Alleviant Medical Secures Financing for Pivotal Trial of No-Implant Atrial Shunt in HFrEF Patients

January 14, 2025—Alleviant Medical, Inc. announced it has completed a $90 million financing round that will fund its second pivotal trial of the company’s no-implant atrial shunt technology that is evaluating the device in the treatment of heart failure with reduced ejection fraction (HFrEF). According to the company, the investigational Alleviant system is designed to relieve excess pressure buildup within the heart by connecting the left and right atrial chambers through a one-time procedure that leaves no permanent implant behind.

On January 7, the company announced that the FDA approved investigational device exemption for the prospective sham-controlled ALLAY-HFrEF pivotal trial. Also, the FDA designated the Alleviant system as a Breakthrough Device for the HFrEF patient population. The ALLAY-HFrEF trial will evaluate the safety and effectiveness of the Alleviant system in HFrEF patients (left ventricular ejection fraction ≤ 40%) who remain symptomatic despite guideline-directed medical therapy. The trial will have an adaptive design and will begin enrolling approximately 350 randomized patients at select sites globally in early 2025, noted the company.

ALLAY-HFrEF will be led by Global Principal Investigators Gregg Stone, MD, and James Udelson, MD. Dr. Stone is the Director of Academic Affairs and Professor of Medicine and of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, New York. Dr. Udelson is Chief of Cardiology and Interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine in Boston, Massachusetts.

“We are fortunate to have the results from a prior study that demonstrated substantial clinical benefits in high-risk HFrEF patients with an implanted permanent atrial shunt,” commented Dr. Stone in Alleviant’s press release. “These findings informed the design of the ALLAY-HFrEF trial, which is testing a novel device that creates an atrial shunt and leaves no permanent implant behind.”

Dr. Udelson added, “Despite progress in treatment options, chronic heart failure remains one of the greatest unmet clinical needs for millions of patients who suffer deeply and whose lives are often cut short by the condition. As we follow the science and expand the evidence base for patients with different ejection fractions, we have the potential to improve clinical outcomes as well as quality of life for millions.”

As noted in the press release, the company’s first pivotal trial of the Alleviant system—ALLAY-HF—is evaluating the device’s safety and efficacy in patients with heart failure and preserved ejection fraction (HFpEF). The technology has previously been granted FDA Breakthrough Device designation for treating HFpEF patients. The company’s website for the trial is https://allayhf.com. Enrollment in ALLAY-HF is expected to be completed within the next year, advised the company.

The new financing was led by Gilde Healthcare. The round also added Omega Funds and included participation from existing shareholders S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, TMC Venture Fund, and undisclosed strategic investors, reported the company.