Ongoing enrollment in the first-in-man trial of CARMAT’s bioprosthetic heart

Paris, France -- CARMAT, the designer and developer of the world’s most advanced total artificial heart project, providing a therapeutic alternative for people suffering from endstage heart failure, today confirms that it has completed half of the feasibility study on its bioprosthetic heart and announces an ongoing enrollment for two more patients.

The study encompasses enrollment of four patients who are in an immediate life-threatening situation due to irreversible biventricular heart failure.

The criteria for success notably include the patient’s 30-day survival following the implant and the functional recovery of their vital organs. On this basis, the two independent committees overseeing the study met on Thursday and Friday. A favorable opinion regarding the enrollment of additional patients was delivered.

“We would like to wholeheartedly thank our investigation centers’ clinical teams for their involvement alongside us, and today especially the experienced teams at the Nantes University Hospital.”, said Marcello Conviti, Chief Executive Officer of CARMAT. “This milestone has been made possible by their trust, as well as that of our staff, partners and shareholders.”

The Company would like to remind readers that, in accordance with good clinical practice and subject to regulatory obligations or specific circumstances, it is not planning to publish any information on the interim results of this ongoing feasibility study.

Source: CARMAT