CVRx, Inc. (NASDAQ: CVRX) has commenced a pivotal clinical trial named BENEFIT-HF, aiming to significantly enlarge the patient population treated with its Barostim device for heart failure. This groundbreaking randomized study benefits from CMS Category B investigational device exemption (IDE) coverage and is positioned to be one of the largest therapeutic cardiac device trials in the history of heart failure treatment. The study plans to enroll 2,500 participants, reflecting a substantial increase compared to previous investigations.
Barostim is a specialized implantable device that delivers targeted electrical stimulation to baroreceptors, which are sensory neurons located on the carotid artery responsible for monitoring blood pressure fluctuations. Through this stimulation, Barostim enhances baroreflex signaling and contributes to rebalancing the autonomic nervous system, mechanisms that collectively work to improve symptoms associated with heart failure.
The device initially received approval by the U.S. Food and Drug Administration (FDA) in 2019, following its designation as a breakthrough device under the FDA's Breakthrough Devices Program. Since gaining approval, Barostim has been available commercially in both U.S. and European markets as a treatment option for patients with heart failure.
The BENEFIT-HF trial is designed to rigorously evaluate Barostim's benefit in an expanded group of patients with heart failure. Its primary endpoint will be a composite measure consisting of all-cause mortality and events of heart failure decompensation, reflecting critical outcomes in this patient population. The enrollment phase is anticipated to start during the first half of 2026.
If the trial successfully meets its endpoints, the approved indication for Barostim could see an approximate threefold increase in eligible patients, enabling significantly broader access to this neuromodulation-based therapy for heart failure management. This expansion would represent a meaningful advancement for patients and physicians seeking new options beyond the existing standard of care.
Industry analysts have emphasized the transformative potential of the study. According to commentary from William Blair, a leading equity research firm, the trial’s scale and methodological rigor are expected to attract substantial attention within the cardiology community. A favorable trial outcome would not only expand the total addressable market (TAM) for CVRx substantially but also likely bolster the overall volume of Barostim implant procedures moving forward.
Further observations highlight the strategic importance of CMS coverage for the trial. Analyst Brandon Vazquez has noted that this coverage unlocks an important revenue upside, given that approximately two-thirds of the enrolled patients (~1,650 individuals) will receive the Barostim therapy during the trial period. Assuming a device pricing level of around $30,000, this patient volume could translate into approximately $50 million in incremental top-line revenue over time, underscoring the commercial significance of the study.
Following the announcement and related market developments, CVRx’s shares experienced notable gains. As reported on the Friday following the announcement, the stock price increased by 15.93%, reaching $7.60 per share according to market data.