to common stock	19,827,003
Converted common stock	3,373,409
Initial Public Offering \| Common Class A, Class B and Class C \| Subsequent Event
Class of Stock [Line Items]
Shares outstanding	6,671,174
Initial Public Offering \| Series C Preferred Stock \| Subsequent Event
Class of Stock [Line Items]
Warrants to purchase common stock	3,196,025
Private Placement Offering \| Subsequent Event
Class of Stock [Line Items]
Common stock, shares issued		1,000,000
Net proceeds from offering \| $		$ 15.6

Leases - Summary of Weighted-average Remaining Lease Term and Discount Rate (Details)	Dec. 31, 2024
Leases [Abstract]
Weighted-average remaining lease term	6 years 3 months 14 days
Weighted-average discount rate	6.69%

Common Stock (Tables)

12 Months Ended

Dec. 31, 2024

Equity [Abstract]

Schedule of Exercise of Both Outstanding and Available for Grant Stock Options

Class B common stock reserved for the potential conversion of Preferred Stock into common stock, as well as the exercise of both outstanding and available for grant stock options consisted of the following:


	December 31, 2024
Convertible preferred stock		19,827,003
Common stock options granted and outstanding		5,667,555
Shares available for issuance under the 2016 Stock Incentive Plan		1,600,371
Total common stock reserved for future issuance		27,094,929

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2024

Income Tax Disclosure [Abstract]

Schedule of Effective Income Tax Rate Reconciliation

A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:


	Year Ended December 31,
	2024				2023
Federal statutory income tax rate		21.0		%		21.0		%
State income tax, net of federal benefit		1.5		%		2.2		%
Federal and state research and development tax credits		2.9		%		2.1		%
Change in fair value of warrant liabilities		(5.1	)	%		(4.8	)	%
Stock-based compensation		(2.1	)	%		(1.1	)	%
Non-deductible items		(0.4	)	%		(0.1	)	%
State rate change		(0.5	)	%		1.3		%
Uncertain tax positions		(0.6	)	%		(2.2	)	%
Other		—		%		0.4		%
Change in deferred tax asset valuation allowance		(16.7	)	%		(18.8	)	%
Effective income tax rate		0.0		%		0.0		%

Schedule of Net Deferred Tax Assets

The Company’s net deferred tax assets consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Deferred tax assets:
NOL carryforwards	$	39,470		$	35,419
Capitalized research and development expenditures		10,728			8,281
Research and development tax credit carryforwards		5,425			4,148
Stock-based compensation		2,892			2,735
Operating lease liabilities		1,687			1,007
Accruals and other temporary differences		2,429			1,256
Total deferred tax assets		62,631			52,846
Valuation allowance		(61,023	)		(51,903	)
Deferred tax assets		1,608			943

Deferred tax liabilities:
Operating lease right-of-use asset		(1,545	)		(888	)
Other		(63	)		(55	)
Total deferred tax liabilities		(1,608	)		(943	)
Net deferred tax assets	$	—		$	—

Schedule of Changes in Valuation Allowance for Deferred Tax Assets

Changes in the valuation allowance for deferred tax assets related primarily to the increase in NOL carryforwards and research and development tax credit carryforwards and were as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Valuation allowance as of beginning of year	$	51,903	$	43,632
Increases		9,120		8,271
Valuation allowance as of end of year	$	61,023	$	51,903

Schedule of Changes in Unrecognized Tax Benefits

The changes in the Company’s unrecognized tax benefits are summarized as follows:


	December 31,
	2024		2023
	(in thousands)
Beginning balance	$	1,053	$	—
Increases related to prior year tax positions		—		854
Increases related to current year tax positions		348		199
Ending balance	$	1,401	$	1,053

Common Stock

12 Months Ended

Dec. 31, 2024

Equity [Abstract]

Common Stock

12.

Common Stock

The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock set forth above.

The Company was issued a certificate of incorporation in connection with its conversion from a Massachusetts benefit corporation to a Delaware corporation. Per the certificate of incorporation, the holders of Class A common stock and Class B common stock are entitled to one vote for each share of Class A common stock and Class B common stock held. The holders of Class C common stock do not have voting rights.

Per the certificate of incorporation, the events requiring the automatic conversion of all shares of outstanding Class A common stock, Class B common stock, and Class C common stock into common stock are defined as (i) the closing of a firm-commitment underwritten public offering of common stock, (ii) the closing of a qualifying SPAC Transaction or (iii) the vote or written consent of the holders of at least a majority of the then-outstanding shares of voting common stock.

Per the certificate of incorporation, the events requiring the automatic conversion of all shares of outstanding preferred stock into Class B common stock are defined as (i) the closing of a firm-commitment underwritten public offering of common stock at a price of at least $14.60 per share (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization), resulting in at least $100.0 million of gross proceeds to the Company, (ii) the closing of a qualifying SPAC Transaction or (iii) the vote or written consent of the holders of at least a majority of the then-outstanding shares of Preferred Stock, voting together as a single class on an as-converted basis.


	December 31, 2024
Convertible preferred stock		19,827,003
Common stock options granted and outstanding		5,667,555
Shares available for issuance under the 2016 Stock Incentive Plan		1,600,371
Total common stock reserved for future issuance		27,094,929

On January 31, 2025, the Company completed its IPO and as a result, all 6,671,174 shares of Class A, Class B, and Class C Common Stock were converted into an equal number of shares of common stock. See Note 1 for further details.

Accrued Expenses and Other Current Liabilities - Schedule of Changes in Product Warranty Liability (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Product Warranties Disclosures [Abstract]
Product warranty liability at beginning of year	$ 22
Warranty expense	1,689	$ 84
Warranty fulfillment	(1,054)	(62)
Product warranty liability at end of year	$ 657	$ 22

Income Taxes

12 Months Ended

Dec. 31, 2024

Income Tax Disclosure [Abstract]

Income Taxes

15.

Income Taxes

During the years ended December 31, 2024 and 2023, the Company did not record income tax benefits for the net operating losses (“NOLs”) incurred or for the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items. The Company does not have any foreign operations and therefore has no foreign income taxes.

A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:


	Year Ended December 31,
	2024				2023
Federal statutory income tax rate		21.0		%		21.0		%
State income tax, net of federal benefit		1.5		%		2.2		%
Federal and state research and development tax credits		2.9		%		2.1		%
Change in fair value of warrant liabilities		(5.1	)	%		(4.8	)	%
Stock-based compensation		(2.1	)	%		(1.1	)	%
Non-deductible items		(0.4	)	%		(0.1	)	%
State rate change		(0.5	)	%		1.3		%
Uncertain tax positions		(0.6	)	%		(2.2	)	%
Other		—		%		0.4		%
Change in deferred tax asset valuation allowance		(16.7	)	%		(18.8	)	%
Effective income tax rate		0.0		%		0.0		%

The Company’s net deferred tax assets consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Deferred tax assets:
NOL carryforwards	$	39,470		$	35,419
Capitalized research and development expenditures		10,728			8,281
Research and development tax credit carryforwards		5,425			4,148
Stock-based compensation		2,892			2,735
Operating lease liabilities		1,687			1,007
Accruals and other temporary differences		2,429			1,256
Total deferred tax assets		62,631			52,846
Valuation allowance		(61,023	)		(51,903	)
Deferred tax assets		1,608			943

Deferred tax liabilities:
Operating lease right-of-use asset		(1,545	)		(888	)
Other		(63	)		(55	)
Total deferred tax liabilities		(1,608	)		(943	)
Net deferred tax assets	$	—		$	—

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. As of December 31, 2024, the Company had U.S. federal net operating loss carryforwards of $175.1 million, which may be available to reduce future taxable income, of which $11.5 million expire at various dates beginning in 2035 while the remaining $163.6 million do not expire but are limited in their usage to an annual deduction equal to 80% of annual taxable income. In addition, as of December 31, 2024, the Company had state net operating loss carryforwards of $42.2 million, which may be available to reduce future taxable income, of which $38.4 million expire at various dates beginning in 2029, while $3.8 million do not expire. As of December 31, 2024, the Company also had U.S. federal and state research and development tax credit carryforwards of $4.0 million and $3.4 million, respectively, which may be available to reduce future tax liabilities and expire at various dates beginning in 2036 and 2032, respectively, with $3.0 million of state research and development tax credits carrying forward indefinitely.

Utilization of the U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. In general, an ownership change, as defined by Section 382 of the Code, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382 of the Code, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382 of the Code, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before their utilization.

The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception, results of recent commercial operations, and projected future taxable income and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2024 and 2023. Management reevaluates the positive and negative evidence at each reporting period.

Changes in the valuation allowance for deferred tax assets related primarily to the increase in NOL carryforwards and research and development tax credit carryforwards and were as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Valuation allowance as of beginning of year	$	51,903	$	43,632
Increases		9,120		8,271
Valuation allowance as of end of year	$	61,023	$	51,903

As of December 31, 2024 and 2023, the Company had unrecognized tax benefits of $1.4 million and $1.1 million, respectively, none of which would affect the effective tax rate due to the existence of the valuation allowance. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2024 and 2023, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts had been recognized in the Company’s statements of operations and comprehensive loss. The Company does not anticipate a significant change in the balance of unrecognized tax benefits within the next 12 months.

The changes in the Company’s unrecognized tax benefits are summarized as follows:


	December 31,
	2024		2023
	(in thousands)
Beginning balance	$	1,053	$	—
Increases related to prior year tax positions		—		854
Increases related to current year tax positions		348		199
Ending balance	$	1,401	$	1,053

The Company files income tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. As of December 31, 2024, and 2023, there were no pending tax examinations and the Company currently is not under tax examination in any tax jurisdiction. The Company is open to future tax examination under statute by the IRS from 2021 to present and by most state tax authorities from 2020 to present. However, to the extent allowed by law, the taxing authorities may have the right to examine periods where NOLs and research and development credits were generated and carried forward, and make adjustments to the amount of the NOL and research credits carryforwards.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
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-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
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-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 12B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
-Subparagraph (SAB Topic 6.I.5.Q1)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

Revenue - Additional Information (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Disaggregation of Revenue [Line Items]
Deferred revenue		$ 0.1
Performance obligation not yet satisfied	$ 2.8	0.3
Revenue remaining performance obligation	0.9	0.1
Amount relates to deferred with unspecified software updates	$ 2.8	$ 0.3
Single-use Products \| Minimum
Disaggregation of Revenue [Line Items]
Number of days revenue replaced by end user	2 days
Single-use Products \| Maximum
Disaggregation of Revenue [Line Items]
Number of days revenue replaced by end user	3 days

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Employee Benefit Plan Additional Information (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Defined Contribution Plan Disclosure [Line Items]
Employee maximum contributions per employee, percent	100.00%
Employer matching contribution, percent of match	100.00%
Employer matching contribution, percent of employees contributions	6.00%
Defined contribution plan, contributed amount	$ 2.2	$ 1.2

Accounts Receivable, Net - Schedule of Change in Allowance for Estimated Credit Losses (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Receivables [Abstract]
Balance at beginning of year	$ 46
Provision for expected credit losses	70	$ 46
Balance at end of year	$ 116	$ 46

Leases - Schedule Components of Lease Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Lease, Cost [Abstract]
Operating lease cost - fixed	$ 1,375	$ 1,008
Operating lease cost - variable	209	138
Short-term lease expense	17	13
Total lease expense	$ 1,601	$ 1,159

Financial Instruments and Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2024

Fair Value Disclosures [Abstract]

Schedule of Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis:


	Fair Value Measurements at December 31, 2024
Assets	Level 1		Level 2		Level 3		Total
	(in thousands)
Cash equivalents:
Money market fund	$	27,107	$	—	$	—	$	27,107
Restricted cash:
Money market fund		100		—		—		100
Short-term investments
U.S. Treasury bills		73,143		—		—		73,143
Total assets	$	100,350	$	—	$	—	$	100,350
Liabilities
Series C warrant liabilities	$	—	$	—	$	9,935	$	9,935
Common B warrant liabilities		—		—		34,963		34,963
Total liabilities	$	—	$	—	$	44,898	$	44,898


	Fair Value Measurements at December 31, 2023
Assets	Level 1		Level 2		Level 3		Total
	(in thousands)
Cash equivalents:
Money market fund	$	24,414	$	—	$	—	$	24,414
Restricted cash:
Money market fund		100		—		—		100
Short-term investments
U.S. Treasury bills		70,179		—		—		70,179
Total assets	$	94,693	$	—	$	—	$	94,693
Liabilities
Series C warrant liabilities	$	—	$	—	$	9,447	$	9,447
Common B warrant liabilities		—		—		28,126		28,126
Total liabilities	$	—	$	—	$	37,573	$	37,573

Schedule of Assumptions used in Fair Value of Warrant Liabilities

The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of the preferred stock warrant liabilities as of December 31, 2024 and 2023:


	December 31,
	2024			2023
Fair value of Series C Preferred Stock	$	19.11		$	18.16
Strike price	$	0.02		$	0.02
Risk-free interest rate		4.39	%		4.69	%
Expected term (in years)		0.38			1.30
Expected volatility		65.00	%		78.00	%
Expected dividend yield		0	%		0	%


	December 31,
	2024			2023
Fair value of Class B common stock	$	13.08		$	8.51
Strike price	$	0.02		$	0.02
Risk-free interest rate		4.53	%		3.88	%
Expected term (in years)		8.70			9.70
Expected volatility		75.77	%		74.64	%
Expected dividend yield		0	%		0	%

Summary of Reconciliation of Level 3 Warrant Liabilities

A reconciliation of the Level 3 warrant liabilities is as follows:


	Series C Warrant Liability
	(in thousands)
Balance at December 31, 2022	$	10,497
Change in fair value		(1,050	)
Balance at December 31, 2023		9,447
Change in fair value		488
Balance at December 31, 2024	$	9,935


	Common B Warrant Liability
	(in thousands)
Balance at December 31, 2022	$	—
Issuance of Common B warrants in connection with Series D preferred stock		22,321
Common B warrant exercises		(5,203	)
Change in fair value		11,008
Balance at December 31, 2023		28,126
Change in fair value		6,837
Balance at December 31, 2024	$	34,963

Revenue - Summary of Disaggregated Revenues (Details) - USD ($)
$ in Thousands

12 Months Ended

Dec. 31, 2024

Dec. 31, 2023

Disaggregation of Revenue [Line Items]

Net sales

$ 65,124

$ 11,995

DME Channel

Disaggregation of Revenue [Line Items]

Net sales

58,806

11,260

PBP Channel

Disaggregation of Revenue [Line Items]

Net sales

6,318

735

iLet | DME Channel

Disaggregation of Revenue [Line Items]

Net sales

^[1]

46,617

10,169

iLet | PBP Channel

Disaggregation of Revenue [Line Items]

Net sales

^[1]

2,099

535

Single-use Products | DME Channel

Disaggregation of Revenue [Line Items]

Net sales

12,189

1,091

Single-use Products | PBP Channel

Disaggregation of Revenue [Line Items]

Net sales

$ 4,219

$ 200

[1]	iLet includes the over-time recognition software updates and mobile app access.

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-41

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Name Accounting Standards Codification
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-Paragraph 32
-Subparagraph (ee)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 4: http://fasb.org/us-gaap/role/ref/otherTransitionRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 4
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-4

+ Details

Common Stock - Additional Information (Details) - USD ($)		12 Months Ended
	Jan. 31, 2025	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Common Stock
Class of Stock [Line Items]
Shares outstanding		6,667,793	6,021,327	5,028,148
IPO \| Subsequent Event
Class of Stock [Line Items]
Net proceeds from offering	$ 190,400,000
IPO \| Common Stock \| Subsequent Event
Class of Stock [Line Items]
Sale of stock, price per share	$ 17
Underwritten Public Offering \| Minimum
Class of Stock [Line Items]
Net proceeds from offering		$ 100,000,000
Underwritten Public Offering \| Minimum \| Common Stock
Class of Stock [Line Items]
Sale of stock, price per share		$ 14.6
Common Class A, Class B and Class C \| IPO \| Subsequent Event
Class of Stock [Line Items]
Shares outstanding	6,671,174

Significant Accounting Policies

12 Months Ended

Dec. 31, 2024

Accounting Policies [Abstract]

Significant Accounting Policies

Use of Estimates

The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, certain judgements regarding revenue recognition, inventory valuation, valuation of common stock and stock-based awards, and convertible preferred stock and common stock warrants. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.

Concentrations of Credit Risk and of Significant Suppliers

Financial instruments that potentially expose the Company to concentrations of credit risk primarily consist of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in accounts at multiple accredited financial institutions and short-term investments in custodian accounts, in excess of federally insured limits. Additionally, the Company has established guidelines regarding investment instruments and their maturities, which are designed to maintain preservation of principal and liquidity. The Company does not believe that it is subject to unusual risk beyond the normal credit risk associated with commercial banking relationships.

The Company is exposed to concentration risk as it relates to its customers. The following table summarizes the percentages of total sales and accounts receivable, net for customers who accounted for 10% or more of the respective amounts for the periods presented:


	Net Sales						Accounts Receivable, net
	Year Ended December 31,						December 31,
	2024			2023			2024			2023
Distributor A		12.8	%		20.6	%		13.7	%		28.9	%
Distributor B		18.3	%		19.0	%		13.3	%		24.5	%
Distributor C		11.6	%		16.3	%		10.6	%		12.3	%
Distributor D		16.3	%		14.2	%		13.0	%	*
Distributor E	*			*				14.8	%	*

* Amount related to the respective customer represented less than 10% for the period presented.

The Company relies on certain materials used in its development and manufacturing processes, some of which are procured from only one or a few sources. The failure of one of these suppliers to deliver on schedule could delay or interrupt the manufacturing or commercialization process and would adversely affect the Company’s operating results. In addition, a disruption in the commercial supply of, or a significant increase in the cost of one of the Company’s materials from these sources could have a material adverse effect on the Company’s business, financial position and results of operations.

Cash and Cash Equivalents

Cash and cash equivalents consist of cash and all highly liquid investments purchased with original maturities of three months or less.

Short-Term Investments

In accordance with ASC 320, Investments – Debt Securities, the Company classifies its short-term investments as available-for-sale securities. Available-for-sale securities are carried at fair market value with net unrealized gains and losses reported as a component of accumulated other comprehensive income in stockholders’ deficit and as a component of other comprehensive loss within the statements of operations and comprehensive loss. The Company determines realized gains or losses on the sale of available-for-sale securities using the specific identification method and includes net realized gains and losses as a component of other income or expense within the statements of operations and comprehensive loss. The Company periodically evaluates its short-term investments for credit losses, considering the significance of the decline in value and the market and economy in general. The Company has not recognized any impairment losses related to its short-term investments during the years ended December 31, 2024 and 2023. All short-term investments are classified as current based on the nature of the investments and their availability for use in current operations.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable consist of amounts billed and currently due from customers. The Company maintains an allowance for its current estimate of expected credit losses and reassesses quarterly based on management’s expectations of the asset’s collectability. Provisions for expected credit losses are based upon specific reserves for known collection issues, as well as a general reserve. Determining the allowance for credit losses involves estimation and is subject to uncertainty. The Company’s allowance for credit losses is developed by using relevant available information including historical collection and loss experience, current economic conditions, and evaluations of customer balances. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible.

Inventories

Inventories are valued at the lower of cost or net realizable value, determined by the first-in, first-out method. Capitalized inventory costs include raw materials, labor, and manufacturing overhead expenses associated with the production process. The Company periodically reviews inventories for potential impairment and adjusts inventory for potentially excess or obsolete goods to state inventories at their net realizable value. Factors influencing these adjustments include quantities on hand and firm purchase commitments, expectations of future use, judgments based on quality control testing data, and assessments of the likelihood of scrapping or obsoleting certain inventories based on future demand for its products and market conditions.

In addition, prior to receiving FDA clearance for the iLet in May 2023, the costs associated with the manufacture of the iLet inventory were expensed as incurred as research and development costs. This resulted in approximately $0.4 million and $1.9 million in inventory being sold during the years ended December 31, 2024 and 2023, respectively, for which the associated costs had been previously expensed as research and development costs. As of December 31, 2024, the Company has no remaining inventory with no cost basis (that was previously expensed).

Restricted Cash

In connection with the Company’s lease agreement entered into in May 2019, the Company is required to maintain a letter of credit of $0.1 million for the benefit of the landlord. As of December 31, 2024 and 2023, this amount was guaranteed by a deposit in a money market fund and classified as restricted cash on the balance sheets.

Deferred Offering Costs

The Company capitalizes as deferred offering costs all direct and incremental legal, professional, accounting and other third-party fees incurred in connection with the Company’s IPO. As of December 31,

2024, the Company had $5.1 million in deferred offering costs, of which $0.9 million were in accrued expenses. The deferred offering costs were offset against the IPO proceeds upon the closing the IPO in January 2025 (see Note 1). As of December 31, 2023, the Company did not have a balance in deferred offering costs.

Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. The Company performs fair value measurements in accordance with ASC 820, Fair Value Measurement. ASC 820 defines fair value as the price received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at their fair values, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the assets or liabilities, such as inherent risk, transfer restrictions and risk of nonperformance. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:


	Level 1 —	Quoted prices in active markets for identical assets or liabilities.

	Level 2 —	Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

	Level 3 —	Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques.

The Company’s cash equivalents, short-term investments and restricted cash are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying value and estimated fair value of certain of the Company’s common stock and preferred stock warrants were determined using the Black-Scholes pricing model as of December 31, 2024 (see Note 4). The fair values of the Company’s accounts receivables, accounts payable and accrued expenses approximate their carrying values due to the short-term nature of these assets and liabilities.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is calculated using the straight-line method over the estimated useful life of the related assets, generally two to five years. Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or the remaining lease term. Repairs and maintenance costs are charged to expense as incurred.

Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Upon retirement or sale, the cost of assets disposed of, and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance that do not improve or extend the life of the respective asset are charged to expense as incurred.

Impairment of Long-lived Assets

Long-lived assets consist of property and equipment. The Company continually evaluates long-lived assets to be held and used for potential impairment whenever events or changes in circumstances indicate the carrying value of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to

expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. The Company did not recognize any impairment losses during the years ended December 31, 2024 or 2023.

Leases

In accordance with ASC 842, Leases, leases include all agreements in which the Company obtains control of an identified asset. A lease liability is recognized at commencement date based on the present value of the lease payments over the lease term. When available, the Company uses the rate implicit in the lease to discount lease payments to present value; otherwise, the Company estimates the incremental borrowing rate to discount the lease payments based on information available at lease commencement (see Note 17).

The Company’s leases have initial lease terms of approximately one to seven years, with some including options to extend for up to five additional years. If a lease includes options to extend the lease term, the Company only includes the periods it is reasonably certain to exercise as of the lease commencement date. The decision to exercise of lease renewal options is at the Company’s sole discretion. Variable lease costs, including maintenance and utilities, real estate taxes, and insurance are expensed as incurred and excluded from the measurement of the lease liability. Lease agreements that include lease and non-lease components are accounted for as a single lease component. Leases with an initial term of 12 months or less are expensed and not recorded on the balance sheet. The Company’s leases provide for fixed rental payments with annual rent escalations. The Company does not have any leases that are classified as financing leases.

Classification and Accretion of Convertible Preferred Stock

The Company’s convertible preferred stock is classified outside of stockholders’ deficit on the balance sheets because the holders of such shares have liquidation rights in the event of a deemed liquidation that, in certain situations, is not solely within the control of the Company and would require the redemption of the then-outstanding convertible preferred stock. The Company’s Series A Preferred Stock, the Series A-2 Preferred Stock, the Series B Preferred Stock, the Series B-2 Preferred Stock, the Series C Preferred Stock, the Series D Preferred Stock and the Series E Preferred Stock are not redeemable, except in the event of a deemed liquidation (see Note 11). Since convertible preferred stock is neither currently redeemable, nor probable of becoming redeemable, the carrying values of the convertible preferred stock are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the convertible preferred stock would be made only when and if it either becomes currently redeemable or probable of becoming redeemable.

The issuance costs from equity financings are netted against the gross proceeds received from the equity financings.

Warrant Liabilities

Preferred Stock Warrants

The Company has classified warrants to purchase its Series C Preferred Stock as a liability on the balance sheets as these warrants are freestanding financial instruments that are exercisable for preferred stock that is contingently redeemable outside of the Company’s control (see Note 4).

Common Stock Warrants

The Company has classified warrants to purchase Class B common stock issued in connection with its Series D Preferred Stock financing as a liability on the balance sheets as these warrants are freestanding financial instruments that are not indexed to the Company’s common stock (see Note 4).

Contingencies

In the normal course of business, the Company is subject to loss contingencies, such as legal proceedings and claims arising out of its business, that cover a wide range of matters. The Company records accruals for those loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company does not recognize gain contingencies until realized. As of December 31, 2024 and 2023, no liabilities were recorded for loss contingencies (see Note 18).

Segment Information

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information presented on a total company basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. As such, the Company has determined that it operates as one operating segment. The measure of segment assets is presented as total assets in the balance sheets. The Company has concluded that gross profit and net income (loss) are the primary measures of segment profit or loss used by the CODM. The CODM assesses performance for the Company, monitors budget versus actual results, and determines how to allocate resources based on net income (loss) as reported in the statements of operations and comprehensive loss. There are no other expense categories regularly provided to the CODM that are not already included in the primary financial statements herein. During the years ended December 31, 2024 and 2023, the Company did not generate any international revenues and as of December 31, 2024 and 2023, the Company did not have any assets located outside of the United States.

Revenue Recognition

Net Sales

Revenue is generated primarily from sales of the iLet and its associated single-use products, such as cartridges for insulin storage and delivery, and infusion sets that connect the iLet to a user’s body. These products are distributed through a network of distributors and pharmacies, which then resell the products to insulin-requiring PWD. In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognizes revenue when it transfers control of the promised goods or services to its distributor and pharmacy customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services, net of estimated returns and estimated variable consideration adjustments, including rebates, patient assistance and chargebacks.

Revenue Recognition for Arrangements with Multiple Performance Obligations

The Company considers the individual deliverables in its contracts with customers as separate performance obligations. The iLet and single-use products that are used together with the iLet are deemed performance obligations that are satisfied at a point in time when the customer obtains control of the promised good, which typically is upon shipment. The Company has determined that the user’s ability to access the mobile application and receive unspecified software updates through the mobile application are considered distinct performance obligations that are satisfied over time, as access and support are provided throughout the typical four-year warranty period of the iLet. Accordingly, revenue related to access the mobile application and unspecified software updates are deferred and recognized ratably over a four-year period. Given that access to the mobile application and unspecified software updates follow the same pattern of transfer to the customer and are provided over the same four-year period, the Company recognizes revenue for these performance obligations as if they were a single performance obligation.

The transaction price is determined based on the consideration expected to be received, based on the stated value in contractual arrangements. The Company allocates the consideration to the individual performance obligations based on the estimated relative standalone selling price of the performance obligations

and recognizes the consideration based on when the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. Where there is no observable standalone selling price, the Company estimates standalone selling price by applying the expected cost plus a margin approach.

Variable Consideration

The amount of variable consideration that is included in the transaction price is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The Company estimates reductions to revenues for rebates paid to pharmacy benefit managers (“PBM”). Rebates are based on contractual arrangements, which may vary by customer. The estimates are based on products sold, historical experience, trends, specific known market events and, as available, channel inventory data. Provisions for rebates and patient assistance are accounted for as a reduction of sales when revenue is recognized and are included within accrued expenses and other current liabilities within the balance sheets. Provisions for chargebacks are accounted for as a reduction of sales when revenue is recognized and are included as a reduction of accounts receivable, net within the balance sheets, as the right of offset exists. If the actual amounts of consideration that the Company receives differ from estimates, the Company adjusts these estimates, which affects reported revenue, in the period that such variances become known or at the end of each reporting period.

Sales Returns

The Company offers a 90-day right of return from the date of shipment of its iLet from one of its authorized distributors, provided a physician’s confirmation of the good faith medical reason for the return is received. Estimated allowances for sales returns are based on historical returned quantities as compared to iLet shipments in those same periods of return, adjusted for known or expected changes in the marketplace when appropriate. Actual product returns have not differed materially from estimated amounts recorded in the accompanying financial statements.

Contract Costs

The Company recognizes an asset for incremental costs of obtaining a contract with a customer if it expects to recover those costs. The Company has elected the practical expedient to expense the costs as they are incurred, within sales and marketing expenses, since the amortization period is less than one year.

Product Warranty

The Company provides a four-year warranty on the iLet to end-users to replace any iLets that do not function as intended in accordance with the product specifications. Estimated warranty costs are recorded at the time of shipment. Warranty costs are estimated primarily based on the current expected product replacement cost and expected replacement rates utilizing management’s understanding of the hardware. Although the Company’s history of product sales is limited, management also utilizes historical warranty cost data to reevaluate the estimated warranty obligation on a regular basis. Product returns and warranty replacements to date have been consistent with amounts accrued. Warranty expense is recorded as a component of cost of sales in the statements of operations and comprehensive loss.

Shipping and Handling Costs

Shipping and handling costs associated with product delivery are included within cost of sales in the Company’s statements of operations and comprehensive loss. The Company does not generally separately charge customers for shipping and handling costs, but any amounts billed to a customer for shipping and handling are reported as revenues.

Research and Development Costs

All research and development costs are expensed as incurred in accordance with ASC 730, Research and Development, which primarily consist of salaries and benefits associated with research and development personnel, overhead and occupancy costs, contract services costs and license costs for technology used in research and development without alternative future uses.

Patent Costs

Costs related to filing and pursuing patent applications are recorded as general and administrative expenses in the statements of operations and comprehensive loss and expensed as incurred as recoverability of such expenditures is uncertain.

Stock-Based Compensation

The cost of a stock-based award is measured at the grant date based on the estimated fair value of the award, and is recognized as expense on a straight-line basis over the requisite service period of the award. Forfeitures of awards are recognized as they occur. The fair value of stock options is estimated using the Black- Scholes option pricing model, which requires the input of subjective assumptions, including the fair value of the underlying Class B common stock, expected volatility, expected term, risk-free interest rate, and expected dividend yield. As the Company’s stock has never been publicly traded, the expected volatility was derived from the average historical volatilities of several comparable public companies within the Company’s industry over a period equivalent to the expected term of the stock-based awards. Due to the lack of historical exercise history, the expected term of the Company’s stock options is determined using the “simplified” method. The risk-free interest rate is rate is based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to expected term of the stock options. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The fair value of Class B common stock underlying the Company’s stock options was estimated by the Board, which considered, among other things, valuations of the Company’s common stock.

Compensation expense for non-employee awards is recognized in the same manner as if the Company had paid cash in exchange for the goods or services, which is generally the vesting period of the respective award.

The Company classifies stock-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

Comprehensive Income (Loss)

Comprehensive loss includes net loss as well as other changes in stockholders’ deficit that result from transactions and economic events other than those with stockholders, including unrealized gains and losses on marketable securities. For the year ended December 31, 2024 and 2023, the unrealized gain (loss) on short-term investments, approximately $(0.1) million and $0.1 million, respectively, was recorded in other comprehensive income (loss).

Net Loss Per Share

The holders of Class A common stock, Class B common stock and Class C common stock participate in earnings and losses equally on a per share basis, as if all shares of common stock were of a single class. Therefore, undistributed earnings and losses are allocated on a proportionate basis and the resulting loss per

share will be the same for Class A common stock, Class B common stock, and Class C common stock on an individual or combined basis.

The Company’s liability classified warrants to purchase Series C preferred stock and Class B common stock are exercisable to the holder at an exercise price of $0.02. The Company does not consider the exercise price of these warrants to be for a nominal amount of consideration as in addition to the exercise price received from the holder, the consideration received as a result of the exercise of a warrant also includes the value of the extinguishment of the associated warrant liabilities. Therefore, the Company does not consider the warrants to be contingently issuable shares and does not include the warrants in the calculation of weighted-average common shares outstanding in the computation of basic loss per share.

The Company’s convertible preferred stock contractually entitles the holders of such shares to participate in any dividends declared. Therefore, convertible preferred shares are considered to be participating securities. The Company’s warrants to purchase shares of Series C Preferred Stock and Class B common stock contractually require the Board to provide advanced notice to warrant holders in the event that a dividend will be declared. As a result, warrant holders would be economically compelled to exercise their warrants prior to the declaration of the dividend. Therefore, the warrants are considered to be participating securities. During periods in which the Company reports net income, the Company allocates a proportional share of net income to participating securities determined by dividing the total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods where the Company reports a net loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in losses.

Income Taxes

The Company recognizes deferred tax assets and liabilities for temporary differences between the financial statements and tax basis of assets and liabilities. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income. To the extent the Company believes that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made.

The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.

Recently Adopted Accounting Pronouncements

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40), which simplifies the accounting for convertible instruments and equity-linked financial instruments in addition to amending the EPS guidance in ASC 260 to improve the consistency of the diluted EPS calculation. The standard addresses issues identified as a result of the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. The standard eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The standard is effective for public companies, excluding entities eligible to be smaller reporting companies, for fiscal years beginning after December 15, 2021, including interim periods

within those fiscal years. For all other entities, the standard is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company adopted ASU 2020-06 on January 1, 2024, using the modified retrospective method for its convertible preferred instruments. Consequently, prior period comparatives have not been restated to align with the current period presentation. The cumulative effect of the adoption of ASU 2020-06 resulted in an adjustment to accumulated deficit as of January 1, 2024 of $12.3 million with a corresponding adjustment to additional paid in capital. In the period of adoption there was no impact in the net loss per share.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU No. 2023-07”). ASU 2023-07 requires that an entity disclose significant segment expenses, a description of “other segment items,” and the title and position of the chief operating decision maker along with an explanation of how the reported segment profit or loss is assessed and allocated. The amendments in this ASU will be applied retrospectively for all prior periods presented in the financial statements. The Company adopted ASU 2023-07 during the year ended December 31, 2024 and the adoption of this guidance did not have a material impact on the Company’s financial statements.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in this ASU address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The amendments in the ASU are effective for fiscal years beginning after December 15, 2024, on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact that this guidance may have on its financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), and in January 2025, the FASB issued ASU 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date ("ASU 2025-01"). ASU 2024-03 requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03, as clarified by ASU 2025-01, is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that this guidance may have on its financial statements.

Leases - Schedule of Future Lease Payments (Details) $ in Thousands	Dec. 31, 2024 USD ($)
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2025	$ 1,581
2026	1,532
2027	929
2028	1,050
2029 and thereafter	4,010
Total future lease payments	9,102
Less: imputed interest	(1,847)
Total lease liabilities	$ 7,255

Financial Instruments and Fair Value Measurements - Schedule of Assumptions used in Fair Value of Warrant Liabilities (Details)	Dec. 31, 2024 $ / shares	Dec. 31, 2023 $ / shares
Series C Preferred Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding, Fair value	$ 19.11	$ 18.16
Warrants and rights outstanding,term	4 months 17 days	1 year 3 months 18 days
Class B Common Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding, Fair value	$ 13.08	$ 8.51
Warrants and rights outstanding,term	8 years 8 months 12 days	9 years 8 months 12 days
Strike Price \| Series C Preferred Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.02	0.02
Strike Price \| Class B Common Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.02	0.02
Risk-Free Interest Rate \| Series C Preferred Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.0439	0.0469
Risk-Free Interest Rate \| Class B Common Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.0453	0.0388
Expected Volatility \| Series C Preferred Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.65	0.78
Expected Volatility \| Class B Common Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0.7577	0.7464
Expected Dividend Yield
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0
Expected Dividend Yield \| Series C Preferred Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0	0
Expected Dividend Yield \| Class B Common Stock
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrants and rights outstanding measurement input	0	0

Income Taxes - Schedule of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Deferred tax assets:
NOL carryforwards	$ 39,470	$ 35,419
Capitalized research and development expenditures	10,728	8,281
Research and development tax credit carryforwards	5,425	4,148
Stock-based compensation	2,892	2,735
Operating lease liabilities	1,687	1,007
Accruals and other temporary differences	2,429	1,256
Total deferred tax assets	62,631	52,846
Valuation allowance	(61,023)	(51,903)
Deferred tax assets	1,608	943
Deferred tax liabilities:
Operating lease right-of-use asset	(1,545)	(888)
Other	(63)	(55)
Total deferred tax liabilities	(1,608)	(943)
Net deferred tax assets	$ 0	$ 0

STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands	Total	Convertible Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Additional Paid-in Capital [Member] Adoption of ASU 2020-06	Accumulated Other Comprehensive Income [Member]	Accumulated Deficit [Member]	Accumulated Deficit [Member] Adoption of ASU 2020-06
Convertible Preferred Stock, beginning balance at Dec. 31, 2022		$ 183,034
Convertible Preferred Stock, beginning balance (in shares) at Dec. 31, 2022		6,730,821
Beginning balance at Dec. 31, 2022	$ (170,034)		$ 1	$ 15,530			$ (185,565)
Beginning balance (in shares) at Dec. 31, 2022			5,028,148
Issuance of preferred stock, net of issuance costs and warrant liabilities		$ 78,679
Issuance of preferred stock, net of issuance costs and warrant liabilities (in shares)		6,145,740
Common B warrant exercises	5,223			5,223
Common B warrant exercises (in shares)			991,957
Stock option exercises	10			10
Stock option exercises (in shares)			1,222
Stock-based compensation expense	5,658			5,658
Unrealized gain (loss) on short-term investments	137					$ 137
Net Income (Loss)	(44,099)						(44,099)
Convertible Preferred Stock, ending balance at Dec. 31, 2023	$ 261,713	$ 261,713
Convertible Preferred Stock, ending balance (in shares) at Dec. 31, 2023	12,876,561	12,876,561
Ending balance at Dec. 31, 2023	$ (203,105)		$ 1	26,421	$ 12,317	137	(229,664)	$ (12,317)
Ending balance (in shares) at Dec. 31, 2023			6,021,327
Accounting Standards Update [Extensible Enumeration]	ASU 2020-06
Issuance of preferred stock, net of issuance costs and warrant liabilities		$ 59,660
Issuance of preferred stock, net of issuance costs and warrant liabilities (in shares)		4,352,393
Common B warrant exercises	$ 6,100			6,100
Common B warrant exercises (in shares)			634,513
Stock option exercises	$ 89			89
Stock option exercises (in shares)	11,953		11,953
Stock-based compensation expense	$ 6,384			6,384
Unrealized gain (loss) on short-term investments	(72)					(72)
Net Income (Loss)	(54,756)						(54,756)
Convertible Preferred Stock, ending balance at Dec. 31, 2024	$ 321,373	$ 321,373
Convertible Preferred Stock, ending balance (in shares) at Dec. 31, 2024	17,228,954	17,228,954
Ending balance at Dec. 31, 2024	$ (245,360)		$ 1	$ 51,311		$ 65	$ (296,737)
Ending balance (in shares) at Dec. 31, 2024			6,667,793

Significant Accounting Policies - Additional Information (Details) - USD ($)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Jan. 01, 2024
Significant Accounting Policies [Line Items]
Impairment losses related to short term investments	$ 0	$ 0
Inventory sold	400,000	1,900,000
Remaining inventory with no cost basis	0
Letter of credit	100,000
Deferred offering costs	5,100,000	0
Impairment losses related to long lived assets	$ 0	0
Operating leases, option to extend	true
Loss contingencies liabilities	$ 0	0
Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration]	srt:ChiefExecutiveOfficerMember
Segment Reporting, Expense Information Used by CODM, Description	The Company has concluded that gross profit and net income (loss) are the primary measures of segment profit or loss used by the CODM. The CODM assesses performance for the Company, monitors budget versus actual results, and determines how to allocate resources based on net income (loss) as reported in the statements of operations and comprehensive loss. There are no other expense categories regularly provided to the CODM that are not already included in the primary financial statements herein.
Assets	$ 149,645,000	$ 110,040,000
Right of return duration	90 days
Expected dividend yield	0.00%	0.00%
Product warranty term	4 years
Unrealized gain (loss) on short-term investments	$ (100,000)	$ 100,000
Income Tax Examination, Likelihood of Unfavorable Settlement	The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement.
Accounting Standards Update [Extensible Enumeration]	ASU 2020-06
Minimum
Significant Accounting Policies [Line Items]
Property and equipment useful life	2 years
Lease initial term	1 year
Maximum
Significant Accounting Policies [Line Items]
Property and equipment useful life	5 years
Lease initial term	7 years
Option to extend additional period	5 years
Class B Common Stock
Significant Accounting Policies [Line Items]
Warrants exercise price	$ 0.02
Series C Preferred Stock
Significant Accounting Policies [Line Items]
Warrants exercise price	$ 0.02
International
Significant Accounting Policies [Line Items]
Revenues	$ 0	0
Assets	0	$ 0
Accrued expenses
Significant Accounting Policies [Line Items]
Deferred offering costs	$ 900,000
ASU 2020-06
Significant Accounting Policies [Line Items]
Change in Accounting Principle, Accounting Standards Update, Adopted [true false]	true
Change in Accounting Principle, Accounting Standards Update, Adoption Date	Jan. 01, 2024
Accounting Standards Update [Extensible Enumeration]	us-gaap:AccountingStandardsUpdate202006RetrospectiveMember
Adjustment to accumulated retained earnings (deficit)			$ 12,300,000
ASU 2023-07
Significant Accounting Policies [Line Items]
Change in Accounting Principle, Accounting Standards Update, Adopted [true false]	true
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false]	true
Change in Accounting Principle, Accounting Standards Update, Adoption Date	Dec. 31, 2024

Accrued Expenses and Other Current Liabilities (Tables)

12 Months Ended

Dec. 31, 2024

Payables and Accruals [Abstract]

Summary of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Accrued employee compensation and benefits	$	9,942	$	5,475
Accrued professional fees		2,119		963
Accrued sales returns, rebates and patient assistance		1,502		592
Accrued inventory in transit		530		342
Accrued royalties		741		294
Other current liabilities		994		462
Accrued expenses and other current liabilities	$	15,828	$	8,128

Schedule of Changes in Product Warranty Liability

Reconciliations of the changes in the Company’s product warranty liability, which is included in other current liabilities, were as follows:


	Year Ended December 31,
	2024			2023
	(in thousands)
Product warranty liability at beginning of year	$	22		$	—
Warranty expense		1,689			84
Warranty fulfillment		(1,054	)		(62	)
Product warranty liability at end of year	$	657		$	22

Financial Instruments and Fair Value Measurements - Schedule of Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	$ 100,350	$ 94,693
Total liabilities	44,898	37,573
Series C Warrant Liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total liabilities	9,935	9,447
Common B Warrant Liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total liabilities	34,963	28,126
Short-Term Investments \| U.S. Treasury bills
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	73,143	70,179
Cash Equivalent \| Money Market Funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	27,107	24,414
Restricted Cash \| Money Market Funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	100	100
Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	100,350	94,693
Level 1 \| Short-Term Investments \| U.S. Treasury bills
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	73,143	70,179
Level 1 \| Cash Equivalent \| Money Market Funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	27,107	24,414
Level 1 \| Restricted Cash \| Money Market Funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total assets	100	100
Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total liabilities	44,898	37,573
Level 3 \| Series C Warrant Liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total liabilities	9,935	9,447
Level 3 \| Common B Warrant Liabilities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Total liabilities	$ 34,963	$ 28,126

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Prepaid Expense and Other Assets, Current [Abstract]
Prepaid expenses	$ 2,982	$ 908
Other current assets	1,050	275
Prepaid expenses and other current assets	$ 4,032	$ 1,183

Income Taxes - Additional Information (Details) - USD ($)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Operating Loss Carryforwards [Line Items]
Percentage of annual deduction taxable income	80.00%
Deferred tax assets tax credit carryforwards percentage	50.00%
Unrecognized tax benefits	$ 1,401,000	$ 1,053,000	$ 0
Unrecognized tax benefits that would impact effective tax rate	0	0
Accrued interest or penalties	0	0
Net Operating Losses Carryforwards and Research and Development Tax Credit Carryforwards
Operating Loss Carryforwards [Line Items]
Income tax benefits	0	$ 0
U.S. Federal
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	175,100,000
Operating loss carryforwards expire amount	11,500,000
Operating loss carryforwards remaining amount	$ 163,600,000
Operating loss carryforwards expiration year	2035
Tax credit carryforwards expiration year	2036
U.S. Federal \| Research and Development Tax Credit Carryforwards
Operating Loss Carryforwards [Line Items]
Tax credit carryforward amount	$ 4,000,000
State
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	42,200,000
Operating loss carryforwards expire amount	38,400,000
Operating loss carryforwards remaining amount	$ 3,800,000
Operating loss carryforwards expiration year	2029
Tax credit carryforwards expiration year	2032
State \| Research and Development Tax Credit Carryforwards
Operating Loss Carryforwards [Line Items]
Tax credit carryforward amount	$ 3,400,000
Tax credit carryforward, amount indefinitely	$ 3,000,000

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2024

Prepaid Expense and Other Assets, Current [Abstract]

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Prepaid expenses	$	2,982	$	908
Other current assets		1,050		275
Prepaid expenses and other current assets	$	4,032	$	1,183

Stock-Based Compensation - Summary of Non-Vested Stock Options (Details)	Dec. 31, 2024 $ / shares shares
Share-Based Payment Arrangement [Abstract]
Number of options, Non-vested options, December 31, 2023 \| shares	3,124,193
Number of options, Non-vested options, December 31, 2024 \| shares	2,779,877
Weighted- average exercise price, Non-vested options, December 31, 2023 \| $ / shares	$ 6.06
Weighted- average exercise price, Non-vested options, December 31, 2024 \| $ / shares	$ 7.07

STATEMENTS OF BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 30,432	$ 26,566
Short-term investments	73,143	70,179
Accounts receivable, net	11,996	4,448
Inventories, net	13,320	1,245
Prepaid expenses and other current assets	4,032	1,183
Total current assets	132,923	103,621
Property and equipment, net	4,776	2,476
Operating lease right-of-use asset	6,645	3,722
Restricted cash	100	100
Deferred offering costs	5,051
Other long-term assets	150	121
Total assets	149,645	110,040
Current liabilities:
Accounts payable	2,852	1,166
Accrued expenses and other current liabilities	15,828	8,128
Operating lease liabilities	1,529	1,224
Deferred revenue	939	87
Total current liabilities	21,148	10,605
Operating lease liabilities, net of current portion	5,726	2,999
Deferred revenue, net of current portion	1,860	255
Warrant liabilities	44,898	37,573
Total liabilities	73,632	51,432
Commitments and contingencies (Note 18)
Convertible preferred stock (Series A, A-2, B, B-2, C, D and E), par value of $0.0001 per share; 34,966,547 and 26,434,390 shares authorized at December 31, 2024 and 2023, respectively; 17,228,954 and 12,876,561 shares issued and outstanding at December 31, 2024 and 2023, respectively; liquidation preference of $355,162 and $295,162 at December 31, 2024 and 2023, respectively	321,373	261,713
Stockholders' deficit:
Additional paid-in capital	51,311	26,421
Accumulated other comprehensive income	65	137
Accumulated deficit	(296,737)	(229,664)
Total stockholders' deficit	(245,360)	(203,105)
Total liabilities, convertible preferred stock and stockholders' deficit	149,645	110,040
Class A Common Stock
Stockholders' deficit:
Common stock	1	1
Class B Common Stock
Stockholders' deficit:
Common stock
Class C Common Stock
Stockholders' deficit:
Common stock

Income Taxes - Schedule of Changes in Valuation Allowance for Deferred Tax Assets (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Valuation Allowance [Line Items]
Valuation allowance as of beginning of year	$ 51,903
Valuation allowance as of end of year	61,023	$ 51,903
Net Operating Losses Carryforwards and Research and Development Tax Credit Carryforwards
Valuation Allowance [Line Items]
Valuation allowance as of beginning of year	51,903	43,632
Increase	9,120	8,271
Valuation allowance as of end of year	$ 61,023	$ 51,903

Net Loss Per Share - Summary of potential dilutive securities, not included in the calculation of diluted net loss per share (Details) - shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive net loss per share	28,867,967	24,685,439
Convertible Preferred Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive net loss per share	19,827,003	15,474,597
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive net loss per share	5,667,555	5,202,905
Warrants to purchase Series C convertible preferred stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive net loss per share	697,874	697,885
Warrants to purchase Class B common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive net loss per share	2,675,535	3,310,052

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Income Statement [Abstract]
Net sales	$ 65,124	$ 11,995
Cost of sales	29,236	5,687
Gross profit	35,888	6,308
Operating expenses:
Research and development	26,184	17,943
Sales and marketing	37,086	11,990
General and administrative	17,869	12,225
Total operating expenses	81,139	42,158
Loss from operations	(45,251)	(35,850)
Other income (expense):
Interest income	3,909	1,777
Other expense	(2)	(68)
Change in fair value of warrant liabilities	(13,412)	(9,958)
Total other expense, net	(9,505)	(8,249)
Net loss	(54,756)	(44,099)
Other comprehensive income (loss):
Unrealized gain (loss) on short-term investments	(72)	137
Comprehensive loss	$ (54,828)	$ (43,962)
Net loss per share attributable to common stockholders, basic	$ (8.60)	$ (8.31)
Net loss per share attributable to common stockholders, diluted	$ (8.60)	$ (8.31)
Weighted-average common shares outstanding, basic	6,365,064	5,303,684
Weighted-average common shares outstanding, diluted	6,365,064	5,303,684

Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Assumptions Used to Determine Grant-date Fair Value of Stock Options Granted

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option pricing model to determine the grant-date fair value of stock options granted:


	Year Ended December 31,
	2024			2023
Fair value of common stock	$	13.08		$	8.51
Risk-free interest rate		4.09	%		3.06	%
Expected term (in years)		6.02			5.39
Expected volatility		86.80	%		75.12	%
Expected dividend yield		0	%		0	%

Summary of Stock Options Activity


						Weighted-
				Weighted- Average		Average Remaining		Aggregate
	Number of Options			Exercise Price		Contractual Term		Intrinsic Value
						(in years)		(in thousands)
Outstanding at December 31, 2023		5,202,905		$	6.30		8.1	$	535
Granted		935,105		$	9.27
Exercised		(11,953	)	$	7.42
Forfeited or cancelled		(415,087	)	$	8.96
Expired		(43,415	)	$	7.58
Outstanding at December 31, 2024		5,667,555		$	6.98		7.6	$	22,962
Vested and expected to vest at December 31, 2024		5,667,555		$	6.98		7.6	$	22,962
Options exercisable at December 31, 2024		2,887,678		$	6.88		6.6	$	12,174

Summary of Non-Vested Stock Options

The following table summarizes the non-vested stock options that were outstanding as of December 31, 2024 and 2023:


			Weighted- Average
	Number of Options		Exercise Price
Non-vested options, December 31, 2024		2,779,877	$	7.07
Non-vested options, December 31, 2023		3,124,193	$	6.06

Schedule of Stock-Based Compensation Expense

Stock-based compensation expense related to the stock options was included in the Company’s statements of operations and comprehensive loss as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Cost of sales	$	275	$	239
Research and development		1,144		1,781
Sales and marketing		1,661		610
General and administrative		3,304		3,028
Total stock-based compensation expense	$	6,384	$	5,658

Revenue (Tables)

12 Months Ended

Dec. 31, 2024

Revenue from Contract with Customer [Abstract]

Summary of Disaggregated Revenues

The following table summarizes the Company’s disaggregated revenues:


	Year Ended December 31,
	2024		2023
	(in thousands)
DME channel
iLet(1)	$	46,617	$	10,169
Single-use products		12,189		1,091
Total DME channel		58,806		11,260

PBP channel
iLet(1)		2,099		535
Single-use products		4,219		200
Total PBP channel		6,318		735
Total net sales	$	65,124	$	11,995

(2)

iLet includes the over-time recognition software updates and mobile app access.

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Total cost	$ 10,029	$ 6,896
Less: Accumulated depreciation	(5,253)	(4,420)
Property and equipment, net	4,776	2,476
Manufacturing Equipment
Property, Plant and Equipment [Line Items]
Total cost	6,252	4,386
Leasehold Improvements
Property, Plant and Equipment [Line Items]
Total cost	810	951
Furniture
Property, Plant and Equipment [Line Items]
Total cost	924	924
Computer Equipment
Property, Plant and Equipment [Line Items]
Total cost	308	468
Construction in Progress
Property, Plant and Equipment [Line Items]
Total cost	$ 1,735	$ 167

Inventories, Net

12 Months Ended

Dec. 31, 2024

Inventory Disclosure [Abstract]

Inventories, Net

Inventories consisted of the following:


	December 31,
	2024		2023
	(in thousands)
Raw materials	$	6,737	$	803
Work in process		637		34
Finished goods		5,946		408
Inventories	$	13,320	$	1,245

Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Income Tax Disclosure [Abstract]
Federal statutory income tax rate	21.00%	21.00%
State income tax, net of federal benefit	1.50%	2.20%
Federal and state research and development tax credits	2.90%	2.10%
Change in fair value of warrant liabilities	(5.10%)	(4.80%)
Stock-based compensation	(2.10%)	(1.10%)
Non-deductible items	(0.40%)	(0.10%)
State rate change	(0.50%)	1.30%
Uncertain tax positions	(0.60%)	(2.20%)
Other	0.00%	0.40%
Change in deferred tax asset valuation allowance	(16.70%)	(18.80%)
Effective income tax rate	0.00%	0.00%

Property and Equipment, Net

12 Months Ended

Dec. 31, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Property and equipment, net consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Manufacturing equipment	$	6,252		$	4,386
Leasehold improvements		810			951
Furniture		924			924
Computer equipment		308			468
Construction in progress		1,735			167
Total cost		10,029			6,896
Less: Accumulated depreciation		(5,253	)		(4,420	)
Property and equipment, net	$	4,776		$	2,476

Depreciation expense for the years ended December 31, 2024 and 2023 was $1.2 million for each period.

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (54,756)	$ (44,099)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481687/323-10-50-3

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 28
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482907/825-10-50-28

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482765/220-10-50-6

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-3

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480175/815-40-65-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Subparagraph (a)
-Publisher FASB
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147483443/250-10-50-11

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/exampleRef
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-Name Accounting Standards Codification
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479105/946-220-45-7

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
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Reference 29: http://www.xbrl.org/2003/role/disclosureRef
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Reference 30: http://www.xbrl.org/2003/role/disclosureRef
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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
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Reference 32: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
-Name Accounting Standards Codification
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Reference 33: http://www.xbrl.org/2003/role/disclosureRef
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Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
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Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
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-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Inventories, Net - Schedule of Inventories (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Raw materials	$ 6,737	$ 803
Work in process	637	34
Finished goods	5,946	408
Inventories	$ 13,320	$ 1,245

STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Cash flows from operating activities:
Net Income (Loss)	$ (54,756)	$ (44,099)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense	1,151	1,226
Provision for expected credit losses	70	46
Stock-based compensation expense	6,384	5,658
Provision for excess and obsolete inventory	(636)	(58)
Change in fair value of warrant liabilities	13,412	9,958
Accretion of discount on short-term investments	(2,905)	(747)
Amortization of operating lease right-of-use asset	1,132	865
Loss on disposal of property and equipment	23	11
Changes in operating assets and liabilities:
Accounts receivable	(7,618)	(4,494)
Inventories	(11,439)	(1,187)
Prepaid expenses and other current assets	(2,849)	(391)
Other long-term assets	(29)	(28)
Accounts payable	1,515	716
Accrued expenses and other current liabilities	6,838	1,825
Funded R&D liability-related party		(1,140)
Operating lease liability	(1,023)	(948)
Deferred revenue	2,457	342
Net cash used in operating activities	(48,273)	(32,445)
Cash flows from investing activities:
Purchases of short-term investments	(72,131)	(69,295)
Proceeds from maturities and redemptions of short-term investments	72,000
Proceeds on disposal of property and equipment	50	4
Purchases of property and equipment	(3,395)	(402)
Net cash used in investing activities	(3,476)	(69,693)
Cash flows from financing activities:
Proceeds from the issuance of convertible preferred stock, net of issuance costs	59,660	101,000
Payments for deferred offering costs	(4,147)
Proceeds from stock option exercises	89	10
Proceeds from common stock warrants exercise	13	19
Net cash provided by financing activities	55,615	101,029
Net increase (decrease) in cash, cash equivalents and restricted cash	3,866	(1,109)
Cash, cash equivalents and restricted cash at beginning of year	26,666	27,775
Cash, cash equivalents and restricted cash at end of year	30,532	26,666
Supplemental disclosure of non-cash investing and financing information:
Purchases of property and equipment included in accounts payable	129	20
Deferred offering costs included in accrued expenses and other current liabilities	862
Deferred offering costs included in accounts payable	42
Unrealized gain (loss) on short-term investments	(72)	137
Common B warrants issued in connection with Series D convertible preferred stock		22,321
Supplemental disclosure of cash flow information:
Operating lease right-of-use asset obtained in exchange for operating lease obligations	4,055	1,038
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	30,432	26,566
Restricted cash	100	100
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 30,532	$ 26,666

Convertible Preferred Stock and Warrants - Summary of Preferred Stock (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Nov. 30, 2024	Dec. 31, 2023	Sep. 30, 2023
Class of Stock [Line Items]
Preferred Stock Authorized	34,966,547		26,434,390
Preferred Stock Issued	17,228,954		12,876,561
Preferred Stock Outstanding	17,228,954		12,876,561
Carrying Value	$ 321,373		$ 261,713
Liquidation Preference	$ 355,162		$ 295,162
Common Stock Issuable Upon Conversion	19,827,003		15,474,610
Series A Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	500,000		500,000
Preferred Stock Issued	253,807		253,807
Preferred Stock Outstanding	253,807		253,807
Carrying Value	$ 6,589		$ 6,589
Liquidation Preference	$ 5,000		$ 5,000
Common Stock Issuable Upon Conversion	317,040		317,040
Series A-2 Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	500,000		500,000
Preferred Stock Issued	253,807		253,807
Preferred Stock Outstanding	253,807		253,807
Carrying Value	$ 6,626		$ 6,626
Liquidation Preference	$ 5,000		$ 5,000
Common Stock Issuable Upon Conversion	317,040		317,040
Series B Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	4,197,930		4,200,000
Preferred Stock Issued	2,130,910		2,130,910
Preferred Stock Outstanding	2,130,910		2,130,910
Carrying Value	$ 61,606		$ 61,606
Liquidation Preference	$ 63,053		$ 63,053
Common Stock Issuable Upon Conversion	3,010,683		3,010,683
Series B-2 Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	3,960,000		4,000,000
Preferred Stock Issued	2,010,144		2,010,144
Preferred Stock Outstanding	2,010,144		2,010,144
Carrying Value	$ 63,228		$ 63,228
Liquidation Preference	$ 63,360		$ 63,360
Common Stock Issuable Upon Conversion	2,892,318		2,892,318
Series C Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	5,127,250		5,127,250
Preferred Stock Issued	2,082,153		2,082,153
Preferred Stock Outstanding	2,082,153		2,082,153
Carrying Value	$ 44,985		$ 44,985
Liquidation Preference	$ 57,049		$ 57,049
Common Stock Issuable Upon Conversion	2,791,789		2,791,789
Series D Preferred Stock
Class of Stock [Line Items]
Preferred Stock Authorized	12,107,140		12,107,140
Preferred Stock Issued	6,145,740		6,145,740	6,145,740
Preferred Stock Outstanding	6,145,740		6,145,740
Carrying Value	$ 78,679		$ 78,679
Liquidation Preference	$ 101,700		$ 101,700
Common Stock Issuable Upon Conversion	6,145,740		6,145,740
Series E Preferred Stock [Member]
Class of Stock [Line Items]
Preferred Stock Authorized	8,574,227
Preferred Stock Issued	4,352,393	4,352,393
Preferred Stock Outstanding	4,352,393
Carrying Value	$ 59,660
Liquidation Preference	$ 60,000
Common Stock Issuable Upon Conversion	4,352,393

Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2024

Accounting Policies [Abstract]

Use of Estimates

Concentrations of Credit Risk and of Significant Suppliers


	Net Sales						Accounts Receivable, net
	Year Ended December 31,						December 31,
	2024			2023			2024			2023
Distributor A		12.8	%		20.6	%		13.7	%		28.9	%
Distributor B		18.3	%		19.0	%		13.3	%		24.5	%
Distributor C		11.6	%		16.3	%		10.6	%		12.3	%
Distributor D		16.3	%		14.2	%		13.0	%	*
Distributor E	*			*				14.8	%	*

* Amount related to the respective customer represented less than 10% for the period presented.

Cash and Cash Equivalents

Cash and cash equivalents consist of cash and all highly liquid investments purchased with original maturities of three months or less.

Short-Term Investments

Accounts Receivable and Allowance for Credit Losses

Inventories

Restricted Cash

Deferred Offering Costs

Fair Value Measurements


	Level 1 —	Quoted prices in active markets for identical assets or liabilities.

	Level 2 —	Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

	Level 3 —	Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques.

Property and Equipment

Impairment of Long-lived Assets

Leases

Classification and Accretion of Convertible Preferred Stock

The issuance costs from equity financings are netted against the gross proceeds received from the equity financings.

Warrant Liabilities

Preferred Stock Warrants

Common Stock Warrants

Contingencies

Segment Information

Revenue Recognition

Net Sales

Revenue Recognition for Arrangements with Multiple Performance Obligations

Variable Consideration

Sales Returns

Contract Costs

Product Warranty

Shipping and Handling Costs

Research and Development Costs

Patent Costs

Stock-Based Compensation

The fair value of Class B common stock underlying the Company’s stock options was estimated by the Board, which considered, among other things, valuations of the Company’s common stock.

Comprehensive Income (Loss)

Net Loss Per Share

share will be the same for Class A common stock, Class B common stock, and Class C common stock on an individual or combined basis.

Income Taxes

Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements

Recently Adopted Accounting Pronouncements

Recently Issued Accounting Pronouncements

Subsequent Event

12 Months Ended

Dec. 31, 2024

Subsequent Events [Abstract]

Subsequent Event

20. Subsequent Event

2025 Equity Incentive Plan

On January 21, 2025, the Company’s board of directors adopted and the Company’s stockholders approved the 2025 Equity Incentive Plan (the “2025 Plan”), which became effective on the date immediately preceding the date on which the Company’s registration statement was declared effective by the SEC. The 2025 Plan replaced the 2016 plan (see Note 13), as the Company’s board of directors has determined to not make additional grants under the 2016 Plan following the closing of the IPO. However, the 2016 Plan will continue to govern outstanding equity awards granted under the 2016 Plan. The 2025 Plan allowed the Company to grant incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other awards. The number of shares initially available for issuance under awards granted pursuant to the 2025 Plan is 12,016,744.

Accounts Receivable, Net

12 Months Ended

Dec. 31, 2024

Receivables [Abstract]

Accounts Receivable, Net

Accounts receivable, net consisted of the following:


	December 31,
	2024			2023
	(in thousands)
Accounts receivable	$	12,112		$	4,494
Less: allowance for credit losses		(116	)		(46	)
Accounts receivable, net	$	11,996		$	4,448

The following table provides a reconciliation of the changes in the allowance for estimated credit losses for the years ended December 31, 2024 and 2023:


	Year Ended December 31,
	2024		2023
	(in thousands)
Balance at beginning of year	$	46	$	—
Provision for expected credit losses		70		46
Balance at end of year	$	116	$	46

Accounts Receivable, Net - Schedule of Accounts Receivable, Net (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Receivables [Abstract]
Accounts receivable	$ 12,112	$ 4,494
Less: allowance for credit losses	(116)	(46)
Accounts receivable, net	$ 11,996	$ 4,448

Financial Instruments and Fair Value Measurements - Summary of Reconciliation of Level 3 Warrant Liabilities (Details) - Level 3 - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Series C Warrant Liability
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance	$ 9,447	$ 10,497
Change in fair value	488	(1,050)
Balance	9,935	9,447
Common B Warrant Liability
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance	28,126
Issuance of Common B warrants in connection with Series D preferred stock		22,321
Warrant exercises		(5,203)
Change in fair value	6,837	11,008
Balance	$ 34,963	$ 28,126

Convertible Preferred Stock and Warrants

12 Months Ended

Dec. 31, 2024

Equity [Abstract]

Convertible Preferred Stock and Warrants

11.

Convertible Preferred Stock and Warrants

The Company has issued Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock, Series B-2 Preferred Stock, Series C Preferred Stock and Series D Preferred Stock, and Series E Preferred Stock (collectively, the “Preferred Stock”).

Upon issuance of each class of Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities and determined that such features did not require the Company to

separately account for these features. The Company also concluded that no beneficial conversion feature existed on the issuance date of each class of Preferred Stock but did identify contingent beneficial conversion features on each class of Preferred Stock related to the down round protective provisions. Although down round protection was triggered with the issuance of the Series C and Series D Preferred Stock, the contingent beneficial conversion features were not triggered requiring recognition by the Company. Upon the adoption of ASU 2020-06, the Company recorded an adjustment to reflect the cumulative effect of the down rounds triggered with the issuance of the Series C and Series D Preferred Stock, resulting in a $12.3 million adjustment to retained earnings (see Note 1 for further details). In November 2024, the Company issued and sold 4,352,393 shares of Series E Preferred Stock, at a price of $13.79 per share, for gross proceeds of $60.0 million. The Company incurred issuance costs in connection with this transaction of $0.3 million. The Series E Preferred Stock has an Original Issuance Price and Conversion Price (each as defined in the Company’s certificate of incorporation) per share of $13.79.

From August to September 2023, the Company issued and sold 6,145,740 shares of Series D Preferred Stock, at a price of $16.55 per share, for gross proceeds of $101.7 million. The Company incurred issuance costs in connection with this transaction of $0.7 million. Each purchaser of the Series D Preferred Stock also received warrants to purchase up to a certain number of shares of Class B common stock equal to 70% of the shares of Series D Preferred Stock purchased by the purchaser. The Common B warrants are exercisable at any time, at an exercise price of $0.02 per share (subject to appropriate adjustment in the event of any stock split, stock dividend, combination or other similar recapitalization) and expire on the earliest to occur of (i) August 28, 2033, (ii) immediately prior to the sale of the Company or a transaction that qualifies as a Deemed Liquidation Event as described below or (iii) immediately prior to the consummation of a qualifying initial public offering or a SPAC Transaction. During the year ended December 31, 2024 and 2023, a total of 634,513 and 991,957, respectively, of the Common B warrants were exercised. The Series D Preferred Stock has an Original Issue Price and Conversion Price (each as defined in the Company’s certificate of incorporation) per share of $16.55.

As part of the Series E Preferred Stock issuance, the Company increased the number of shares of Class B common stock authorized for issuance from 65,000,000 shares to 70,000,000 shares and increased the number of shares of preferred stock authorized for issuance from 26,434,390 shares to 34,966,547 shares, of which 8,574,227 shares were designated as Series E Preferred Stock.

At the balance sheet dates, Preferred Stock consisted of the following:


	December 31, 2024
	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value (in thousands)		Liquidation Preference (in thousands)		Common Stock Issuable Upon Conversion
Series A Preferred Stock		500,000		253,807	$	6,589	$	5,000		317,040
Series A-2 Preferred Stock		500,000		253,807		6,626		5,000		317,040
Series B Preferred Stock		4,197,930		2,130,910		61,606		63,053		3,010,683
Series B-2 Preferred Stock		3,960,000		2,010,144		63,228		63,360		2,892,318
Series C Preferred Stock		5,127,250		2,082,153		44,985		57,049		2,791,789
Series D Preferred Stock		12,107,140		6,145,740		78,679		101,700		6,145,740
Series E Preferred Stock		8,574,227		4,352,393		59,660		60,000		4,352,393
		34,966,547		17,228,954	$	321,373	$	355,162		19,827,003


	December 31, 2023
	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value (in thousands)		Liquidation Preference (in thousands)		Common Stock Issuable Upon Conversion
Series A Preferred Stock		500,000		253,807	$	6,589	$	5,000		317,040
Series A-2 Preferred Stock		500,000		253,807		6,626		5,000		317,040
Series B Preferred Stock		4,200,000		2,130,910		61,606		63,053		3,010,683
Series B-2 Preferred Stock		4,000,000		2,010,144		63,228		63,360		2,892,318
Series C Preferred Stock		5,127,250		2,082,153		44,985		57,049		2,791,789
Series D Preferred Stock		12,107,140		6,145,740		78,679		101,700		6,145,740
		26,434,390		12,876,561	$	261,713	$	295,162		15,474,610

Voting

The holders of the Preferred Stock are entitled to vote, together with the holders of Class A common stock and Class B common stock as a single class, on all matters submitted to stockholders for a vote. Each holder of Preferred Stock is entitled to the number of votes equal to the number of shares of Class B common stock into which each share of Preferred Stock is convertible as of the record date for determining stockholders entitled to vote on such matters. The holders of Class C common stock do not have voting rights. The holders of record of the Series D Preferred shares are entitled to elect five members of the Board jointly designated from time to time by the holders of a majority of the outstanding shares of Series D Preferred Stock, exclusively and voting as a separate series, (i) one of whom shall be designated by Sands Capital Life Sciences Pulse Fund II, L.P. and its affiliates, (ii) one of whom shall be designated by Omega Fund VII, L.P. and its affiliates; (iii) one of whom shall be designated by Soleus Private Equity Fund II, L.P. and its affiliates; (iv) one of whom shall be designated by Eventide Gilead Fund and Eventide Healthcare & Life Sciences Fund and affiliates of the foregoing; and (v) one of whom shall be designated by Zone Healthcare Holdings, LLC and its affiliates. The holders of record of the shares of Series C Preferred Stock, exclusively and as a separate class, shall be entitled to elect one director of the Company. The holders of record of the shares of Series B Preferred Stock and Series B-2 Preferred Stock, voting together as a single class, on an as-converted basis, shall be entitled to elect one director of the Company. The holders of record of the shares of Class A common stock, exclusively and as a separate class, shall be entitled to elect one director of the Company.

The CEO shall also serve as a director.

Conversion

Each series of Preferred Stock will automatically convert into shares of Class B common stock at the then applicable conversion rate in the event of (i) the closing of the sale of common stock to the public at a price per share equal to at least $14.60 (subject to adjustments for stock dividends, splits, combinations and similar events) and gross proceeds to the Company of not less than $100.0 million (a “Qualified IPO”); (ii) the closing of a Qualified SPAC Transaction; or (iii) upon the written consent of the Requisite Holders. The conversion ratio of each series of Preferred Stock is determined by dividing the Original Issue Price of each series by the Conversion Price of each series. The Original Issue Price is $19.70 per share for Series A Preferred Stock, $19.70 per share for Series A-2 Preferred Stock, $29.59 per share for Series B Preferred Stock, $31.52 per share for Series B-2 Preferred Stock, $27.40 per share for share for Series C Preferred Stock and $16.55 per share for Series D Preferred Stock. The Conversion Price is $15.77 per share for Series A Preferred Stock, $15.77 per share for Series A-2 Preferred Stock, $20.94 per share for Series B Preferred Stock, $21.91 per share for Series B-2 Preferred Stock, $20.43 per share for Series C Preferred Stock, $9.73 per share for Series D Preferred Stock and $13.79 per share for Series E Preferred Stock, each subject to appropriate adjustment in the event of any stock split, stock dividend, combination or other similar recapitalization and other adjustments as set forth in the Company’s certificate of incorporation.

Prior to August 2023, if the Company issued additional common or preferred stock at a price lower than the current Conversion Price of each series in effect immediately prior to such issuance, the applicable Conversion Price of each series of Preferred Stock would be reduced, to prevent dilution of existing holders of Preferred Stock (the “Series C Down Round Protection”). The Series C Down Round Protection was in effect until the Company amended and restated it certificate of incorporation with the issuance of Series D in August 2023. The issuance of Series D Preferred Stock triggered down round protection for existing Preferred Stockholders, as the issuance price per share was below the Conversion Price of certain Preferred Stock in effect immediately prior to the issuance.

With the issuance of the Series D Preferred Stock in August 2023, the Company amended and restated its certificate of incorporation, replacing the Series C Down Round Protection with the Series D Down Round Protection (defined below). The amendment and restatement of certificate of incorporation specified that if any additional common or preferred stock was issued at an issuance price lower than the Series D Conversion Price, the Conversion Price of each series of Preferred Stock would be reduced to prevent dilution of existing holders (the “Series D Down Round Protection”). The Series D Down Round Protection remained in effect until the Company’s certificate of incorporation was amended and restated with the issuance of Series E in November 2024. The Series E Preferred Stock issuance did not trigger down round protection for existing shareholders of the Preferred Stock as the per share issuance price was not lower than the Series D Conversion price in effect immediately prior to the issuance.

With the issuance of the Series E Preferred Stock in November 2024, the Company amended and restated its certificate of incorporation, replacing the Series D Down Round Protection with the Series E Down Round Protection (defined below). The amendment and restatement of Series E specified if any additional shares common or preferred stock was issued at an issuance price lower than the Series E Conversion Price, the Conversion Price of each series of Preferred Stock would be reduced to prevent dilution of existing holders of Preferred Stock (the “Series E Down Round Protection”). The Series E Down Round Protection remained in effect as of December 31, 2024.

As of December 31, 2024, each outstanding share of Series A Preferred Stock and Series A-2 Preferred Stock was convertible into Class B common stock on a 1.24914:1 basis, each outstanding share of Series B Preferred Stock was convertible into Class B common stock on a 1.41287:1 basis, each outstanding share of Series B-2 Preferred Stock was convertible into Class B common stock on a 1.43886:1 basis, each outstanding share of Series C Preferred Stock was convertible into Class B common stock on a 1.34082:1 basis, each outstanding share of Series D Preferred Stock was convertible into Class B common stock on a 1:1 basis and each share of Series E Preferred Stock was convertible into Class B common stock on a 1:1 basis. The Series D Preferred Stock issuance triggered down round protection for existing holders of the Preferred Stock, as set forth in the Company’s certificate of incorporation. In connection with the triggering of the down round protections for existing holders of Preferred Stock, the Company evaluated the redemption features of the Preferred Stock, which becomes redeemable in the event of a Deemed Liquidation Event (as described below). As of December 31, 2024, the Deemed Liquidation Event was not probable and no remeasurement of the redemption price was recognized.

On January 31, 2025, the Company completed its IPO and as a result, all 17,228,954 outstanding shares of the Company’s Preferred Stock were converted into 19,827,003 shares of common stock, and all 3,196,025 outstanding warrants to purchase shares of Series C Preferred Stock and Class B Common Stock were converted into 3,373,409 shares of common stock. See Note 1 for further details.

Dividends

The holders of shares of Series D Preferred Stock, Series E Preferred Stock, Series A Preferred Stock and Series A-2 Preferred Stock are entitled to receive, when, as and if declared by the Board on a pari passu basis, non-cumulative cash dividends of 4% per annum of each respective Original Issue Price, and the holders of Series B Preferred Stock, B-2 Preferred Stock and Series C Preferred Stock are entitled to receive, when, as and if declared by the Board on a pari passu basis, non-cumulative cash dividends of 2% per annum of each respective Original Issue Price (the Annual Dividend, for each respective series).

The Company shall not declare, pay or set aside any dividends on shares of any other class or series of stock of the Company unless the holders of the Preferred Stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Preferred Stock in an amount at least equal to the greater of: (i) in the case of a dividend on common stock or any class or series of stock that is convertible into common stock, a dividend per share of Preferred Stock that would equal the product of (A) the dividend payable on each share of such class or series determined, if applicable, as if all shares of such class or series had been converted into common stock and (B) the number of shares of common stock issuable upon conversion of a share of Preferred Stock; or (ii) in the case of a dividend on any class or series of stock that is not convertible into common stock, at a rate per share of Preferred Stock determined by (A) dividing the amount of the dividend payable on each share of such class or series of stock by the Original Issue Price of such class or series of stock (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to such class or series) and (B) multiplying such fraction by an amount equal to the Original Issue Price of such class or series. If the Company declares, pays or sets aside, on the same date, a dividend on shares of more than one class or series of stock of the Company, the dividend payable to the holders of the Preferred Stock will be calculated based upon the dividend on the class or series of stock that would result in the highest Preferred Stock dividend.

Through December 31, 2024, no dividends had been declared on any series or class of shares.

Liquidation

In the event of any voluntary or involuntary liquidation, dissolution or winding-up of the Company or Deemed Liquidation Event (as described below), the holders of shares of Series E Preferred Stock and Series D Preferred Stock are entitled to be paid out of the assets of the Company available for distribution to its stockholders before any payments are made to the holders of shares of Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock, Series B-2 Preferred Stock and Series C Preferred Stock. The holders of shares of Series E Preferred Stock and Series D Preferred Stock are entitled to an amount per share equal to the greater of (i) the Original Issue Price per share of the Series E Preferred Stock or Series D Preferred Stock,

plus any dividends declared but unpaid thereon, or (ii) the amount that would have been payable had all shares of Series E Preferred Stock or Series D Preferred Stock been converted to common stock immediately prior to the liquidation, dissolution, winding-up or Deemed Liquidation Event. If upon any such liquidation event, the assets of the Company available for distribution are insufficient to pay the holders of the Series E Preferred Stock and Series D Preferred Stock the full amount to which they are entitled, the holders of Series E Preferred Stock and Series D Preferred Stock will share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would be otherwise payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares of Series E Preferred Stock and Series D Preferred Stock were paid in full.

In the event of any voluntary or involuntary liquidation, dissolution or winding-up of the Company or Deemed Liquidation Event (as described below), after the payment in full to the holders of shares of the Series D Preferred Stock, the holders of shares of Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock, Series B-2 Preferred Stock and Series C Preferred Stock are entitled to be paid out of the assets of the Company available for distribution to its stockholders pari passu before any payments are made to holders of the common stock. The holders of shares of Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock, Series B-2 Preferred Stock and Series C Preferred Stock are entitled to an amount per share equal to the greater of (i) the applicable Original Issue Price per share of each respective share of Preferred Stock, plus any dividends declared but unpaid thereon, or (ii) the amount that would have been payable had all shares of the series been converted to common stock immediately prior to the liquidation, dissolution, winding-up or Deemed Liquidation Event. If upon any such liquidation event, the assets of the Company available for distribution are insufficient to pay the holders of Preferred Stock the full amount to which they are entitled, the holders of shares of Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock, Series B-2 Preferred Stock and Series C Preferred Stock will share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would be otherwise payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

Unless both (A) the holders of a majority of the outstanding shares of Series E Preferred Stock, voting as a separate class, (B) the holders of a majority of the outstanding shares of Series D Preferred Stock, voting as a separate class which majority shall include at least one of the “Lead Investors” and (C) the holders of at least a majority of the outstanding shares of Series A Preferred Stock, Series A-2 Preferred Stock, Series B Preferred Stock Series B-2 Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis, elect otherwise, a Deemed Liquidation Event shall include a merger, consolidation, or share exchange (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares of the surviving or acquiring corporation) or a sale, lease, transfer, exclusive license or other disposition of all or substantially all of the assets of the Company.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478448/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
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-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

Leases (Tables)

12 Months Ended

Dec. 31, 2024

Leases [Abstract]

Schedule of Components of Lease Expense

The components of lease expense were as follows:


	Year Ended December 31,
	2024		2023
	(in thousands)
Operating lease cost–fixed	$	1,375	$	1,008
Operating lease cost–variable		209		138
Short-term lease expense		17		13
Total lease expense	$	1,601	$	1,159

Summary of Weighted-average Remaining Lease Term and Discount Rate

The weighted-average remaining lease term and discount rate were as follows:


	December 31, 2024
Weighted-average remaining lease term	6.29 years
Weighted-average discount rate		6.69	%

Schedule of Future Lease Payments

Future lease payments under non-cancellable leases as of December 31, 2024 were as follows:


(in thousands)
Year Ending December 31,
2025	$	1,581
2026		1,532
2027		929
2028		1,050
2029 and thereafter		4,010
Total future lease payments		9,102
Less: imputed interest		(1,847	)
Total lease liabilities	$	7,255

Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 6,384	$ 5,658
Cost of Sales
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	275	239
Research and Development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	1,144	1,781
Sales and Marketing
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	1,661	610
General and Administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 3,304	$ 3,028

Award Timing Disclosure	12 Months Ended
Award Timing Disclosure	Dec. 31, 2024
Award Timing Disclosures [Line Items]
Award Timing MNPI Disclosure	From time to time, the Company grants stock options to its employees, including the named executive officers. Per the Company’s Equity Incentive Grant Policy, (i) new hire and promotion equity incentive grants shall be granted on the first 15th day of the each month (Regular Grant Date) immediately following the later of (x) the month in which the employee’s employment commences (or promotion is effective, as applicable) and (y) the date of approval by the appropriate governing body (Approval), (ii) annual equity incentive grants shall be made on the 15th day of March (or if such day is not a trading day, the immediately preceding trading day in March) and (iii) consultant equity awards and merit-based and retention equity incentive grants shall be granted on the first Regular Grant Date following Approval. Also, non-employee directors receive automatic grants of initial and annual RSU awards, at the time of a director’s initial election or appointment to the board and at the time of each annual meeting of the Company’s stockholders, respectively, pursuant to the Compensation Policy, as further described under the heading, “Non-Employee Director Compensation—Non-Employee Director Compensation Policy” above. Option grants are made on the regular, predetermined grant dates pursuant to the Company’s Equity Incentive Grant Policy and the Compensation Policy regardless of whether there is any material nonpublic information (MNPI) about the Company on such dates, and such grant dates are not specifically timed in relation to the Company’s disclosure of MNPI. The Company has not timed the release of MNPI for the purpose of affecting the value of executive compensation.
Award Timing Method	From time to time, the Company grants stock options to its employees, including the named executive officers. Per the Company’s Equity Incentive Grant Policy, (i) new hire and promotion equity incentive grants shall be granted on the first 15th day of the each month (Regular Grant Date) immediately following the later of (x) the month in which the employee’s employment commences (or promotion is effective, as applicable) and (y) the date of approval by the appropriate governing body (Approval), (ii) annual equity incentive grants shall be made on the 15th day of March (or if such day is not a trading day, the immediately preceding trading day in March) and (iii) consultant equity awards and merit-based and retention equity incentive grants shall be granted on the first Regular Grant Date following Approval.
Award Timing Predetermined	true
Award Timing MNPI Considered	false
MNPI Disclosure Timed for Compensation Value	false

Short-Term Investments

12 Months Ended

Dec. 31, 2024

Investments, Debt and Equity Securities [Abstract]

Short-Term Investments

The following represents a summary of the estimated fair value of short-term investments at December 31, 2024 and 2023:


	At December 31, 2024
	Amortized		Unrealized		Unrealized		Estimated
	Cost		Gains		Losses		Fair Value
	(in thousands)
Short-term investments
U.S. Treasury bills	$	73,078	$	65	$	—	$	73,143
Total	$	73,078	$	65	$	—	$	73,143


	As of December 31, 2023
	Amortized		Unrealized		Unrealized		Estimated
	Cost		Gains		Losses		Fair Value
	(in thousands)
Short-term investments
U.S. Treasury bills	$	70,042	$	137	$	—	$	70,179
Total	$	70,042	$	137	$	—	$	70,179

Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 1,151	$ 1,226

Net Loss Per Share - Summary of computation of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Numerator:
Net loss attributable to Class A, Class B and Class C common stockholders, basic and diluted	$ (54,756)	$ (44,099)
Denominator:
Weighted-average common stock outstanding, basic	6,365,064	5,303,684
Weighted-average common stock outstanding, diluted	6,365,064	5,303,684
Net loss per share attributable to common stockholders, basic	$ (8.60)	$ (8.31)
Net loss per share attributable to common stockholders, diluted	$ (8.60)	$ (8.31)
Class A Common Stock
Denominator:
Weighted-average common stock outstanding, basic	2,952,123	2,989,847
Weighted-average common stock outstanding, diluted	2,952,123	2,989,847
Class B Common Stock
Denominator:
Weighted-average common stock outstanding, basic	3,364,023	2,264,919
Weighted-average common stock outstanding, diluted	3,364,023	2,264,919
Class C Common Stock
Denominator:
Weighted-average common stock outstanding, basic	48,918	48,918
Weighted-average common stock outstanding, diluted	48,918	48,918

Related Party Transactions - Additional Information (Details) - Boston University - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Related Party Transaction [Line Items]
Royalties expense	$ 2.2	$ 0.5
Payment to related party reimbursed legal costs	0.2	0.2
Related Party [Member]
Related Party Transaction [Line Items]
Other liabilities	$ 0.7	$ 0.3

- Definition

Amount of liabilities classified as other.

+ References + Details

Convertible Preferred Stock and Warrants - Additional Information (Details)		1 Months Ended	2 Months Ended	12 Months Ended
	Jan. 31, 2025 shares	Nov. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) shares	Jan. 01, 2024 USD ($)
Class of Stock [Line Items]
Preferred Stock Issued \| shares				17,228,954	12,876,561
Gross proceeds \| $				$ 59,660,000	$ 101,000,000
Stock issuance cost \| $				$ 4,147,000
Convertible preferred stock \| shares				19,827,003
Dividends declared \| $				$ 0
IPO \| Subsequent Event
Class of Stock [Line Items]
Preferred stock outstanding \| shares	17,228,954
Common Stock \| IPO \| Subsequent Event
Class of Stock [Line Items]
Convertible preferred stock \| shares	19,827,003
Converted common stock \| shares	3,373,409
Common B Warrants
Class of Stock [Line Items]
Warrants exercise price \| $ / shares			$ 0.02
Warrants exercised \| shares				634,513	991,957
Class B Common Stock
Class of Stock [Line Items]
Share Price, Per share \| $ / shares				$ 14.6
Warrants exercise price \| $ / shares				$ 0.02
Stock authorized \| shares				65,000,000
Share Authorized Increased \| shares				70,000,000
Conversion of stock, number of shares issued \| shares				1
Preferred stock, convertible terms for vote				Each holder of Preferred Stock is entitled to the number of votes equal to the number of shares of Class B common stock into which each share of Preferred Stock is convertible as of the record date for determining stockholders entitled to vote on such matters.
Class B Common Stock \| Maximum \| IPO
Class of Stock [Line Items]
Gross proceeds \| $				$ 100,000,000
Series A Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares				253,807	253,807
Original issue price \| $ / shares				$ 19.7
Conversion price \| $ / shares				$ 15.77
Preferred stock, convertible, conversion ratio				1.24914
Non-cumulative cash dividends percentage				4.00%
Series A-2 Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares				253,807	253,807
Original issue price \| $ / shares				$ 19.7
Conversion price \| $ / shares				$ 15.77
Preferred stock, convertible, conversion ratio				1.24914
Non-cumulative cash dividends percentage				4.00%
Series B Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares				2,130,910	2,130,910
Original issue price \| $ / shares				$ 29.59
Conversion price \| $ / shares				$ 20.94
Preferred stock, convertible, conversion ratio				1.41287
Non-cumulative cash dividends percentage				2.00%
Series B-2 Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares				2,010,144	2,010,144
Original issue price \| $ / shares				$ 31.52
Conversion price \| $ / shares				$ 21.91
Preferred stock, convertible, conversion ratio				1.43886
Non-cumulative cash dividends percentage				2.00%
Series C Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares				2,082,153	2,082,153
Original issue price \| $ / shares				$ 27.4
Conversion price \| $ / shares				20.43
Warrants exercise price \| $ / shares				$ 0.02
Preferred stock, convertible, conversion ratio				1.34082
Non-cumulative cash dividends percentage				2.00%
Series C Preferred Stock \| IPO \| Subsequent Event
Class of Stock [Line Items]
Warrants to purchase common stock \| shares	3,196,025
Series D Preferred Stock
Class of Stock [Line Items]
Preferred Stock Issued \| shares			6,145,740	6,145,740	6,145,740
Share Price, Per share \| $ / shares			$ 16.55
Original issue price \| $ / shares			$ 16.55	$ 16.55
Gross proceeds \| $			$ 101,700,000
Stock issuance cost \| $			$ 700,000
Conversion price \| $ / shares			$ 16.55	$ 9.73
Share purchase percentage			70.00%
Preferred stock, convertible, conversion ratio				1
Non-cumulative cash dividends percentage				4.00%
Series C and Series D Preferred Stock
Class of Stock [Line Items]
Adjustment to accumulated retained earnings (deficit) \| $						$ 12,300,000
Series E Preferred Stock [Member]
Class of Stock [Line Items]
Preferred Stock Issued \| shares		4,352,393		4,352,393
Share Price, Per share \| $ / shares		$ 13.79
Original issue price \| $ / shares		$ 13.79
Gross proceeds \| $		$ 60,000,000
Stock issuance cost \| $		$ 300,000
Conversion price \| $ / shares		$ 13.79		$ 13.79
Stock authorized \| shares				26,434,390
Share Authorized Increased \| shares				34,966,547
Designated Shares \| shares				8,574,227
Preferred stock, convertible, conversion ratio				1
Non-cumulative cash dividends percentage				4.00%

Related Party Transactions

12 Months Ended

Dec. 31, 2024

Related Party Transactions

19. Related Party Transactions

Boston University

Edward Damiano, Ph.D., the Co-Founder and Executive Chairman of the Company, was affiliated with Boston University (“BU”) during the execution and amendments of key agreements and currently serves as a volunteer research professor. Under the agreements, BU and Dr. Damiano are entitled to a specified percentage of royalties from net sales of licensed products.

In December 2015, the Company executed hardware and software license agreements with the Trustees of BU under which the Company received exclusive, non-transferable, sublicensable, worldwide, royalty-bearing licenses to certain patent rights and copyrights.

The Company incurred $2.2 million and $0.5 million of royalties expense under the Control Algorithm Agreement during the year ended December 31, 2024 and 2023, respectively, which was included as a component of cost of sales in the Company’s statements of operations and comprehensive loss.

Under the agreements, the Company is responsible for all costs related to the amendment, prosecution and maintenance of the licensed patent rights. During the years ended December 31, 2024 and 2023, the Company paid BU $0.2 million and $0.2 million, respectively, for reimbursed legal costs in connection with the agreements.

As of December 31, 2024 and 2023, $0.7 million and $0.3 million, respectively, was due to BU from the Company.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-5

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-6

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Section 50
-Paragraph 2
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
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-Name Accounting Standards Codification
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.6-07(2)(g)(3))
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(e))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479134/946-220-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/850/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
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-Section 50
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-URI https://asc.fasb.org/1943274/2147483326/850-10-50-6

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
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-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

+ Details