Alleviant Medical – a privately held medical device company developing a no-implant atrial shunt for heart failure – announced a $90 million financing to fund its second pivotal trial. The round was led by Gilde Healthcare, and it also included Omega Funds with participation from existing shareholders S3 Ventures, RiverVest Venture Partners, Ventana 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, which is a condition in which the heart is unable to effectively pump blood to meet the body’s needs, remains the 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. And 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.
Alleviant will be the only atrial shunt company to have ongoing clinical trials for the full spectrum of heart failure. And 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).
KEY QUOTES:
“We are compelled by the innovative technology and de-risked clinical trial programs 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.”
– Geoff Pardo, General Partner, Gilde Healthcare Investors
“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. We welcome Gilde Healthcare and Omega to this strong partnership.”
– Adam Berman, CEO of Alleviant Medical
