Form 8-K

8-K — CVRx, Inc.

Accession: 0001104659-26-092005

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0001235912

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2622361d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2622361d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event

reported): August 6, 2026

CVRx,

Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-40545

41-1983744

(State

or other jurisdiction of

incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification No.)

9201

West Broadway Avenue, Suite 650

Minneapolis,

MN 55445

(Address of principal executive offices) (Zip

Code)

(763)

416-2840

(Registrant’s telephone number, including

area code)

N/A

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see

General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange

on which registered

Common stock,

par value $0.01 per share

CVRX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is

an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2

of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging

growth company x

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02. Results of Operations and Financial Condition.

On August 6, 2026, CVRx, Inc. issued a press

release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is attached as Exhibit

99.1 and is incorporated herein by reference.

The information contained in this Item 2.02, including Exhibit 99.1,

is being furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section

18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that

section and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether

made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements

and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release of CVRx, Inc., dated August 6, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934,

the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CVRx, Inc.

Date:

August 6, 2026

By:

/s/

Jared Oasheim

Name: Jared

Oasheim

Its: Chief

Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2622361d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

CVRx Reports Second Quarter 2026

Financial and Operating Results

MINNEAPOLIS,

August 6, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company

focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases,

today announced its financial and operating results for the second quarter of 2026.

Recent Highlights

· Total

revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16%

over the prior year quarter

· U.S.

revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior

year quarter

· Active

implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as

of June 30, 2025

· Humana

issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy,

which is the first coverage policy of its kind for Barostim

"We are

pleased with the strong revenue growth and margin performance in the second quarter along with the

reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with

our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and

a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive

Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals

of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF

trial and our broader clinical and reimbursement strategies."

Second

Quarter 2026 Financial and Operating Results

Revenue

was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30,

2025.

Revenue

generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the

three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and

2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into

new sales territories, new accounts, and increased physician and patient awareness of Barostim.

of June 30, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025.

Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30,

2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025.

Revenue

generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the

three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from

61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026.

Gross

profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended

June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively.

R&D

expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months

ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical

trial expenses.

SG&A

expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months

ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and

a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease

in travel expenses.

Interest

expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025,

driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners.

Other

income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted

of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance.

Net

loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or

$0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares

outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended

June 30, 2025.

of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million

for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025.

Humana

Medicare Advantage Coverage Policy

May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national

health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million

Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well

as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following

the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect

in the first quarter of 2026.

Business

Outlook

For

the full year of 2026, the Company now expects:

· Total

revenue between $58.0 million and $60.0 million;

· Gross

margin between 86% and 87%;

· Operating

expenses between $99.0 million and $101.0 million.

For

the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 million.

Webcast and Conference Call Information

The Company

will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call

will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference

call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes

prior to the start time.

About CVRx, Inc.

CVRx is a commercial-stage medical device

company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular

diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients

with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid

artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure.

Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been

certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension

in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.

Forward-Looking Statements

This press release contains forward-looking

statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical

facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance

regarding full year and third quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing,

enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits

of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify

forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,”

“anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,”

“project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”

or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain

these words.

The forward-looking statements in this

press release are only predictions and are based largely on our current expectations and projections about future events and financial

trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak

only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including,

but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history

of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single

product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians

and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use

of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier

to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers

and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S.

or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time

consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption

and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF

trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that

are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31,

2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required

by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of

any new information, future events, changed circumstances or otherwise.

Investor Contact:

Mark Klausner or Mike Vallie

ICR Healthcare

443-213-0501

ir@cvrx.com

Media Contact:

Emily Meyers

CVRx, Inc.

763-416-2853

emeyers@cvrx.com

CVRx, INC.

Condensed Consolidated

Balance Sheets

(In thousands,

except share and per share data)

(Unaudited)

June 30,

2026

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

$ 64,586

$ 75,708

Accounts receivable, net of allowances of $869 and $871, respectively

9,401

10,665

Inventory

13,028

12,205

Prepaid expenses and other current assets

2,473

3,069

Total current assets

89,488

101,647

Property and equipment, net

2,061

2,243

Operating lease right-of-use asset

708

878

Other non-current assets

Total assets

$ 92,283

$ 104,794

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 3,874

$ 3,833

Accrued expenses

7,250

9,484

Total current liabilities

11,124

13,317

Long-term debt

58,571

49,514

Operating lease liability, non-current portion

448

638

Other long-term liabilities

2,187

2,001

Total liabilities

72,330

65,470

Commitments and contingencies

Stockholders’ equity:

Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

266

263

Additional paid-in capital

637,707

629,916

Accumulated deficit

(617,816 )

(590,652 )

Accumulated other comprehensive loss

(204 )

(203 )

Total stockholders’ equity

19,953

39,324

Total liabilities and stockholders’ equity

$ 92,283

$ 104,794

CVRx, INC.

Condensed Consolidated

Statements of Operations and Comprehensive Loss

(In thousands,

except share and per share data)

(Unaudited)

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

Revenue

$ 15,705

$ 13,589

$ 30,474

$ 25,937

Cost of goods sold

1,981

2,139

3,869

4,175

Gross profit

13,724

11,450

26,605

21,762

Operating expenses:

Research and development

3,130

2,469

6,214

4,986

Selling, general and administrative

23,617

23,357

45,575

44,589

Total operating expenses

26,747

25,826

51,789

49,575

Loss from operations

(13,023 )

(14,376 )

(25,184 )

(27,813 )

Interest expense

(1,578 )

(1,473 )

(3,129 )

(2,930 )

Other income, net

560

1,110

1,153

2,233

Loss before income taxes

(14,041 )

(14,739 )

(27,160 )

(28,510 )

Benefit (provision) for income taxes

(3 )

(4 )

Net loss

(14,044 )

(14,736 )

(27,164 )

(28,502 )

Cumulative translation adjustment

—

Comprehensive loss

$ (14,044 )

$ (14,733 )

$ (27,164 )

$ (28,499 )

Net loss per share, basic and diluted

$ (0.53 )

$ (0.57 )

$ (1.03 )

$ (1.10 )

Weighted-average common shares used to compute net loss per share, basic and diluted

26,515,442

26,071,316

26,435,958

25,974,229

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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dei_TradingSymbol

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

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dei_WrittenCommunications

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