CARMAT sets sail for the United States

(AOF) – Carmat jumped more than 5% to 21.75 euros. The French medtech can afford to dream of America, its first potential global market. The company has announced that it has been approved by the Food and Drug Administration (FDA) to launch a feasibility study in the United States with its artificial heart, invented by Professor Alain Carpentier, who has no equivalent in the world. The protocol covers five eligible transplant recipients recruited from a network of seven leading US clinical centers.

The designer and developer of the total artificial heart project will submit the study documents to the Ethical Committees (IRBs) of the selected clinical sites and will be able to begin recruiting the study patients from the first IRB approval.

Recruitment will focus on patients eligible for transplantation with a better survival prognosis than those included in the feasibility study in France.

"This target of patients eligible for transplant seems to be leading the group towards the Bridge To Transplant market, while the initial ambitions were located in the Destination Therapy market, suffering from a greater medical need," said Invest Securities. .

Carmat's Managing Director, Stéphane Piat, said: "The conditional approval to initiate a US study marks a milestone for Carmat and the field of mechanical circulatory assistance in general.This approval demonstrates the FDA's confidence in our ability to conduct this feasibility study and reflects the great need for a safe and effective solution for patients with biventricular heart failure while waiting for a heart transplant ".

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Pharmacy – Health

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