CVRx, Inc. (NASDAQ:CVRX) on Thursday initiated 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 (sensory neurons that monitor blood pressure) 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 the U.S. and Europe.
The company on Thursday said that 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.
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.
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.
Analyst Commentary
William Blair on Friday wrote, “If successful, this trial would roughly triple the company’s TAM. Importantly, we think the scale and rigor of this trial will turn heads in the cardiology community, ultimately drawing more attention to Barostim and likely providing a tailwind to procedures overall.”
In previous analyst notes, analyst Brandon Vazquez wrote that securing CMS coverage for the trial would be a key milestone for the company, as it would unlock a potential upside lever. With two-thirds of the 2,500 patients set to receive Barostim therapy (~1,650) throughout the life of the trial, an assumed $30,000 price would represent an incremental $50 million in top-line revenue.
William Blair maintains the Outperform rating.
CVRX Price Action: CVRx shares were up 15.93% at $7.60 at the time of publication on Friday, according to Benzinga Pro data.
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