STOCK TITAN
  1. Home
  2. Sec-filings
  3. CVRX
  4. [8-K] CVRx, Inc. Reports Material Event

CVRx (NASDAQ: CVRX) grows Q1 2026 revenue 20% but remains loss-making

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

CVRx, Inc. reported first quarter 2026 revenue of $14.8 million, up 20% from $12.3 million a year earlier, driven mainly by U.S. sales growth. U.S. revenue reached $13.7 million, while Europe contributed $1.1 million.

Gross profit was $12.9 million with gross margin improving to 87% from 84%. Operating expenses rose to $25.0 million, and net loss was $13.1 million, or $0.50 per share, slightly better than the $13.8 million, or $0.53 per share, loss in 2025. Cash and cash equivalents totaled $72.3 million at March 31, 2026.

The company activated the first site and enrolled the first patient in its BENEFIT-HF trial, which is designed to assess whether Barostim can help a broader group of heart failure patients. For the second quarter of 2026, CVRx expects revenue between $15.1 million and $16.1 million and maintained its full-year 2026 revenue and expense guidance while updating its gross margin outlook.

Positive

  • None.

Negative

  • None.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q1 2026 Revenue $14.8 million Three months ended March 31, 2026; up 20% year over year
U.S. Revenue Q1 2026 $13.7 million Three months ended March 31, 2026; up 22% year over year
Gross Margin Q1 2026 87% Three months ended March 31, 2026; improved from 84% in 2025
Net Loss Q1 2026 $13.1 million Three months ended March 31, 2026; compared to $13.8 million in 2025
Net Loss Per Share Q1 2026 $0.50 per share Basic and diluted, based on 26.4 million weighted-average shares
Cash and Cash Equivalents $72.3 million Balance as of March 31, 2026
Long-term Debt $58.5 million Balance as of March 31, 2026
Q2 2026 Revenue Guidance $15.1–$16.1 million Expected total revenue for the second quarter of 2026
BENEFIT-HF clinical trial medical
"the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial"
gross margin financial
"Gross margin was 87% and 84% for the three months ended March 31, 2026 and March 31, 2025, respectively."
Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.
operating expenses financial
"Total operating expenses were $25,042 and $23,749 for the three months ended March 31, 2026 and 2025, respectively."
Operating expenses are the routine costs a company pays to keep its business running day to day — things like salaries, rent, utilities, office supplies, and marketing. Investors watch them because they reduce the profit available to shareholders and reveal how efficiently a company runs; lower or well-controlled operating expenses (relative to revenue) are like trimming household bills to improve savings.
FDA Breakthrough Device designation medical
"Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S."
A FDA Breakthrough Device Designation is a U.S. regulatory status that gives certain medical devices faster and more flexible review because they may offer more effective treatment or diagnosis for unmet medical needs. Think of it as a “fast lane” through the regulatory process that can shorten development time and reduce regulatory uncertainty, which matters to investors because it can accelerate potential revenue, lower time-to-market risk, and make a product more attractive—while not guaranteeing final approval or commercial success.
NT-proBNP levels medical
"patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL."
Revenue $14.8 million +20% year over year
Guidance

For Q2 2026, CVRx expects revenue between $15.1 million and $16.1 million and maintained full-year 2026 revenue and expense guidance while updating its gross margin range.

Understanding 8-K Material Events →
false 0001235912 0001235912 2026-05-11 2026-05-11 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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

 

If 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

 

 

 

 

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   26    26 
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)   (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)   5 
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 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

How did CVRx (CVRX) perform financially in Q1 2026?

CVRx generated Q1 2026 revenue of $14.8 million, up 20% year over year. Gross profit was $12.9 million with an 87% gross margin, and net loss narrowed slightly to $13.1 million, or $0.50 per share, compared to a $13.8 million loss in 2025.

What drove CVRx (CVRX) revenue growth in the first quarter of 2026?

Revenue growth was mainly driven by the U.S. heart failure business. U.S. revenue rose to $13.7 million, up 22% year over year, supported by more sales territories, new accounts, higher awareness of Barostim, and an increase in U.S. revenue units from 359 to 429.

What is CVRx’s cash and debt position as of March 31, 2026?

As of March 31, 2026, CVRx held $72.3 million in cash and cash equivalents. Total assets were $99.7 million, long-term debt was $58.5 million, and total stockholders’ equity stood at $29.1 million, reflecting ongoing investment in growth while operating at a net loss.

What guidance did CVRx (CVRX) provide for Q2 and full-year 2026?

For the second quarter of 2026, CVRx expects revenue between $15.1 million and $16.1 million. The company maintained its previously issued full-year 2026 revenue and expense guidance and updated its gross margin guidance range, underscoring its current operating and growth expectations.

What is the BENEFIT-HF trial mentioned by CVRx (CVRX)?

BENEFIT-HF is a randomized controlled trial evaluating Barostim’s effect on all-cause mortality and heart failure events in a broader patient group. The first site was activated on March 31, 2026, and the first patient was enrolled in Q2 2026, targeting potentially threefold indication expansion.

How many implanting centers and sales territories does CVRx have?

As of March 31, 2026, CVRx had 257 active implanting centers in the U.S., up from 252 at December 31, 2025. U.S. sales territories increased by three to 56, while European sales territories remained at five, supporting the company’s expanding commercial footprint.

Filing Exhibits & Attachments

4 documents

Press Releases

Other Documents