Picard Medical Advancing Total Artificial Heart Technology

SynCardia system provides bridge to transplant while next generation fully implantable platform progresses toward clinical trials.

Picard Medical develops total artificial heart technology designed to support patients with end stage biventricular heart failure who are awaiting a donor heart.

Through its subsidiary SynCardia Systems LLC, the Company markets the SynCardia Total Artificial Heart (“STAH”). The device replaces the pumping function of both ventricles and all four heart valves when the native heart can no longer support circulation.

Advanced heart failure leaves thousands of patients waiting for a donor organ each year. Demand for donor hearts continues to exceed supply, creating a critical need for technologies that can sustain patients while they await transplantation.

The STAH addresses this gap by fully replacing the pumping function of the failing heart and providing a bridge to transplant. The device is approved in the United States and Canada and is used at leading transplant centers, where physicians have developed significant clinical experience with the therapy and reported strong survival outcomes among patients successfully bridged to transplantation. The system has been used in more than 2,100 patients, with some individuals supported for more than two years before receiving a donor heart.

Picard Medical is also developing its next generation total artificial heart known as the Emperor. Unlike the current STAH, which relies on external pneumatic drivers, the Emperor platform is being designed as a fully implantable total artificial heart powered by internal components and rechargeable batteries. The goal is to develop this next generation system as a potential alternative to heart transplantation.

Preclinical studies are underway and the company is targeting the initiation of human clinical studies in 2028.

The potential need for technologies like total artificial hearts remains significant as the number of patients with advanced heart failure continues to outpace the availability of donor organs.

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