Alleviant Medical Nabs Funding for Second Heart Failure Treatment Trial

Alleviant Medical Inc. has completed a $90 million financing round that will help fund a second pivotal trial for its investigational heart failure treatment device.

Led by Gilde Healthcare, the round attracted interest from Omega Funds as well as existing shareholders S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and several undisclosed strategic investors. The new pivotal trial, ALLAY-HFrEF, reportedly will be the first prospective sham-controlled trial in the atrial shunt space focused solely on patients with heart failure and reduced ejection fraction (HFrEF).

Heart failure occurs when the heart cannot effectively pump blood to meet the body’s needs. It remains a leading cause of mortality and hospitalizations and is estimated to cost the U.S. healthcare system at least $70 billion annually. 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 technology and de-risked clinical trial programs at Alleviant,” Glide Healthcare Investors General Partner Geoff Pardo said. “We are confident the Alleviant team is building a category-leading product, working toward providing relief for millions of patients suffering from heart failure.”

Related: FDA Approves New Trial for Alleviant Medical’s Heart Failure Tech

Alleviant claims it 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,” Alleviant Medical CEO Adam Berman stated. “We are grateful to partner with a top-tier investor syndicate as we advance this mission together for patients, while building a healthcare company focused on this massive market opportunity. We welcome Gilde Healthcare and Omega to this partnership.”

Alleviant Medical Inc. is a privately held medical device company developing minimally invasive therapies to treat heart failure, collaborating with leaders in cardiovascular medicine to advance patient care. The Alleviant System has been granted U.S. Food and Drug Administration Breakthrough Device designation for both major forms of heart failure. The company is headquartered in Austin, Texas, and is backed by various strategic investors.

The Alleviant System is an Investigational Device and is limited by U.S. law to investigational use.

Gilde Healthcare is a specialized healthcare investor managing €2.6 billion across two fund strategies: Venture & Growth and Private Equity. The Venture&Growth fund of Gilde Healthcare invests in fast growing companies active in therapeutics, medtech and digital health, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in Northwestern Europe.