BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, announced it has received FDA Investigational Device Exemption (IDE) approval with conditions to commence enrollment in its landmark INNOVATE trial. The study will assess the effectiveness and safety of its novel BrioVAD™ System, a magnetically levitated ventricular assist device, in treating refractory left ventricular heart failure. With the notice, BrioHealth Solutions has initiated clinical site start-up activities in the US.

The BrioVAD Left Ventricular Assist System is designed to aid patients suffering from advanced heart failure, offering both temporary and long-term support solutions. The BrioVAD System consists of a novel hemocompatible blood pump with a fully magnetically levitated rotor and two small, lightweight, patient-worn components. This advanced technology is designed to help patients overcome the limitations of heart failure and enhance quality of life. The BrioVAD system will be evaluated in the INNOVATE trial randomized relative to technology previously approved by the FDA.

"Achieving this stage of FDA approval for the INNOVATE trial marks an important step in providing more options to clinicians and patients seeking advanced heart failure therapies," said Francis D. Pagani, M.D., Ph.D., the Otto Gago MD Endowed Professor in Cardiac Surgery at the University of Michigan and the study's National Principal Investigator. "The clinical evaluation of the BrioVAD System is a significant leap forward for the entire field of heart failure. Countless patients go untreated each year and continue to suffer with this seriously debilitating condition," Dr. Pagani emphasized.

"We are excited to have achieved this crucial milestone. Our goal is to deliver patient-centered solutions for advanced heart failure patients and their families," remarked Chen Chen, Ph.D. CEO of BrioHealth Solutions. "The innovative BrioVAD System, with its compact pump designed for hemocompatibility along with small, lightweight peripherals, has been engineered to restore patients back to active lifestyles."