AUSTIN, Texas — Alleviant Medical, a medical device company focused on developing a non-implant atrial shunt for heart failure, has raised $90 million to support its second pivotal clinical trial. This financing round is led by Gilde Healthcare, with participation from Omega Funds, as well as existing investors including S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and other undisclosed strategic backers.
The new trial, named ALLAY-HFrEF, will be the first sham-controlled study in the atrial shunt space to target patients with heart failure and reduced ejection fraction (HFrEF).
“We are impressed with the innovative technology and de-risked clinical trial programs at Alleviant,” said Geoff Pardo, General Partner at Gilde Healthcare. “We are confident the Alleviant team is developing a leading product aimed at alleviating the suffering of millions of heart failure patients.”
Alleviant Medical will be the only company in the atrial shunt field to conduct clinical trials for the full range of heart failure conditions. The company’s initial pivotal trial, ALLAY-HF, is assessing the safety and efficacy of the Alleviant System in patients with heart failure and preserved ejection fraction (HFpEF). The company expects enrollment for this trial to conclude within the next year. The new ALLAY-HFrEF trial will extend the research to patients with the reduced ejection fraction form of heart failure.
“We are committed to providing an effective treatment for heart failure through our minimally invasive, no-implant solution,” said Adam Berman, CEO of Alleviant Medical. “This partnership with top-tier investors will help us advance our mission for patients while building a leading company in a significant market.”
Heart failure, a condition where the heart cannot pump enough blood to meet the body’s needs, remains a major cause of death and hospitalization. It is also a significant financial burden, costing the U.S. healthcare system over $70 billion annually. The Alleviant System aims to alleviate the excess pressure in the heart by creating a connection between the left and right atria through a one-time, implant-free procedure.
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