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.

Aeson® total artificial heart highlighted as a very promising solution for heart failure patients with pulmonary hypertension in The Journal of Heart and Lung Transplantation

• Up to 25% of advanced heart failure patients suffer from pulmonary hypertension
• Aeson® could potentially become a standard treatment for these thousands of patients, both as a bridge-to-transplant and destination therapy

Paris, February 17, 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”), today announces the publication in The Journal of Heart and Lung Transplantation, of an article on the performance of Aeson® total artificial heart in treating heart failure patients with pulmonary hypertension.

Study description and key findings

The article, entitled “Precise Monitoring of Transpulmonic Resistance in Bridge to Transplant Patients Supported by The Aeson Total Artificial Heart^[1]”, features the results of a single-center study conducted at the University Medical Center of Astana (Kazakhstan) on 3 heart failure patients with pulmonary hypertension (PHT).

One of Aeson®’s innovative features is its ability to estimate transpulmonic resistance (eTPR) in real time, based on embedded pressure sensors. This is useful for monitoring patients with PHT, an indication that often excludes them from heart transplant candidacy.

Following the Aeson® implant, all three patients experienced improved functional capacity, as demonstrated by 6-minute walk distances test, and were discharged from hospital on the Aeson® respectively 68, 48 and 48 days after implant. Over time, their pulmonary hypertension indicators improved, rendering them eligible for heart transplant, which effectively took place after 243, 155 and 109 days respectively.

Dr. Yuriy Pya, Cardiac Surgeon at University Medical Center of Astana and lead author of the study, stated: “In our experience with patients suffering from pulmonary hypertension, the Aeson® total artificial heart provided autoregulated blood flow to optimize patients’ condition. Moreover, the non-invasive monitoring of pulmonary resistance with data generated by Aeson® has helped us to determine the best timing for a successful heart transplant in all cases.”

Aeson®: a very promising solution for heart failure patients with pulmonary hypertension

Up to 25% of patients with advanced heart failure suffer from pulmonary hypertension, which represents several thousand patients in a difficult-to-treat situation, as they are mostly subject to a contra-indication to heart transplant.

While left ventricular assist devices are often used in an attempt to relieve pulmonary hypertension, prolonged support may lead to onset of right heart failure. These patients face significant risks of morbidity and mortality, emphasizing the need for alternative strategies.

Aeson®, providing balanced biventricular support and integrating pressure sensors for real-time blood flow regulation, could offer an innovative approach to the management of pulmonary hypertension in advanced heart failure patients, both as a viable bridge-to-transplant solution or, potential definitive therapy.

Piet Jansen, Chief Medical Officer of CARMAT, concluded: “Pulmonary hypertension is a condition that can temporarily delay heart transplantation. This publication in a prestigious scientific journal highlights the potential of Aeson® to safely bridge patients with pulmonary hypertension to a heart transplant. The ability of the device to provide real-time hemodynamic monitoring and to facilitate clinical decision-making has led to improved outcomes for these high-risk heart transplant candidates. Although larger studies are needed to confirm these findings and establish standardized protocols for pulmonary hypertension management with Aeson®, our device represents an important advancement in mechanical circulatory support and a real hope for thousands of patients with this challenging condition.”

[1] https://www.jhltonline.org/article/S1053-2498(25)00069-5/fulltext   

CARMAT publishes its 2024 half-year results and provides an update on its outlook
 

• Half-year sales of €3.3 million, exceeding 2023 full-year sales
• 20 implants of the Aeson® artificial heart performed in the first half of 2024
• 17% cash-burn¹ reduction compared to the first half of 2023
• 2024 anticipated annual sales of €8 to €12 million
• Other 2024 operational objectives on track
• Active exploration of financing options to extend in the near-term the Company’s cash runway beyond the end of September 2024

Paris, September 6, 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 announces its results for the first half ending June 30, 2024², and provides an update on its progress and prospects.
 
Stéphane Piat, Chief Executive Officer of CARMAT, comments: “The outcome of the first half of 2024 is very positive. With sales of €3.3 million, we have in just 6 months, exceeded our 2023 full-year sales. Achieving 20 Aeson® implants in the first half of the year is a very encouraging indicator for such an innovative device, which is still in its launch phase. In the second quarter of 2024, we performed twice as many implants as in the first quarter.
But beyond these numbers, the feedback and numerous spontaneous testimonials from European physicians who have carried out Aeson® implants, speak for themselves and give us confidence in the progressive development of our truly unique therapy, which meets a real need and literally “gives life back to patients”.
For the rest of the year, we anticipate a traction in implants, both in the EFICAS study and commercially, which should enable us to achieve annual sales of €8 to €12 million in 2024. In 2024, we therefore plan to multiply our revenue by 3 or 4 versus 2023.
 
In addition, we anticipate several key catalysts in 2025, including the publication of significant clinical results, which should confirm these expert testimonials, and thus objectify the safety and efficacy of our therapy. These results should play a key role in accelerating our growth. Finally, in 2025, we also anticipate resuming our PIVOTAL study in Europe, with patients not eligible for heart transplant, with a view to eventually obtaining the destination therapy indication that has always been and remains CARMAT’s ultimate goal.
 
The development of a breakthrough therapy such as ours is necessarily an obstacle race. So far, we have overcome all hurdles, not without difficulty, but successfully. We therefore look forward to the next steps with confidence, resilience and the same winning spirit.”

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¹ Cash flow from operating and investing activities
² The interim financial statements were approved by the Board of Directors on September 5, 2024; The statutory auditor’s limited review procedures are currently in progress. The 2024 half-year financial report is published today and can be consulted on the Company’s website.

Paris, September 3, 2024 – 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 announced its participation in the following scientific and investor conferences during the 2^nd half of 2024: