CVRx Announces Initiation of BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population

CVRx (NASDAQ: CVRX) announced initiation of BENEFIT-HF, a randomized trial planned to enroll 2,500 patients across ~150 U.S. and German centers to evaluate Barostim in a significantly expanded heart failure population.

Rhea-AI Summary

CVRx (NASDAQ: CVRX) announced initiation of BENEFIT-HF, a randomized trial planned to enroll 2,500 patients across ~150 U.S. and German centers to evaluate Barostim in a significantly expanded heart failure population. The primary endpoint is a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. BENEFIT-HF will test Barostim in patients with LVEF 50% (vs current indication 35%) and NT-proBNP 5,000 pg/mL (vs current 1,600 pg/mL), potentially expanding the indicated population roughly threefold. The trial has CMS Category B IDE coverage to support patient access during the study period.

Positive

• Planned randomization of 2,500 patients
• Study to run in ~150 centers across the U.S. and Germany
• Primary endpoint: composite of all-cause mortality and HF decompensation
• Eligibility broadened to LVEF <50% and NT-proBNP <5,000 pg/mL
• CMS Category B IDE coverage supports patient access during the trial

Negative

• None.

Argus Jan 23 session

+11.43% close to close Open Argus

Details

News Market Reaction – CVRX

On Jan 23, the first trading day after this news, CVRX closed 11.43% above the previous close.

Data tracked by StockTitan Argus for the Jan 23 session.

Key Figures

Planned enrollment: 2,500 patients Trial centers: Approximately 150 centers LVEF criterion: <50% +5 more

Planned enrollment

2,500 patients

BENEFIT-HF randomized heart failure trial

Trial centers

Approximately 150 centers

Sites in United States and Germany

LVEF criterion

<50%

BENEFIT-HF inclusion vs current Barostim indication <35%

NT-proBNP criterion

<5,000 pg/mL

BENEFIT-HF inclusion vs current indication <1,600 pg/mL

Barostim FDA approval year

2019

FDA approval following Breakthrough Devices designation

Potential population expansion

Approximately three times

Possible expansion of indicated Barostim patient population

CMS IDE regulation

42 CFR § 405 Subpart B

Category B IDE coverage for BENEFIT-HF

CMS IDE coverage effective date

January 1, 2015

Effective date for Category B IDE coverage referenced

Historical Context

5 past events · Latest: Jan 12

5 events

1. Jan 12

   Prelim FY25 results

   24h Move

   -9.9%

   Prelim 2025 revenue, 2026 guidance, IDE and loan expansion details.

2. Jan 06

   Reimbursement update

   24h Move

   +3.3%

   Category I CPT codes implemented for Barostim reimbursement.

3. Dec 22

   Conference presentation

   24h Move

   -2.6%

   Announcement of J.P. Morgan Healthcare Conference presentation.

4. Nov 19

   Conference participation

   24h Move

   -1.1%

   Participation in Piper Sandler healthcare conference fireside chat.

5. Nov 05

   Q3 2025 earnings

   24h Move

   -2.0%

   Q3 2025 results with revenue growth and higher gross margins.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

baroreceptors, autonomic nervous system, left ventricular ejection fraction (LVEF), nt-probnp, +4 more

8 terms

baroreceptors medical

"delivers electrical signals to baroreceptors located on the carotid artery"

Baroreceptors are tiny pressure sensors located in the walls of large blood vessels that continuously monitor blood pressure and send signals to the brain to adjust heart rate and vessel tightness. For investors, they matter because drugs, implants or procedures that alter how these sensors work can change a treatment’s safety and effectiveness, influence regulatory reviews and affect market demand—like a thermostat that controls a building’s heating and cooling.

autonomic nervous system medical

"rebalancing the autonomic nervous system, and improving heart failure symptoms"

A network of nerves that automatically controls involuntary body functions such as heart rate, blood pressure, digestion and breathing, operating without conscious effort. Like an automatic thermostat that keeps a building’s climate steady, it is a major clinical target: drugs, devices or tests that affect this system can change patient outcomes, regulatory approval prospects and commercial value, so investors watch developments closely.

left ventricular ejection fraction (LVEF) medical

"Have a left ventricular ejection fraction (LVEF) <50% (compared to the current"

Left ventricular ejection fraction (LVEF) is the percentage of blood the heart’s main pumping chamber pushes out with each beat, a simple measure of how effectively the heart pumps like the efficiency rating on a water pump. Investors care because LVEF is a key clinical indicator used to diagnose and guide treatment for heart failure and other cardiac conditions, which affects demand for drugs, devices, reimbursement, trial outcomes, and company valuation.

nt-probnp medical

"Have NT-proBNP levels <5,000 pg/mL (compared to the current Barostim indication"

A blood test marker released when the heart is under strain; higher NT‑proBNP levels indicate the heart is working harder or may be failing, similar to a dashboard warning light that signals engine stress. Investors watch NT‑proBNP because changes in the marker can drive clinical trial results, treatment approvals, hospital use, and insurance decisions for heart drugs and devices, all of which affect revenue, adoption and valuation in healthcare companies.

guideline-directed medical and device therapies (gdmt) medical

"Remain symptomatic after receiving optimized guideline-directed medical and device therapies (GDMT)"

Guideline-directed medical and device therapies (GDMT) are the treatments and implanted or external devices that leading medical organizations recommend as the standard of care for a condition based on current clinical evidence. For investors, GDMT signals which products and drugs are likely to be adopted, reimbursed, and used as the benchmark in trials—think of it as the industry’s rulebook that shapes market demand, regulatory decisions, and competitive positioning.

cms category b ide coverage regulatory

"a landmark randomized study supported by CMS Category B IDE coverage"

CMS Category B IDE coverage is a Medicare policy that determines when Medicare will pay for routine care and certain costs tied to clinical trials of investigational medical devices operating under an Investigational Device Exemption (IDE). For investors, this matters because CMS coverage decisions influence patient access and trial enrollment, which can speed or slow a device maker’s path to market and future revenue — like whether a bridge is open for traffic, affecting how quickly goods can move.

breakthrough devices program regulatory

"following its designation under the FDA’s Breakthrough Devices Program"

A regulatory pathway that gives certain medical devices an “express lane” through reviews when they offer a substantial improvement in diagnosing or treating serious conditions. For investors, the label can shorten time to market and reduce regulatory uncertainty by enabling closer, faster interaction with regulators and priority review—potentially accelerating revenue and competitive advantage—though it does not guarantee final approval or commercial success.

investigational device exemption regulatory

"The FDA granted an investigational device exemption for the BENEFIT-HF trial"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Study is Expected to Be One of the Largest Therapeutic Cardiac Device Trials in Heart Failure Ever Performed, and is Supported by CMS Category B IDE Coverage

MINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population.

Barostim™ is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim™ received FDA approval in 2019 following its designation under the FDA’s Breakthrough Devices Program and is now commercially available in both the U.S. and Europe.

The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026.

The BENEFIT-HF trial is designed to evaluate Barostim in patients with heart failure who:

• Remain symptomatic after receiving optimized guideline-directed medical and device therapies (GDMT)
• Have a left ventricular ejection fraction (LVEF) <50% (compared to the current Barostim indication of <35%)
• Have NT-proBNP levels <5,000 pg/mL (compared to the current Barostim indication of <1,600 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.

Importantly, the Centers for Medicare & Medicaid Services (CMS) has approved Category B IDE coverage for the BENEFIT-HF clinical trial under IDE regulations (42 CFR § 405 Subpart B), effective January 1, 2015, supporting patient access to therapy during the trial period and reinforcing the trial’s feasibility at scale.

“The BENEFIT-HF trial represents an important evolution in our clinical strategy to treat patients with heart failure,” said Philip Adamson, MD, Chief Medical Officer of CVRx. “Our earlier BeAT-HF trial provided robust clinical insights that showed clear improvement in symptoms and functional status within a segment of the heart failure population. BENEFIT-HF is now designed to rigorously evaluate morbidity and mortality in a broader heart failure population already being treated with standard of care.”

“Heart failure remains one of the most significant unmet needs in cardiovascular medicine,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Launching a trial of this magnitude demonstrates our leadership in the field and our commitment to advancing the science of heart failure care, building upon the outstanding patient outcomes experienced by Barostim patients in both clinical studies and real-world experience. We are seeing tremendous excitement from physicians and clinical partners for the BENEFIT-HF trial and the role Barostim may play in treating a much broader heart failure population.”

CVRx plans to provide additional details regarding trial design, site activation, and enrollment timelines on its February earnings release call.

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, including statements regarding the expected timing, enrollment, scope, and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy. 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, the resulting impact of our addressable market 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.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the design and size of CVRx BENEFIT-HF trial (CVRX)?

BENEFIT-HF is a randomized trial planned to enroll 2,500 patients at ~150 U.S. and German centers, with a composite primary endpoint of all-cause mortality and heart failure decompensation.

When will enrollment for the CVRx (CVRX) BENEFIT-HF trial begin?

Enrollment is expected to begin in the first half of 2026.

How does BENEFIT-HF expand Barostim indications compared with current approval?

BENEFIT-HF will evaluate Barostim in patients with LVEF <50% (current indication <35%) and NT-proBNP <5,000 pg/mL (current <1,600 pg/mL), potentially expanding the indicated population ~threefold.

What patient access or reimbursement support does BENEFIT-HF have for CVRx (CVRX)?

The trial has CMS Category B IDE coverage, which supports patient access to the therapy during the study period under IDE regulations.

What is the primary endpoint CVRx (CVRX) will use in BENEFIT-HF?

The primary endpoint is a composite of all-cause mortality and heart failure decompensation events.