Postponement of the publication of the 2025 interim financial report

Paris, July 28, 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 obtained CE marking under Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation – MDR), which replaces the former Medical Device Directive (MDD 93/42/EEC). This new certification covers the bridge to transplant (BTT) indication and applies to the Aeson® system as a Class III active implantable medical device.

MDR CE marking certifies Aeson®’s compliance with the most stringent European regulatory requirements

The MDR CE marking certifies Aeson®’s compliance with the latest European standards and requirements relating to patient safety, clinical performance, risk management, and post-market surveillance. It was granted following a rigorous and comprehensive review conducted by the notified body DEKRA.

In December 2020, Aeson® had obtained CE marking in the bridge to transplant indication, under the Medical Device Directive (MDD), which was in force at the time. Since then, the MDD has been replaced by the Medical Device Regulation (MDR), which significantly strengthens the requirements to be met. Class III medical devices such as Aeson®, which were CE marked under the MDD before May 2021, have until May 2027 to obtain MDR CE marking. Failing to do so would mean the device could no longer be marketed in the European Union after this date.

The MDR certification confirms and reinforces Aeson®’s recognition by health authorities.

A strengthened regulatory foundation to support European and international growth and future extension of Aeson®’s indications

Obtaining MDR CE marking, well ahead of the transition deadline, means that from a regulatory perspective, Aeson® can continue to be marketed in the European Union[1] beyond May 2027.

This certification also reinforces the Company’s position in view of a future expansion of Aeson®’s indications, notably towards destination therapy[2] (DT), as well as in its U.S. market access strategy, currently targeted for 2028.

As a reminder, Aeson® is currently the only CE-marked implantable total artificial heart.

Readers are also reminded that the Company is currently placed in receivership procedure (opened on July 1, 2025) and is therefore facing a very high risk of default, including in the very short term.

Stéphane Piat, Chief Executive Officer of CARMAT, concludes: “I would like to congratulate our teams on obtaining MDR CE marking for the Aeson® artificial heart, following an extremely demanding process that mobilized many of our employees for months. I would like to underline that Aeson® is, and currently remains, the only implantable artificial heart being CE-marked and thus marketed in Europe. In the particular context in which CARMAT currently finds itself, this MDR certification is a further independent recognition of Aeson®’s quality and performance by health authorities. From a regulatory perspective, we have thus already secured the right to continue marketing Aeson® across Europe even beyond 2027, for patients suffering from advanced heart failure. I hope we will successfully get out of the receivership procedure we are currently in, so that patients can effectively continue benefitting from our therapy going forward. Finally, I would like to add that the “MDR” CE marking is also extremely important in view of getting access to the U.S. market, and future extension of Aeson®’s indications towards permanent patient support.”

[1] and in other countries which recognize CE marking.

[2] Destination therapy (or DT): in this indication, Aeson® would be implanted permanently without subsequent heart transplantation.

CARMAT announces the initiation of a call for public tenders (buyers or investors) as part of the receivership procedure

Paris, July 3, 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 initiation of a call for public tenders (buyers or investors)[1] as part of the receivership procedure[2] opened on July 1, 2025.

A notice will be published in “Les Echos” French newspaper by the judiciary administrator appointed by the Versailles Economic Affairs Court[3] (AJRS – Maître Philippe Jeannerot), on July 4, 2025. The Notice will however be available in the digital version of the newspaper as early as July 3, 2025 in the evening.

People interested and willing to take part in the call for public tenders are invited to get in touch with Mr Valentin Laigneau (AJRS): valentin.laigneau@aj-rs.com

It is reminded that CARMAT’s operations carry on during the observation period, and that CARMAT continues to endeavor to provide continuous support to patients who currently benefit from its Aeson® artificial heart.

Press releases will continue to be issued regularly as the Company’s situation evolves and the proceedings progress.

[1] « Appel d’Offres (recherche de repreneurs ou d’investisseurs »)

[2] « Redressement judiciaire »

[3] « Tribunal des Affaires Economiques de Versailles (France) »

Suspension of CARMAT shares trading starting June 30, 2025, before stock market opening

Paris, June 30, 2025 – 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 announces filing for insolvency[1] and requesting to be placed in receivership[2] to the Versailles Economic Affairs Court[3], as well as the suspension of CARMAT shares trading, starting June 30, 2025, before stock market opening.

Insolvency filing and request to be placed in receivership

On June 20, 2025, CARMAT announced in a press release being at risk of insolvency as early as the end of June 2025 unless managing before then, to secure additional cash of at least €3.5 million.

Despite its continued efforts, the Company has not managed at this stage, to secure neither additional cash nor new financing.

Given this, the Company will today file for insolvency and request to be placed in receivership to the Versailles Economic Affairs Court (“the Court”).

The Court will rule on this request, following a hearing expected in the coming days.

As a reminder, according to its current business plan and assuming “business as usual” situation, the Company estimates its funding requirements over the next 12 months at approximately €35 million, including approximately €20 million by the end of December 2025.

[1] « Déclaration de cessation des paiements »

[2] « Redressement judiciaire »

[3] « Tribunal des Affaires Economiques de Versailles »

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.

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.