
Austin, Texas-based Alleviant develops a no-implant atrial shunt for treating heart failure. That includes reduced ejection fraction (HFrEF), a common form of heart failure. Its novel shunt leaves behind no permanent implant in the body.
The transcatheter device uses a short pulse of energy to create a durable passage between the left and right atrium. It aims to reduce excess pressure within the left atrium through a less invasive approach.
Alleviant received FDA investigational device exemption (IDE) and breakthrough device designation for its atrial shunt last week.
Gilde Healthcare led the financing. Omega Funds joined the funding round as a new investor as well. Existing shareholders S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund and undisclosed strategic investors, all participated. Funds support the company’s new pivotal trial, ALLAY-HFrEF.
The study evaluates the safety and effectiveness of Alleviant’s novel no-implant device. It evaluates patients with reduced left ventricular ejection fraction (LVEF≤40%). Alleviant expects to begin enrolling 350 randomized patients across select global sites this year. The company projects finalized enrollment within the next year.
“We are committed to developing an effective treatment for patients suffering from heart failure with our minimally invasive, no-implant approach,” said Adam Berman, CEO of Alleviant Medical. “We are incredibly grateful to partner with a top-tier investor syndicate as we advance this mission together for patients, while building a leading healthcare company focused on this massive market opportunity.”