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

Rhea-AI Summary

CVRx (NASDAQ: CVRX) reported preliminary unaudited revenue of approximately $15.9M–$16.1M for Q4 2025 and $56.5M–$56.7M for full year 2025. The company provided 2026 guidance of $63M–$67M total revenue, 84%–86% gross margin and $103M–$107M operating expenses. Category I CPT codes and favorable physician fee payments took effect Jan 1, 2026. FDA granted an IDE for the BENEFIT-HF randomized trial; CMS IDE Category B coverage has been applied for and trial net costs are expected to be $20M–$30M over 5–7 years. The term loan facility was amended to increase capacity to $100M, with $60M outstanding and extended maturity to May 2031. Cash and cash equivalents were $75.7M at Dec 31, 2025.

Positive

• Full‑year 2025 revenue up ~10%–11% to $56.5M–$56.7M
• Fiscal 2026 revenue guidance of $63M–$67M
• Gross margin guidance strong at 84%–86%
• FDA granted IDE for BENEFIT‑HF randomized trial
• Category I CPT codes effective Jan 1, 2026
• Cash and cash equivalents of $75.7M at Dec 31, 2025

Negative

• Operating expense guidance of $103M–$107M exceeds revenue materially
• Term loans outstanding increased to $60M, raising leverage
• Initial amended term loan interest at minimum 9.40%
• BENEFIT‑HF CMS IDE Category B coverage is pending
• Projected trial net cost $20M–$30M over 5–7 years

News Market Reaction

-9.86% 2.3x vol

50 alerts

-9.86% News Effect

-21.7% Trough in 29 hr 38 min

-$22M Valuation Impact

$202M Market Cap

2.3x Rel. Volume

On the day this news was published, CVRX declined 9.86%, reflecting a notable negative market reaction. Argus tracked a trough of -21.7% from its starting point during tracking. Our momentum scanner triggered 50 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $22M from the company's valuation, bringing the market cap to $202M at that time. Trading volume was elevated at 2.3x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q4 2025 revenue: $15.9M–$16.1M FY 2025 revenue: $56.5M–$56.7M FY 2026 revenue guide: $63M–$67M +5 more

8 metrics

Q4 2025 revenue $15.9M–$16.1M Preliminary range; 4%–5% growth vs Q4 2024

FY 2025 revenue $56.5M–$56.7M Preliminary range; 10%–11% growth vs 2024

FY 2026 revenue guide $63M–$67M Implied 11%–18% year-over-year growth

Cash balance $75.7M Cash and cash equivalents as of Dec 31, 2025

Debt facility size $100M Term loan capacity after $50M increase; $60M drawn

2026 gross margin guide 84%–86% Guided full-year 2026 gross margin range

2026 opex guide $103M–$107M Guided operating expenses for full-year 2026

BENEFIT-HF size 2,500 patients; up to 200 centers Prospective randomized trial in U.S. and Germany

Market Reality Check

Price: $6.56 Vol: Volume 156,405 is below t...

normal vol

$6.56 Last Close

Volume Volume 156,405 is below the 20-day average of 192,131 (relative volume 0.81x). normal

Technical Shares at $8.11 were trading above the 200-day MA of $7.95, despite being 56.28% below the 52-week high.

Peers on Argus

Peer moves were mixed: BSGM up 39.91%, STIM up 4.55%, while ELMD, SGHT, and TLSI...

1 Up

Peer moves were mixed: BSGM up 39.91%, STIM up 4.55%, while ELMD, SGHT, and TLSI were down. Only one momentum-screened peer (BWAY, up 5.58%) appeared, offering limited evidence of a broad sector move.

Common Catalyst At least one peer (TLSI) also issued preliminary results and 2026 revenue guidance, pointing to an earnings/guidance news cycle in medical devices.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Reimbursement update	Positive	+3.3%	Implementation of Category I CPT codes for Barostim effective Jan 1, 2026.
Dec 22	Conference appearance	Neutral	-2.6%	Announcement of presentation at 44th J.P. Morgan Healthcare Conference.
Nov 19	Conference appearance	Neutral	-1.1%	Participation in Piper Sandler 37th Annual Healthcare Conference.
Nov 05	Quarterly earnings	Positive	-2.0%	Q3 2025 revenue growth, higher gross margin, narrowed net loss, updated guidance.
Nov 04	Conference appearance	Neutral	-3.6%	Jefferies Global Healthcare Conference presentation announcement.

Pattern Detected

Earnings-related releases have often seen negative price reactions even when fundamentals showed growth, while coding/reimbursement updates skewed positive.

Recent Company History

Over the last several months, CVRx has combined operational updates with expanding reimbursement support. The company reported Q3 2025 revenue of $14.7M with improving 87% gross margin, and repeatedly highlighted Category I CPT code progress and major conference participation. A January 2026 update confirmed Category I CPT implementation effective Jan 1, 2026, which previously coincided with a modest positive move. Conference announcements have generally had neutral-to-slightly-negative reactions, while earnings and preliminary results have shown a tendency for downside moves despite revenue growth.

Regulatory & Risk Context

Active S-3 Shelf · $150,000,000

Shelf Active

Active S-3 Shelf Registration 2025-11-06

$150,000,000 registered capacity

An effective Form S-3 shelf filed on Nov 6, 2025 allows CVRx to issue up to $150,000,000 of securities over time, providing flexibility to raise capital via equity, debt, or other instruments through future prospectus supplements.

Market Pulse Summary

The stock moved -9.9% in the session following this news. A negative reaction despite revenue growth...

Analysis

The stock moved -9.9% in the session following this news. A negative reaction despite revenue growth could fit prior patterns where earnings updates drew selling pressure even as fundamentals improved. Preliminary FY 2025 revenue of $56.5M–$56.7M and 2026 guidance of $63M–$67M come alongside higher operating expense guidance of $103M–$107M and a larger $100M term loan capacity. The existing $150M shelf may also weigh on sentiment as investors assess future capital-raising scenarios.

Key Terms

category i cpt codes, ide, centers for medicare & medicaid services, term loan, +3 more

7 terms

category i cpt codes regulatory

"The transition to Category I CPT codes, which took effect on January 1st..."

Category I CPT codes are standardized numeric labels used by doctors and hospitals to describe common medical procedures and services for billing and insurance purposes. Think of them like a universal price tag and barcode for a medical service: having a Category I code makes it easier for providers to bill insurers and for payers to decide coverage, which directly affects how reliably and quickly a procedure generates revenue and is adopted across the health system.

ide regulatory

"the Food and Drug Administration (“FDA”) granted an IDE for the BENEFIT-HF trial..."

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

centers for medicare & medicaid services regulatory

"The Company has since applied to the Centers for Medicare & Medicaid Services (“CMS”) for IDE Category B coverage..."

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

term loan financial

"amended its term loan agreement with an affiliate of Innovatus Capital Partners..."

A term loan is a type of loan that is borrowed for a set period of time, with a fixed schedule for repaying the money, usually in regular payments. It matters to investors because it represents a company's borrowing costs and financial stability; reliable repayment of these loans can indicate strong financial health, while difficulties may signal potential risks.

interest-only period financial

"The interest-only period is extended four years from the closing date..."

A period during a loan when the borrower pays only the interest charges and none of the original principal, so monthly payments are lower but the loan balance does not shrink. For investors, this affects cash flow and risk: borrowers may have higher near-term liquidity but face larger payments or refinancing later, which can influence a company’s ability to pay dividends, meet obligations, or require new financing — similar to paying rent on borrowed money before starting to pay it down.

randomized controlled trial medical

"designed as a prospective, multi-center, randomized controlled trial to evaluate Barostim's impact..."

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

aggregate principal amount financial

"to increase the existing facility by $50 million, to an aggregate principal amount of up to $100 million..."

The aggregate principal amount is the total amount of money borrowed through a bond or loan that the borrower promises to repay. It’s like the original price tag on a loan or bond, showing how much money is involved in the deal. This number matters because it indicates the size of the debt and helps investors understand the scale of the borrowing.

AI-generated analysis. Not financial advice.

• Fourth quarter revenue expected to be $15.9 million to $16.1 million, representing growth of 4% to 5%
• Full year revenue expected to be $56.5 million to $56.7 million, representing growth of 10% to 11%
• Fiscal 2026 revenue expected to be between $63 million and $67 million, representing growth of 11% to 18%
• Category I CPT codes and the related favorable physician fee payment levels took effect on Jan. 1, 2026
• FDA approved the BENEFIT-HF trial design in November and the Company has since applied to CMS for coverage for the trial
• Debt facility amended to extend maturity date to 2031 and to increase the facility from the $50 million of term loans already drawn by an additional $50 million, of which $10 million was funded at closing
  
  

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:

• Total revenue between $63.0 million and $67.0 million;
• Gross margin between 84% and 86%;
• Operating expenses between $103.0 million and $107.0 million.
  
  

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.

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 first quarter 2026 results and our expectations about the BENEFIT-HF trial), our anticipated growth strategies, 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, reimbursement and expenses related to the BENEFIT-HF trial and the resulting impact of 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; 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, 2024 and “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 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 Fourth Quarter/Full Year 2025 Results

This press release includes estimated financial results for the fourth quarter and full year of 2025, 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 fourth quarter and full year 2025 in February.

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

FAQ

What were CVRX Q4 2025 revenue results and YoY change?

Q4 2025 revenue is expected at $15.9M–$16.1M, up ~4%–5% versus Q4 2024.

What guidance did CVRx issue for fiscal 2026 revenue and margins?

CVRx guided $63M–$67M revenue for 2026 and gross margin of 84%–86%.

How much cash did CVRX report at December 31, 2025?

Cash and cash equivalents were $75.7 million as of Dec 31, 2025.

What is the status of the BENEFIT‑HF trial and CMS coverage for CVRX?

FDA granted an IDE in Nov 2025; CVRx has applied to CMS for IDE Category B coverage, which is pending.

What changed in CVRX's debt facility on Jan 9, 2026?

The term loan facility was amended to increase capacity to $100M, with an additional $10M borrowed bringing outstanding principal to $60M, maturity May 2031.

How will Category I CPT codes affect CVRx (CVRX) commercialization?

Category I CPT codes effective Jan 1, 2026 are expected to improve reimbursement and reduce adoption barriers for Barostim procedures.