CVRx’s stock has risen nearly 20% after the company revealed that its heart failure device is set to be investigated in an expanded patient population.
In the BENEFIT-HF clinical trial (NCT07232030), Barostim will be trialled in patients with heart failure who remain symptomatic after receiving optimised guideline-directed medical and device therapies (GDMT), have a left ventricular ejection fraction (LVEF) <50%, or have NT-proBNP levels <5,000 pg/mL.
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If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this neuromodulation-based approach to heart failure management.
Barostim is an implantable neuromodulation device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signalling, rebalancing the autonomic nervous system, and improving heart failure symptoms.
It gained US Food and Drug Administration (FDA) approval in 2019 following its designation under the FDA’s Breakthrough Devices Program and is now commercially available in both the US and Europe. The device is already approved for use in heart failure patients who have an LVEF of <35% and patients with NT-proBNP levels of <1,600 pg/mL. In Europe, Barostim was approved for heart failure in September 2014.
Its potential for an expansion of that approval has excited investors, with the company’s stock value rising by 19.51%, from a 22 January close of $6.56 to a 23 January high of $7.84 (correct at 10.30am ET 23 January).
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By GlobalDataThe BENEFIT-HF trial will enrol 2,500 patients from approximately 150 centres in the US and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events.
Kevin Hykes, President and CEO of CVRx, said: “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.”
The device was also investigated in the BeAT-HF study (NCT02627196), with data demonstrating the long-term sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction.
The global neuromodulation device market is expected to reach $11.4bn by 2033, according to a report by GlobalData.
GlobalData is the parent company of Clinical Trials Arena.
