Alleviant Medical, an Austin, TX-based medical device company, raised $75M in equity funding.
The round was led by S3 Ventures and RiverVest Venture Partners with participation from Vensana Capital, Longview Ventures, TMC Venture Fund, Gilmartin Capital, ShangBay Capital.
The company intends to use the funds to conduct its global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure).
Led by CEO Adam Berman, Alleviant Medical is a medical device company developing a minimally invasive, implant-free device under clinical investigation for the treatment of chronic heart failure. Its System was granted U.S. FDA Breakthrough Device Designation in 2021.
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.