BrioHealth Solutions obtains FDA approval to proceed with the Pivotal Phase of their Investigational Device Exemption (IDE) Trial -INNOVATE- with the novel BrioVAD® System for Advanced Heart Failure Patients

BURLINGTON, MA August 05, 2025 – BrioHealth Solutions, Inc. (www.briohealthsolutions.com) announced today that after successful completion of the Safety Phase, it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Pivotal Phase of the INNOVATE (Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE) Trial.

The objective of the INNOVATE Trial is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.

The BrioVAD System features a novel, fully magnetically levitated blood pump engineered for enhanced cardiac support, along with an innovative driveline design. The system is also distinguished by having only two external components that the patient needs to carry while ambulatory.

“With successful completion of the Safety Phase, we are excited to move forward with the Pivotal Phase of the INNOVATE Trial. Our continued goal is to provide Advanced Heart Failure treatment options to the clinicians caring for the thousands of patients currently affected by Advanced Heart Failure.” remarked 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. 

On receiving word from the FDA, Chen Chen, Ph.D. CEO of BrioHealth Solutions, Inc. stated “Our mission to become the global leader in innovative solutions for advanced and persistent heart failure, pushing the boundaries of what’s possible, is one step closer.  We are thrilled to move forward with the INNOVATE trial which will now expand to up to 60 clinical partner sites allowing for evaluation towards the short-term and long-term outcomes.”

About BrioHealth Solutions:                          

BrioHealth Solutions is developing the BrioVAD® System, a Left Ventricular Assist System representing a significant advance in the heart failure treatment space. The company’s founding mission is a commitment to restoring, extending and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what’s possible and deliver the best medical technologies and solutions.

CAUTION: The BrioVAD System is an Investigational Device limited by Federal (US) Law to use in the INNOVATE Trial.

For more information on BrioHealth Solutions, please visit www.briohealthsolutions.com.

Contacts:

Pranesh Thirukkonda, VP of Clinical and Field Services

Pranesh.thirukkonda@briohealth.com