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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
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 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 |
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.
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.
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.
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
