AUSTIN, Texas– Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners. This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure). ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression.
“Alleviant’s mission is to bring a safe, effective no-implant treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward,” said Adam Berman, CEO of Alleviant Medical. “We could not ask for a stronger group of institutional and strategic healthcare investors as we accelerate our global efforts to bring this technology to patients.”
ALLAY-HF is a global prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive trial. The trial will evaluate the safety and effectiveness of the Alleviant System in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy. The trial will enroll 400 to 700 patients at select sites worldwide. The trial’s composite primary endpoint analysis will be conducted at one year.
“The Alleviant team is a real force in trailblazing novel solutions for heart failure,” said Brian R. Smith, managing director, S3 Ventures. “The team’s thoughtful approach to the ALLAY-HF trial demonstrates great insight into heart failure modalities and we remain bullish about their long-term prospects.”
“Alleviant Medical is poised to significantly improve the quality of life for millions of heart failure patients for whom there has been a lack of meaningful options,” said Jay Schmelter, managing director, RiverVest Venture Partners. “We are thrilled to be part of a strong investment syndicate supporting Alleviant’s talented, experienced management team as they drive forward this truly innovative technology.”
The Alleviant System, which was granted Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA) in November 2022, has demonstrated significant clinical improvement (functional and symptomatic) in studies across 38 heart failure patients to date. In these studies, shunt durability was confirmed through six months and sustained improvement was observed through 12 months.
S3 Ventures and RiverVest Venture Partners, along with investors Vensana Capital, Longview Ventures, TMC Venture Fund, and a strategic investor are joined by Gilmartin Capital, ShangBay Capital and another undisclosed strategic investor in this new financing round.
