Form 8-K

8-K — CVRx, Inc.

Accession: 0001104659-26-058655

Filed: 2026-05-11

Period: 2026-05-11

CIK: 0001235912

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2614163d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614163d1_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): May 11, 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 May 11, 2026, CVRx, Inc. issued a press

release announcing its financial results for the first quarter ended March 31, 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 May 11, 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:

May 11, 2026

By:

/s/

Jared Oasheim

Name: Jared Oasheim

Its: Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614163d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

CVRx Reports First Quarter 2026 Financial

and Operating Results

MINNEAPOLIS, May 11, 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 first quarter of 2026.

Recent Highlights

· Total revenue for the first quarter of 2026 was $14.8 million, an increase

of approximately 20% over the prior year quarter

· U.S. revenue for the first quarter of 2026 was $13.7 million, an increase

of 22% over the prior year quarter

· Active implanting centers in the U.S. grew to 257 as of March 31, 2026,

as compared to 227 as of March 31, 2025

· First site activated and first patient enrolled in BENEFIT-HF clinical trial

"We delivered a strong

start to 2026, with U.S. revenue growing 22% as the investments we made in our team and programs throughout 2025 begin to translate into

results," said Kevin Hykes, President and Chief Executive Officer of CVRx. "We are seeing continued progress from our sales

organization and the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial. Together,

these developments reinforce our confidence in the path ahead and in our ability to make Barostim more accessible to heart failure patients."

First Quarter 2026 Financial

and Operating Results

Revenue was $14.8 million

for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025.

Revenue generated in the U.S.

was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31,

2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 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.

As of March 31, 2026,

the Company had a total of 257 active implanting centers in the U.S., as compared to 252 as of December 31, 2025. Active implanting

centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in

the U.S. increased by three to a total of 56 during the three months ended March 31, 2026.

Revenue generated in Europe

was $1.1 million for the three months ended March 31, 2026, a decrease of $27,000, or 2%, over the three months ended March 31,

2025. Total revenue units in Europe decreased to 56 for the three months ended March 31, 2026 from 59 in the prior year period. The

number of sales territories in Europe remained consistent at five for the three months ended March 31, 2026.

Gross profit was $12.9 million

for the three months ended March 31, 2026, an increase of $2.6 million, or 25%, over the three months ended March 31, 2025.

Gross margin was 87% and 84% for the three months ended March 31, 2026 and March 31, 2025, respectively.

R&D expenses increased

$0.6 million, or 23%, to $3.1 million for the three months ended March 31, 2026 compared to the three months ended March 31,

2025. This change was driven by a $0.4 million increase in consulting expenses, a $0.3 million increase in compensation expenses, and

a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses.

SG&A expenses increased

$0.7 million, or 3%, to $22.0 million for the three months ended March 31, 2026, compared to the three months ended March 31,

2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3 million increase in non-cash stock-based

compensation expenses, partially offset by a $0.3 million decrease in consulting expenses and a $0.3 million decrease in advertising expenses.

Interest expense increased

$0.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven by the increased

borrowings under the term loan agreement with Innovatus Capital Partners.

Other income, net was $0.6

and $1.1 million for the three months ended March 31, 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 $13.1 million,

or $0.50 per share, for the three months ended March 31, 2026, compared to a net loss of $13.8 million, or $0.53 per share, for the

three months ended March 31, 2025. Net loss per share was based on 26.4 million weighted average shares outstanding for three months

ended March 31, 2026 and 25.9 million weighted average shares outstanding for the three months ended March 31, 2025.

As of March 31, 2026,

cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months

ended March 31, 2026 as compared to $12.9 million for the three months ended March 31, 2025.

BENEFIT-HF Clinical Trial

Update

On March 31, 2026, the

first site was activated in the BENEFIT-HF trial and the first patient was enrolled in the second quarter of 2026. This trial, as previously

disclosed, is a landmark randomized controlled trial designed to evaluate Barostim's impact on all-cause mortality and heart failure decompensation

events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up

to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times,

significantly broadening access to this proven neuromodulation-based approach to heart failure management.

Business Outlook

For the full year of 2026,

the Company maintained its revenue and expense guidance, and updated its guidance range for gross margin, as follows:

· Total revenue between $63.0 million and $67.0 million;

· Gross margin between 85% and 87%, compared to prior guidance of 84% and 86%;

· Operating expenses between $103.0 million and $107.0 million.

For the second quarter of

2026, the Company expects to report total revenue between $15.1 million and $16.1 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

second 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)

March 31,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 72,303

$ 75,708

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

9,104

10,665

Inventory

12,403

12,205

Prepaid expenses and other current assets

2,940

3,069

Total current assets

96,750

101,647

Property and equipment, net

2,159

2,243

Operating lease right-of-use asset

793

878

Other non-current assets

Total assets

$ 99,728

$ 104,794

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 2,998

$ 3,833

Accrued expenses

6,488

9,484

Total current liabilities

9,486

13,317

Long-term debt

58,490

49,514

Operating lease liability, non-current portion

544

638

Other long-term liabilities

2,099

2,001

Total liabilities

70,619

65,470

Commitments and contingencies

Stockholders’ equity:

Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2026 and December 31, 2025; 26,428,767 and 26,311,607 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

264

263

Additional paid-in capital

632,820

629,916

Accumulated deficit

(603,772 )

(590,652 )

Accumulated other comprehensive loss

(203 )

Total stockholders’ equity

29,109

39,324

Total liabilities and stockholders’ equity

$ 99,728

$ 104,794

CVRx, INC.

Condensed Consolidated Statements of Operations

and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

Three months ended

March 31,

2026

2025

Revenue

$ 14,769

$ 12,348

Cost of goods sold

1,888

2,036

Gross profit

12,881

10,312

Operating expenses:

Research and development

3,084

2,517

Selling, general and administrative

21,958

21,232

Total operating expenses

25,042

23,749

Loss from operations

(12,161 )

(13,437 )

Interest expense

(1,551 )

(1,457 )

Other income, net

593

1,123

Loss before income taxes

(13,119 )

(13,771 )

Benefit (provision) for income taxes

(1 )

Net loss

(13,120 )

(13,766 )

Cumulative translation adjustment

—

Comprehensive loss

$ (13,120 )

$ (13,766 )

Net loss per share, basic and diluted

$ (0.50 )

$ (0.53 )

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

26,355,591

25,876,062

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