CVRx, Inc. will present late-breaking clinical data and real-world evidence on its Barostim therapy across eight events at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, scheduled for October 9-12 in Phoenix.

The presentations span late-breaking clinical data, a rapid-fire session, posters, and podium sessions. BENEFIT-HF, the landmark clinical trial initiated earlier this year evaluating Barostim in an expanded population, will also be featured in the clinical trial ePoster hub. CVRx will additionally host two sponsored symposia focused on Barostim's integration into clinical practice.

New REBALANCE registry and real-world HFmrEF evidence

Two presentations highlight new data from real-world patient populations. Dr. Dmitry Yaranov will present new analyses from the REBALANCE Registry, described as the largest real-world study of Barostim-treated patients to date, evaluating the safety and benefits of Barostim in commercial use, in a late-breaking Sunday plenary session. In a separate rapid-fire session, Dr. Javed Butler will present Baroreflex Activation Therapy in HFmrEF: First Real-World Evidence of Reduced Hospitalization Burden.

Barostim on the HFSA 2026 agenda

The following table outlines all scheduled Barostim presentations and activities across the four-day meeting.

CVRx sponsored symposia

CVRx will host two symposia during the meeting, each addressing practical aspects of Barostim adoption.

• Friday, Oct. 9, 7:00-8:30 a.m.: Device-Based Neurohormonal Intervention: The Role of Barostim in Heart Failure Care will explore clinical evidence supporting Barostim, patient selection, integration into guideline-directed care, and practical considerations for implementation.
• Sunday, Oct. 11, 1:00-2:00 p.m.: Successful Barostim Program Development: A Critical Component of the Heart Failure Care Continuum will address multidisciplinary collaboration, patient identification, referral pathways, workflow integration, and best practices for developing and sustaining a successful Barostim program.

About Barostim and CVRx

CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases. Barostim is described as the first medical technology approved by the FDA that uses neuromodulation to improve the symptoms of patients with heart failure. The implantable device delivers electrical pulses to baroreceptors located in the wall of the carotid artery, designed to restore balance to the autonomic nervous system. Barostim received the FDA Breakthrough Device designation and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area, certified as compliant with the EU Medical Device Regulation (MDR).

Hagens Berman has opened an investigation into CVRx Inc. (NASDAQ: CVRX) regarding potential violations of federal securities laws. The inquiry follows a 59% decline in the company's stock price on August 7, 2026, triggered by disclosures of a U.S. Department of Justice Civil Investigative Demand and severe operational setbacks.

The litigation firm is examining whether CVRx misled investors about the state of its commercial sales force and Medicare Advantage reimbursement rates. The investigation also seeks to determine if there is a direct connection between the Department of Justice demand and the abrupt termination of Chief Revenue Officer Robert John on August 10, 2026.

Operational and legal headwinds

CVRx’s sole commercial product, Barostim, is an FDA-approved implantable neuromodulation device for heart failure patients. Historically, the company assured investors that its growth strategy relied on a completed sales force transformation and high approval rates from Medicare Advantage payers. CVRx had repeatedly highlighted a $10.5 billion market opportunity with less than 1% penetration.

However, after market close on August 6, 2026, the company disclosed significant issues:

• DOJ Civil Investigative Demand: Received on May 14, 2026, investigating whether CVRx caused false claims submissions to government health programs through improper marketing or kickbacks.
• Sales Force Deterioration: The company cut its 2026 revenue expectations, citing sequentially flat growth in sales territories, high turnover, and strained onboarding.
• Reimbursement Collapse: A primary Medicare Advantage payer increased initial denials, reducing 30-day approvals to 25% from a historical 80%.

What the numbers show

The divergence between CVRx’s prior assurances and its August disclosures highlights a critical dependency risk. The company previously marketed its sales force transformation as "largely complete" while relying heavily on a single Medicare Advantage payer that historically approved 80% of prior authorizations within 30 days. The sudden drop in approvals to 25% directly contradicts the stability implied by the earlier claims, suggesting that the reported market penetration potential was contingent on reimbursement conditions that deteriorated rapidly.

Investor recourse

Hagens Berman partner Reed Kathrein stated the firm is investigating whether there is a direct connection between the Department of Justice demand and the immediate termination of the Chief Revenue Officer. Investors who suffered substantial losses are encouraged to contact the firm to evaluate their legal rights. Whistleblowers with non-public information may also participate in the SEC Whistleblower program, which offers rewards of up to 30% of successful recoveries.