Half of enrolments targeted in the EFICAS study reached by CARMAT

• 7 Aeson® implants have been performed as part of the study, including 4 over the last 4 weeks
• The pace of implants allows the Company to anticipate the completion of the study in 2025, in line with its objective

Paris, October 23, 2023 – 7:00 am (CEST)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), announces that it has presented its progress on the EFICAS clinical trial at the 36^th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, organized by the cardiology institute of the Pitié Salpêtrière hospital from October 18 to 20, 2023 in Paris.

Prof. Christian Latrémouille, Director of Surgical Affairs at CARMAT, provided an update on the latest progress of this large-scale study at a session dedicated to innovations: “Seven Aeson® implants have been performed as part of the study since its initiation in several of the French centers involved. The pace of study enrollment is accelerating, with 4 implants performed over the last 4 weeks. This ramp-up is the result of growing experience in patient selection and attest to the steep learning curve of the surgical procedure. Post-operative patient recovery is increasingly satisfactory, which gives us great confidence in Aeson®’s performance and the success of the study, anticipated to be completed in 2025. I would like to thank all the participating teams for their commitment and look forward to seeing additional centers join us in our efforts to offer as many patients as possible an effective alternative to heart transplant.”

EFICAS is a prospective study designed to include 52 patients eligible for transplants, currently enrolled by a network of 6 French cardiology centers. It will enable CARMAT to gather additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France. The primary objective of the study is 180-day post-implantation survival without disabling stroke, or successful heart transplant within 180 days of implantation.

Pr. Lebreton of Pitié Salpêtrière Hospital (AP-HP), Paris, says: “We are delighted to have implanted a first patient with the Aeson® total artificial heart as part of the EFICAS clinical study. The patient is recovering very quickly, and most of his symptoms of advanced heart failure have already disappeared.”

Pr. Obadia of Hôpital Louis Pradel (Hospices Civils de Lyon), principal investigator of the EFICAS study, comments: “With our second Aeson® implant within a month, our learning curve is rapid, and we remain impressed with the device’s performance. The CARMAT team provides excellent support to the hospital teams, before, during and after each implant.”

Pr. Vincentelli of the Lille Regional University Hospital (CHRU), says: “The Aeson® heart is an absolute necessity in the therapeutic arsenal against end-stage heart failure. This total artificial heart has enabled us to safely prepare and wait for heart transplants in young patients who have no longer responded to conventional treatment.”

CARMAT teams also attended the 7^th “Journée” VAD Meeting, organized by the French-speaking coordination for the development of cardiac assistance (COFDAC), on October 19, 2023. This was an opportunity to demonstrate the Aeson® device to VAD coordinators in France, who play a key role in the management of patients on circulatory assistance.

CARMAT completes a €7 million capital increase with several historical financial shareholders  

• Extension of the Company’s cash runway to early 2024
• Active work on other financing solutions and measures to extend this horizon
• Confirmation of Aeson®’s early sales momentum

Paris, October 16, 2023 – 07:00 am (CEST)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announced the completion of a capital increase for a total amount of €7 million, subscribed in its vast majority by several of its historical financial shareholders (“Capital Increase“).

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “As the early momentum of Aeson® sales bas been confirming in recent weeks, I am delighted by the confidence in our project, demonstrated by three of our long-standing shareholders (Lohas, Santé Holdings and Therabel Invest). Their financial support will enable us to continue the deployment of our strategic plan over the coming months, and particularly to support the acceleration of our sales and our EFICAS clinical trial in France.

We are also very actively working on other financing solutions and measures which, combined with a strict financial discipline, should enable us to further extend our financial visibility.

We are confident in the robustness and safety of our artificial heart, and in its strong potential, and are determined to lead CARMAT to commercial success and profitability, with the support of our teams, shareholders and partners, for the benefit of patients suffering from advanced biventricular heart failure.”

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, 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, 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).

Paris, March 30, 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, informs its shareholders that the annual general meeting (AGM) of March 30, 2020 was able to deliberate, quorum having been reached.

Given the ongoing restrictions associated with the COVID-19 context, CARMAT’s Shareholders’ Meeting was held behind closed doors and streamed online. This AGM approved all the resolutions tabled, with the exception of the 30^th resolution, which was rejected on the recommendation of the Board of Directors. 

Mr. André Muller is appointed as an Independent Director

The Company’s shareholders notably ratified the appointment of Mr. André Muller as an Independent Director. Mr. Muller will bring his extensive experience within the health sector as a Chief Financial Officer, Director and investor to CARMAT’s Board of Directors. He was notably Chief Financial Officer of Actelion, a Swiss biotechnology company acquired by American pharmaceutical group Johnson & Johnson for USD 30 billion in 2017. He also contributed to the creation, and led the IPO, of Idorsia Ltd, the spin-off comprising Actelion’s clinical R&D activities.

The Board of Directors thus now consists of 10 members, 6 of them independent.

At this stage, the impact of the COVID-19 pandemic is expected to be limited

Within the context of the COVID-19 pandemic, CARMAT has implemented measures to protect its employees and has adapted its work organization in order to guarantee business continuity while complying with the guidelines and restrictions imposed by the government.

At this stage, the Company does not expect the pandemic to have a significant impact on its operational activity or its 2020 schedule:

• Manufacturing: the new procedures put in place in 2019 enable greater fluidity and the ramping up of its production capacity. Particular attention is being paid to supplier relations in order to guarantee continuous production, which has not been impacted so far.
• PIVOTAL study: due to ongoing international travel restrictions and hospital medical staff having to focus entirely on fighting COVID-19, CARMAT’s teams are currently unable to access implant centers. 3 new patients corresponding to the criteria of the study are thus currently waiting to receive the CARMAT heart. The Company estimates that, if the pandemic is resolved by the end of the second quarter of 2020, the impact on its clinical schedule will be limited, given the time required to complete enrollment in the study (estimated at 4 to 5 months). To date, 12 patients in the PIVOTAL study have been implanted and the prosthesis has achieved individual support of 25 months.
• “Forfait Innovation”: as indicated in the press release of February 17, 2020, CARMAT has submitted, to the French National Authority for Health (HAS), the protocol for a clinical study within the framework of the Forfait Innovation program (EFFICAS study). At this stage, the Company is not expecting the COVID-19 crisis to have an impact on the timetable of its discussions with HAS.
• Feasibility study in the United States: talks are ongoing with the FDA, the CMS (Centers for Medicare & Medicaid Services) and the ethical committees of the selected centers, and the objective is still to treat a first patient during the fourth quarter of 2020.
• CE marking: the discussions currently taking place with DEKRA have not been affected at this stage.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “I would like to thank all of our shareholders for their commitment and support in this highly unusual context. We are delighted that Mr. André Muller is joining our Board of Directors, to which he will bring his financial expertise and his knowledge of the health sector. Last but not least, I would like to pay tribute to the commitment of our teams during this unprecedented health emergency. Thanks to their efforts, our activities are continuing in line with our objectives. We will keep the public informed of our project’s progress and outlook in light of the evolution of the COVID-19 situation.”