BURLINGTON, Mass., April 24, 2026 /PRNewswire/ -- BrioHealth Solutions (www.briohealthsolutions.com) announced that it has received FDA conditional approval to initiate a clinical evaluation of the BrioVAD^® System in pediatric patients with advanced heart failure. The Brio4Kids Trial will be conducted under the existing Investigational Device Exemption (IDE) for the INNOVATE Trial.

This milestone marks an important step toward expanding treatment options for children with advanced heart failure, a population with significant unmet need.

Dr. Angela Lorts, Professor of Heart Failure at Cincinnati Children's Hospital Medical Center and a national principal investigator in the study, commented: "In pediatric heart failure, including in school-age children, the lack of durable LVAD options remains a major challenge. This represents a significant unmet need, and we are encouraged to explore the potential of the BrioVAD System through the Brio4Kids study."

The BrioVAD^® System is designed to address key challenges in heart failure care through next-generation technology and clinician collaboration. Its compact pump, thin driveline, and lightweight components may better meet the needs of pediatric patients.

"This is another important milestone in our journey to becoming a global leader in innovation and delivering best-in-class service in our field," said Chen Chen, Ph.D., CEO of BrioHealth Solutions.

Enrollment in the Brio4Kids U.S. clinical trial is expected to commence in mid- 2026, with initial data anticipated in the fourth quarter of 2026. BrioHealth Solutions will continue to engage closely with clinical investigators, the FDA, and healthcare stakeholders as the study progresses.

About BrioHealth Solutions
BrioHealth Solutions, with operations in the United States, China, and Europe, is developing the BrioVAD^® System, a left ventricular assist system aiming to significantly advance 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 is 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 and Brio4Kids Trials.

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SOURCE BrioHealth Solutions, Inc.