Alleviant Medical develops the Alleviant System, a minimally invasive, no-implant atrial shunt designed to relieve excess pressure by creating a temporary connection between the left and right atrial chambers. The procedure is one-time and leaves no permanent implant behind. The Alleviant System has received U.S. FDA Breakthrough Device designation for both major forms of heart failure. The company is running pivotal clinical programs across the full spectrum of heart failure, with ALLAY-HF evaluating patients with preserved ejection fraction (HFpEF) and on track to finalize enrollment within the next year. The new program, ALLAY-HFrEF, will investigate patients with reduced ejection fraction (HFrEF) and is planned as a prospective sham-controlled pivotal trial. Alleviant is headquartered in Austin, Texas. Alleviant Medical is developing the Alleviant System, a minimally invasive, implant-free interatrial shunt intended to decompress the left atrium and treat chronic heart failure. The company has FDA Breakthrough Device designation (2021) and received an IDE approval in November 2022 to support clinical investigation. Clinical studies to date have enrolled 38 heart failure patients, showing functional and symptomatic improvement with shunt durability confirmed through six months and sustained improvement through 12 months. Alleviant will use the new financing to fund ALLAY-HF, a global, prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive pivotal trial enrolling 400–700 patients with HFpEF and HFmrEF. The trial’s composite primary endpoint analysis will be conducted at one year and is designed to demonstrate safety and effectiveness of the Alleviant System. The company is headquartered in Austin, Texas and is backed by a syndicate of institutional and strategic healthcare investors.

Total raised

$165M

Funding rounds

2

Latest round

Equity

Latest activity

Jan 2025