September 9th 2020
Paris, September 9, 2020 – 5.45 pm CEST
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today reports its results for the first half of the year to June 30, 2020 and issues an update on its activities and development prospects.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “The first half of 2020 was unusual because of the COVID-19 pandemic that affected healthcare systems around the world. For CARMAT, the impact was insofar limited as our activities in France continued with limited hindrances and in strict compliance with the health and safety measures imposed by the authorities. During the first half of the year, we continued our work to ramp up production and enhance the reliability of production processes at our Bois-d’Arcy plant, with a particular emphasis on securing supplies with a view to the commercial phase. On a clinical level, with the gradual easing of restrictions in Europe from mid-May 2020, Rigshopitalet in Denmark was able to perform its first implantation of our device, thus taking the total number of patients in the PIVOTAL study to 13. Given the persistence of the COVID-19 situation and the resulting procurement problems encountered by certain suppliers, CARMAT is now expecting to complete enrollment in the PIVOTAL study by the end of the first quarter of 2021. This delay does not jeopardize the timeframe of the submission and review of the CE marking dossier making it possible for this CE marking to be granted by the end of 2020. We are also continuing to hold discussions with the FDA and various stakeholders in the U.S. feasibility study to enable patient enrollment to begin before the end of 2020 as planned, subject to the public health emergency improving. The “Forfait Innovation” dossier was definitively approved by the French National Authority for Health (HAS) in April, budgetary discussions initiated with the Ministry of Health and Solidarity have entered their final phase and official notification of the decision should be published in the coming weeks. Today, given what we have achieved in recent months and despite the ongoing pandemic context, we are confirming our development strategy and, with a cash position of €45.3 million, have the necessary resources to meet our project’s key milestones.”
 First-half accounts were approved by the Board on September 7, 2020 and have been the subject of a limited review by the statutory auditors. The 2020 half-year financial report was published today and is available on the Company’s website.