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CARMAT achieves the milestone of 100 implants of its Aeson® total artificial heart

• Milestone of 30 heart transplants post Aeson® support, passed
• Strong interest in Aeson® from the medical community: more than 100 European experts will share their experience at the first ‘Aeson® European User Meeting’ at the end of November

Paris, November 13, 2024 – 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”), provides an update on Aeson® artificial heart’s uptake as a bridge to transplant in Europe.

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• Enrolment expected to be completed in the first half of 2025
• Publication of study results on 52 patients anticipated at the end 2025

Paris, September 12, 2024 – 7:00 am CEST
CCARMAT (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 reached half of the enrolments targeted in the EFICAS study.

Continued momentum in the EFICAS study implants

The 26th Aeson® implant recently carried out as part of the EFICAS study has enabled CARMAT to reach the half-way mark in the 52 recruitments targeted as part of this study carried out exclusively in France.

The continuing good momentum in implants testifies to the very encouraging spread of the therapy in France, and to its increasing adoption by the medical community. Of the 10 hospitals taking part in the study, 9 have already carried out at least one implant, and 8 at least two.

EFICAS is the largest study ever initiated by CARMAT. It is a key study both for obtaining reimbursement for Aeson® in France, and for obtaining the “PMA” (marketing authorization for Aeson® in the United States), which the Company anticipates for 2027 (subject in particular to the successful completion of the EFS study in the United States, the second cohort of which is anticipated to start in Q1 2025).

Significant scientific publications expected in 2025

The momentum in the EFICAS study allows the Company to anticipate the completion of the enrolment (52 patients) in the first half of 2025, and the publication of the study results1 at the end of 2025.

In addition, the Company anticipates in the first half of 2025, the publication in a scientific journal of the clinical results of Aeson® in a cohort of 10 patients who have been on ECMO2 support prior to being implanted with Aeson®. This publication aims to demonstrate the efficacy and safety of Aeson® in high-risk patients.

CARMAT believes that these scientific publications will enable Aeson®’s clinical results to be widely disseminated within the medical community and will be a key factor for wider adoption of its therapy and for the Company’s growth.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “EFICAS is an essential study for scientifically objectifying the clinical results of Aeson® on a large sample of patients, and thus facilitating their dissemination within the medical community. If the final results of the study confirm their interim results, their publication at the end of 2025 should contribute to a significant acceleration in the adoption of Aeson® by European physicians.

We also anticipate another major scientific publication in the first half of 2025, focusing on the clinical results of Aeson® in high-risk patients.

These publications should be a key catalyst for our growth in Europe, from next year onwards. They will also be decisive for our medium-term objectives, namely the access to the U.S. market, on the one hand, and ultimately, the approval of Aeson® as a destination therapy, on the other.”

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1 Results on 52 patients. The primary endpoint of the study is a support with Aeson® at 6 months without disabling stroke or a heart transplant within 6 months.
2 ECMO = Extra-corporeal membrane oxygenation.

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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.

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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 2nd half of 2024:

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  • 20 implants of the Aeson® artificial heart performed in the first half of 2024
  • Pace of 4 implants per month in the second quarter
  • Half-year sales at €3.2 million, higher than the 2023 full-year sales
  • Unique safety and performance profile of Aeson® confirmed, based on more than 70 implants made since inception

 

Videoconference in French this evening at 6:00 pm CEST. To participate, please register by clicking on this link.

 

Paris, July 9, 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”), provides an update on its achievements over the first half of 2024 and reiterates its confidence in its development outlook.

 

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “Overall, our first-half achievements are very positive. With sales of €3.2 million (i.e., 20 implants) in the first 6 months of the year, we have already exceeded our 2023 annual sales; and the trajectory is extremely encouraging, with twice as many implants in the second quarter as in the first.

With 14 implants since January 1st and a total of 25 since its initiation, the momentum of our EFICAS study in France is excellent. We expect to pass the halfway mark of the targeted 52 inclusions in the study very soon, which means we can anticipate completing these inclusions in the first half of 2025. This progress demonstrates that, once introduced to Aeson®, healthcare professionals rapidly adopt the therapy, which is a positive signal for our ongoing commercial development.

Building on these achievements, on a European network of 42 hospitals trained for commercial implants, on 3 commercially active countries (Germany, Italy, and Poland) and 6 others now ready, as well as on our growing and convincing clinical experience (70 implants carried out since the inception of CARMAT), I am confident that our sales will continue to grow gradually, quarter after quarter; and this, all the more as awareness around Aeson® is growing, notably driven by spontaneous communication from many centers that have implanted Aeson®.

I would like to thank our teams for their commitment and determination, and all our shareholders, whose support make these advances possible. More than ever, we remain resolutely committed to making CARMAT a leader in the field of advanced heart failure.”

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Videoconference in French on July 9, 2024 at 6:00 pm CEST.

To participate, please register by clicking on this link.

 

Paris, July 8, 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”), will publish a half-year update on Tuesday, July 9, 2024 before the market opens.

 

The Company will also hold a videoconference in French on July 9, 2024 at 6:00 pm (CEST).

 

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

 

  • Stéphane Piat, Chief Executive Officer
  • Pascale d’Arbonneau, Chief Financial Officer
  • Francesco Arecchi, Director of Global Market Development

 

You will be able to submit your questions via the videoconferencing platform throughout the presentation.

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