CARMAT provides an update on the ongoing receivership procedure – resumption of trading

In a context of critical financial situation, CARMAT launches a donation campaign open to all to contribute to its funding and continuation of its activities

• Risk of insolvency as early as end of June 2025
• Launch of a donation campaign open to all via the onparticipe.fr online platform

To listen to CARMAT CEO’s message, click here

Paris, June 20, 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”), today announces the launch of a donation campaign open to all, to help fund its operations and continue its mission.

Critical financial situation and risk of insolvency at the end of June 2025

In a separate press release published today (see the press release), CARMAT announced that it is currently in a critical financial situation and facing a risk of insolvency as early as the end of June 2025.

The Company estimates its 12-month financial needs at approximately €35 million, including €3.5 million needed urgently before the end of June 2025, and an additional €4.5 million by the end of July 2025.

Despite efforts that are still ongoing, the Company has not yet been able to secure the financing required to continue its operations.

Launch of a donation campaign

Against this backdrop, and while continuing its efforts to raise funds, particularly through potential capital increases, CARMAT is today launching a donation campaign open to all. This initiative aims to allow individuals and organizations who support CARMAT’s mission and wish to contribute to the continuity of its operations to do so.

Practical information on the donation campaign

The campaign opens on Friday, June 20, 2025.

Donations can only be made via the onparticipe.fr platform (available on this link). Should they experience issues, donors are invited to contact CARMAT at the following email address: donor@carmatsas.com

Main risks associated with donations

Potential donors’ attention is drawn to the fact that donations made as part of this campaign are non-refundable and do not entail any equity stake in the Company. Donors will therefore not become creditors or shareholders of CARMAT through their donation.

Donors should also be aware that there is no guarantee that the donations received as part as this campaign, even in combination with any potential capital increases or other financing solutions that the Company could secure, will be sufficient to prevent a default at the end of June 2025 or beyond. As such, a default of the Company remains possible, even in the very short term.

Furthermore, donations made in the context of this campaign do not entitle donors to any tax benefits of any kind.

CARMAT, one of the most innovative French medtech companies in the world

• A technological breakthrough: Aeson®, the world’s first physiological artificial heart, to be both pulsatile, self-regulated, and highly hemocompatible
• Increasing adoption by the medical community: over 120 patients treated worldwide, including more than 70 over the past 18 months
• Recognition by experts worldwide: more than 60 hospitals trained across 17 countries
• A team of around 180 highly skilled and committed people

Stéphane Piat, Chief Executive Officer of CARMAT, concludes: “After 30 years of research and with 120 patients treated, CARMAT’s artificial heart heart is now the most advanced artificial heart in the world and the most credible solution to address the major challenge of advanced heart failure. This condition is currently the world’s leading cause of death. As of today, heart transplantation remains the gold standard treatment, but human donor hearts are unfortunately not available in sufficient numbers, leaving thousands of patients without any solution every year.

CARMAT’s heart is therefore absolutely essential to fight this growing health crisis and bring hope to patients and their families.

In order to continue its mission, CARMAT urgently needs €3.5 million by the end of June 2025, and approximately €35 million over the next 12 months. Failing that, we will most likely be forced to cease operations.

Despite our best efforts in a highly deteriorated environment, we have not yet been able to secure the financing required to continue our mission. This is why we are today calling on everyone’s generosity to help CARMAT continue saving lives.”

• Immediate need to secure approximately €3.5 million to avoid insolvency at the end of June 2025
• Total funding needs of around €35 million over the next 12 months
• Ongoing active exploration of financing options

Paris, June 20, 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”), today announces being in a critical financial situation and at risk of insolvency as early as the end of June 2025.

Critical financial situation and risk of insolvency at the end of June 2025

When reporting its full-year 2024 results (press release dated April 29, 2025), on April 29, 2025, the Company had indicated that it was funded until mid-June 2025 and actively working on financing options to secure, in the short term, the resources needed to continue its operations beyond that date.

Despite all its efforts, in a very challenging funding environment—particularly for small and mid-cap companies—the Company has not, to date, been able to secure such financing and will be in a situation of insolvency at the end of June 2025 unlesss it manages, before then, to secure additional cash of at least €3.5 million.

More generally, based on its current business plan, the Company estimates its 12-month financial needs at approximately €35 million, including around €20 million by end-December 2025 (broken down into €8 million by end-July, an additional €4 million by end-September, and a further €8 million by end-December 2025).

Next steps and launch of a donation campaign

CARMAT continues to actively explore all financing options to ensure business continuity beyond June 2025.

In parallel to this, the Company is today launching a donation campaign through an online platform, which is the subject of a separate press release (link to the press release).

Press releases will be issued regularly to keep shareholders and the financial community informed of any developments regarding the Company’s financial situation.

Two implants have recently been performed in Israel

Paris, June 2, 2025 – 7 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 announces the first implants of its Aeson® artificial heart in a commercial set-up, outside the European Union (EU).

Two implants of Aeson® artificial heart were performed during the week commencing May 26, 2025 in Israel.

The first one was carried out at Hadassah Ein Kerem Hospital in Jerusalem by a team led by Pr Offer Amir, Pr Rabea Asleh and Dr Amit Korach, respectively director of the Heart Institute, director of heart failure unit and director of the cardiac surgery department at Hadassah Medical Center.

The second one was carried out at Sheba Medical Center in Ramat Gan (Tel Aviv), by a team led by Dr Jeff Morgan, Dr Leonid Sternik, Dr Alex Fardman and Dr Eyal Nachum, respectively head of mechanical support unit, director of cardiac surgery department, heart failure cardiologist and cardiac transplant surgeon.

Those are the first Aeson® implants made in a commercial set-up outside the European Union.

These implants bring to 5 the total number of countries^[1] where commercial implants have been performed so far. They confirm the trust placed in the device by healthcare professionals, and the growing interest in the therapy.

^[1] Germany, Italy, Spain, Poland and Israel.

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.