CARMAT announces the first commercial implants of its Aeson® artificial heart outside the European Union

• Three US centers successfully trained in November
• Commercial configuration of CARMAT prosthesis in final stage of approval by the FDA
• First enrolment in the study postponed to Q1 2021, and completion of the enrolment of the study still expected by end-2021

Paris, November 26, 2020 – 7 am CET

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 provides an update on its early feasibility study (EFS) in the United States.

The EFS was fully approved by the US Food and Drug Administration (FDA) in February 2020 and CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020.

In order to be able to use the “commercial configuration” of its artificial heart in the study, CARMAT submitted certain amendments to the FDA. The company believes that this latest version of the prosthesis should improve patient safety and quality of life. At this stage, thanks to a very constructive collaboration with the FDA, 8 amendments out of 9 have already been approved, and the last one should be approved in the coming weeks.

CARMAT is finalizing the study preparation with three US centers successfully trained in November at Pitt MIRM Centre for Preclinical Studies (Pittsburgh, Pennsylvania): VCU Health Pauley Heart Center (Richmond, Virginia), University of Louisville Jewish Hospital (Louisville, Kentucky), and Baylor University Medical Center (Dallas, Texas). All other steps necessary to start the EFS have already been taken.

In view of this, CARMAT now expects the first implants to be performed in Q1 2021 and the enrolment of the 10 patients to be completed by the end of 2021.

The Company confirms that its available resources[1] enable it to fund its activities through to Q3 2021.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “Despite the COVID-19 pandemic, we have been able to train the first three US centers selected for our Early Feasibility Study. They all went out of this experience very enthusiastic and committed to the success of this study. As we intend to use a new version of the CARMAT system, including features reinforcing the safety and the quality of life of patients, we had to submit amendments to supplement our initial dossier approved in February 2020. Based on ongoing discussions with the FDA, we expect to start to treat patients in the US with the new prosthesis in Q1 2021.”

[1] Including cash on-hand, €10m of ‘PGE’ Loan (loan guaranteed by the French State) drawn in November 2020, the last tranche (€10m) of the European Investment Bank Loan which can be drawn at any time until December 2021, and the non-dilutive financing of €13m granted by the French state to fund the EFICAS study (this amount will be perceived over the duration of the study); excluding the balance of the Kepler-Cheuvreux equity line, which can be used until September 27, 2021.

Paris, November 2, 2020 – 7 am CET

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 obtained, from a banking syndicate, a €10 million loan in the form of a State-Guaranteed Loan.

This loan is 90% guaranteed by the French State with an initial maturity of 12 months and an extension option enabling CARMAT to defer the reimbursement of the principal amount for an additional period of up to 5 years.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We would like to thank the French government and our partner banks for this non-dilutive financing that allows us to continue our activities with confidence. In an environment made uncertain by the COVID-19 crisis, this financial facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021”.

Paris, October 20, 2020 – 5.45 pm 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 obtained ANSM (French agency for the safety of medicines and health products) and CPP Ouest III (ethics committee) approval to perform implants of its device within the framework of the PIVOTAL study in France.

These approvals open up the possibility for French patients to receive the CARMAT device and for French hospitals to contribute to the completion of enrollment in the PIVOTAL study by the end of the first quarter of 2021.

To date, the number of implants performed within the framework of the PIVOTAL study stands at 13, including 10 in the first cohort, now closed, and 3 in the 2^nd cohort, which is currently enrolling patients.

As a reminder, the study protocol provides for the enrollment of a total of 10 patients in the 2^nd cohort, and the primary endpoint of the study is 6-month survival with the bioprosthesis or a successful heart transplant within 6 months of the device being implanted.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are delighted to be able to resume implants of the CARMAT heart in France. The enrollment pace, impacted by the COVID-19 situation in the centers in the Czech Republic, Denmark and Kazakhstan, could hence accelerate with the participation of highly specialized French centers to complete this key study. This is also very important in view of the future EFICAS study, insofar as the chosen French centers will thus be able to acquire valuable clinical experience before the launch of this broad study that is expected to begin in the second quarter of 2021. We are simultaneously working with centers in the United States to enable the US early feasibility study (EFS) to begin before the end of the year, as planned”.

Professor Jean-François Obadia, Head of the Cardiothoracic Surgery and Heart Transplant department at Louis Pradel hospital (CHU LYON) and the study’s national Principal Investigator, added: “Our participation in the PIVOTAL study will finally give us access to this innovative technology that meets an urgent clinical need for which we so far had no satisfactory solution. The prosthesis’ performances observed in the first patients already implanted abroad and our recent experience during the training of our teams in France are very encouraging. We are delighted to have this opportunity, particularly as our teams will subsequently participate in the EFICAS study, supported by the French Ministry of Health and Solidarity”.

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.