Form 8-K

8-K — CVRx, Inc.

Accession: 0001104659-26-042354

Filed: 2026-04-13

Period: 2026-04-13

CIK: 0001235912

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Other Events

Item: Financial Statements and Exhibits

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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): April 13, 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 April 13, 2026, CVRx, Inc. (the

“Company”) issued a press release announcing certain preliminary 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 (the “SEC”) 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 (the “Securities Act”), 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 8.01. Other Events.

As disclosed above, on April 13, 2026,

the Company issued a press release announcing certain preliminary financial results for the

first quarter ended March 31, 2026, and provided information about reimbursements and its BENEFIT-HF trial.

First Quarter 2026

Total revenue for the first quarter of 2026

is expected to be in the range of $14.7 million to $14.8 million compared to revenue for the first quarter of 2025 of $12.3

million, representing growth of approximately 20%.

Gross margin for the first quarter of 2026

is expected to be approximately 87% compared to 84% in the first quarter of 2025.

Total operating expenses for the first quarter

of 2026 are expected to be approximately $25 million compared to $23.7 million in the first quarter of 2025.

As of March 31, 2026, the Company had

a total of 257 U.S. active implanting centers, as compared to 252 as of December 31, 2025. 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.

As of March 31, 2026,

cash and cash equivalents were approximately $72.3 million.

The foregoing estimated financial

results for the three months ended March 31, 2026 are preliminary, unaudited and represent the most recent current information available

to management. Our actual results may differ from these estimated financial results, including due to the completion of our financial

closing procedures and final adjustments. We expect to issue full financial results for the three months ended March 31, 2026 in

mid-May.

Reimbursement Update

As previously disclosed, the Category I Current

Procedural Terminology (CPT) codes for baroreflex activation therapy using the Company’s Barostim device replaced Category III codes

as of Jan. 1, 2026, which eliminates the automatic denials regularly seen with Category III codes and improves prior authorization

predictability to fairly pay physicians for the procedure. Early data in 2026 shows an increase in the 30-day approval rate for Medicare

Advantage prior authorizations managed by the Company’s in-house market access team, which has increased from 31% in 2024 to 44%

in 2025 and to 50% for the first two months of 2026.

First Site Activated in BENEFIT-HF Clinical

Trial

On March 31, 2026, the first site was activated in the

BENEFIT-HF trial and enrollment is expected to begin 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.

Forward-Looking Statements

This Form 8-K contains forward-looking statements within the meaning

of the Private Securities Litigation Reform Act of 1995. The statements regarding the Company’s future financial performance and

expectations about the BENEFIT-HF trial enrollment and timing and expected addressable market are forward-looking statements. These statements

speak only as of the date of this Form 8-K and are based on the Company’s current expectations and projections about the future

and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause actual results to differ from the

Company’s expectations, including the Company’s ability to enroll patients in the trial, the time it takes to complete the

enrollment and follow-up and the expenses the Company incurs to conduct the trial, as well as the actual size of the addressable market

of the expanded patient population. Except as required by applicable law, the Company does 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.

Item 9.01. Financial Statements

and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release of CVRx, Inc., announcing certain preliminary financial results, dated April 13, 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: April 13,

2026

By:

/s/

Jared Oasheim

Name: Jared Oasheim

Its: Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2611335d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

CVRx Reports

Preliminary First Quarter 2026 Financial Results

· Delivered

strong topline performance with first quarter revenue expected to be $14.7 million to $14.8

million, approximately 20% growth compared to first quarter of 2025

· Early

data in 2026 shows an increase in the 30-day approval rate for Medicare Advantage prior authorizations

managed by our market access team

· First

site activated in BENEFIT-HF clinical trial

MINNEAPOLIS,

Apr. 13, 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 certain preliminary unaudited first quarter 2026 financial and operating results.

"The

investments we made in our team and programs in 2025 are beginning to pay off, allowing us to deliver strong revenue growth in the

first quarter,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are also starting to observe

positive effects from the Category I CPT Code that took effect at the beginning of the year, as early data shows improved 30-day

prior authorization approval rates compared to what we saw in 2025. Our continued progress in reducing the barriers to adoption for

Barostim have enabled us to start the year off with positive momentum, and we are excited about what that means for the balance of

2026 and beyond.”

First

Quarter 2026

Total

revenue for the first quarter of 2026 is expected to be in the range of $14.7 million to $14.8 million compared to revenue

for the first quarter of 2025 of $12.3 million, representing growth of approximately 20%.

Gross

margin for the first quarter of 2026 is expected to be approximately 87% compared to 84% in the first quarter of 2025.

Total

operating expenses for the first quarter of 2026 are expected to be approximately $25 million compared to $23.7 million in the first

quarter of 2025.

of March 31, 2026, the Company had a total of 257 U.S. active

implanting centers, as compared to 252 as of December 31, 2025. 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.

of March 31, 2026, cash and cash equivalents were approximately $72.3 million.

Reimbursement

Update

previously disclosed, the Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using the Company’s

Barostim device replaced Category III codes as of Jan. 1, 2026, which eliminates the automatic denials regularly seen with Category

III codes and improves prior authorization predictability to fairly pay physicians for the procedure. Early data in 2026 shows an increase

in the 30-day approval rate for Medicare Advantage prior authorizations managed by the Company’s in-house market access team, which

has increased from 31% in 2024 to 44% in 2025 and to 50% for the first two months of 2026.

First

Site Activated in BENEFIT-HF Clinical Trial

March 31, 2026, the first site was activated in the BENEFIT-HF trial and enrollment is expected to begin 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.

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, our anticipated growth strategies

(including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial), 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 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; the constant growth and development of technology, including artificial intelligence; 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 clinical 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.

Preliminary First Quarter 2026 Results

This press release includes estimated

financial results for the first quarter of 2026, which are preliminary, unaudited and represent the most recent current information available

to Company management. The Company’s actual results may differ from these estimated financial results, including due to the completion

of its financial closing procedures and final adjustments. The Company expects to issue full financial results for the first quarter

of 2026 in mid-May.

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

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