CARMAT completes enrolment in the EFICAS clinical study and receives approval from French authorities for 21 additional Aeson® implants, while awaiting potential reimbursement of the device in France

• 2023 sales of €2.8 million, i.e. 17 Aeson® implants, including 11 in the last quarter
• 2024 sales forecast of around €14 million
• Active exploration of financing options to extend, in the short-term, the Company’s financial horizon beyond May 2024.
• 12-month financing requirements estimated at around €45 million

Paris, April 24, 2024 – 7.00 am CEST

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today reports its annual results for the year ending December 31, 2023, and provides an update on its progress and prospects for 2024.

The annual financial statements were approved by the Board of Directors on April 22, 2024, on a going concern basis. On April 30, 2024, the Company will publish its 2023 Universal Registration Document, including the annual financial report and the statutory auditor’s report, whose audit procedures are being finalized.

Readers’ attention is drawn to the fact that the Company’s cash runway extends to mid-May 2024. Should the financings anticipated by the CARMAT not materialize by that date, the Company would then have to make significant adjustments to his annual financial statements.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “In many respects, 2023 has been a structuring year for CARMAT, crowned in December by the symbolic milestone of 50 CARMAT heart implants since the start of our clinical experience, and by the opening of a second production building in Bois-d’Arcy.

Backed by a first-class industrial tool, sized to support our growth, we can now look forward with confidence to the commercial deployment of our therapy. The momentum in Aeson® sales that began in the last quarter of 2023, with 11 implantations, has continued since the start of 2024, at an average rate of around 3 implants per month.

To date, we are on track with our targets for the training of additional hospitals, and implants as part of the EFICAS study. Our geographical deployment is continuing, and 25 of the 39 hospitals trained to commercial implants have already referred patients to CARMAT, confirming the medical community’s strong interest in our therapy and its potential. All these advances enable us to anticipate a substantial gradual growth in our sales over the coming months, and revenue of around €14 million for 2024.

I would like to thank all our teams for their resilience, particularly over the past two challenging years. I would also like to express my gratitude to our shareholders, both historical and more recent, whose trust enables us to make progress towards our goal of making CARMAT a leading player in the treatment of advanced heart failure.”

Paris, April 4, 2024 – 6:00 pm CEST

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), announces today its participation in the following scientific and investor conferences during the second quarter of 2024:

Scientific Conferences

• 44^th ISHLT Annual Meeting

April 10 to 13, 2024 (Prague, Czech Republic)

Scientific Conference of the International Society of Heart and Lung Transplantation (ISHLT); one of the largest events dedicated to the treatment of advanced heart and lung diseases. The CARMAT team will be present on stand 36.

For more information, click here.

• Mechanical Circulatory Support (MCS) Master-Class 2024

June 7 to 8, 2024 (Turin, Italy)

International Society for Mechanical Circulatory Support (ISMCS) event dedicated to training in implantation techniques for mechanical circulatory support systems. CARMAT proctors will present the Aeson® heart implantation procedure during hands-on sessions.

For more information, click here.

• EACTAIC ECHO Course 2024

June 15 to 18, 2024 (Milan, Italy)

The European Association of Cardiothoracic and Vascular Anesthesia and Intensive Care (EACTAIC) ECHO 2024 course features innovations to enhance the learning experience and promote skills development.

For more information, click here.

Investor Conferences

• Gilbert Dupont Société Générale MidCap Forum

May 16, 2024 (Paris, France)

Investor forum organised by Gilbert Dupont (Société Générale Group), a leading player in the intermediation and financial operations in the French small and mid-cap segment.

• Portzamparc BNP Paribas Mid & Small Caps Seminar

June 12, 2024 (Paris, France)

Mid & Smallcaps conference organised by Portzamparc, BNP Paribas investment banking partner specialising in French small and medium-sized companies.

• 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.