Alleviant Medical, a medical device company focused on heart failure treatment, has raised $90m in financing to expand its interventional heart failure pivotal trial programme.
Gilde Healthcare is leading the funding round, which saw participation from Omega Funds, S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and other undisclosed strategic investors.
Texas-based Alleviant Medical is developing a no-implant atrial shunt for heart failure patients.
Last week, the medical device firm secured US Food and Drug Administration (FDA) investigational device exemption (IDE) approval and breakthrough device designation for its atrial shunt.
Gilde Healthcare Investors general partner Geoff Pardo said: “We are compelled by the innovative technology and de-risked clinical trial programmes at Alleviant.
“We are confident that the Alleviant team is building a category-leading product, working toward providing relief for millions of patients suffering from heart failure.”
Alleviant Medical will be the only atrial shunt company with ongoing trials for all heart failure types.
Its first trial (ALLAY-HF) is nearing enrolment completion for heart failure with preserved ejection fraction (HFpEF).
This second trial, ALLAY-HFrEF, is a prospective sham-controlled study for heart failure patients with reduced ejection fraction (HFrEF) in the atrial shunt space.
The Alleviant System relieves heart pressure by creating a temporary connection between the left and right atrial chambers via a one-time procedure, without leaving a permanent implant.
The new trial will assess the Alleviant System’s safety and effectiveness in heart failure patients with reduced left ventricular ejection fraction (LVEF ≤ 40%) who remain symptomatic despite guideline-directed medical therapy (GDMT).
It will enrol around 350 randomised patients at select global sites, starting in early 2025.
Alleviant Medical CEO Adam Berman said: “We are committed to developing an effective treatment for patients suffering from heart failure with our minimally invasive, no-implant approach.
“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.”
