0001558370-23-013225 | 10-Q | XBRL Viewer

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Debt (Maturities of debt) (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Long-Term Debt, Fiscal Year Maturity [Abstract]
2027	$ 10,000
2028	5,000
Total	15,000
Less: Unamortized debt costs and discounts	(747)
Long-term debt	$ 14,253	$ 6,747

Income Taxes

6 Months Ended

Jun. 30, 2023

Income Taxes [Abstract]

Income taxes

8.	Income taxes

As of June 30, 2023 and December 31, 2022, a valuation allowance was recorded against all deferred tax assets due to the Company’s cumulative net loss position. Provision for income taxes for the three months ended June 30, 2023 and 2022 was $34,000 and $23,000, respectively. Provision for income taxes for the six months ended June 30, 2023 and 2022 was $68,000 and $49,000, respectively.

As of December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOLs”) of approximately $361.0 million and $6.2 million, respectively. The federal NOLs began expiring in 2021 and the state NOLs began expiring in 2020. As of December 31, 2022, the Company had federal and state tax credit carryforwards of approximately $9.3 million and $1.8 million, respectively. The federal tax credit carryforwards began expiring in 2021 and the state tax credit carryforwards will begin 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 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.

- 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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+ Details

Business Organization

6 Months Ended

Jun. 30, 2023

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.

Commitments and Contingencies (Narrative) (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Commitments and Contingencies [Abstract]
Contingent liabilities accrual amount	$ 0	$ 0

Leases (Details) $ in Thousands	6 Months Ended
Leases (Details) $ in Thousands	Jun. 30, 2023 USD ($) ft²	Jun. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)
Right-of-use assets:
Operating lease right-of-use asset	$ 1,113		$ 334
Operating lease liabilities:
Accrued expenses	$ 185		$ 222
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration]	Accrued expenses		Accrued expenses
Operating lease liability, non-current portion	$ 946		$ 117
Present value of lease liability	$ 1,131		$ 339
Remaining lease term	5 years 2 months 12 days
Discount rate	5.00%
Operating cash outflows	$ 200	$ 600
Office space in Minneapolis, Minnesota
Lessee, Lease, Description [Line Items]
Area of land leased \| ft²	23,890
Lessee, Operating Lease, Existence of Option to Extend [true false]	true
Lessee, Operating Lease, Renewal Term	3 years

Stock-Based Compensation (Assumptions Used in Determine the Grant Date Fair Value of Stock Options) (Details) - $ / shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield	0.00%
Stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average fair value of options granted	$ 10.42	$ 4.41
Expected volatility, Minimum	77.20%	56.30%
Expected volatility, Maximum	79.20%	58.60%
Expected dividend yield	0.00%	0.00%
Risk-free interest rate, Minimum	3.40%	1.75%
Risk-free interest rate, Maximum	4.18%	3.07%
ESPP
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average fair value of options granted	$ 5.71	$ 1.76
Expected term (in years)	6 months	6 months
Expected volatility	84.60%	51.30%
Expected dividend yield	0.00%	0.00%
Risk-free interest rate	4.77%	0.22%
Non officer employees \| Stock options \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	5 years 6 months	5 years 6 months
Non officer employees \| Stock options \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 6 days	6 years 1 month 6 days
Officer employees \| Stock options \| Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	2 years 6 months	3 years 2 months 12 days
Officer employees \| Stock options \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 6 days	6 years 1 month 6 days

Commitments and Contingencies

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies [Abstract]

Commitments and contingencies

10.

Commitments and 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 June 30, 2023 or December 31, 2022.

Leases (Tables)

6 Months Ended

Jun. 30, 2023

Leases [Abstract]

Schedule of lease balances within the balance sheets

The following table presents the lease balances within the condensed consolidated balance sheets:


	June 30,		December 31,
(in thousands)	2023		2022
Right-of-use assets:
Operating lease right-of-use asset	$	1,113	$	334
Operating lease liabilities:
Accrued expenses		185		222
Operating lease liability, non-current portion		946		117
Total operating lease liabilities	$	1,131	$	339

Maturities of lease liability

Maturities of our lease liability for our operating lease are as follows as of June 30, 2023:


	June 30,
(in thousands)	2023
2023, remainder	$	119
2024		223
2025		255
2026		262
2027		270
2028		161
Total undiscounted lease payments		1,290
Less: imputed interest		(159)
Present value of lease liability	$	1,131

Leases

6 Months Ended

Jun. 30, 2023

Leases [Abstract]

Leases

5. Leases

We lease 23,890 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility. We lease this space under an operating lease agreement that commenced December 1, 2008 and was scheduled to expire August 31, 2024. On April 21, 2023, we extended our operating lease for our office space in Minneapolis, Minnesota for an additional 49 consecutive months through August 31, 2028. We intend to add new facilities as we grow, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations. Our operating lease agreement includes an option to renew for one additional period of three

years. The exercise of the lease renewal option is at our sole discretion and was not included in the lease term for the calculation of the ROU asset and lease liability, as it is not reasonably certain of exercise.

In addition to base rent, we also pay our proportionate share of operating expenses, as defined in the lease. These payments are made monthly and are adjusted annually to reflect actual charges incurred for operating expenses, such as common area maintenance, taxes and insurance.

The following table presents the lease balances within the condensed consolidated balance sheets:


	June 30,		December 31,
(in thousands)	2023		2022
Right-of-use assets:
Operating lease right-of-use asset	$	1,113	$	334
Operating lease liabilities:
Accrued expenses		185		222
Operating lease liability, non-current portion		946		117
Total operating lease liabilities	$	1,131	$	339

Maturities of our lease liability for our operating lease are as follows as of June 30, 2023:


	June 30,
(in thousands)	2023
2023, remainder	$	119
2024		223
2025		255
2026		262
2027		270
2028		161
Total undiscounted lease payments		1,290
Less: imputed interest		(159)
Present value of lease liability	$	1,131

As of June 30, 2023, the remaining lease term was 5.2 years and the discount rate was 5.0%. The operating cash outflows from our operating lease were $0.2 million and $0.6 million for the six months ended June 30, 2023 and 2022, respectively.

Debt

6 Months Ended

Jun. 30, 2023

Debt [Abstract]

Debt

4. Debt

Innovatus Loan Agreement

On October 31, 2022, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, under which the Company may borrow, subject to the Company’s achievement of certain milestones, up to a total of $50.0 million in a series of term loans. On the closing date, the Company borrowed the minimum amount of $7.5 million under the Loan Agreement. On March 10, 2023, the Company borrowed the $7.5 million remaining under the first tranche of the Loan Agreement, with $4.0 million received on March 13, 2023 and $3.5 million received on March 15, 2023. The Loan Agreement initially requires interest only payments through November 2027, followed by three monthly principal and interest payments. A final payment of $0.7 million, equal to 4.5% of the original borrowed principal, is due in January 2028. The term loans advanced pursuant to the Loan Agreement (collectively, the “Term Loans”) bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50% plus (b) 2.65%. The Term Loans are secured by substantially all of the personal property of the Company. The Company has the option to draw down (i) up to $30.0 million less the amount funded from the first tranche between September 1, 2023 and December 15, 2023 if the Company achieves trailing three months revenue of $5.75 million prior to June 30, 2023 (which was achieved), and (ii) up to $20.0 million between September 1, 2024 and December 15, 2024 if the Company achieves trailing three months revenue of $9.0 million prior to June 30, 2024. A performance covenant takes effect at the earlier of September 30, 2025 or the third tranche funding requiring that the Company achieve 50% of the trailing twelve months revenue target set in the Board-approved revenue plan in effect for such period. The Loan Agreement requires the payment of certain penalties if the Term Loans are paid off prior to maturity for any reason, including pursuant to an acceleration clause, and includes various restrictive covenants, including a restriction on the payment of dividends or making other distributions or payments on the Company’s capital stock, subject to limited exceptions. The Company was in compliance with these covenants as of June 30, 2023.

In connection with the Loan Agreement, the Company recorded $0.8 million of debt issuance costs and discounts as a reduction of long-term debt.

The annual principal maturities of debt under the Loan Agreement are as follows:


	June 30,
(in thousands)	2023
2023	$	—
2024		—
2025		—
2026		—
2027		10,000
2028		5,000
		15,000
Less: Unamortized debt costs and discounts		(747)
Long-term debt	$	14,253

- 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

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+ Details

Selected Balance Sheet Information (Schedule of Accrued Expenses) (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Selected Balance Sheet Information [Abstract]
Bonuses	$ 2,033	$ 2,303
Paid time off	1,234	960
Clinical trial and other professional fees	1,086	1,733
Customer rebates	282	256
Operating lease liability, current portion	185	222
Taxes	83	120
Other	1,089	775
Total accrued expenses	$ 5,992	$ 6,369

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2023

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 unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) applicable to interim financial statements. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company’s statements of financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole or any other future period.

The condensed 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 condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 June 30, 2023 and December 31, 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of June 30, 2023 and December 31, 2022, our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits.

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 evaluate the collectability of our accounts receivable based on known collection risks and historical experience. In circumstances where we are aware of a specific customer's inability to meet its financial obligations to us, we record a specific allowance for bad debts against amounts due to reduce the carrying amount of accounts receivable to the amount we reasonably believe will be collected.

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.

Leases

Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability – non-current portion in our balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. We used the incremental borrowing rate based on information readily available at the time of recognition to determine the present value of the lease payments. The determination of our incremental borrowing rate requires management judgement based on information available at lease commencement.

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 (“ASC”) 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 ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all equity-based compensation awards to employees and non-employee 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 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.

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (23,025)	$ (21,062)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	3,181	1,893
Depreciation of property and equipment	256	157
Loss on disposal of equipment	4	0
Amortization of deferred financing costs and loan discount	73	0
Changes in operating assets and liabilities:
Accounts receivable	(1,222)	(1,041)
Inventory	(3,971)	(1,954)
Prepaid expenses and other current assets	689	1,421
Accounts payable	1,214	98
Accrued expenses	(256)	(252)
Net cash used in operating activities	(23,057)	(20,740)
Cash flows from investing activities:
Purchase of property and equipment	(383)	(342)
Net cash used in investing activities	(383)	(342)
Cash flows from financing activities:
Proceeds from the exercise of common stock options	156	74
Proceeds from Employee Stock Purchase Plan	452	295
Proceeds from debt financing	7,500	0
Debt financing costs	(67)	0
Net cash provided by financing activities	8,041	369
Effect of currency exchange on cash and cash equivalents	20	(13)
Net change in cash and cash equivalents	(15,379)	(20,726)
Cash and cash equivalents at beginning of period	106,194	142,072
Cash and cash equivalents at end of period	90,815	121,346
Supplemental Information:
Cash paid for interest	563	0
Cash paid for income taxes	$ 4	$ 1

Segment, Geographic Information and Revenue Disaggregation

6 Months Ended

Jun. 30, 2023

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 periods indicated (in thousands):


	Three months ended				Six months ended
	June 30,				June 30,
	2023		2022		2023		2022
U.S.	$	8,297	$	3,938	$	15,239	$	6,996
Germany		1,126		1,008		2,017		1,811
Other countries		77		85		223		300
	$	9,500	$	5,031	$	17,479	$	9,107

As of June 30, 2023 and December 31, 2022, 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
-Section 50
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Loss Per Share (Basic and Diluted Net Loss per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Numerator:
Net loss	$ (11,651)	$ (11,071)	$ (23,025)	$ (21,062)
Denominator:
Weighted average common shares outstanding - basic	20,711,850	20,505,228	20,702,589	20,479,427
Weighted average common shares outstanding - diluted	20,711,850	20,505,228	20,702,589	20,479,427
Net loss per share attributable to common stockholders - basic	$ (0.56)	$ (0.54)	$ (1.11)	$ (1.03)
Net loss per share attributable to common stockholders - diluted	$ (0.56)	$ (0.54)	$ (1.11)	$ (1.03)

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The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1A
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Reference 32: http://www.xbrl.org/2003/role/disclosureRef
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Reference 33: http://www.xbrl.org/2003/role/disclosureRef
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Reference 34: http://www.xbrl.org/2003/role/disclosureRef
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

+ Details

Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2023

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, 2022	3,756,835	$	8.28		$	36,616
Granted	993,401		13.73
Cancelled / Forfeited	(187,897)		9.27
Exercised	(52,753)		2.95
Balance as of June 30, 2023	4,509,586	$	9.50		$	28,416
Options exercisable as of June 30, 2023	2,165,087	$	6.81		$	19,577

Recognized Stock-Based Compensation Expense

The following table presents the components and classification of stock-based compensation expense for the periods indicated:


	Three Months Ended				Six months ended
	June 30,				June 30,
(in thousands)	2023		2022		2023		2022
Stock options	$	1,401	$	998	$	2,984	$	1,791
Employee Stock Purchase Plan		75		102		197		102
Total stock-based compensation expense	$	1,476	$	1,100	$	3,181	$	1,893

Selling, general & administrative	$	1,258	$	943	$	2,438	$	1,617
Research & development		198		133		705		235
Cost of goods sold		20		24		38		41
	$	1,476	$	1,100	$	3,181	$	1,893

ESPP

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

The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the six months ended June 30, 2023 and 2022:


	June 30,
		2023			2022
Weighted average fair value per ESPP purchase right	$	5.71		$	1.76
Expected term (in years)		0.5			0.5
Expected volatility		84.6	%		51.3	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		4.77	%		0.22	%

Stock options

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

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 six months ended June 30, 2023 and 2022:


	June 30,
		2023			2022
Weighted average fair value of options granted	$	10.42		$	4.41
Expected term (in years) — non-officer employees		5.5 to 6.1			5.5 to 6.1
Expected term (in years) — officer employees		2.5 to 6.1			3.2 to 6.1
Expected volatility		77.2% to 79.2	%		56.3% to 58.6	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		3.40% to 4.18	%		1.75% to 3.07	%

Stockholders' Equity

6 Months Ended

Jun. 30, 2023

Stockholders' Equity [Abstract]

Stockholders' equity

6.	Stockholders’ equity

Common Stock Warrants

The Company has common stock warrants exercisable for 716,131 shares of common stock upon conversion at a weighted average exercise price of $2.39 per share.

- 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://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-Paragraph 13
-Subparagraph (b)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (c)
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-Section S99
-Paragraph 1
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-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-Paragraph 13
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-Paragraph 18
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 1
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 6
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract]
Revenue	$ 9,500,000	$ 5,031,000	$ 17,479,000	$ 9,107,000
Cost of goods sold	1,517,000	1,201,000	2,845,000	2,150,000
Gross profit	7,983,000	3,830,000	14,634,000	6,957,000
Operating expenses:
Research and development	3,280,000	2,355,000	6,696,000	4,613,000
Selling, general and administrative	16,455,000	12,489,000	31,852,000	23,266,000
Total operating expenses	19,735,000	14,844,000	38,548,000	27,879,000
Loss from operations	(11,752,000)	(11,014,000)	(23,914,000)	(20,922,000)
Interest expense	(481,000)	0	(721,000)	0
Other income (expense), net	616,000	(34,000)	1,678,000	(91,000)
Loss before income taxes	(11,617,000)	(11,048,000)	(22,957,000)	(21,013,000)
Provision for income taxes	(34,000)	(23,000)	(68,000)	(49,000)
Net loss	(11,651,000)	(11,071,000)	(23,025,000)	(21,062,000)
Cumulative translation adjustment	17,000	(7,000)	20,000	(13,000)
Comprehensive loss	$ (11,634,000)	$ (11,078,000)	$ (23,005,000)	$ (21,075,000)
Net loss per share, basic	$ (0.56)	$ (0.54)	$ (1.11)	$ (1.03)
Net loss per share, diluted	$ (0.56)	$ (0.54)	$ (1.11)	$ (1.03)
Weighted-average common shares used to compute net loss per share, basic	20,711,850	20,505,228	20,702,589	20,479,427
Weighted-average common shares used to compute net loss per share, diluted	20,711,850	20,505,228	20,702,589	20,479,427

Loss Per Share (Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from the computation of diluted net loss per share	5,225,717	4,168,211
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	4,509,586	3,452,080
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	716,131

Loss Per Share (Tables)

6 Months Ended

Jun. 30, 2023

Loss Per Share [Abstract]

Basic and Diluted Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated for the periods indicated (in thousands, except share and per share data):


	Three Months Ended				Six months ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Net loss	$	(11,651)	$	(11,071)	$	(23,025)	$	(21,062)
Denominator:
Weighted average common shares outstanding — basic and diluted		20,711,850		20,505,228		20,702,589		20,479,427
Net loss per share attributable to common stockholders — basic and diluted	$	(0.56)	$	(0.54)	$	(1.11)	$	(1.03)

Antidilutive Securities Excluded from Computation of Earnings Per Share


	Six months ended
	June 30,
	2023	2022
Options to purchase common stock	4,509,586	3,452,080
Warrants to purchase common stock	716,131	716,131
	5,225,717	4,168,211

Stock-Based Compensation (Recognized Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,476	$ 1,100	$ 3,181	$ 1,893
Unrecognized compensation expense	14,800		$ 14,800
Weighted average period			2 years 8 months 12 days
Stock options
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	1,401	998	$ 2,984	1,791
ESPP
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	75	102	197	102
Selling, general & administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	1,258	943	2,438	1,617
Research & development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	198	133	705	235
Cost of goods sold
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 20	$ 24	$ 38	$ 41

Income Taxes (Narrative) (Details) - USD ($)	3 Months Ended		6 Months Ended
Income Taxes (Narrative) (Details) - USD ($)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Operating Loss Carryforwards [Line Items]
Income tax expense	$ 34,000	$ 23,000	$ 68,000	$ 49,000
Federal
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards					$ 361,000,000.0
Tax credit carryforwards					9,300,000
State
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards					6,200,000
Tax credit carryforwards					$ 1,800,000

- Definition

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

+ References + Details

Debt (Narrative) (Details) $ in Thousands					6 Months Ended
Debt (Narrative) (Details) $ in Thousands	Mar. 15, 2023 USD ($)	Mar. 13, 2023 USD ($)	Mar. 10, 2023 USD ($)	Oct. 31, 2022 USD ($) item	Jun. 30, 2023 USD ($)	Jun. 30, 2022 USD ($)
Debt Instrument [Line Items]
Proceeds from debt financing					$ 7,500	$ 0
Loan and Security Agreement
Debt Instrument [Line Items]
Maximum borrowing capacity				$ 50,000
Proceeds from debt financing	$ 3,500	$ 4,000	$ 7,500	$ 7,500
Variable interest rate (as a percent)				5.50%
Interest rate ( as a percent)				2.65%
Number of monthly payments of principal plus interest \| item				3
Final payment				$ 700
Percentage of final payment on original principal				4.50%
Debt issuance costs and discounts				$ 800
Loan and Security Agreement \| Draw down from 10-K filing to September 30, 2023
Debt Instrument [Line Items]
Proceeds from debt financing				30,000
Three months of trailing revenue				5,750
Loan and Security Agreement \| Draw down from September 1, 2023 to December 15, 2023
Debt Instrument [Line Items]
Proceeds from debt financing				20,000
Three months of trailing revenue				$ 9,000
Loan and Security Agreement \| Draw down from September 1, 2024 to December 15, 2024
Debt Instrument [Line Items]
Percentage of trailing twelve months revenue goal				50.00%

Selected Balance Sheet Information (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 4,343	$ 3,978
Less: Accumulated depreciation and amortization	2,522	2,280
Property and equipment, net	$ 1,821	1,698
Maximum
Property, Plant and Equipment [Line Items]
Estimated useful lives	5 years
Minimum
Property, Plant and Equipment [Line Items]
Estimated useful lives	3 years
Office furniture and equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 402	350
Lab equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	2,684	2,684
Computer equipment and software
Property, Plant and Equipment [Line Items]
Property and equipment, gross	687	618
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property and equipment, gross	95	95
Capital equipment in process
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 475	$ 231

Stockholders' Equity (Narrative) (Details) - Warrants to purchase common stock	6 Months Ended
	Jun. 30, 2023 $ / shares shares
Temporary Equity [Line Items]
Preferred stock warrants converted to common stock warrants at IPO \| shares	716,131
Preferred stock warrants converted to common stock warrants at IPO, Weighted Average Exercise Price \| $ / shares	$ 2.39

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 90,815	$ 106,194
Accounts receivable, net of allowances of $602 and $679, respectively	6,726	5,504
Inventory	10,928	6,957
Prepaid expenses and other current assets	3,543	4,223
Total current assets	112,012	122,878
Property and equipment, net	1,821	1,698
Operating lease right-of-use asset	1,113	334
Other non-current assets	27	27
Total assets	114,973	124,937
Current liabilities:
Accounts payable	2,933	1,719
Accrued expenses	5,992	6,369
Total current liabilities	8,925	8,088
Long-term debt	14,253	6,747
Operating lease liability, non-current portion	946	117
Other long-term liabilities	885	805
Total liabilities	25,009	15,757
Commitments and contingencies (Note 10)
Stockholders' equity:
Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2023 and December 31, 2022; 20,750,910 and 20,633,736 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	208	207
Additional paid-in capital	549,150	545,362
Accumulated deficit	(459,207)	(436,182)
Accumulated other comprehensive loss	(187)	(207)
Total stockholders' equity	89,964	109,180
Total liabilities and stockholders' equity	$ 114,973	$ 124,937

Stock-Based Compensation

6 Months Ended

Jun. 30, 2023

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, non-employee directors, consultants, or independent contractors. Options granted under the 2001 Plan have vesting terms that range from the date of grant to four years and expire within a maximum term of 10 years from the grant date.

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 600,737 shares that remained available for issuance under the 2001 Plan. The shares available for issuance under the 2021 Plan 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 annual increase resulted in an additional 1,033,186 shares being reserved for issuance under the 2021 Plan as of January 1, 2023. 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 June 30, 2023, there were 1,741,895 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 the initial public offering (the “IPO”), the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain non-employee 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 non-employee 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, 2022	3,756,835	$	8.28		$	36,616
Granted	993,401		13.73
Cancelled / Forfeited	(187,897)		9.27
Exercised	(52,753)		2.95
Balance as of June 30, 2023	4,509,586	$	9.50		$	28,416
Options exercisable as of June 30, 2023	2,165,087	$	6.81		$	19,577

As of June 30, 2023, stock options outstanding included 8,796 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of June 30, 2023, the weighted average remaining contractual life was 7.7 years. For options exercisable as of June 30, 2023, the weighted average remaining contractual life was 6.4 years.

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 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 annual increase resulted in an additional 206,637 shares being reserved for issuance under the ESPP as of January 1, 2023. The ESPP permits 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 date under the ESPP was June 30, 2022. For the six months ended June 30, 2023, 34,421 shares of common stock were purchased under the ESPP for $0.5 million of employee contributions. As of June 30, 2023, there were 540,489 shares available for issuance under the ESPP.

Stock-based compensation expense

The Company uses the Black-Scholes option pricing model to determine the fair value of stock options and ESPP purchase rights 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 for stock options and the offering period for ESPP purchase rights. The amount of stock-based compensation expense recognized for stock option awards during a period is based on the portion of the awards that are ultimately expected to vest. The amount of stock-based compensation expense recognized for ESPP purchase rights during a period is based on the estimated purchase rights as of the grant date. The Company accounts for forfeitures as they occur.


	June 30,
		2023			2022
Weighted average fair value of options granted	$	10.42		$	4.41
Expected term (in years) — non-officer employees		5.5 to 6.1			5.5 to 6.1
Expected term (in years) — officer employees		2.5 to 6.1			3.2 to 6.1
Expected volatility		77.2% to 79.2	%		56.3% to 58.6	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		3.40% to 4.18	%		1.75% to 3.07	%


	June 30,
		2023			2022
Weighted average fair value per ESPP purchase right	$	5.71		$	1.76
Expected term (in years)		0.5			0.5
Expected volatility		84.6	%		51.3	%
Expected dividend yield		—	%		—	%
Risk-free interest rate		4.77	%		0.22	%

The Company reviews these assumptions on a periodic basis and adjusts them, as necessary. The expected term of a stock option award was determined based on the Company’s analysis of historical exercise behavior while taking into consideration various participant demographics and option characteristics. The expected term of an ESPP purchase right is based on the offering period. 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.

The following table presents the components and classification of stock-based compensation expense for the periods indicated:


	Three Months Ended				Six months ended
	June 30,				June 30,
(in thousands)	2023		2022		2023		2022
Stock options	$	1,401	$	998	$	2,984	$	1,791
Employee Stock Purchase Plan		75		102		197		102
Total stock-based compensation expense	$	1,476	$	1,100	$	3,181	$	1,893

Selling, general & administrative	$	1,258	$	943	$	2,438	$	1,617
Research & development		198		133		705		235
Cost of goods sold		20		24		38		41
	$	1,476	$	1,100	$	3,181	$	1,893

As of June 30, 2023, unrecognized compensation expense related to unvested stock-based compensation arrangements was $14.8 million. As of June 30, 2023, the related weighted average period over which the expense is expected to be recognized is approximately 2.7 years.

Selected Balance Sheet Information (Tables)

6 Months Ended

Jun. 30, 2023

Selected Balance Sheet Information [Abstract]

Schedule of Inventory

Inventory consists of the following at:


	June 30,		December 31,
(in thousands)	2023		2022
Raw material	$	4,420	$	2,390
Work-in-process		2,333		1,033
Finished goods		4,175		3,534
	$	10,928	$	6,957

Schedule of Property and Equipment, Net


	June 30,		December 31,
(in thousands)	2023		2022
Office furniture and equipment	$	402	$	350
Lab equipment		2,684		2,684
Computer equipment and software		687		618
Leasehold improvements		95		95
Capital equipment in process		475		231
		4,343		3,978
Less: Accumulated depreciation and amortization		2,522		2,280
	$	1,821	$	1,698

Schedule of Accrued Expenses

Accrued expenses consist of the following at:


	June 30,		December 31,
(in thousands)	2023		2022
Bonuses	$	2,033	$	2,303
Paid time off		1,234		960
Clinical trial and other professional fees		1,086		1,733
Customer rebates		282		256
Operating lease liability, current portion		185		222
Taxes		83		120
Other		1,089		775
	$	5,992	$	6,369

Selected Balance Sheet Information (Narrative) (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Selected Balance Sheet Information [Abstract]
Depreciation	$ 127	$ 95	$ 256	$ 157

Segment, Geographic information and revenue disaggregation (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023 USD ($)	Jun. 30, 2022 USD ($)	Jun. 30, 2023 USD ($) segment	Jun. 30, 2022 USD ($)
Segment Reporting Information [Line Items]
Total revenues	$ 9,500	$ 5,031	$ 17,479	$ 9,107
Number of segments \| segment			1
U.S.
Segment Reporting Information [Line Items]
Total revenues	8,297	3,938	$ 15,239	6,996
Germany
Segment Reporting Information [Line Items]
Total revenues	1,126	1,008	2,017	1,811
Other countries
Segment Reporting Information [Line Items]
Total revenues	$ 77	$ 85	$ 223	$ 300

- 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
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI https://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Loss Per Share

6 Months Ended

Jun. 30, 2023

Loss Per Share [Abstract]

Loss Per Share

9. Loss Per Share

Basic and diluted net loss per share attributable to common stockholders was calculated for the periods indicated (in thousands, except share and per share data):


	Three Months Ended				Six months ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Net loss	$	(11,651)	$	(11,071)	$	(23,025)	$	(21,062)
Denominator:
Weighted average common shares outstanding — basic and diluted		20,711,850		20,505,228		20,702,589		20,479,427
Net loss per share attributable to common stockholders — basic and diluted	$	(0.56)	$	(0.54)	$	(1.11)	$	(1.03)

The Company’s potentially dilutive securities, which include stock options 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:


	Six months ended
	June 30,
	2023	2022
Options to purchase common stock	4,509,586	3,452,080
Warrants to purchase common stock	716,131	716,131
	5,225,717	4,168,211

Stock-Based Compensation (Summary of Stock Option Activity) (Details) $ / shares in Units, $ in Thousands	6 Months Ended
	Jun. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($)
Number of Options
Outstanding as of Beginning of period (in shares)	3,756,835
Granted (in shares)	993,401
Cancelled / Forfeited (in shares)	(187,897)
Exercised (in shares)	(52,753)
Balance as of End of period (in shares)	4,509,586
Options exercisable as of June 30, 2023 (in shares)	2,165,087
Weighted Average Exercise Price
Outstanding as of Beginning of period (in dollars per share) \| $ / shares	$ 8.28
Granted (in dollars per share) \| $ / shares	13.73
Cancelled / Forfeited (in dollars per share) \| $ / shares	9.27
Exercised (in dollars per share) \| $ / shares	2.95
Balance as of End of period (in dollars per share) \| $ / shares	9.50
Options exercisable as of June 30, 2023 (in dollars per share) \| $ / shares	$ 6.81
Aggregate Intrinsic Value
Aggregate intrinsic value \| $	$ 28,416	$ 36,616
Options exercisable as of June 30, 2023 \| $	$ 19,577
Weighted average remaining contractual term, outstanding (in years)	7 years 8 months 12 days
Weighted average remaining contractual life, exercisable (in years)	6 years 4 months 24 days
Options not granted under the 2001 or 2021 Plans
Number of Options
Balance as of End of period (in shares)	8,796

Selected Balance Sheet Information

6 Months Ended

Jun. 30, 2023

Selected Balance Sheet Information [Abstract]

Selected balance sheet information

3.	Selected balance sheet information

Inventory consists of the following at:


	June 30,		December 31,
(in thousands)	2023		2022
Raw material	$	4,420	$	2,390
Work-in-process		2,333		1,033
Finished goods		4,175		3,534
	$	10,928	$	6,957

Property and equipment, net consists of the following at:


	June 30,		December 31,
(in thousands)	2023		2022
Office furniture and equipment	$	402	$	350
Lab equipment		2,684		2,684
Computer equipment and software		687		618
Leasehold improvements		95		95
Capital equipment in process		475		231
		4,343		3,978
Less: Accumulated depreciation and amortization		2,522		2,280
	$	1,821	$	1,698

Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the term of the lease. Depreciation expense was $127,000 and $95,000 for the three months ended June 30, 2023 and 2022, respectively, and $256,000 and $157,000 for the six months ended June 30, 2023 and 2022, respectively.

Accrued expenses consist of the following at:


	June 30,		December 31,
(in thousands)	2023		2022
Bonuses	$	2,033	$	2,303
Paid time off		1,234		960
Clinical trial and other professional fees		1,086		1,733
Customer rebates		282		256
Operating lease liability, current portion		185		222
Taxes		83		120
Other		1,089		775
	$	5,992	$	6,369

Debt (Tables)

6 Months Ended

Jun. 30, 2023

Debt [Abstract]

Schedule of Annual Principal Maturities of Debt


	June 30,
(in thousands)	2023
2023	$	—
2024		—
2025		—
2026		—
2027		10,000
2028		5,000
		15,000
Less: Unamortized debt costs and discounts		(747)
Long-term debt	$	14,253

Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands		1 Months Ended	6 Months Ended
	Jul. 02, 2021	Jun. 30, 2001	Jun. 30, 2023	Jun. 30, 2022	Jan. 01, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield			0.00%
Proceeds from Employee Stock Purchase Plan			$ 452	$ 295
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	600,737
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				206,637
Number of shares available for grant			540,489
Shares issued/purchased under ESPP			34,421
Annual incremental percentage	1.00%
Minimum Percentage			85.00%
Expected dividend yield			0.00%	0.00%
Proceeds from Employee Stock Purchase Plan			$ 500
2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Reserved for future issuance	1,854,490		1,741,895		1,033,186
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]
Expected dividend yield			0.00%	0.00%
Options to purchase common stock \| 2001 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting Period			48 months

Summary of Significant Accounting Policies (Policies)	6 Months Ended
Summary of Significant Accounting Policies (Policies)	Jun. 30, 2023
Summary of Significant Accounting Policies [Abstract]
Statement presentation and basis of consolidation	Statement presentation and basis of consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) applicable to interim financial statements. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company’s statements of financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole or any other future period. The condensed 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 condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 June 30, 2023 and December 31, 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of June 30, 2023 and December 31, 2022, our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits.
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 evaluate the collectability of our accounts receivable based on known collection risks and historical experience. In circumstances where we are aware of a specific customer's inability to meet its financial obligations to us, we record a specific allowance for bad debts against amounts due to reduce the carrying amount of accounts receivable to the amount we reasonably believe will be collected.
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.
Leases	Leases Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability – non-current portion in our balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. We used the incremental borrowing rate based on information readily available at the time of recognition to determine the present value of the lease payments. The determination of our incremental borrowing rate requires management judgement based on information available at lease commencement.
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 (“ASC”) 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 ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all equity-based compensation awards to employees and non-employee 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 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.

Selected Balance Sheet Information (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Selected Balance Sheet Information [Abstract]
Raw material	$ 4,420	$ 2,390
Work-in-process	2,333	1,033
Finished goods	4,175	3,534
Total inventory	$ 10,928	$ 6,957

Condensed Consolidated Statements of Stockholders Equity - USD ($) $ in Thousands	Common stock	Additional paid-in capital	Accumulated deficit	Accumulated and other comprehensive loss	Total
Balances, Beginning at Dec. 31, 2021	$ 204	$ 540,707	$ (394,754)	$ (198)	$ 145,959
Balances, Beginning (in shares) at Dec. 31, 2021	20,399,337
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options	$ 1	73			74
Exercise of stock options (in shares)	119,131
Proceeds from Employee Stock Purchase Plan	$ 1	294			295
Proceeds from Employee Stock Purchase Plan (shares)	57,681
Employee stock compensation		1,893			1,893
Net loss			(21,062)		(21,062)
Cumulative translation adjustment				(13)	(13)
Balances, Ending at Jun. 30, 2022	$ 206	542,967	(415,816)	(211)	127,146
Balances, Ending (in shares) at Jun. 30, 2022	20,576,149
Balances, Beginning at Mar. 31, 2022	$ 205	541,547	(404,745)	(204)	136,803
Balances, Beginning (in shares) at Mar. 31, 2022	20,486,971
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options		26			26
Exercise of stock options (in shares)	31,497
Proceeds from Employee Stock Purchase Plan	$ 1	294			295
Proceeds from Employee Stock Purchase Plan (shares)	57,681
Employee stock compensation		1,100			1,100
Net loss			(11,071)		(11,071)
Cumulative translation adjustment				(7)	(7)
Balances, Ending at Jun. 30, 2022	$ 206	542,967	(415,816)	(211)	127,146
Balances, Ending (in shares) at Jun. 30, 2022	20,576,149
Balances, Beginning at Dec. 31, 2022	$ 207	545,362	(436,182)	(207)	109,180
Balances, Beginning (in shares) at Dec. 31, 2022	20,663,736
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options	$ 1	155			$ 156
Exercise of stock options (in shares)	52,753				52,753
Proceeds from Employee Stock Purchase Plan		452			$ 452
Proceeds from Employee Stock Purchase Plan (shares)	34,421
Employee stock compensation		3,181			3,181
Net loss			(23,025)		(23,025)
Cumulative translation adjustment				20	20
Balances, Ending at Jun. 30, 2023	$ 208	549,150	(459,207)	(187)	89,964
Balances, Ending (in shares) at Jun. 30, 2023	20,750,910
Balances, Beginning at Mar. 31, 2023	$ 207	547,195	(447,556)	(204)	99,642
Balances, Beginning (in shares) at Mar. 31, 2023	20,708,940
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of stock options	$ 1	27			28
Exercise of stock options (in shares)	7,549
Proceeds from Employee Stock Purchase Plan		452			452
Proceeds from Employee Stock Purchase Plan (shares)	34,421
Employee stock compensation		1,476			1,476
Net loss			(11,651)		(11,651)
Cumulative translation adjustment				17	17
Balances, Ending at Jun. 30, 2023	$ 208	$ 549,150	$ (459,207)	$ (187)	$ 89,964
Balances, Ending (in shares) at Jun. 30, 2023	20,750,910

Segment, Geographic Information and Revenue Disaggregation (Tables)

6 Months Ended

Jun. 30, 2023

Segment, Geographic Information and Revenue Disaggregation [Abstract]

Schedule of Segment Reporting


	Three months ended				Six months ended
	June 30,				June 30,
	2023		2022		2023		2022
U.S.	$	8,297	$	3,938	$	15,239	$	6,996
Germany		1,126		1,008		2,017		1,811
Other countries		77		85		223		300
	$	9,500	$	5,031	$	17,479	$	9,107

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2023	Jul. 27, 2023
Document and Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-40545
Entity Registrant Name	CVRx, Inc
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	41-1983744
Entity Address, Address Line One	9201 West Broadway Avenue
Entity Address, Address Line Two	Suite 650
Entity Address, City or Town	Minneapolis
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	55445
City Area Code	763
Local Phone Number	416-2840
Title of 12(b) Security	Common stock,
Trading Symbol	CVRX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
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		20,756,651
Entity Central Index Key	0001235912
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Condensed Consolidated Balance Sheets [Abstract]
Allowance for accounts receivable, net	$ 602	$ 679
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued		20,663,736
Common stock, shares outstanding	20,750,910

Leases (Maturities of lease liability) (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
2023, remainder	$ 119
2024	223
2025	255
2026	262
2027	270
2028	161
Total undiscounted lease payments	1,290
Less: imputed interest	(159)
Present value of lease liability	$ 1,131	$ 339

Employee Benefit Plans

6 Months Ended

Jun. 30, 2023

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.