CARMAT announces that it has received regulatory approvals to resume its clinical study in France
PARIS–(BUSINESS WIRE)–Regulatory news:
CARMAT (FR0010907956, ALCAR), designer and developer of Aeson®, the most advanced total artificial heart in the world, intended to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces today that it has obtained regulatory authorizations necessary approvals from the National Agency for the Safety of Medicines and Health Products (ANSM) and the Patient Protection Committee (CPP Ile-de-France XI) to relaunch the EFICAS Clinical Study.
The study will include 52 patients eligible for transplant in France and will enable CARMAT to collect both additional data on the efficacy and safety of its artificial heart, and medico-economic data to support the value proposition and the reimbursement of the device, particularly in France.
Prior to the restart, four centers received refresher training on the product and the clinical protocol and are ready to screen patients (APHP-HU Pitié Salpêtrière, CHRU Lille, CHU Rennes and CHU Strasbourg).
As a reminder, CARMAT benefits from funding of 13 million euros from the National Innovation Fund, to partially finance this study.
Given this approval, which follows the green light recently announced to also resume commercial implants, CARMAT confirms its intention to resume implants in Europe in the near future, at a gradual pace depending on the reconstitution of its stock of prostheses. .
Stéphane Piat, Managing Director of CARMAT, declared: “This authorization is very good news for French patients who will now be able to benefit from Aeson® as part of the EFICAS study that we will soon be initiating in France. This study is also decisive for the Company because it will allow us to collect essential medico-economic data to support the reimbursement of our therapy, particularly in France. Our teams are working hard to build up a stock of prostheses to support the recovery of our implants in Europe.
CARMAT is a French MedTech that designs, manufactures and markets the Aeson® artificial heart. The Company’s ambition is to make Aeson® the first alternative to heart transplantation, and thus provide a therapeutic solution for people with end-stage biventricular heart failure, faced with a notorious shortage of available human grafts. The world’s first highly hemocompatible, pulsatile and self-regulating physiological artificial heart, Aeson® could save the lives of thousands of patients waiting for a heart transplant every year. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power system permanently connected to the implanted prosthesis. Aeson® is commercially available as a gateway to transplantation in the European Union and other countries that recognize the CE mark. Aeson® is also being evaluated in an Early Feasibility Study (EFS) in the United States. Created in 2008, CARMAT is based in the Paris region, with its head office in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The Company can count on the talent and expertise of a multidisciplinary team of more than 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).
Last name: CAR CARPET
ISIN code: FR0010907956
This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an offer to buy or subscribe for CARMAT shares (the “Company”) in any country whatsoever. . This press release may contain–forward-looking statements that relate to the objectives and prospects of the Company. Such a front–forward-looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risks and uncertainties, including, without limitation, the Company’s ability to successfully implement its strategy, the rate of development of CARMAT’s production and sales, the rate and results of and future clinical trials, new products or technological developments introduced by competitors, regulatory changes and risks related to growth management. The objectives of the Company as mentioned in this press release may not be achieved for any of these reasons or due to other risks and uncertainties.
The significant and specific risks of the Company are those described in the Universal Registration Document (“Universal Registration Document”) filed with the Financial Markets Authority (AMF) under number D. 22-0332. The attention of readers and investors is however drawn to the fact that other risks, unknown or not considered significant or specific, may or could exist.
Aeson® is an active implantable medical device commercially available in the European Union and other countries that recognize the CE mark. The Aeson® Total Artificial Heart is intended to replace the ventricles of the native heart and is indicated as a gateway to transplantation in patients with end-stage biventricular heart failure (INTERMACS classes 1-4) who are not amenable to maximal medical therapy or a left ventricular assist device (LVAD) and are likely to undergo a heart transplant within 180 days of device implantation. The implantation decision and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (doctor’s manual, patient manual and alarm booklet) must be read carefully to understand the characteristics of Aeson® and the information necessary for the selection of patients and the proper use of Aeson® (contraindications, precautions, side effects). In the United States, Aeson® is currently only available as part of an Early Feasibility Study authorized by the Food & Drug Administration (FDA).