BrioHealth Solutions Begins Patient Recruitment for the INNOVATE Study of the BrioVAD® System in Advanced Heart Failure

About BrioHealth Solutions

BrioHealth Solutions is a medical device company headquartered in Burlington, Massachusetts. The company develops, manufactures and markets devices for the treatment of patients with advanced and persistent heart failure. BrioHealth Solutions is committed to restoring, extending and improving the lives of patients worldwide by collaborating with healthcare providers to push the boundaries of what is possible and provide the best medical technologies available. For more information, please visit the Company’s website at www.briohealthsolutions.com and follow the Company on LinkedIn and Twitter/X.

About the BrioVAD system

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

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

The external, patient-worn components of the BrioVAD system have several unique design features, requiring only two components, which can improve the user experience and patient quality of life.

The BrioVAD system is a research device whose use in the INNOVATE study is restricted by federal law.

About the INNOVATE study

The INNOVATE study is a prospective, non-blinded, randomized, controlled trial enrolling patients for both short- 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 in which the heart muscle loses its ability to pump enough oxygen-rich blood throughout the body. Advanced heart failure is a serious 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 United States1 Approximately 75% of heart failure patients die within five years of diagnosis.2 As heart failure progresses and the patient enters later stages of the disease, the use of mechanical circulatory support devices such as LVADs may be necessary to help the heart pump blood effectively throughout the body and allow the patient to participate in daily activities.

1American Heart Association (heart.org)

2Severino P, Mather PJ, Pucci M, et al. (2019). Advanced heart failure and end-stage heart failure: is there a difference? Diagnostics (Basel), 9(4), 170.

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

Jessica Volchok

Merryman Communications

310-849-7985

[email protected]

Justin Callaway

BrioHealth solutions

[email protected]

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