0001558370-22-001539 | 10-K | XBRL Viewer

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Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 142,072	$ 59,112
Accounts receivable, net	2,560	1,281
Inventory	3,880	3,343
Prepaid expenses and other current assets	2,585	605
Total current assets	151,097	64,341
Property and equipment, net	1,425	410
Other non-current assets	26	26
Total assets	152,548	64,777
Current liabilities:
Accounts payable	510	483
Accrued expenses	5,398	3,583
Warrant liability	0	3,911
Total current liabilities	5,908	7,977
Long-term debt	0	19,278
Other long-term liabilities	681	777
Total liabilities	6,589	28,032
Commitments and contingencies (Note 10)
Convertible preferred stock, $0.01 par value, 10,000,000 and 237,370,645 authorized as of December 31, 2021 and December 31, 2020, respectively; 0 and 223,541,754 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively	0	329,983
Stockholders' equity (deficit):
Common stock, $0.01 par value, 200,000,000 and 625,217,795 authorized as of December 31, 2021 and December 31, 2020, respectively; 20,399,337 and 360,412 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively	204	4
Additional paid-in capital	540,707	58,624
Accumulated deficit	(394,754)	(351,676)
Accumulated other comprehensive loss	(198)	(190)
Total stockholders' equity (deficit)	145,959	(293,238)
Total liabilities, convertible preferred stock, and stockholders' equity (deficit)	$ 152,548	$ 64,777

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
Consolidated Balance Sheets [Abstract]
Convertible preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Convertible preferred stock, shares authorized	10,000,000	237,370,645
Convertible preferred stock, shares issued	0	223,541,754
Convertible preferred stock, shares outstanding	0	223,541,754
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	200,000,000	625,217,795
Common stock, shares issued	20,399,337	360,412
Common stock, shares outstanding	20,399,337	360,412

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Consolidated Statements of Operations [Abstract]
Revenue	$ 13,036	$ 6,053
Cost of goods sold	3,640	1,440
Gross profit	9,396	4,613
Operating expenses:
Research and development	7,501	6,410
Selling, general and administrative	27,863	9,717
Total operating expenses	35,364	16,127
Loss from operations	(25,968)	(11,514)
Interest expense	(2,219)	(2,470)
Other expense, net	(14,800)	(40)
Loss before income taxes	(42,987)	(14,024)
Provision for income taxes	(91)	(85)
Net loss	(43,078)	(14,109)
Cumulative translation adjustment	(8)	(1)
Comprehensive loss	$ (43,086)	$ (14,110)
Net loss per share, basic and diluted	$ (4.16)	$ (37.01)
Weighted-average common shares used to compute net loss per share, basic and diluted	10,360,054	387,083

Consolidated Statements of Convertible Preferred Stock and Stockholders Equity (Deficit) - USD ($) $ in Thousands	Convertible preferred stock	Common stock	Additional paid-in capital	Accumulated deficit	Accumulated and other comprehensive loss	Total
Balances, Beginning at Dec. 31, 2019	$ 279,983
Balances, Beginning (in shares) at Dec. 31, 2019	161,041,754
Increase (Decrease) in Temporary Equity [Roll Forward]
Issuance of Series G preferred stock, net of costs	$ 49,783
Issuance of Series G preferred stock, net of costs (in shares)	62,500,000
Accretion of Series G issuance costs	$ 217
Balances, Ending at Dec. 31, 2020	$ 329,983					$ 329,983
Balances, Ending (in shares) at Dec. 31, 2020	223,541,754					223,541,754
Balances, Beginning at Dec. 31, 2019		$ 5	$ 58,708	$ (337,567)	$ (189)	$ (279,043)
Balances, Beginning (in shares) at Dec. 31, 2019		483,931
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options (in shares)		175				175
Repurchase of common stock		$ (1)	1
Repurchase of common stock (in shares)		(123,694)
Employee stock compensation			132			$ 132
Accretion of Series G issuance costs			(217)			(217)
Net loss				(14,109)		(14,109)
Cumulative translation adjustment					(1)	(1)
Balances, Ending at Dec. 31, 2020		$ 4	58,624	(351,676)	(190)	(293,238)
Balances, Ending (in shares) at Dec. 31, 2020		360,412
Increase (Decrease) in Temporary Equity [Roll Forward]
Conversion of Series G preferred stock	$ (329,983)
Conversion of Series G preferred stock (in shares)	(223,541,754)
Balances, Ending at Dec. 31, 2021						$ 0
Balances, Ending (in shares) at Dec. 31, 2021						0
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options			23			$ 23
Exercise of stock options (in shares)		59,341				59,341
Employee stock compensation			1,912			$ 1,912
Issuance of common stock, net of offering costs		$ 81	133,080			133,161
Issuance of common stock, net of offering costs (in shares)		8,050,000
Reverse stock split			(1)			(1)
Conversion of Series G preferred stock		$ 119	347,069			347,188
Conversion of Series G preferred stock (in shares)		11,929,584
Net loss				(43,078)		(43,078)
Cumulative translation adjustment					(8)	(8)
Balances, Ending at Dec. 31, 2021		$ 204	$ 540,707	$ (394,754)	$ (198)	$ 145,959
Balances, Ending (in shares) at Dec. 31, 2021		20,399,337

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cash flows from operating activities:
Net loss	$ (43,078)	$ (14,109)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,912	132
Depreciation of property and equipment	168	75
Amortization of deferred financing costs and loan discount	229	286
Loss on debt extinguishment	1,325	0
Changes in fair value of convertible preferred stock warrants	13,294	371
Changes in operating assets and liabilities:
Accounts receivable	(1,279)	(562)
Inventory	(537)	(1,271)
Prepaid expenses and other current assets	(1,980)	(226)
Accounts payable	27	46
Accrued expenses	2,187	(838)
Net cash used in operating activities	(27,732)	(16,096)
Cash flows from investing activities:
Purchase of property and equipment	(1,183)	(311)
Net cash used in investing activities	(1,183)	(311)
Cash flows from financing activities:
Proceeds from the exercise of common stock options	23	0
Proceeds from issuance of Series G Preferred Stock, net of fees	0	49,783
Payments related to reverse stock split	(1)	0
Proceeds from the issuance of common stock, net of offering costs	133,161	0
Repayment on debt financing	(21,300)	0
Net cash provided by financing activities	111,883	49,783
Effect of currency exchange on cash and cash equivalents	(8)	(5)
Net change in cash and cash equivalents	82,960	33,371
Cash and cash equivalents at beginning of year	59,112	25,741
Cash and cash equivalents at end of period	142,072	59,112
Supplemental Information:
Cash paid for interest	1,706	2,033
Cash paid for income taxes	$ 2	$ 10

Business Organization

12 Months Ended

Dec. 31, 2021

Business Organization [Abstract]

Business organization

1.	Business organization

CVRx, Inc. (the “Company”) was incorporated in Delaware and is headquartered in Minneapolis, Minnesota. The Company has developed and is marketing a medical device, Barostim, for heart failure (“HF”) and resistant hypertension. The Company is focused on the sale of its product in the U.S. and Europe.

Management expects that operating losses and negative cash flows from operations could continue in the foreseeable future. There is no assurance that the Company will generate sufficient product sales to produce positive earnings or cash flows.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2021

Summary of Significant Accounting Policies [Abstract]

Summary of significant accounting policies

2.	Summary of significant accounting policies

Statement presentation and basis of consolidation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and with the applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”).

The consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy. All intercompany balances and transactions have been eliminated in consolidation.

JOBS Act accounting election

The Company is an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, the Company has elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies.

Use of estimates

Preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.

Cash and cash equivalents

Cash and cash equivalents include highly liquid investments with an original maturity of three months or less. As of December 31, 2021 and 2020, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value.

Accounts Receivable

Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the standard generally being net 30 days. We do not record an allowance on our trade accounts receivable but monitor the collectability of individual customer accounts on an ongoing basis.

Inventory

Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company regularly reviews inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate.

Revenue recognition

The Company sells its products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. The Company’s revenue consists primarily of the sale of its Barostim, which consists of two implantable components: a pulse generator and a stimulation lead.

Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”), revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. The Company recognizes net revenue on product sales when the customer obtains control of the Company’s product, which generally occurs at a point in time upon delivery based on the contractual shipping terms of a contract.

Stock-Based Compensation

We recognize equity-based compensation expense for awards of equity instruments to employees and non- employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all equity-based compensation awards to employees and nonemployee directors, including grants of restricted shares and stock options, to be recognized as expense in the statements of operations and comprehensive loss based on their grant date fair values. We estimate the grant date fair value of stock options using the Black-Scholes option pricing model. We use an estimate of the value of our common stock, with the assistance of an independent appraiser, to determine the fair value of options. We account for forfeitures as they occur. We expense the fair value of our equity-based compensation awards granted to employees on a straight-line basis over the associated service period, which is generally the period in which the related services are received.

Recently accounting pronouncements

In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-02, Leases (“Topic 842”). The purpose of Topic 842 is to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet, including those previously classified as operating leases under current U.S. GAAP and disclosing key information about leasing arrangements. Topic 842 is effective for private companies and smaller reporting companies for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted, and the Company must elect whether the date of initial application is the beginning of the earliest comparative period presented in the financial statements, or the beginning of the period of adoption. Under the alternative modified retrospective transition approach, the reported results for 2022 reflect the application of Topic 842 guidance, whereas comparative periods and their respective disclosures prior to the adoption of Topic 842 are presented using the legacy guidance of Accounting Standards Classification (“ASC”) 840. As a result of adopting the new standard, the Company will recognize right-of-use assets of $579,000 and lease liabilities of $561,000 million as of January 1, 2022. The

difference between the amount of right-of-use assets and lease liabilities recognized includes adjustments to prepaid rent. There will be no change to net deferred tax balances as a result of the Company’s adoption of Topic 842. The adoption of Topic 842 did not impact the Company’s results of operations or cash flows.

Selected Balance Sheet Information

12 Months Ended

Dec. 31, 2021

Selected Balance Sheet Information [Abstract]

Selected balance sheet information

3.	Selected balance sheet information

Inventory consists of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Raw material	$	1,593	$	1,361
Work-in-process		482		321
Finished goods		1,805		1,661
	$	3,880	$	3,343

Property and equipment, net consists of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Office furniture and equipment	$	271	$	189
Lab equipment		1,565		1,272
Computer equipment and software		556		516
Leasehold improvements		88		44
Capital equipment in process		813		89
		3,293		2,110
Less: Accumulated depreciation and amortization		1,868		1,700
	$	1,425	$	410

Depreciation expense was $0.2 million and $0.1 million for the years ended December 31, 2021 and 2020, respectively.

Accrued expenses consist of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Clinical trial and other professional fees	$	1,607	$	1,690
Bonuses		2,028		794
Paid time off		699		552
Customer rebates		380		—
Taxes		351		42
Interest payable		—		356
Other		333		149
	$	5,398	$	3,583

Fair Value Measurements

12 Months Ended

Dec. 31, 2021

Fair Value Measurements [Abstract]

Fair value measurements

4.	Fair value measurements

Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows:

●	Level 1 — Inputs are quoted prices in active markets for identical assets or liabilities.

●

Level 2 — Inputs include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and inputs (other than quoted prices) that are observable for the asset or liability, either directly or indirectly.

●	Level 3 — Inputs are unobservable for the asset or liability.

The following table sets forth the Company’s liabilities that were measured at fair value on a recurring basis by level within the fair value hierarchy. There was no convertible preferred stock warrant liability as of December 31, 2021.


(in thousands)
Balance as of December 31, 2020	Level 1		Level 2		Level 3		Total
Liabilities:
Convertible preferred stock warrant liability	$	—	$	—	$	3,911	$	3,911
Total liabilities	$	—	$	—	$	3,911	$	3,911

The convertible preferred stock warrant liability related to warrants issued in connection with loan and security agreements entered into in September 2014, as amended in July 2015, in May 2016 and in September 2019. These warrants were originally issued to purchase shares of Series F-2 convertible preferred stock and Series G convertible preferred stock (“Series G Preferred Shares”). In connection with the closing of the initial public offering (“IPO”), these convertible preferred stock warrants became warrants to purchase 108,406 shares of common stock and were reclassified to equity.

The convertible preferred stock warrant liability also related to a warrant issued to Biosense Webster, Inc. (“BWI”), an affiliate of Johnson & Johnson Innovation — JJDC, Inc., to purchase Series G Preferred Shares with an exercise price of $0.01 per share. In connection with the closing of the IPO, the BWI warrant to purchase Series G Preferred Shares became exercisable to purchase 607,725 shares of common stock at an exercise price of $0.16 per share.

The Company’s recurring fair value measurements using significant unobservable inputs (Level 3) related solely to the Company’s convertible preferred stock warrant liability. The convertible preferred stock warrant liability was remeasured at each financial reporting period with any changes in fair value being recognized as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. In connection with the closing of the IPO, all of the outstanding convertible preferred stock warrants were converted to common stock warrants. The related liability was remeasured at the time of the IPO and reclassed to additional paid-in capital.

The following table sets forth a summary of changes in the estimated fair value of the Company’s convertible preferred stock warrants during the years ended:


	December 31,
(in thousands)	2021		2020
Beginning of the period	$	3,911	$	3,540
Change in fair value		13,294		371
Conversion to common stock warrants		(17,205)		—
End of the period	$	—	$	3,911

There were no transfers in or out of Level 1, Level 2 or Level 3 fair value measurements during the periods ended December 31, 2021 and 2020.

- 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.

+ References + Details

Debt

12 Months Ended

Dec. 31, 2021

Debt [Abstract]

Debt

Debt

Horizon loan agreement

In September 2019, the Company entered into a loan and security agreement (“Horizon loan agreement”) with Horizon Technology Finance Corporation (“Horizon”) under which it could borrow up to a total of $20.0 million at a floating per annum rate equal to 10% plus the amount by which the 30-day U.S. dollar LIBOR rate on the first business day of the month exceeds 2.2%. The Horizon loan agreement initially required interest only payments through October 2021 and then 36 monthly principal and interest payments beginning in November 2021. A final payment of $0.7 million, equal to 3.5% of the original principal, was due in October 2024. The Horizon loan agreement initially required the Company to maintain cash on deposit of not less than $5.0 million in accounts over which Horizon maintained an account control agreement. This minimum cash on deposit requirement was released in July 2020, following the satisfaction of a financing milestone. The borrowings were collateralized by all or substantially all of the assets of the Company. The Horizon loan agreement required the payment of certain penalties if the loan was paid off prior to maturity for any reason, including pursuant to a subjective acceleration clause, and included various restrictive covenants, including a restriction on the payment of dividends.

In August 2020, the Company entered into an amended agreement with Horizon to extend the interest only period through April 2022, followed by 30 monthly principal and interest payments beginning in May 2022.

In connection with the Horizon loan agreement, the Company recorded $1.1 million of debt issuance costs and discounts as a reduction of long-term debt. Of this total, $0.5 million related to legal fees and an investment bank fee and $0.6 million related to the warrants to purchase Series G Preferred Shares issued by the Company. These warrants were exercisable on the grant date at a price of $0.80 per share and expire in September 2029. The Company used the Black-Scholes option pricing model to determine the grant date fair value of these warrants.

On November 3, 2021 the Company fully repaid all amounts outstanding under the Horizon loan agreement. The total repayment amount was $21.3 million, inclusive of $1.3 million of prepayment and other fees, which represent a loss on extinguishment of debt and are included in Other expense, net on the consolidated statements of operations. The Company was in compliance with all related covenants at the time the principal balance was fully repaid. There was no debt outstanding in relation to the Horizon loan agreement as of December 31, 2021.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI http://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stockholders Equity

12 Months Ended

Dec. 31, 2021

Stockholders' Equity [Abstract]

Stockholders' equity

6.	Stockholders’ equity

Initial Public Offering

During 2016, the Company issued 72,125,000 shares of Series G Preferred Shares at a price of $0.80 per share, for net proceeds to the Company of approximately $57.4 million after deducting offering expenses payable by the Company. The same Series G investors agreed to purchase an additional $35.3 million of Series G Preferred Shares upon the Company’s achievement of a certain operational milestone, subject to limited closing conditions. In January 2019, May 2019 and August 2019, the Series G investors purchased additional Series G Preferred Shares, resulting in net proceeds to the Company of $24.7 million.

In July of 2020, the Company issued 62,500,000 additional Series G Preferred Shares, at a price of $0.80 per share, for net proceeds to the Company of $49.8 million after deducting offering expenses payable by the Company.

On May 31, 2016, holders of the requisite number of the Company’s then-outstanding convertible preferred stock approved the conversion of all preferred stock into shares of the Company’s common stock in connection with a new equity financing. Accordingly, all of the Company’s then-outstanding preferred stock was converted on a one-for-one basis into shares of the Company’s common stock. Under the terms of the equity financing, each prior holder of preferred stock who purchased a required amount of securities in the new financing was entitled to exchange certain of the shares of common stock received in the conversion described above into new prime series of preferred stock corresponding to the series of preferred stock from which the common stock was previously converted. All of the previously held Series A-1, B-1, C-1, D-1, E-1 and F preferred stock had similar features as the Series A-2 preferred stock (“Series A-2 Preferred Shares”), Series B-2 preferred stock (“Series B-2 Preferred Shares”), Series C-2 preferred stock (“Series C-2 Preferred Shares”), Series D-2 preferred stock (“Series D-2 Preferred Shares”), Series E-2 preferred stock (“Series E-2 Preferred Shares”) and Series F-2 preferred stock (“Series F-2 Preferred Shares”) described below. The Series A-2, Series B-2, Series C-2, Series D-2, Series E-2, Series F-2 and Series G Preferred Shares are referred to collectively as the “Preferred Shares.”

As of December 31, 2020, convertible preferred stock consisted of the following:


					Aggregate
					Liquidation
		Issued and	Carrying Value		Preference
	Authorized	Outstanding	(in thousands)		(in thousands)
Series A‑2	2,454,686	2,454,686	$	4,909	$	4,909
Series B‑2	2,963,069	2,963,069		7,526		7,526
Series C‑2	4,308,394	4,308,394		13,141		13,141
Series D‑2	8,631,967	8,631,967		53,518		53,518
Series E‑2	12,114,211	10,135,320		76,826		91,806
Series F‑2	29,773,318	29,548,318		41,663		104,783
Series G	177,125,000	165,500,000		132,400		494,550
	237,370,645	223,541,754	$	329,983	$	770,233

On July 2, 2021, the Company closed its IPO of 8,050,000 shares of its common stock at a public offering price of $18.00 per share, which included 1,050,000 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares, for net proceeds from the IPO, after deducting the underwriting discount and other offering expenses payable by the Company totaling $1.6 million, of $133.2 million.

Upon the closing of the IPO, all shares of convertible preferred stock were automatically converted into common stock. Series G Preferred Shares were converted into common stock on a 15.819-for-1 basis, and all other shares of convertible preferred stock were automatically converted into common stock on a 39.548-for-1 basis. The conversion of the outstanding preferred stock resulted in an aggregate of 11,929,584 shares of common stock. As of December 31, 2021, no preferred stock is outstanding.

Reverse Stock Split

In connection with the IPO, the Company’s Board of Directors and stockholders approved a 1-for-39.548 reverse stock split of the Company’s common stock. The reverse stock split became effective on June 22, 2021. The par value of the common stock was not adjusted as a result of the reverse stock split. Adjustments corresponding to the reverse stock split were made to the ratio at which the convertible preferred stock will convert into common stock in connection with the closing of the IPO. Accordingly, all share and per-share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the reverse stock split and the adjustment of the conversion ratio of the convertible preferred stock.

Preferred Stock Warrants and Common Stock Warrants

In connection with the loan and security agreement entered into by the Company in September 2014 and the amendment in July 2015, the Company issued a warrant to purchase shares of Series F-2 convertible preferred stock.

In connection with the loan and security agreement entered into in May 2016, the Company issued a warrant to purchase Series G Preferred Shares.

The Company issued to BWI a warrant to purchase shares of Series E-2 convertible preferred stock that only would have become exercisable in the event of an acquisition or asset transfer involving the Company and it expired upon our IPO.

In September of 2018, the Company also issued to BWI a warrant to purchase up to 10,000,000 Series G Preferred Shares with an exercise price of $0.01 per share. The warrant to purchase Series G Preferred Shares became exercisable upon our IPO and would have expired on the earlier of (i) an acquisition or asset transfer involving the Company or (ii) 180 days after receipt of the data from the post-market stage of the BeAT-HF pivotal trial.

In connection with the IPO, the warrants to purchase shares of convertible preferred stock automatically converted into warrants to purchase common stock, resulting in the reclassification of the related convertible preferred stock warrant liability to additional paid-in capital. Upon the closing of the IPO these warrants to purchase convertible preferred stock became exercisable for 716,131 shares of common stock upon conversion at a weighted average exercise price of $2.39 per share.

Warrants to purchase shares of our common stock are summarized below:



		Weighted Average
	Common Stock Warrants	Exercise Price
Outstanding at December 31, 2020	—	$	—
Preferred stock warrants converted to common stock warrants at IPO	716,131		2.39
Exercised	—		—
Outstanding at December 31, 2021	716,131	$	2.39

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stock-Based Compensation

12 Months Ended

Dec. 31, 2021

Stock-Based Compensation [Abstract]

Stock-Based Compensation

7.	Stock-Based compensation

Summary of plans and activity

In June 2001, the Company’s Board of Directors and stockholders established the 2001 Stock Incentive Award Plan (“2001 Plan”). Under the 2001 Plan, as amended, 2,674,749 shares of common stock had been reserved for the issuance of incentive stock options granted to employees, nonemployee directors, consultants or independent contractors. Options granted under the 2001 Plan have vesting terms that range from the day of grant to four years and expire within a maximum term of 10 years from the grant date.

In connection with the IPO in 2021, the Company’s Board of Directors and stockholders established the 2021 Equity Incentive Plan (“2021 Plan”). The number of shares of common stock initially reserved for issuance under the 2021 Plan was 1,854,490 newly reserved shares in addition to the 600,373 shares that remained available for issuance under the 2001 Plan. The shares available for issuance under the 2021 Plan will automatically increase on the first day of each year, commencing January 1, 2022 and ending on (and including) January 1, 2031, in an amount equal to 5% of the total number of shares of the Company’s common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The 2021 Plan provides for the

issuance of stock options, stock appreciation rights, restricted stock awards, stock unit awards and other stock-based awards and cash incentive awards to employees, consultants and non-employee directors of the Company and its subsidiaries. Awards granted under the 2021 Plan will have such vesting schedules and other terms as determined by the Compensation Committee and stock options and stock appreciation rights have a maximum term of 10 years from the grant date. No further awards can be made under the 2001 Plan following the adoption of the 2021 Plan. As of December 31, 2021, there were 1,789,453 shares available for future issuance under the 2021 Plan.

Options are granted at exercise prices not less than the fair market value (as determined by the Board of Directors) of the Company’s common stock on the date of grant.

During the years 2008 through December 31, 2021, the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain nonemployee directors. The options were not granted under the 2001 Plan or the 2021 Plan, but terms are substantially the same as the Company’s standard form of option agreement for nonemployee directors as they have an exercise price not less than the fair market value on the grant date and vest over 48 months from the date of grant.

The following is a summary of stock option activity:


		Weighted
	Number	Average		Aggregate
	of	Exercise		Intrinsic
	Options	Price		Value
				(in thousands)
Balance as of December 31, 2019	966,146	$	1.58		$	2,256
Granted	517,566	$	4.35
Cancelled / Forfeited	(10,178)	$	4.35
Exercised	(175)	$	0.40
Balance as of December 31, 2020	1,473,359	$	2.77		$	3,745
Granted	1,411,717	$	13.31
Cancelled / Forfeited	(76,294)	$	11.25
Exercised	(59,341)	$	0.39
Balance as of December 31, 2021	2,749,441	$	7.93		$	16,262
Options exercisable as of December 31, 2021	1,060,820	$	2.53		$	10,303

As of December 31, 2021, stock options outstanding included 9,993 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of December 31, 2021, the weighted average remaining contractual life was 8.1 years. For options exercisable as of December 31, 2021, the weighted average remaining contractual life was 6.6 years.

In connection with the IPO, the Company’s Board of Directors and stockholders also established an Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock initially reserved for issuance under the ESPP was 278,170. The shares available for issuance under the ESPP will automatically increase on the first day of each year, commencing January 1, 2022 and ending on (and including) January 1, 2031, in an amount equal to 1% of the total number of shares of the Company’s common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The ESPP will permit certain of the Company’s U.S. employees to purchase shares of the Company’s common stock at a price per share not less than 85% of the lower of (i) the closing market price per share of the Company’s common stock on the first day of the applicable purchase period or (ii) the closing market price per share of the Company’s common stock on the purchase date at the end of the applicable six-month purchase period. The first purchase period commenced January 1, 2022. Accordingly, as of December 31, 2021, no shares of common stock have been purchased under the ESPP.

Stock-based compensation expense

The Company uses the Black-Scholes option pricing model to determine the fair value of stock options on the grant date. The Company measures stock-based compensation expense based on the grant date fair value of the award and recognizes compensation expense over the requisite service period, which is generally the vesting period. The amount of stock-based compensation expense recognized during a period is based on the portion of the awards that are ultimately expected to vest. The Company accounts for forfeitures as they occur.

The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the years ended December 31, 2021 and 2020.


		Year ended December 31,
		2021		2020
Weighted average fair value of options granted	$	5.64		$	1.98
Expected term (in years) — non-officer employees		2.7 to 6.1			2.7
Expected term (in years) — officer employees		3.0			3.0
Expected volatility		56.1% to 63.4	%		62.6	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		0.17% to 1.44	%		0.16% to 0.18	%

The Company reviews these assumptions on a periodic basis and adjusts them, as necessary. The expected term of an award was determined based on the Company’s analysis of historical exercise behavior while taking into consideration various participant demographics and option characteristics. We utilize the simplified method to develop the estimate of the expected term. The expected volatility is based upon observed volatility of comparable public companies. The expected dividend yield is assumed to be zero, as the Company has never paid dividends and has no current plans to do so. The risk-free interest rate is based on the yield on U.S. Treasury securities for a period approximating the expected term of the options being valued.

For the years ended December 31, 2021 and 2020, the Company recognized stock-based compensation expense as follows:


	Year Ended December 31,
(in thousands)	2021		2020
Selling, general & administrative	$	1,468	$	88
Research & development		420		43
Cost of goods sold		24		1
	$	1,912	$	132

As of December 31, 2021, unrecognized compensation expense related to unvested stock-based compensation arrangements was $6.9 million. As of December 31, 2021, the related weighted average period over which it is expected to be recognized is approximately 3.3 years.

Early exercise of stock options

Under the 2001 Plan, the Company has issued options to certain executive officers with early-exercise provisions. The options may be exercised by the holder any time after they are granted. The Company has the right to repurchase, at the original option exercise price, shares issued pursuant to such early-exercise provisions, upon the termination of employment or death of the stockholder. This repurchase right expires based upon the original option vesting schedule. As of December 31, 2021 and 2020, there have been no early exercises and therefore there is no liability recorded for the early exercise of stock options.

Income Taxes

12 Months Ended

Dec. 31, 2021

Income Taxes [Abstract]

Income taxes

8.	Income taxes

As of December 31, 2021 and 2020, a valuation allowance was recorded against all deferred tax assets due to the Company’s cumulative net loss position.

The components of our provision for income taxes are as follows:


		Year Ended December 31,
(in thousands)		2021		2020
Current
Federal and state	$	—	$	—
Foreign		91		85
Total current		91		85
Total provision for income taxes	$	91	$	85

Provision for income taxes for the years ended December 31, 2021 and 2020 was $91,000 and $85,000, respectively.

The reconciliation of taxes at the federal statutory rate to our provision for income taxes are as follows:


	Year Ended December 31,
	2021		2020
Tax at federal statutory rate	21.0	%	21.0	%
Permanent differences	(9.0)		(0.5)
Research and development ("R&D") tax credit	0.9		2.6
Uncertain tax position	(0.2)		(0.5)
State, net of federal benefit	(0.7)		0.3
Deferred rate change	2.5		(0.3)
Change in valuation allowance	(14.7)		(23.2)
Total	(0.2)	%	(0.6)	%

Significant components of net deferred tax assets were as follows:


		Year Ended December 31,
(in thousands)		2021		2020
Deferred tax assets
Net operating loss carryforwards	$	74,716	$	68,957
R&D tax credits		8,711		8,318
IRC Section 59e election		8,577		7,955
Start-up costs		1,104		1,198
Non-qualified stock options		350		136
Property and equipment		91		90
Accrued vacation		151		106
Preferred stock warrants		-		607
Other		59		67
Total deferred tax assets		93,759		87,434
Valuation allowance		(93,759)		(87,434)
Net deferred tax assets	$	—	$	—

As of December 31, 2021, the Company had federal and state net operating loss carryforwards (“NOLs”) of approximately $324.8 million and $6.5 million, respectively. The federal NOLs began expiring in 2021 and the state NOLs began expiring in 2020. As of December 31, 2021, the Company had federal and state tax credit carryforwards of approximately $8.9 million and $1.6 million, respectively. The federal tax credit carryforwards began expiring in 2021 and the state tax credits began expiring in 2028.

Utilization of NOLs may be subject to an annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The Company has not performed a detailed analysis to determine whether an ownership change has occurred. Such a change of ownership would limit the Company’s utilization of the NOLs and could be triggered by subsequent sales of securities by the Company or its stockholders.

The changes to our gross unrecognized tax benefits were as follows:


		Year Ended December 31,
(in thousands)		2021		2020
Gross unrecognized tax benefits at beginning of year	$	1,840	$	1,757
Gross increases:
Prior year tax positions		10		—
Current year tax positions		91		83
Gross decreases:
Prior year tax positions		(2)		—
Gross unrecognized tax benefits at end of year	$	1,939	$	1,840

All of these unrecognized tax benefits, if recognized, would impact the effective tax rate before taking consideration of the valuation allowance. The Company recognized approximately $61,000 and $56,000 of interest or penalties for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021 and 2020, total accrued interest and penalties are $0.3 million and $0.3 million, respectively. The Company recognizes accrued interest and penalties related to unrecognized tax positions as a component of income tax expense. The Company does not expect a significant change in the amount of unrecognized tax benefits in the next year.

The Company is subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. Tax years from 2001 through present remain open for audit under the applicable statute of limitations due to the carryover of the unused NOLs and tax credit carryforwards. The Company does not have any tax audits or other proceedings pending.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

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+ Details

(Loss) Earnings Per Share

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

(Loss) Earnings Per Share

9. (Loss) Earnings Per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data):


	Year Ended December 31,
(in thousands)	2021		2020
Numerator:
Net loss	$	(43,078)	$	(14,109)
Accretion of preferred stock to redemption value		—		(217)
Net loss attributable to common stockholders	$	(43,078)	$	(14,326)
Denominator:
Weighted average common shares outstanding — basic and diluted		10,360,054		387,083
Net loss per share attributable to common stockholders — basic and diluted	$	(4.16)	$	(37.01)

The Company’s potentially dilutive securities, which include stock options, shares of convertible preferred stock, warrants to purchase shares of convertible preferred stock and warrants to purchase shares of common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders, as the effect would be to reduce the net loss per share attributable to common stockholders. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period

end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:


	Year Ended December 31,
	2021	2020
Options to purchase common stock	2,749,441	1,473,359
Warrants to purchase redeemable convertible preferred stock (as converted to common stock)	—	108,406
Warrants to purchase common stock	716,131	—
Redeemable convertible preferred stock (as converted to common stock)	—	11,929,584
	3,465,572	13,511,349

Commitments and Contingencies

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies [Abstract]

Commitments and contingencies

10.

Commitments and contingencies

Commitments

Operating Leases

The Company has entered into an operating lease agreement for its office, manufacturing and research facility, which expires in 2024. Rent expense for the years ended December 31, 2021 and 2020 was $0.4 million and $0.4 million, respectively.

Future minimum lease payments under all operating leases as of December 31, 2021 are as follows for the years ending:


(in thousands)
December 31, 2022	$	227
December 31, 2023		234
December 31, 2024		138
	$	599

Contingencies

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual or disclosure as of December 31, 2021 or December 31, 2020.

Employee Benefit Plans

12 Months Ended

Dec. 31, 2021

Employee Benefit Plans [Abstract]

Employee benefit plans

11.

Employee benefit plans

The Company sponsors a voluntary defined-contribution employee retirement plan (the “401(k) plan”) for its U.S. employees. The 401(k) plan provides that each participant may contribute pre-tax or post-tax compensation up to the statutory limit allowable. Under the 401(k) plan, each participant is fully vested in his or her deferred salary contributions when contributed. The Company does not provide matching contributions to employees.

Segment, Geographic Information and Revenue Disaggregation

12 Months Ended

Dec. 31, 2021

Segment, Geographic Information and Revenue Disaggregation [Abstract]

Segment, geographic information and revenue disaggregation

12.

Segment, geographic information and revenue disaggregation

The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The Company

and its Chief Executive Officer evaluate performance based primarily on revenue in the geographic locations in which the Company operates.

The Company derives all its revenues from sales to customers in Europe and the U.S. The following table provides revenue by country for each location accounting for more than 10% of the total revenue for the years ended:


	Year ended
	December 31,
(in thousands)	2021		2020
U.S.	$	9,147	$	1,733
Germany		3,250		3,790
Other countries		639		530
	$	13,036	$	6,053

As of December 31, 2021 and 2020, long-lived assets were located primarily in the U.S.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
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+ Details

Summary of Significant Accounting Policies (Policies)	12 Months Ended
Summary of Significant Accounting Policies (Policies)	Dec. 31, 2021
Summary of Significant Accounting Policies [Abstract]
Statement presentation and basis of consolidation	Statement presentation and basis of consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and with the applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy. All intercompany balances and transactions have been eliminated in consolidation.
JOBS Act accounting election	JOBS Act accounting election The Company is an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, the Company has elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies.
Use of estimates	Use of estimates Preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.
Cash and cash equivalents	Cash and cash equivalents Cash and cash equivalents include highly liquid investments with an original maturity of three months or less. As of December 31, 2021 and 2020, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value.
Accounts Receivable	Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the standard generally being net 30 days. We do not record an allowance on our trade accounts receivable but monitor the collectability of individual customer accounts on an ongoing basis.
Inventory	Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company regularly reviews inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate.
Revenue recognition	Revenue recognition The Company sells its products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. The Company’s revenue consists primarily of the sale of its Barostim, which consists of two implantable components: a pulse generator and a stimulation lead. Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”), revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. The Company recognizes net revenue on product sales when the customer obtains control of the Company’s product, which generally occurs at a point in time upon delivery based on the contractual shipping terms of a contract.
Stock-Based Compensation	Stock-Based Compensation We recognize equity-based compensation expense for awards of equity instruments to employees and non- employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all equity-based compensation awards to employees and nonemployee directors, including grants of restricted shares and stock options, to be recognized as expense in the statements of operations and comprehensive loss based on their grant date fair values. We estimate the grant date fair value of stock options using the Black-Scholes option pricing model. We use an estimate of the value of our common stock, with the assistance of an independent appraiser, to determine the fair value of options. We account for forfeitures as they occur. We expense the fair value of our equity-based compensation awards granted to employees on a straight-line basis over the associated service period, which is generally the period in which the related services are received.
Recent accounting pronouncements	Recently accounting pronouncements In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-02, Leases (“Topic 842”). The purpose of Topic 842 is to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet, including those previously classified as operating leases under current U.S. GAAP and disclosing key information about leasing arrangements. Topic 842 is effective for private companies and smaller reporting companies for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted, and the Company must elect whether the date of initial application is the beginning of the earliest comparative period presented in the financial statements, or the beginning of the period of adoption. Under the alternative modified retrospective transition approach, the reported results for 2022 reflect the application of Topic 842 guidance, whereas comparative periods and their respective disclosures prior to the adoption of Topic 842 are presented using the legacy guidance of Accounting Standards Classification (“ASC”) 840. As a result of adopting the new standard, the Company will recognize right-of-use assets of $579,000 and lease liabilities of $561,000 million as of January 1, 2022. The difference between the amount of right-of-use assets and lease liabilities recognized includes adjustments to prepaid rent. There will be no change to net deferred tax balances as a result of the Company’s adoption of Topic 842. The adoption of Topic 842 did not impact the Company’s results of operations or cash flows.

Selected Balance Sheet Information (Tables)

12 Months Ended

Dec. 31, 2021

Selected Balance Sheet Information [Abstract]

Schedule of Inventory

Inventory consists of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Raw material	$	1,593	$	1,361
Work-in-process		482		321
Finished goods		1,805		1,661
	$	3,880	$	3,343

Schedule of Property and Equipment, Net

Property and equipment, net consists of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Office furniture and equipment	$	271	$	189
Lab equipment		1,565		1,272
Computer equipment and software		556		516
Leasehold improvements		88		44
Capital equipment in process		813		89
		3,293		2,110
Less: Accumulated depreciation and amortization		1,868		1,700
	$	1,425	$	410

Schedule of Accrued Expenses

Accrued expenses consist of the following at:


	December 31,		December 31,
(in thousands)	2021		2020
Clinical trial and other professional fees	$	1,607	$	1,690
Bonuses		2,028		794
Paid time off		699		552
Customer rebates		380		—
Taxes		351		42
Interest payable		—		356
Other		333		149
	$	5,398	$	3,583

Fair value measurements (Tables)

12 Months Ended

Dec. 31, 2021

Fair Value Measurements [Abstract]

Liabilities Measured at Fair Value on a Recurring Basis


(in thousands)
Balance as of December 31, 2020	Level 1		Level 2		Level 3		Total
Liabilities:
Convertible preferred stock warrant liability	$	—	$	—	$	3,911	$	3,911
Total liabilities	$	—	$	—	$	3,911	$	3,911

Fair Value of the Company's Convertible Preferred Stock Warrants

The following table sets forth a summary of changes in the estimated fair value of the Company’s convertible preferred stock warrants during the years ended:


	December 31,
(in thousands)	2021		2020
Beginning of the period	$	3,911	$	3,540
Change in fair value		13,294		371
Conversion to common stock warrants		(17,205)		—
End of the period	$	—	$	3,911

Stockholders Equity (Tables)

12 Months Ended

Dec. 31, 2021

Stockholders' Equity [Abstract]

Schedule of Convertible Preferred Stock

As of December 31, 2020, convertible preferred stock consisted of the following:


					Aggregate
					Liquidation
		Issued and	Carrying Value		Preference
	Authorized	Outstanding	(in thousands)		(in thousands)
Series A‑2	2,454,686	2,454,686	$	4,909	$	4,909
Series B‑2	2,963,069	2,963,069		7,526		7,526
Series C‑2	4,308,394	4,308,394		13,141		13,141
Series D‑2	8,631,967	8,631,967		53,518		53,518
Series E‑2	12,114,211	10,135,320		76,826		91,806
Series F‑2	29,773,318	29,548,318		41,663		104,783
Series G	177,125,000	165,500,000		132,400		494,550
	237,370,645	223,541,754	$	329,983	$	770,233

Summary of Warrants to Purchase Shares

Warrants to purchase shares of our common stock are summarized below:



		Weighted Average
	Common Stock Warrants	Exercise Price
Outstanding at December 31, 2020	—	$	—
Preferred stock warrants converted to common stock warrants at IPO	716,131		2.39
Exercised	—		—
Outstanding at December 31, 2021	716,131	$	2.39

Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2021

Stock-Based Compensation [Abstract]

Schedule of Stock Option Activity

The following is a summary of stock option activity:


		Weighted
	Number	Average		Aggregate
	of	Exercise		Intrinsic
	Options	Price		Value
				(in thousands)
Balance as of December 31, 2019	966,146	$	1.58		$	2,256
Granted	517,566	$	4.35
Cancelled / Forfeited	(10,178)	$	4.35
Exercised	(175)	$	0.40
Balance as of December 31, 2020	1,473,359	$	2.77		$	3,745
Granted	1,411,717	$	13.31
Cancelled / Forfeited	(76,294)	$	11.25
Exercised	(59,341)	$	0.39
Balance as of December 31, 2021	2,749,441	$	7.93		$	16,262
Options exercisable as of December 31, 2021	1,060,820	$	2.53		$	10,303

Schedule of Assumptions Used to Determine the Grant-Date Fair Value of Stock Options


		Year ended December 31,
		2021		2020
Weighted average fair value of options granted	$	5.64		$	1.98
Expected term (in years) — non-officer employees		2.7 to 6.1			2.7
Expected term (in years) — officer employees		3.0			3.0
Expected volatility		56.1% to 63.4	%		62.6	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		0.17% to 1.44	%		0.16% to 0.18	%

Recognized Stock-Based Compensation Expense

For the years ended December 31, 2021 and 2020, the Company recognized stock-based compensation expense as follows:


	Year Ended December 31,
(in thousands)	2021		2020
Selling, general & administrative	$	1,468	$	88
Research & development		420		43
Cost of goods sold		24		1
	$	1,912	$	132

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2021

Income Taxes [Abstract]

Components of Provision for Income Taxes

The components of our provision for income taxes are as follows:


		Year Ended December 31,
(in thousands)		2021		2020
Current
Federal and state	$	—	$	—
Foreign		91		85
Total current		91		85
Total provision for income taxes	$	91	$	85

Reconciliation of Taxes at the Federal Statutory Rate

The reconciliation of taxes at the federal statutory rate to our provision for income taxes are as follows:


	Year Ended December 31,
	2021		2020
Tax at federal statutory rate	21.0	%	21.0	%
Permanent differences	(9.0)		(0.5)
Research and development ("R&D") tax credit	0.9		2.6
Uncertain tax position	(0.2)		(0.5)
State, net of federal benefit	(0.7)		0.3
Deferred rate change	2.5		(0.3)
Change in valuation allowance	(14.7)		(23.2)
Total	(0.2)	%	(0.6)	%

Components of Net Deferred Tax Assets


	Year Ended December 31,
	2021		2020
Tax at federal statutory rate	21.0	%	21.0	%
Permanent differences	(9.0)		(0.5)
Research and development ("R&D") tax credit	0.9		2.6
Uncertain tax position	(0.2)		(0.5)
State, net of federal benefit	(0.7)		0.3
Deferred rate change	2.5		(0.3)
Change in valuation allowance	(14.7)		(23.2)
Total	(0.2)	%	(0.6)	%

Changes to Gross Unrecognized Tax Benefits

The changes to our gross unrecognized tax benefits were as follows:


		Year Ended December 31,
(in thousands)		2021		2020
Gross unrecognized tax benefits at beginning of year	$	1,840	$	1,757
Gross increases:
Prior year tax positions		10		—
Current year tax positions		91		83
Gross decreases:
Prior year tax positions		(2)		—
Gross unrecognized tax benefits at end of year	$	1,939	$	1,840

(Loss) Earnings Per Share (Tables)

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

Basic and Diluted Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data):


	Year Ended December 31,
(in thousands)	2021		2020
Numerator:
Net loss	$	(43,078)	$	(14,109)
Accretion of preferred stock to redemption value		—		(217)
Net loss attributable to common stockholders	$	(43,078)	$	(14,326)
Denominator:
Weighted average common shares outstanding — basic and diluted		10,360,054		387,083
Net loss per share attributable to common stockholders — basic and diluted	$	(4.16)	$	(37.01)

Antidilutive Securities Excluded from Computation of Earnings Per Share


	Year Ended December 31,
	2021	2020
Options to purchase common stock	2,749,441	1,473,359
Warrants to purchase redeemable convertible preferred stock (as converted to common stock)	—	108,406
Warrants to purchase common stock	716,131	—
Redeemable convertible preferred stock (as converted to common stock)	—	11,929,584
	3,465,572	13,511,349

Commitments and Contingencies (Tables)

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies [Abstract]

Schedule of Future Minimum Lease Payments

Future minimum lease payments under all operating leases as of December 31, 2021 are as follows for the years ending:


(in thousands)
December 31, 2022	$	227
December 31, 2023		234
December 31, 2024		138
	$	599

Segment, Geographic Information and Revenue Disaggregation (Tables)

12 Months Ended

Dec. 31, 2021

Segment, Geographic Information and Revenue Disaggregation [Abstract]

Schedule of Segment Reporting


	Year ended
	December 31,
(in thousands)	2021		2020
U.S.	$	9,147	$	1,733
Germany		3,250		3,790
Other countries		639		530
	$	13,036	$	6,053

Summary of significant accounting policies (Details) - Cumulative Effect, Period of Adoption, Adjustment $ in Millions	Jan. 01, 2022 USD ($)
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Right-of-use assets	$ 579,000
lease liabilities	$ 561,000

Selected Balance Sheet Information (Narrative) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Selected Balance Sheet Information [Abstract]
Depreciation	$ 168	$ 75

Selected Balance Sheet Information (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Selected Balance Sheet Information [Abstract]
Raw material	$ 1,593	$ 1,361
Work-in-process	482	321
Finished goods	1,805	1,661
Total inventory	$ 3,880	$ 3,343

Selected Balance Sheet Information (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 3,293	$ 2,110
Less: Accumulated depreciation and amortization	1,868	1,700
Property and equipment, net	1,425	410
Office furniture and equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	271	189
Lab equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,565	1,272
Computer equipment and software
Property, Plant and Equipment [Line Items]
Property and equipment, gross	556	516
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property and equipment, gross	88	44
Capital equipment in process
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 813	$ 89

Selected Balance Sheet Information (Schedule of Accrued Expenses) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Selected Balance Sheet Information [Abstract]
Clinical trial and other professional fees	$ 1,607	$ 1,690
Bonuses	2,028	794
Paid time off	699	552
Customer rebates	380
Taxes	351	42
Interest payable		356
Other	333	149
Total accrued expenses	$ 5,398	$ 3,583

Fair value measurements (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Jul. 02, 2021	Dec. 31, 2021	Dec. 31, 2020	Sep. 30, 2018
Warrant exercise price		$ 2.39	$ 0
Transfer from level 1 to 2		$ 0	$ 0
Transfer from level 2 to level 1		0	0
Transfer into level 3		0	0
Transfer out of level 3		$ 0	$ 0
Warrants to Purchase Series G Preferred Shares \| Biosense Webster, Inc.
Number of common shares converted from warrants	607,725
Warrant exercise price	$ 0.16			$ 0.01
Warrant outstanding term				180 days
Warrants to purchase common stock
Number of common shares converted from warrants	108,406

Fair Value Measurements (Liabilities Measured at Fair Value on a Recurring Basis) (Details) - Recurring $ in Thousands	Dec. 31, 2020 USD ($)
Liabilities:
Total liabilities	$ 3,911
Convertible Preferred Stock Warrant Liability [Member]
Liabilities:
Total liabilities	3,911
Level 1
Liabilities:
Total liabilities	0
Level 1 \| Convertible Preferred Stock Warrant Liability [Member]
Liabilities:
Total liabilities	0
Level 2
Liabilities:
Total liabilities	0
Level 2 \| Convertible Preferred Stock Warrant Liability [Member]
Liabilities:
Total liabilities	0
Level 3
Liabilities:
Total liabilities	3,911
Level 3 \| Convertible Preferred Stock Warrant Liability [Member]
Liabilities:
Total liabilities	$ 3,911

Fair Value Measurements (Fair Value of Convertible Preferred Stock Warrants) (Details) - Convertible Preferred Stock Warrant Liability [Member] - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning of the period	$ 3,911	$ 3,540
Change in fair value	13,294	371
Conversion to common stock warrants	(17,205)	0
End of the period	$ 0	$ 3,911

Debt (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended		12 Months Ended
	Nov. 03, 2021	Aug. 31, 2020	Sep. 30, 2019	Dec. 31, 2021	Dec. 31, 2020
Debt Instrument [Line Items]
Exercise price				$ 2.39	$ 0
Prepayment and other fees,				$ (1,325)	$ 0
Horizon Technology Finance Corporation [Member]
Debt Instrument [Line Items]
Long-term debt				$ 0
Convertible Preferred Stock Warrant Liability [Member]
Debt Instrument [Line Items]
Issuance costs of warrants			$ 600
Exercise price			$ 0.80
Loan and Security Agreement [Member] \| Horizon Technology Finance Corporation [Member]
Debt Instrument [Line Items]
Maximum borrowing capacity			$ 20,000
Interest rate on first business day of month (as a percent)			2.20%
Term (in months)		30 months	36 months
Final payment			$ 700
Percentage of final payment on original principal			3.50%
Minimum cash on deposit requirement			$ 5,000
Debt issuance costs and discounts			1,100
Legal fees and an investment bank fee			$ 500
Total debt extinguishment cost	$ 21,300
Loan and Security Agreement [Member] \| Horizon Technology Finance Corporation [Member] \| Other expense, net
Debt Instrument [Line Items]
Prepayment and other fees,	$ 1,300
Loan and Security Agreement [Member] \| LIBOR [Member] \| Horizon Technology Finance Corporation [Member]
Debt Instrument [Line Items]
Interest rate (as a percent)			10.00%

Stockholders Equity (Narrative) (Details) $ / shares in Units, $ in Millions			1 Months Ended				12 Months Ended
	Jul. 02, 2021 USD ($) $ / shares shares	Jun. 22, 2021	Jul. 31, 2020 USD ($) $ / shares shares	Aug. 31, 2019 USD ($)	May 31, 2019 USD ($)	Jan. 31, 2019 USD ($)	Dec. 31, 2021 $ / shares shares	Dec. 31, 2016 USD ($) $ / shares shares	Dec. 31, 2020 $ / shares	Sep. 30, 2018 $ / shares shares	May 31, 2016
Temporary Equity [Line Items]
Shares issued							0
Temporary equity share price (in dollars per share) \| $ / shares							$ 0.01		$ 0.01
Preferred stock warrants converted to common stock warrants at IPO							716,131
Preferred stock warrants converted to common stock warrants at IPO, Weighted Average Exercise Price \| $ / shares							$ 2.39
Conversion ratio							39.548
Reverse stock split		0.025
Conversion of convertible preferred stock (in shares)	11,929,584
Warrant exercise price \| $ / shares							$ 2.39		$ 0
Warrants to purchase common stock
Temporary Equity [Line Items]
Preferred stock warrants converted to common stock warrants at IPO							716,131
Preferred stock warrants converted to common stock warrants at IPO, Weighted Average Exercise Price \| $ / shares							$ 2.39
Warrants to Purchase Series G Preferred Shares \| Biosense Webster, Inc.
Temporary Equity [Line Items]
Warrants to purchase shares										10,000,000
Warrant exercise price \| $ / shares	$ 0.16									$ 0.01
Warrant outstanding term										180 days
IPO
Temporary Equity [Line Items]
Shares issued	8,050,000
Share price \| $ / shares	$ 18.00
Payment of stock issuance costs \| $	$ 1.6
Net proceeds \| $	$ 133.2
Underwriters option
Temporary Equity [Line Items]
Shares issued	1,050,000
Series G Preferred Shares
Temporary Equity [Line Items]
Shares issued			62,500,000					72,125,000
Temporary equity share price (in dollars per share) \| $ / shares			$ 0.80					$ 0.80
Proceeds from Issuance of Redeemable Convertible Preferred Stock \| $			$ 49.8	$ 24.7	$ 24.7	$ 24.7		$ 57.4
Conversion ratio							15.819				1
Series G Preferred Shares \| Operational milestone closing
Temporary Equity [Line Items]
Proceeds from Issuance of Redeemable Convertible Preferred Stock \| $								$ 35.3

Stockholders Equity (Schedule of Convertible Preferred Stock) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Temporary Equity [Line Items]
Preferred stock authorized	10,000,000	237,370,645
Preferred stock issued	0	223,541,754
Preferred stock outstanding	0	223,541,754
Redeemable convertible preferred stock, Carrying Value	$ 0	$ 329,983
Aggregate Liquidation Preference		$ 770,233
Series A2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		2,454,686
Preferred stock issued		2,454,686
Preferred stock outstanding		2,454,686
Redeemable convertible preferred stock, Carrying Value		$ 4,909
Aggregate Liquidation Preference		$ 4,909
Series B2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		2,963,069
Preferred stock issued		2,963,069
Preferred stock outstanding		2,963,069
Redeemable convertible preferred stock, Carrying Value		$ 7,526
Aggregate Liquidation Preference		$ 7,526
Series C2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		4,308,394
Preferred stock issued		4,308,394
Preferred stock outstanding		4,308,394
Redeemable convertible preferred stock, Carrying Value		$ 13,141
Aggregate Liquidation Preference		$ 13,141
Series D2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		8,631,967
Preferred stock issued		8,631,967
Preferred stock outstanding		8,631,967
Redeemable convertible preferred stock, Carrying Value		$ 53,518
Aggregate Liquidation Preference		$ 53,518
Series E2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		12,114,211
Preferred stock issued		10,135,320
Preferred stock outstanding		10,135,320
Redeemable convertible preferred stock, Carrying Value		$ 76,826
Aggregate Liquidation Preference		$ 91,806
Series F2 Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		29,773,318
Preferred stock issued		29,548,318
Preferred stock outstanding		29,548,318
Redeemable convertible preferred stock, Carrying Value		$ 41,663
Aggregate Liquidation Preference		$ 104,783
Series G Preferred Shares
Temporary Equity [Line Items]
Preferred stock authorized		177,125,000
Preferred stock issued		165,500,000
Preferred stock outstanding		165,500,000
Redeemable convertible preferred stock, Carrying Value		$ 132,400
Aggregate Liquidation Preference		$ 494,550

Stockholders Equity (Summary of Warrants) (Details)	12 Months Ended
Stockholders Equity (Summary of Warrants) (Details)	Dec. 31, 2021 $ / shares shares
Stockholders' Equity [Abstract]
Common Stock Warrants, Outstanding \| shares	0
Preferred stock warrants converted to common stock warrants at IPO \| shares	716,131
Exercised \| shares	0
Common Stock Warrants, Outstanding \| shares	716,131
Warrants Outstanding, Weighted Average Exercise Price \| $ / shares	$ 0
Preferred stock warrants converted to common stock warrants at IPO, Weighted Average Exercise Price \| $ / shares	2.39
Exercised, Weighted Average Exercise Price \| $ / shares	0
Warrants Outstanding, Weighted average exercise price \| $ / shares	$ 2.39

Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands		12 Months Ended
	Jun. 01, 2021	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options outstanding		2,749,441	1,473,359	966,146
Stock-based compensation expense		$ 1,912	$ 132
Expected dividend yield		0.00%	0.00%
Exercise of stock options (in shares)		59,341	175
2001 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Reserved for future issuance	2,674,749
Number of shares available for grant		600,373
Vesting Period	4 years
2001 Plan \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting Period	10 years
ESPP
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Reserved for future issuance		278,170
Shares issued/purchased under ESPP		0
Annual incremental percentage		1.00%
Minimum Percentage		85.00%
2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Reserved for future issuance		1,854,490
Number of shares available for grant		1,789,453
Annual incremental percentage		5.00%
2021 \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based payment award, term		10 years
Options to purchase common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options outstanding		9,993
Options to purchase common stock \| 2001 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting Period		48 months
Stock options with early exercise option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise of stock options (in shares)		0
Liability recorded			$ 0

Stock-Based Compensation (Summary of Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Number of Options
Outstanding as of Beginning of period (in shares)	1,473,359	966,146
Granted (in shares)	1,411,717	517,566
Cancelled / Forfeited (in shares)	(76,294)	(10,178)
Exercised (in shares)	(59,341)	(175)
Balance as of End of period (in shares)	2,749,441	1,473,359
Options exercisable as of December 31, 2021 (in shares)	1,060,820
Weighted Average Exercise Price
Outstanding as of Beginning of period (in dollars per share)	$ 2.77	$ 1.58
Granted (in dollars per share)	13.31	4.35
Cancelled / Forfeited (in dollars per share)	11.25	4.35
Exercised (in dollars per share)	0.39	0.40
Balance as of End of period (in dollars per share)	7.93	$ 2.77
Options exercisable as of December 31, 2021 (in dollars per share)	$ 2.53
Aggregate Intrinsic Value
Aggregate intrinsic value	$ 16,262	$ 3,745	$ 2,256
Options exercisable as of December 31, 2020	$ 10,303
Weighted average remaining contractual term, outstanding (in years)	8 years 1 month 6 days
Weighted average remaining contractual life, exercisable (in years)	6 years 7 months 6 days
Options to purchase common stock
Number of Options
Balance as of End of period (in shares)	9,993

Stock-Based Compensation (Assumptions Used in Determine the Grant Date Fair Value of Stock Options) (Details) - $ / shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)	1,411,717	517,566
Weighted average fair value of options granted	$ 5.64	$ 1.98
Expected volatility, Minimum	56.10%	62.60%
Expected volatility, Maximum	63.40%
Expected dividend yield	0.00%	0.00%
Risk-free interest rate, Minimum	0.17%	0.16%
Risk-free interest rate, Maximum	1.44%	0.18%
Non officer employees
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)		2 years 8 months 12 days
Non officer employees \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	2 years 8 months 12 days
Non officer employees \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 6 days
Officer employees
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	3 years	3 years

Stock-Based Compensation (Recognized Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,912	$ 132
Unrecognized compensation expense	$ 6,900
Weighted average period	3 years 3 months 18 days
Selling, general & administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,468	88
Research & development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	420	43
Cost of goods sold
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 24	$ 1

Income Taxes (Narrative) (Details) - USD ($) $ in Thousands	12 Months Ended
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Operating Loss Carryforwards [Line Items]
Income tax expense	$ 91	$ 85
Unrecognized Tax Benefits, Income Tax Penalties and Interest Expense	61,000	56,000
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued	300	$ 300
Federal
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	324,800
Tax credit carryforwards	8,900
State
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	6,500
Tax credit carryforwards	$ 1,600

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes (Components of Provision for Income Taxes) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Taxes [Abstract]
Provision for income taxes, federal and state	$ 0	$ 0
Provision for income taxes, foreign	91	85
Provision for income taxes, total current	91	85
Total provision for income taxes	$ 91	$ 85

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes (Reconciliation of Taxes at the Federal Statutory Rate) (Details)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Taxes [Abstract]
Tax at federal statutory rate	21.00%	21.00%
Permanent differences	(9.00%)	(0.50%)
Research and development ("R&D") tax credit	0.90%	2.60%
Uncertain tax position	(0.20%)	(0.50%)
State, net of federal benefit	(0.70%)	0.30%
Deferred rate change	2.50%	(0.30%)
Change in valuation allowance	(14.70%)	(23.20%)
Total	(0.20%)	(0.60%)

Income Taxes (Components of Net Deferred Tax Assets) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Income Taxes [Abstract]
Net operating loss carryforwards	$ 74,716	$ 68,957
R&D tax credits	8,711	8,318
IRC Section 59e election	8,577	7,955
Start-up costs	1,104	1,198
Non-qualified stock options	350	136
Property and equipment	91	90
Accrued vacation	151	106
Preferred stock warrants		607
Other	59	67
Total deferred tax assets	93,759	87,434
Valuation allowance	(93,759)	(87,434)
Net deferred tax assets	$ 0	$ 0

Income Taxes (Changes to Gross Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Taxes [Abstract]
Gross unrecognized tax benefits at beginning of year	$ 1,840	$ 1,757
Gross increases: Prior year tax positions	10	0
Gross increases: Current year tax positions	91	83
Gross decreases: Prior year tax positions	(2)	0
Gross unrecognized tax benefits at end of year	$ 1,939	$ 1,840

(Loss) Earnings Per Share (Basic and Diluted Net Loss per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Numerator:
Net loss	$ (43,078)	$ (14,109)
Accretion of preferred stock to redemption value	0	(217)
Net loss attributable to common stockholders	$ (43,078)	$ (14,326)
Denominator:
Weighted average common shares outstanding - basic	10,360,054	387,083
Net loss per share attributable to common stockholders - basic	$ (4.16)	$ (37.01)

- Definition

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

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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+ Details

(Loss) Earnings Per Share (Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	3,465,572	13,511,349
Options to purchase common stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	2,749,441	1,473,359
Warrants to purchase redeemable convertible preferred stock (as converted to common stock)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	0	108,406
Warrants to purchase common stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	716,131	0
Redeemable convertible preferred stock (as converted to common stock)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	0	11,929,584

Commitments and Contingencies (Narrative) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Commitments and Contingencies [Abstract]
Rent expense	$ 400	$ 400
Contingent liabilities accrual amount	$ 0	$ 0

Commitments and Contingencies (Future Minimum Lease Payments) (Details) $ in Thousands	Dec. 31, 2021 USD ($)
Future minimum lease payments
December 31, 2022	$ 227
December 31, 2023	234
December 31, 2024	138
Total	$ 599

Segment, Geographic Information and Revenue Disaggregation (Schedule of Segment Reporting) (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) segment	Dec. 31, 2020 USD ($)
Segment Reporting Information [Line Items]
Total revenues	$ 13,036	$ 6,053
Number of segments \| segment	1
U.S.
Segment Reporting Information [Line Items]
Total revenues	$ 9,147	1,733
Germany
Segment Reporting Information [Line Items]
Total revenues	3,250	3,790
Other countries
Segment Reporting Information [Line Items]
Total revenues	$ 639	$ 530

- 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.

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+ Details