MINNEAPOLIS (US) – CVRx, Inc., a private medical device company, announced today that its BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain Premarket Approval (PMA) from the United States Food and Drug Administration (“FDA”) to market its BAROSTIM NEO device for improvement of symptoms in patients with heart failure (“HF”) in the United States.
“Publication of the BeAT-HF trial results in the esteemed, peer reviewed JACC journal provides further validation that we finally have an effective neuromodulation therapy for advanced HF patients, who did not have access to device-based therapy.” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair Person of the BeAT-HF Executive Steering Committee. “The BAROSTIM NEO improves patient-centered symptomatic endpoints of quality of life score, exercise capacity and functional status. These results are supported by objective evidence of a significant reduction in NT-proBNP, which in recent studies was associated with a lower rate of cardiovascular death or heart failure hospitalization.”
“The interactive and adaptive design of BeAT-HF is groundbreaking.” wrote James L. Januzzi, M.D. and Nasrien E. Ibrahim, M.D. (Massachusetts General Hospital, Harvard Medical School) in their editorial. “With growing incidence, prevalence, and risk of patients affected by HF, all hands must be on deck to ‘beat the clock’ and get safe, effective treatments to our patients.”
BeAT-HF was a multi-center, prospective, randomized, controlled trial. Patients were randomized one-to-one to receive BAROSTIM NEO plus optimal medical management or optimal medical management alone (control).
- NYHA Class III or Class II (with recent history of Class III)
- Left ventricular ejection fraction ? 35%
- On current HF guideline-directed medical therapy
- NT-proBNP < 1600 pg/mL
- Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines
The BeAT-HF trial results represent the intended use population that reflects the FDA approved instructions for use included 264 randomized patients.
Key six-month results:
- BAROSTIM NEO is safe to use for patients with HFrEF, with a MANCE free rate of 97%*.
- BAROSTIM NEO demonstrated clinically significant improvements in patient-centered symptomatic endpoints as compared to the control group:
- Improved quality of life score by 14.1 (p<0.001) points using the Minnesota Living with Heart Failure Questionnaire.
- Improved exercise capacity by 60 meters (p<0.001) as measured by the standardized 6-minute hall walk test.
- Improved functional status as assessed by NYHA classification: 65% BAROSTIM NEO versus 31% control patients experienced NYHA class improvement (p<0.001).
- These results were supported by objective evidence of a significant 25% reduction in NT-proBNP (p<0.001).
- These clinically significant differences in treatment effect were observed despite an increase in the number of medications in the control arm.
* Major adverse neurological and cardiovascular related device or procedure event free rate (MANCE)
About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology, designed to send electrical pulses to baroreceptors located in the wall of the carotid artery, delivering BAROSTIM THERAPY™, and is designed to restore balance to the autonomic nervous system and thereby improve the symptoms of HF. The BAROSTIM NEO has received the sought-after “Breakthrough Device” designation by the FDA in the United States, and is the first device approved by FDA to use the power of the brain and the nervous system to improve the symptoms of patients with HFrEF. The BAROSTIM NEO has received the CE Marking for HF and resistant hypertension in the European Economic Area (“EEA”).
About CVRx, Inc.
CVRx is a leader in innovative technologies that address the unmet needs in cardiovascular diseases with safe and effective therapies. Headquartered near Minneapolis, Minn., CVRx is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel baroreceptor neuromodulation therapies. Learn more at www.cvrx.com.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion ($1.5 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in digital health, medtech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com.