AUSTIN, Texas– Alleviant Medical, Inc., a privately held medical device company developing a no-implant atrial shunt for heart failure, today announced a $90 million financing to fund its second pivotal trial. Led by Gilde Healthcare, the round also adds Omega Funds and includes participation from existing shareholders S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and undisclosed strategic investors. The new pivotal trial, ALLAY-HFrEF, will be the first prospective sham-controlled trial focused on patients with heart failure and reduced ejection fraction (HFrEF) in the atrial shunt space.
Heart failure, a condition in which the heart is unable to effectively pump blood to meet the body’s needs, remains a leading cause of mortality and hospitalizations among patients with heart failure and is estimated to cost the U.S. healthcare system at least $70 billion per year. The Alleviant System is designed to relieve excess pressure buildup within the heart by creating a connection between the left and right atrial chambers through a one-time procedure that leaves no permanent implant behind.
“We are compelled by the innovative technology and de-risked clinical trial programs at Alleviant,” said Geoff Pardo, General Partner, Gilde Healthcare Investors. “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 will be the only atrial shunt company to have ongoing clinical trials for the full spectrum of heart failure. The company’s first pivotal trial (ALLAY-HF), evaluating the Alleviant System’s safety and efficacy in patients with heart failure and preserved ejection fraction (HFpEF), is on track to finalize enrollment within the next year. The new trial (ALLAY-HFrEF) will expand investigation to patients with the other primary form of heart failure, those with reduced ejection fraction (HFrEF).
“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. We welcome Gilde Healthcare and Omega to this strong partnership.”
