Alleviant Medical’s Financing Round Will Fund ALLAY-HF Pivotal Trial

January 26, 2023—Alleviant Medical, Inc. announced the closing of a $75 million equity financing that will fund the company’s global pivotal trial, ALLAY-HF. The trial is designed to demonstrate the safety and efficacy of the Alleviant system for no-implant interatrial shunt creation to treat chronic heart failure through left atrial decompression.

According to the company, ALLAY-HF is a global prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive trial composed of chronic heart failure patients with preserved and mildly reduced ejection fraction (≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy.

The trial will enroll 400 to 700 patients at select sites worldwide. The trial’s composite primary endpoint analysis will be conducted at 1 year.

The company stated that the Alleviant system has demonstrated significant clinical improvement (functional and symptomatic) in studies across 38 heart failure patients to date. In these studies, shunt durability was confirmed through 6 months and sustained improvement was observed through 12 months.

Investigational device exemption for the Alleviant system was granted by the FDA in November 2022. In January 2021, the company announced that the FDA granted Breakthrough Device designation for the Alleviant technology.

In the United States, the Alleviant system is an investigational device and is limited by federal law to investigational use, advised the company.

The financing was led by S3 Ventures and RiverVest Venture Partners. Additional investors Vensana Capital, Longview Ventures, TMC Venture Fund, and a strategic investor are joined by Gilmartin Capital, ShangBay Capital, and another undisclosed strategic investor in this new financing round.