CVRx Reports Preliminary Fourth Quarter and Fiscal Year 2025 Financial Results and Issues Fiscal 2026 Guidance (Form 8-K)

CVRx Reports Preliminary Fourth Quarter and Fiscal Year 2025 Financial Results and Issues Fiscal 2026 Guidance

MINNEAPOLIS, Jan. 12, 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 fourth quarter and full year 2025 revenue results as well as provided a 2026 business outlook.

"We're pleased with our execution in 2025 as we delivered solid results while making significant strategic progress across the organization," said Kevin Hykes, President and Chief Executive Officer of CVRx. "Our focus on driving deeper penetration within high-potential accounts continued to gain traction, and we expanded our customer base as our sales organization developed throughout the year. The transition to Category I CPT codes, which took effect on January 1st, represents an important milestone that removes key adoption barriers and directly supports our commercial efforts going forward."

"We enter 2026 well-positioned to accelerate growth with favorable reimbursement dynamics now in place, a maturing sales organization, and a strengthened balance sheet following our recent debt amendment. Our focus remains on positively impacting the lives of patients who suffer from heart failure, and we're confident in our ability to drive increased Barostim adoption in the year ahead."

Fourth Quarter 2025

Total revenue for the fourth quarter of 2025 is expected to be in the range of approximately $15.9 million to $16.1 million, representing an increase of approximately 4% to 5% over fourth quarter 2024 revenue of $15.3 million.

Full Year 2025

Total revenue for full year 2025 is expected to be in the range of approximately $56.5 million to $56.7 million, representing an increase of approximately 10% to 11% over full year 2024 revenue of $51.3 million.

As of December 31, 2025, the Company had a total of 252 active implanting centers, as compared to 250 as of September 30, 2025. The number of sales territories in the U.S. increased by three to a total of 53 during the three months ended December 31, 2025.

As of December 31, 2025, cash and cash equivalents were $75.7 million.

Business Outlook

For the full year of 2026, the Company expects:

For the first quarter of 2026, the Company expects to report total revenue between $13.7 million and $14.7 million.

BENEFIT-HF

In November 2025, the Food and Drug Administration ("FDA") granted an IDE for the BENEFIT-HF trial, designed as a prospective, multi-center, randomized controlled trial to evaluate Barostim's impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients. The trial is designed to randomize 2,500 patients at up to 200 centers across the U.S. and Germany. The Company has since applied to the Centers for Medicare & Medicaid Services ("CMS") for IDE Category B coverage, a necessary condition for the Company to proceed with the trial. If approved by CMS, the net trial costs are expected to be $20 million to $30 million spread over the next five to seven years.

Debt Facility

On January 9, 2026, the Company amended its term loan agreement with an affiliate of Innovatus Capital Partners, LLC to increase the existing facility by $50 million, to an aggregate principal amount of up to $100 million, subject to the Company's achievement of certain milestones. Also on the closing date, the Company borrowed an additional $10 million under the term loan agreement, bringing the total outstanding principal amount of term loans to $60 million. The initial interest rate under the amended term loan agreement is equal to the greater of 9.40% or prime plus 2.65%. The interest-only period is extended four years from the closing date and is extendable to five years from the closing date upon achieving certain revenue milestones. The term loans mature in May 2031 and continue to be secured by substantially all of the Company's assets.

Upcoming Investor Conference Presentation

The Company will be participating in the 44^th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026. The Company is scheduled to present at 3:45 p.m. Pacific Time. A live audio webcast of the conference presentation will be available online on the investor relations page of the Company's website at ir.cvrx.com. The Company's presentation for the conference will be posted on the investor relations page of the Company's website by 8:30 a.m. Central Time today.

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.

About Innovatus Capital Partners, LLC

Innovatus Capital Partners, LLC, is an independent adviser and asset management firm with approximately $1.4 billion in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset categories with a unifying theme of capital preservation, income generation, and upside optionality. The firm has a dedicated team of life sciences investment professionals with deep experience in healthcare, including life sciences. Innovatus and its principals have significant experience providing debt financing to biotechnology, pharmaceutical, medical device, diagnostic, and life sciences tools companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare expenditures. To date, the Innovatus Life Sciences Strategy has made over $1.4 billion in capital commitments for debt and equity support. Further information can be found at www.innovatuscp.com.