CARMAT announces updates in its governance

Paris, October 12, 2020 – 7 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has been granted €13 million in funding by the French Ministry of Health and Solidarity to conduct the EFICAS clinical study, already approved by the HAS (the French health authority) last April.

Through the budget agreement with the French Ministry of Health and Solidarity, two thirds of the total cost of the EFICAS study will be funded by the French state, which represents non-dilutive financing of €13 million for CARMAT.

EFICAS is a prospective, multicenter, non-randomized study that is expected to include 52 patients (cohort 1) implanted with the CARMAT heart as a bridge to transplantation. The primary objective of the study is survival for 180 days after implantation of the device without a disabling stroke, or a successful heart transplant within 180 days of implantation.

Moreover, all 52 patients will be compared to a second cohort (cohort 2) of patients receiving standard bridge to transplant therapies in a cost-effectiveness analysis. Data from this cohort, composed of transplant candidates meeting the eligibility criteria for the study, except for the anatomical compatibility criterion for the CARMAT heart, will also be collected prospectively.

The EFICAS study aims to demonstrate the efficacy and safety of the CARMAT Total Artificial Heart in patients suffering from irreversible biventricular heart failure as a bridge to transplantation, and its superiority over existing treatments for the same target patient population in terms of cost and effectiveness.

Patient enrollment in the five selected hospitals is expected to start in the second quarter of 2021.

CARMAT confirms that its available financial resources allow the company to fund its activities until mid-2021.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “First and foremost, we are grateful to the Ministry of Health for this substantial financial support that makes this very important study possible. This major clinical trial in the Mechanical Circulatory Support segment will allow us to both collect data in order to drive product adoption and establish the Health Economic model that will support the pricing of the service that CARMAT aims to provide. It will ultimately support our request for reimbursement of the prosthesis in France for the commercial phase.”

• Cash position of €45.3 million at June 30, 2020, covering the next major stages of its project
• Despite the COVID-19 crisis, CARMAT still on track to meet key deadlines:
  • CE marking expected by the end of 2020, allowing a commercial launch in 2021
  • Implants within the framework of the feasibility study in the United States expected to begin by the end of 2020
• Videoconference with Stéphane Piat at 6.30 pm Paris time today

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[1] 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.”

[1] 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.

Paris, May 25, 2020 – 6.30 am 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, announces the first implantation of its bioprosthetic artificial heart in Denmark.

The implant procedure was performed by the team of Dr. Peter Skov Olsen, cardio-thoracic surgeon at the Heart Center of Rigshospitalet in Copenhagen. It is the first Danish hospital to implant the CARMAT total artificial heart and the third international medical center contributing to the PIVOTAL study, together with the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, and the National Research Center for Cardiac Surgery in Nur-Sultan, Kazakhstan.

Finn Gustafsson, MD, PhD, Professor of Advanced Heart Failure and Transplantation at the Heart Center and principal investigator of the study, comments: “We are excited to gain clinical experience with the CARMAT artificial heart and to contribute to the PIVOTAL study. With its hemocompatibility, autoregulation and silent operation, the CARMAT TAH could become a real alternative treatment to heart transplantation for patients suffering from end-stage heart-failure.”

Stéphane Piat, Chief Executive Officer of CARMAT, adds: “Rigshospitalet has developed a strong expertise in treating advanced heart failure and has participated in front-line clinical studies with innovative medical therapies and devices in this field. I am delighted that such an internationally recognized site becomes the third international center to implant our device. With the recent release of certain COVID-19 pandemic-related restrictions, CARMAT’s teams and proctors were able to prepare and participate in the surgical procedure and early post-operative follow up. To date, 13 patients have received our device in the PIVOTAL study and, subject to the progressive ramp-up in recruitments across our three active study centers, we estimate that 4-5 months are needed to complete enrollment and reach the total of 20 patients.”

In accordance with good clinical practice and subject to regulatory obligations or specific circumstances, CARMAT will not provide individual updates on patients’ implantations or their health condition. However, it is planning to communicate when major milestones in the PIVOTAL study are reached, such as the opening of new centers and the overall progression of patient recruitment.

Paris, May 13, 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, announces that the “Centers for Medicare & Medicaid Services” (CMS) has approved coverage of the device and routine care items and services supplied to Medicare beneficiaries to be enrolled in the clinical feasibility study.

The approval confirms the Food and Drug Administration (FDA) Category B designation of the device, which refers to a non-experimental/investigational device for which initial questions of safety and effectiveness have been resolved. It enables the company to accelerate its discussions with the purchase departments, research contract offices and institutional review boards (IRB) at the 7 sites selected for the study. As a reminder, CARMAT has already obtained the conditional approval of two IRB.

The study aims to include 10 transplant-eligible patients, and the primary endpoint corresponds to patient survival at 180 days after the implant or a successful heart transplant within 180 days of the implant.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “This approval of CMS coverage marks a very important milestone for CARMAT, as it substantially supports its development in the United States. Indeed, hospitals will be able to receive payments for the device, routine care items and services during the clinical study. Given the ongoing discussions at the study centers, and subject to the positive evolution of the COVID-19 situation, we expect patient enrolment to begin in Q4 2020, as planned.

Paris, April 14, 2020 – 7.00 am 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 announces the publication of a coverage initiation report by Ladenburg Thalmann, a leading international investment bank.

Ladenburg Thalmann will now cover the CARMAT share on the stock exchange and values the company at €381 million, i.e. €30.25 per share*.

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country.

With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France

Paris, April 6, 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, announces that the French National Authority for Health (HAS) has given its definitive approval to initiate a clinical study of the CARMAT device within the framework of the Forfait Innovation program^[1].

Through this definitive approval, the HAS confirmed its positive opinion regarding the financing by special exemption of the CARMAT total artificial heart within the framework of the EFICAS study, a prospective, multicenter, non-randomized study, to be undertaken in France. The design of the study, which includes 52 patients to be implanted with the CARMAT heart as a bridge to a heart transplant, has been adjusted in accordance with the observations expressed by the HAS in the conditional approval received by CARMAT in February 2020. The primary endpoint of the study is the survival rate at 180 days after implantation without a disabling stroke or a successful cardiac transplantation within 180 days post-implant.

CARMAT has already received approval from the French National Agency for Medicine and Health Product Safety (ANSM) and the Île-de-France Patient Protection Committee (CPP) to undertake such a study.

The Company will now initiate budget discussions with the Ministry of Health and Solidarity.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are delighted with this positive opinion from the HAS, received within a particularly complex context. The definitive eligibility of our device to the Forfait Innovation program now enables us to open budgetary discussions pertaining to the EFICAS study aimed at facilitating the access of French patients suffering from end-stage biventricular heart failure to our cutting-edge technology”.

^[1] The Forfait Innovation is granted by the Ministry of Health and Solidarity, following an initial eligibility assessment by the HAS (https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation).