CVRx (NASDAQ: CVRX) lifts credit facility, outlines BENEFIT-HF trial

Rhea-AI Filing Summary

CVRx, Inc. amended its term loan agreement on January 9, 2026, increasing total term loan availability by $50 million to up to $100 million, extending interest-only payments to four years from the closing date and pushing final maturity to May 9, 2031. The interest rate is now a floating rate equal to the greater of the prime rate or 6.75%, plus a margin of 2.65%, which falls to 2.00% after two consecutive quarters of positive adjusted EBITDA. The company immediately borrowed an additional $10 million, bringing total term loans outstanding to $60 million, and may draw a further $40 million if future revenue and market capitalization milestones are met.

CVRx expects fourth-quarter 2025 revenue of about $15.9–$16.1 million, up roughly 4–5% from $15.3 million a year earlier, and full-year 2025 revenue of about $56.5–$56.7 million, up 10–11% from $51.3 million in 2024. As of December 31, 2025, it had $75.7 million in cash and cash equivalents, 252 active implanting centers, and 53 U.S. sales territories.

The FDA granted an investigational device exemption for the BENEFIT-HF trial of the Barostim device in an expanded heart failure population. CVRx has applied to CMS for IDE Category B coverage; if approved, it plans to enroll across about 150 centers in the first half of 2026, with enrollment expected to complete within five years and a two-year follow-up. Net trial costs are expected at $20–$30 million, and a successful outcome could expand Barostim’s U.S. addressable market from roughly 339,000 to 983,000 patients, increasing the estimated sales opportunity from $10.5 billion to $30.5 billion.

Insights

Medical device and capital structure analyst

CVRx secures more flexible debt, posts steady growth, and pursues a large but costly BENEFIT-HF trial.

CVRx expanded its term loan capacity to $100M, with $60M already drawn, while locking in an interest-only period of four years and extending maturity to May 9, 2031. The floating rate based on at least 6.75% plus a 2.65% margin (dropping to 2.00% after two positive adjusted EBITDA quarters) links financing cost directly to both rates and operating performance. Milestone-based access to another $40M ties additional leverage to revenue and market capitalization thresholds.

Operationally, preliminary results show full-year 2025 revenue of about $56.5–$56.7M, roughly 10–11% growth from $51.3M in 2024, and cash and cash equivalents of $75.7M as of December 31, 2025. Modest quarterly growth, a slight increase in active implanting centers to 252, and 53 U.S. sales territories indicate measured commercial expansion backed by a strengthened balance sheet.

Strategically, the FDA’s IDE for the BENEFIT-HF study and the CMS Category B coverage application set up a long, expensive trial. CVRx expects net trial costs of $20–$30M over five to seven years, but a successful outcome could expand Barostim’s U.S. addressable prevalence-based market from about 339,000 to 983,000 heart failure patients and raise the estimated sales opportunity from $10.5B to $30.5B. Actual impact will depend on CMS coverage, enrollment execution, and final trial results over the coming years.

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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): January 9, 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 1.01. Entry into a Material Definitive Agreement.

On January 9, 2026 (the “Closing Date”), CVRx, Inc. (the “Company”) entered into an amendment (the “Amendment”) to its existing Loan and Security Agreement dated October 31, 2022, as previously amended on March 13, 2023 (as amended, the “Loan Agreement”), among the Company, Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, and the other lenders from time to time party thereto. Pursuant to the Amendment, (a) the terms loans available to the Company are increased by $50 million, to an aggregate principal amount of up to $100 million, subject to the Company’s achievement of certain milestones, (b) the interest rate applicable to the term loans is adjusted to a floating rate per annum equal to the sum of (i) the greater of (A) the prime rate and (B) 6.75% plus (ii) a margin equal to 2.65%, which margin will decrease to 2.00% after the Company achieves a positive adjusted EBITDA for two consecutive quarters, (c) the interest only period is extended to four years from the Closing Date, subject to a further one-year extension upon the Company’s achievement of certain revenue milestones and (d) the maturity date of the term loans is extended to May 9, 2031. The existing performance covenant was unchanged, which requires the Company to achieve 50% of trailing 12-month revenue targets set in the most recent Board approved management plan, suspended when trailing 12-month revenue exceeds $100 million. The term loans continue to be secured by substantially all of the Company’s assets.

Also on the Closing Date, the Company borrowed an additional $10 million under the Loan Agreement, bringing the total outstanding principal amount of term loans to $60 million. The Company has the option to draw (i) $15 million between June 1, 2027 and December 31, 2027 upon achieving trailing 6-month revenue of $37.5 million and market capitalization greater than $190 million, and (ii) $25 million between March 1, 2028 and September 30, 2028 upon achieving trailing 6-month revenue of $47.5 million and market capitalization greater than $300 million.

The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment filed as Exhibit 10.1 hereto.

Item 2.02. Results of Operations and Financial Condition.

On January 12, 2026, the Company issued a press release announcing certain preliminary financial results for the fourth quarter and fiscal year ended December 31, 2025. 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 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information under Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.03.

Item 8.01. Other Events.

As disclosed above, on January 12, 2026, the Company issued a press release announcing preliminary financial results for the fourth quarter and fiscal year ended December 31, 2025, and provided information about its planned BENEFIT-HF trial.

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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.

The foregoing estimated financial results for the fourth quarter and full year 2025 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 2024 in February 2026.

BENEFIT-HF

In November 2025, the Food and Drug Administration granted an investigational device exemption (“IDE”) study designed as a prospective, multi-center, randomized controlled trial to evaluate the Barostim device’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients.

The Company has 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, the Company expects to begin enrolling the trial across approximately 150 centers in the first half of 2026 and complete enrollment within five years. The trial provides for a two-year follow-up period, resulting in the expected conclusion of the trial in five to seven years. If approved by CMS, the Company expects net trial costs of $20 million to $30 million spread over the period of the trial. A successful outcome could expand Barostim’s total addressable prevalence-based U.S. market from approximately 339,000 patients to approximately 983,000 patients, representing a sales market opportunity from $10.5 billion to $30.5 billion.

Design summary

· Prospective, randomized, controlled trial at up to 200 centers in the U.S. and Germany, randomizing 2,500 patients with a two-year follow-up.

· 2:1 randomization to Barostim implantation plus guideline-directed medical and device therapies or control group only receiving guideline-directed medical and device therapies.

· Eligibility: NYHA Class II or III symptoms, LVEF <50%, and NT-proBNP levels of 400 to <5,000 pg/mL, despite optimal medical and device therapies.

· Primary efficacy endpoint: Composite of all-cause death, LVAD implantation, heart transplant, and heart failure events requiring emergency department visits or hospitalization.

· Secondary endpoints: Improvements in quality of life (MLWHF), 6-MHW test, days alive and out of hospital through 24 months, NT-proBNP changes at 12 months, and all-cause mortality through 24 months.

· Supplemental endpoint: LVEF changes at 6, 12, and 24 months.

· Safety assessment: MANCE within 180 days post-implantation.

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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 expectations about the BENEFIT-HF trial enrollment, reimbursement and expenses and the 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 whether CMS approves coverage for the trial, 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
10.1		Second Amendment to Loan and Security Agreement, dated as of January 9, 2026, among the Company, Innovatus Life Sciences Lending Fund I, LP, as the collateral agent and a lender, and the other lenders from time to time party thereto
99.1		Press release of CVRx, Inc., dated January 12, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: January 12, 2026	By:	/s/ Jared Oasheim
		Name: Jared Oasheim
		Its: Chief Financial Officer

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FAQ

What loan changes did CVRx (CVRX) disclose in this 8-K?

CVRx amended its Loan and Security Agreement to increase total term loan availability by $50 million to an aggregate principal amount of up to $100 million. The interest-only period now extends to four years from the January 9, 2026 closing date, with a possible one-year extension if certain revenue milestones are met, and the maturity date was extended to May 9, 2031.

How much debt did CVRx (CVRX) draw and what is currently outstanding?

On the closing date of the amendment, CVRx borrowed an additional $10 million under the loan agreement, bringing the total outstanding principal amount of term loans to $60 million. The company also has options to draw another $15 million in 2027 and $25 million in 2028 if it meets specified revenue and market capitalization milestones.

What preliminary 2025 revenue did CVRx (CVRX) report?

For the fourth quarter of 2025, CVRx expects total revenue of approximately $15.9–$16.1 million, about 4–5% above fourth quarter 2024 revenue of $15.3 million. For full year 2025, it expects total revenue of approximately $56.5–$56.7 million, an increase of about 10–11% over full year 2024 revenue of $51.3 million.

What is CVRx’s (CVRX) cash position and commercial footprint as of December 31, 2025?

As of December 31, 2025, CVRx reported $75.7 million in cash and cash equivalents. It had 252 active implanting centers, up from 250 as of September 30, 2025, and its U.S. sales organization included 53 sales territories, an increase of three during the fourth quarter of 2025.

What is the BENEFIT-HF trial that CVRx (CVRX) plans to conduct?

The BENEFIT-HF trial is an FDA-approved investigational device exemption study to evaluate the Barostim device’s impact on all-cause mortality and heart failure decompensation events in an expanded heart failure population. CVRx has applied to CMS for IDE Category B coverage, and, if approved, plans to enroll across approximately 150 centers starting in the first half of 2026, with enrollment expected to complete within five years and a two-year follow-up period.

How could the BENEFIT-HF trial affect CVRx’s (CVRX) market opportunity and costs?

CVRx estimates net BENEFIT-HF trial costs of $20–$30 million over the trial period. If the trial outcome is successful, the company expects Barostim’s U.S. prevalence-based addressable market to expand from about 339,000 to approximately 983,000 heart failure patients, increasing the estimated sales market opportunity from roughly $10.5 billion to about $30.5 billion.