VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial

Milestone in pivotal IDE evaluation of VisONE™ Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation

PORTLAND, Ore., July 09, 2026 (GLOBE NEWSWIRE) -- VisCardia, Inc. today announced the first U.S. patient has been implanted in its RECOVER-HF pivotal trial of VisONE™ Synchronized Diaphragmatic Stimulation (SDS) Therapy, also known as cardiac diaphragm support, a novel investigational therapy for symptomatic heart failure with reduced ejection fraction (HFrEF) that has been granted FDA Breakthrough Device Designation. The implant procedure was performed at the University of Pennsylvania by Jarrod Predina, MD, MTR in collaboration with Lee R. Goldberg, MD, MPH, Vice Chair of Medicine and a member of the Advanced Heart Failure and Cardiac Transplant program, and national principal investigator of RECOVER-HF.

"The first U.S. implant marks a significant milestone for VisCardia and the RECOVER-HF trial, more importantly, for the patients with symptomatic heart failure who continue to need better options," said Peter Bauer, Ph.D., President & CEO of VisCardia. "RECOVER-HF is the pivotal evaluation that VisONE Synchronized Diaphragmatic Stimulation Therapy deserves, and we're grateful to Dr. Goldberg and the entire trial team for their leadership in advancing it."

Heart failure with reduced ejection fraction affects millions of patients. For symptomatic patients who remain limited despite optimized guideline-directed medical therapy (GDMT), few therapeutic options exist short of advanced mechanical support or transplantation, particularly for patients who are not candidates for cardiac resynchronization therapy.

"VisONE represents a promising and intuitive therapy for the substantial population of heart failure patients who continue to struggle despite optimized medical therapy," said Dr. Goldberg. "By leveraging the diaphragm's natural physiologic contribution to cardiac function, VisONE supports the heart without placing any hardware in or on it. RECOVER-HF is designed to rigorously evaluate whether this approach can benefit patients with symptomatic HFrEF."

VisONE cardiac diaphragm support is a minimally invasive, implantable system that delivers precisely timed electrical stimulation to a small region of the left hemi-diaphragm in synchrony with the cardiac cycle. The system is implanted laparoscopically through a two-port technique. Because no hardware is placed in or on the heart, patients remain candidates for any future device therapy they may require, including cardiac resynchronization therapy and implantable defibrillators.

About the RECOVER-HF Pivotal Trial

RECOVER-HF (NCT06552637) is a prospective, multi-center, double-blinded, sham-controlled, randomized clinical trial evaluating VisONE Synchronized Diaphragmatic Stimulation Therapy in patients with symptomatic HFrEF. Eligible patients have NYHA Class II or III heart failure, left ventricular ejection fraction of 40% or less, QRS duration of 130 ms or less, and are on guideline-directed medical therapy. Primary endpoints include change in left ventricular end-systolic volume, six-minute walk distance, quality of life, and safety. The trial is enrolling at sites across the United States and well recognized international centers.

About VisCardia, Inc.

VisCardia, Inc. is a privately held medical device company based in Portland, Oregon, dedicated to developing minimally invasive therapies for the millions of patients living with heart failure. The company's VisONE Synchronized Diaphragmatic Stimulation Therapy, also known as cardiac diaphragm support, has been granted Breakthrough Device Designation by the U.S. FDA and is currently being evaluated in the RECOVER-HF pivotal IDE trial, enrolling at up to 30 sites, as the company advances toward PMA submission. For more information, visit viscardia.com.

Media Contact:
Jennifer Matson
matsonj@viscardia.com

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