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CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces that it has received the approval to perform, within the framework of the PIVOTAL study protocol approved by the ANSM (French national agency for the safety of medicines and health products), implants of its total artificial heart in human patients at the National Research Center for Cardiac Surgery (Astana, Kazakhstan). (2-0)
LONDON, UK / ACCESSWIRE / July 31, 2017 / Carmat (PARIS: ALCAR) resumed the EU pivotal trial of its artificial heart after addressing regulator concerns. We anticipate that the study could be completed in mid-2019, leading to a potential EU launch in 2020. The Carmat device could potentially fill a significant need among those waiting for human transplants and/or with terminal heart failure (HF) or acute myocardial infarction (MI).
Carmat SA (OTC:CKMTF) (market cap 476 million euros) is fresh from its recent triumph in performing the first artificial heart implant. The heart weighs 700 grams and was the product of long and intensive investment by this bio-med company. The French company makes no bones (or makes no livers?) in stating that today the heart, tomorrow other organs. Skeptics take note: Carmat has the backing of the French state (via the Banque Public d'Investissements, created by the French government in 2012) and the deep pockets of French aeronautic company EADS (with a 30% shareholder investment in the company).