INNOVATE Trial Assessing Safety and Effectiveness of Company’s Investigational Left Ventricular Assist Device Compared to Standard of Care LVAD

BrioHealth Solutions, Inc., a developer of world-leading technology in ventricular assist systems, announced today it has enrolled its first patients in the U.S. for the INNOVATE Trial of the BrioVAD^® System.

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The BrioVAD® System features the innovative BrioVAD Pump, a fully magnetically suspended blood pump, paired with uniquely engineered external components aimed at reducing adverse events and enhancing patients' quality of life. (Graphic: Business Wire)

“We are thrilled to kick off the INNOVATE trial, following a phenomenal journey of innovation, engineering, and quality refinement to bring the BrioVAD System to life,” said Chen Chen, Ph.D., Chief Executive Officer of BrioHealth Solutions. “Despite advancements in ventricular assist devices, there remains a pressing need for improved device performance and patient outcomes, and BrioHealth is committed to addressing this gap. It is also incredibly rewarding to see the enthusiasm from our participating centers in advancing heart failure treatment through this study.”

BrioHealth has focused on developing its proprietary BrioVAD technology since 2008. The BrioVAD System features the innovative BrioVAD Pump, a fully magnetically suspended blood pump, paired with uniquely engineered external components aimed at reducing adverse events and enhancing patients' quality of life. More than 350 patients outside the U.S. have been treated with a ventricular assist system that incorporates the BrioVAD Pump.^*

The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study designed to evaluate the safety and effectiveness of the BrioVAD System for treating advanced, refractory left ventricular heart failure.

“Patients with advanced heart failure have limited options when it comes to treatment, with currently just one LVAD system available in the U.S.,” said Francis D. Pagani, M.D., Ph.D., the Otto Gago, M.D., Professor of Cardiac Surgery at University of Michigan Medical School and the study's National Principal Investigator. “Despite treatment advances, complications still occur among LVAD patients. The INNOVATE Trial will provide important insights on if the BrioVAD System can help reduce complications and improve quality of life for patients with advanced heart failure.”

“The initiation of the INNOVATE Trial is an important milestone in advancing treatment options for advanced heart failure patients,” said Mani Daneshmand, M.D., Andrew J. McKelvey Professor, Emory University School of Medicine and Director – Thoracic Transplant and MCS Surgery. “We are excited to learn how the BrioVAD System can make an impact in this patient population.”

About BrioHealth Solutions

BrioHealth Solutions is a medical device company headquartered in Burlington, Massachusetts. It develops, produces, and commercializes devices to treat patients suffering from advanced and persistent heart failure. BrioHealth Solutions is committed 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 available. For additional information, please visit the Company's website at www.briohealthsolutions.com and follow the company on LinkedIn and Twitter/X.

About BrioVAD System

The BrioVAD System is a full-support, durable ventricular assist device comprised of an implantable BrioVAD Pump and external components, designed to provide long-term support for heart failure patients. The BrioVAD Pump features an innovative magnetic bearing design that achieves a smaller pump size with a larger impeller, as compared to the only FDA-approved durable ventricular assist system currently available. The compact pump may potentially reduce surgical invasiveness. Additionally, the BrioVAD Pump incorporates a novel driveline design that electrically connects the pump to the external components, resulting in a significantly thinner and more flexible driveline, which may potentially reduce driveline-associated infections.

The combination of the BrioVAD Pump’s magnetic bearing construction and the large diameter impeller facilitates significant innovation in the design of the pump’s blood flow pathway within the pump. This advanced flow path design has the potential to improve device hemocompatibility and hemodynamics, minimizing the risk of serious complications.

The BrioVAD System's external patient worn components incorporate several unique design features, resulting in only two components, which may enhance user experience and patient quality of life.

The BrioVAD System is an Investigational Device limited by Federal Law to use in the INNOVATE Trial.

About the INNOVATE Trial

The INNOVATE Trial is a prospective, non-blinded, randomized, controlled study that will enroll patients for both short-term and long-term Mechanical Circulatory Support indications. For more information, visit www.theinnovatetrial.com

About Advanced Heart Failure

Heart failure is a chronic, progressive disease where the heart muscle loses its ability to pump enough oxygen-rich blood throughout the body. Advanced heart failure is a serious medical condition that refers to the later stages of the disease, and occurs in approximately 650,000, or 10 percent of people with heart failure in the U.S.¹ Approximately 75% of heart failure patients die within five years of diagnosis.² As heart failure progresses and the patient enters the later stages of the disease, the use of mechanical circulatory support devices, such as LVADs, may be needed to help the heart effectively pump blood throughout the body and enable the patient to participate in daily activities.

¹American Heart Association (heart.org)

²Severino, P., Mather, P.J., Pucci, M., et al. (2019). Advanced Heart Failure and End-Stage Heart Failure: Does a Difference Exist. Diagnostics (Basel), 9(4), 170.

*The BrioVAD Pump is the same pump used in the CH-VAD System.

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BrioHealth Solutions announced today the first patients have been enrolled in the INNOVATE Trial for the BrioVAD® System, a left ventricular assist device (LVAD) for patients with advanced #heartfailure. #clinicaltrial