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

Paris, May 12, 2025 – 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”), today announces the completion of enrolment of the 52 patients planned in the EFICAS study, and the approval from the French authorities to perform 21 additional Aeson® implants, while awaiting potential reimbursement of the device in France.

Stéphane Piat, Chief Executive Officer of CARMA, commented: “The very strong momentum in the EFICAS study, which enrolment is now complete, reflects the quality and performance of our Aeson® artificial heart and its ability to address the unmet need expressed by healthcare professionals and patients. I am convinced that this study paves the way for strong sales development in Europe and beyond – particularly once its results will have been published, hopefully as soon as end of 2025.

I am also very pleased that, by approving 21 additional implants, the French authorities enable patients in France to continue benefitting from our therapy beyond the EFICAS study. This is a strong sign of confidence in Aeson® artificial heart.

Given the study design, we anticipate to be in a position to file for Aeson®’s reimbursement in France early next year, which could lead to coverage of our artificial heart by the French Social Security system during 2026.

The EFICAS study is also important given our strategy to access the U.S. market, which we are expecting to achieve in 2028.

I would like to thank all patients and healthcare professionals, as well as our teams for their contribution to this important step in Aeson®’s development.”

Enrolment completed in the EFICAS study

Initiated in November 2022, the EFICAS clinical study is the largest ever one conducted by CARMAT. It involves 52 patients eligible for a heart transplant and is carried out across 10 hospitals in France[1].

The primary endpoint of EFICAS is patient survival at 6 months post-Aeson® implant, without disabling stroke, or a successful heart transplant within that period.

EFICAS is key to support Aeson®’s commercial rollout in Europe[2] (through ‘evidence-based medicine’), and secure its reimbursement in France, and is also expected to contribute to securing the Pre-Market Approval (PMA) in the United States, currently targeted for 2028[3].

Given the 6-month post-implant follow-up of patients, CARMAT expects completing the EFICAS study (primary endpoint) early November 2025, which will be followed by the publication of its results.

Approval obtained from French authorities for 21 additional Aeson® implants – and filing for reimbursement in France planned early 2026

As a reminder, the EFICAS study is partially funded by the French State (€13 million for 52 implants[4]), through the “Forfait Innovation” program.

In order to allow patients in France to continue benefitting from Aeson® artificial heart after the completion of the 52 implants in the EFICAS study, the French authorities[5] have approved 21 additional implants, under financial terms equivalent to those of the ‘Forfait Innovation.

In parallel, CARMAT is taking all necessary steps to be in position to submit a reimbursement application (so-called “LPPR”) for Aeson® at the beginning of 2026, which could allow Aeson® to be covered by the French Social Security system during the same year.

[1] CHRU Lille, AP-HP Hôpital Européen Georges Pompidou, GHU Pitié Salpêtrière, CHU Dijon, Hospices Civils de Lyon, Hôpital Marie-Lannelongue, CHU Rennes, CHU Montpellier, CHU Nantes and CHU Strasbourg.

[2] The Aeson® artificial heart has received CE marking for the “bridge to transplant” indication, allowing its commercialization throughout the European Union.

[3] Subject in particular to the quality of Aeson®’s clinical results and the completion of all required regulatory steps.

[4] The Company benefits from this funding progressively as implants are performed.

[5] DGOS – Direction Générale de l’Offre de Soins.

Recruitment of the second cohort expected to begin in H2 2025

Paris, April 14, 2025 – 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”), today announces that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate the second cohort of its Early Feasibility Study (EFS) with Aeson® artificial heart in the United States.

Stéphane Piat, Chief Executive Officer of CARMAT, stated: “The authorization to initiate the second cohort of our Early Feasibility Study (EFS) in the United States, received from the FDA, marks a very important milestone in CARMAT’s journey. It reflects Aeson® artificial heart’s quality and performance and its potential to address the unmet need expressed by healthcare professionals and patients around the world.

This authorization will allow U.S. patients to benefit from our therapy as early as the second half of 2025. It also represents a key step towards a potential commercial launch of Aeson® in the United States, which—subject to factors including the quality of our clinical results—could occur from 2028.

I would like to thank all our team for their contribution to this key achievement.“

Conditional approval to initiate the second cohort of the EFS study in the United States

The EFS study in the United States is a feasibility study involving a total of 10 patients eligible for heart transplant. The study’s primary endpoint is patient survival at 6 months post-Aeson® implant, or a successful transplant within this timeframe.

The study design includes two successive cohorts. The first cohort of 3 patients was completed in Q3 2021.

Following the completion of this initial cohort, CARMAT implemented enhancements to Aeson®, which were submitted to the FDA. All of these changes have now been reviewed and approved by the FDA, allowing CARMAT to start recruiting patients in the second cohort[1].

This second cohort will include a total of 7 patients, with an interim report on the first 3 implants.

Initiation of the second cohort expected in H2 2025

CARMAT will now take all necessary steps – including obtaining approvals from ethics committees[2] and refreshing the training of participating hospitals – with the objective to initiate implants in the second half of 2025.

Meanwhile, CARMAT will seek the FDA to approve Aeson®’s most recent version, currently used in Europe, in order to be able to use it in the EFS study.

This second part of the EFS study represents an important step in the Company’s US market access strategy, the United States being the largest market in the world in the field of implantable cardiac devices.

[1] In view of this, CARMAT is required, with no suspensive effect, to provide the FDA with a limited number of clarifications within 45 days.

[2] IRB – Institutional Review Board.

• Quarterly sales of €2.4m – multiplied by 2.4 vs Q1 2024
• EFICAS clinical trial – recruitment 94% complete
• 2 scientific publications – a strong driver of Aeson® adoption
• Final stage of discussions with the FDA with a view to resume the EFS study in the United States shortly

Paris, April 9, 2025 – 5:45 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”), today presents its achievements for the first quarter of 2025 and outlook.

Stéphane Piat, Chief Executive Officer of CARMAT, stated: “We have delivered a solid first quarter, in line with our objectives.

The beginning of 2025 has confirmed 2024 positive momentum in terms of implants, with 16 implants carried out in the first quarter, at a pace of more than 5 implants per month. CARMAT has thus generated sales of €2.4 million, 2.4 times more than in the first quarter of 2024.

Enrolment in EFICAS is 94% complete, which means this French study is progressing remarkably well, and should be finalized very soon, in line with our objectives. This study represents a major driver for the adoption of our therapy in France and, so will it be internationally as well, once study results are obtained at the end of the year. We are also delighted with the two recent publications featuring Aeson® in renowned scientific journals, which underline the strength and potential of our therapy. These articles are also powerful vectors for Aeson®’s dissemination.

We are also in final stage of discussions with the FDA (Food & Drug Administration), which should enable us to obtain very soon the authorization to initiate the second cohort of our EFS (early feasibility study) in the United States.

Finally, we remain more than ever focused on our long-term support goal, which would enable patients to remain under Aeson® support on a long-term basis. With this objective in mind, we should be in a position to make an enhanced version of our artificial heart available by the end of 2025, which will enable the Company to progress towards a new phase of its development and gradually unlock the full potential of its therapy.“

Record quarter with 16 Aeson® implants

During the first quarter of 2025, CARMAT performed 16 Aeson® heart implants in 3 countries (France, Germany, Italy), vs 7 implants in the 1^st quarter of 2024.

Quarterly sales thus amounted to €2.4 million, a 2.4-fold increase vs the first quarter of 2024.

At the end of March 2025, CARMAT had reached a total of 108 Aeson® implants since the first implant in 2013, including 58 in the last 15 months, which reflects a tangible acceleration in the adoption of the therapy.

Recruitment of the EFICAS study in France close to completion

Thirteen implants were made in the first quarter of 2025 as part of the EFICAS study, bringing their total number to 49 at the end of March, i.e. an enrollment rate of 94%, which suggests that recruitment will be completed very shortly (52 patients in total).

The results of this study, expected at the end of 2025, are of strategic interest to CARMAT both from a regulatory point of view, to get the reimbursement in France, and for the adoption of Aeson® internationally.

The EFICAS study plays a major role in developing the experience of surgical and medical teams, enabling the emergence of “centers of excellence” for Aeson® implants. The Lille University Hospital has thus already performed 10 implants, and three other French hospitals have each performed 7.

The Company considers that the dynamics of implants observed in the centers participating in the EFICAS study is a good predictor of forthcoming commercial momentum.

Final stage of discussions with the FDA to initiate the second cohort of the EFS

CARMAT is currently in final stage of discussions with the Food and Drug Administration (FDA) with a view to get the authorization to start the second cohort of the EFS (Early Feasibility Study) in the United States.

Involving 7 patients, this second part of the study represents an important step in the Company’s US market access strategy. The United States are the largest market in the world in the field of implantable cardiac devices.

Progressive strengthening of financial flexibility

In January 2025, CARMAT completed a €9.7 million fund raising. In March 2025, the implementation of an equity financing line with IRIS Capital Investment, of a potential amount of up to €7.9 million[1], which can be activated at the Company’s discretion, offers CARMAT additional flexibility in the management of its working capital.

CARMAT, which cash runway extends to the end of May 2025[2], is actively exploring other financing solutions to extend its cash runway to a longer term.

Governance

Professor Christian Latrémouille, previously Director of Surgical Affairs at CARMAT, was appointed Medical Director with effect April 1, 2025, taking over from Dr. Piet Jansen, who is retiring after more than 15 years devoted to the development of Aeson® within the Company.

A Doctor of Medicine specialized in cardiac surgery and University Professor, Christian Latrémouille has been involved in the development of Aeson® since its inception, initially as a hospital practitioner, particularly alongside Professor Alain Carpentier, and then at CARMAT, which he joined in 2021.

“I would like to thank Piet Jansen warmly for his long-standing commitment, which has enabled Aeson® to reach key milestones, including the first implants, getting CE marking and the initiation of a clinical study in the United States. Today, I am delighted to benefit from Christian Latrémouille’s expertise to anchor Aeson® in clinical practice and gradually make it a first-intent solution for physicians and patients around the world,” commented Stéphane Piat.

Outlook

The sales momentum of the first quarter is in line with CARMAT’s objective to double its sales in 2025.

In France, the Company has initiated discussions with the authorities to enable patients to get continued access to its therapy, post-completion of the EFICAS study and until reimbursement is obtained, which is anticipated from the end of 2026.

In Europe, CARMAT anticipates continued sales growth, supported by an increasing number of trained centers, the first implants in new countries, the positive feedback from the 1^st “Aeson® European User Meeting” held in November 2024, and the recent publications of promising clinical results in peer-reviewed journals.

In the United States, the authorization to start the second cohort of the EFS study, expected from the FDA, should allow a resumption of implants in the second half of 2025, and potentially pave the way for a commercial launch in the United States in a horizon estimated to be 2028.

With a view to preparing for the future and accelerating the deployment of its therapy, CARMAT is already focused on its long-term support goal, which would enable patients to remain under Aeson® support on a long-term basis, and ultimately without subsequent heart transplant.

In view of this, the Company anticipates being in a position to make an enhanced version of its artificial heart available to healthcare professionals by the end of 2025. This would enable long-term support for patients and thus broaden access for Aeson® in the European market, particularly in countries such as Germany, where waiting times for a transplant can be long. The Company thinks that getting the destination therapy indication could take a few years.

[1] Based on the closing price of March 26, 2025, i.e. €0.879.

[2] Excluding the flexible equity financing line entered into with IRIS, which was announced on March 27, 2025.

The retrospective analysis on 10 patients shows a 90% survival rate at 6 months, suggesting Aeson® as a therapeutic solution for these patients at risk of death in the short term.

Paris, April 3, 2025 – 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”), today announces the publication of the results of the initial clinical experience with Aeson® in cardiogenic shock patients previously on temporary extracorporeal life support[2], in the JACC: Heart Failure.

Study characteristics and key findings: 90% survival rate at 6 months, recovery of renal and hepatic function, improvement in functional capacity

The article, entitled “Initial Experience with Aeson Total Artificial Heart in Cardiogenic Shock Patients on Extracorporeal Life Support[3]”, features the results of a retrospective analysis conducted in seven hospitals across France and Germany between November 2022 and April 2024. The analysis is about 10 patients with refractory cardiogenic shock, who were initially stabilized on extracorporeal life support (ECLS) for a median duration of 9 days before receiving an Aeson® total artificial heart.

The analysis reports a 90% survival rate at 6 months following Aeson® implant, with 5 patients successfully transplanted and 4 still on Aeson® support at that time.

In addition, the analysis highlights that Aeson® improves kidney and liver recovery and allows for hospital discharge after a median hospital stay of 42 days, contributing to an improvement in functional capacity and overall health status of the patient while awaiting a heart transplant.

Dr. Anne-Céline Martin, Cardiologist at Hôpital Européen Georges-Pompidou (Paris) and lead author of the article, commented: “Even for critically ill patients in refractory cardiogenic shock requiring temporary circulatory support, transitioning to the Aeson® total artificial heart has demonstrated highly promising results, with a 6-month survival rate of 90%. Moreover, thanks to Aeson®’s autoregulated and pulsatile flow, patients experienced a significant improvement in exercise capacity and quality of life, enabling them to face the challenge of a heart transplant.”

Aeson®: a promising solution for very high-risk patients initially placed on temporary extracorporeal life support

Cardiogenic shock is an acute heart failure condition that poses a life-threatening risk to patients, with still high mortality rates (30% to 60%) despite advancements in treatment. In the most severe cases, extracorporeal life support can be used temporarily to stabilize patients; however, this approach is only viable for a short period of time (around ten days) due to the risk of complications.

Heart transplant often remains the best option for these patients initially placed on extracorporeal life support. However, its access is limited by the lack of available human grafts, and by the sometimes too fragile health status of patients, who may present temporary contraindications to such a transplant.

Aeson® is therefore emerging as a promising therapeutic solution for this population of patients at very high risk of death in the short term, enabling them to improve their state of health before they can benefit from a heart transplant.

Over the past two years, around half of patients treated with Aeson® had previously been placed on extracorporeal life support.

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “This new publication in a leading scientific journal validates the relevance and clinical value of our therapy, confirming that Aeson® can be used as a bridge to transplant even for the most critical patients, at risk of death in the short term. After several days on extracorporeal life support (ECMO), these patients have no other options but heart transplant or the implant of a total artificial heart if a human graft is not available or if a transplant can’t be made immediately due to the patient’s state of health. Our promising results bring hope to patients and their families. I am convinced that their dissemination within the medical community will drive an always broader adoption of Aeson® across Europe.”

[1] Journal of the American College of Cardiology

[2] Also known as “ECMO” (Extra-Corporeal Membrane Oxygenation) or “ECLS” (Extra-Corporeal Life Support).

[3] https://www.sciencedirect.com/science/article/pii/S2213177925001763?dgcid=author   

Please register to the videoconference by clicking on one of the following links:

Videoconference in French at 6:00 pm CEST

–

Videoconference in English at 8:00 pm CEST

Paris, March 31, 2025 – 6:30 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”), will publish a business update and host a videoconference on Wednesday, April 9, 2025 after the market closes.

The videoconference will be held in French at 6:00 pm (CEST) and then in English at 8:00 pm (CEST).

The presentation, followed by a Q&A session, will be hosted by:

• Stéphane Piat, Chief Executive Officer
• Pascale d’Arbonneau, Deputy Chief executive Officer & Chief Financial Officer
• Francesco Arecchi, Director of Global Market Development
• Christian Latrémouille, Director of Surgical Affairs

 You will have the opportunity to submit your questions via the videoconferencing platform throughout the presentation.

Paris, March 27, 2025 – 7:00 am (CET)

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 the implementation of a flexible equity financing line with IRIS Capital Investment (“IRIS”), for a maximum of 9,000,000 shares (i.e., approximately 15% of its current share capital), over a 24-month period.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “I am very pleased with the implementation of this financing line with IRIS Capital Investment, which, based on our current share price, provides us with a potential total financing amount of approximately €7.9 million over the next 24 months, and thus offers substantial room for manoeuvre that we can start benefitting from immediately. In parallel, we are actively working on securing additional funding to ensure the long-term development of our Company and our sales growth. Following a strong start this year, we are determined to progressively establish Aeson® as a reference solution for patients suffering from advanced biventricular heart failure — today in Europe, and within a few years in the United States.”

Pursuant to the terms of the agreement signed on March 26, 2025 between the Company and IRIS, the latter has undertaken to subscribe up to 9,000,000 new ordinary shares of the Company, over a 24-month period, at its own initiative and subject to the conditions set out in the appendix to this press release.

The main purpose of this financing is to strengthen CARMAT’s equity and to contribute to the funding of its working capital requirements, particularly to support the development of its sales and the completion of its EFICAS clinical trial in France.

Based on the current share price[1], the Company could receive a total gross amount of €7.9 million should it make full use of this financing line (although this amount is not guaranteed).

The financing line has been structured via the issuance of warrants giving the right to subscribe new ordinary shares of the Company (the “Warrants”), exclusively for the benefit of IRIS[2]. This issuance was decided by the Board of Directors of the Company on March 26, 2025, pursuant to the delegation granted by the combined shareholders’ meeting of the Company held on December 30, 2024, under its 6^th resolution, and in accordance with the provisions of Article L. 225-138 of the French Commercial Code. The main characteristics of the Warrants (in particular their exercise conditions) are described in the appendix to this press release.

CARMAT controls the exercise schedule of the Warrants, having the option to suspend, reactivate or terminate this financing agreement at any time without penalty, but also the right to set a maximum number of Warrants that can be exercised over a given period. In addition, the number of new shares issued upon exercise of the Warrants during each calendar quarter cannot exceed 15% of the volume of CARMAT shares traded on the Euronext Growth market of Euronext Paris during that quarter, unless expressly agreed by the Company.

The issuance of the Warrants does not give rise to the publication of a prospectus subject to the approval of the French Financial Markets Authority (AMF) nor to the publication of an information document subject to filing with the AMF.

The number of shares issued and admitted to trading under this agreement will be disclosed on the Company’s website.

The flexible equity financing line implemented with IRIS only partially finances CARMAT’s estimated funding needs over the next 12 months, amounting to c. €35 million based on its current business plan. In this context, the Company is actively exploring various additional financing options and is particularly holding discussions with several financial stakeholders which could support it over the long term. However, it should be noted that, to date, there is no guarantee that such discussions will ultimately lead to any financial support for the Company, regardless of the amount, nor that they will materialize before the end of the Company’s current cash runway, i.e. end of May 2025[3].

[1] Closing price on March 26, 2025, i.e., €0.879.

[2] The latter being part of the category defined by the combined shareholders’ meeting of the Company held on December 30, 2024, under its 6^th resolution, namely: “natural persons, companies or investment funds, French or foreign, whether shareholders or not of the Company, investing on a regular basis, or having invested more than €1 million over the past 36 months prior to the issue concerned, in the life sciences or technology sectors.”

[3] Cash runway excluding the equity financing line entered into with IRIS, the proceeds of which by the end of May 2025 cannot be determined with certainty.