Alleviant Medical, Inc. has secured $75 million in equity financing to support the ALLAY-HF pivotal trial, designed to evaluate the safety and efficacy of its novel Alleviant System for treating chronic heart failure. The financing, co-led by S3 Ventures and RiverVest Venture Partners, will propel the global, multi-center study of this no-implant interatrial shunt technology.
The ALLAY-HF trial is a prospective, randomized, sham-controlled, double-blinded, adaptive trial. It will enroll between 400 and 700 patients with chronic heart failure who have preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) and remain symptomatic despite stable guideline-directed medical therapy. The trial's primary endpoint analysis will be conducted at one year.
Addressing Unmet Needs in Heart Failure
Heart failure remains a significant global health challenge, with millions affected worldwide. Current treatment options often fall short of providing adequate relief for many patients, highlighting the need for innovative therapeutic approaches. The Alleviant System offers a potentially less invasive method to manage heart failure symptoms by creating a shunt between the left and right atria, decompressing the left atrium and reducing pressure.
"Alleviant’s mission is to bring a safe, effective no-implant treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward," said Adam Berman, CEO of Alleviant Medical.
The Alleviant System: A Novel Approach
The Alleviant System is a catheter-delivered device that uses a short pulse of energy to create a durable passage between the heart's left and right atria. This interatrial shunt aims to alleviate excess pressure within the left atrium, a key factor in heart failure pathophysiology. The system received Investigational Device Exemption (IDE) from the FDA in November 2022 and Breakthrough Device Designation in 2021.
Prior studies involving 38 heart failure patients have demonstrated significant clinical improvements with the Alleviant System. These studies confirmed shunt durability through six months and sustained improvement through 12 months.
Investor Confidence
The $75 million financing round saw participation from a strong syndicate of investors, including Vensana Capital, Longview Ventures, TMC Venture Fund, Gilmartin Capital, ShangBay Capital, and other strategic investors. This level of financial backing underscores the confidence in Alleviant Medical's technology and its potential to address a critical unmet need in heart failure treatment.
"Alleviant Medical is poised to significantly improve the quality of life for millions of heart failure patients for whom there has been a lack of meaningful options," said Jay Schmelter, managing director, RiverVest Venture Partners.
