Paris, January 13, 2025 – 5:45 pm (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 announced its participation in the following scientific and investor conferences during the 1st half of 2025.
Paris, January 8, 2025 – 5:45 pm 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 its 2024 annual sales[2] and provides an update on its development outlook.
Stéphane Piat, Chief Executive Officer of CARMAT, stated: “With 42 implants of our Aeson® artificial heart and €7 million in sales, i.e. 2.5 times higher than in 2023, we delivered a very solid commercial performance in 2024, while reducing our cash burn by over 20%.
All our operational indicators are trending positively, reflecting increasing interest and growing adoption of our therapy by hospitals: 60 centers are now trained on Aeson®, including 50 internationally for commercial implants, 43% of them have already performed at least one implant, and among those, six have performed at least four implants. In 2024, Aeson® was sold in four European countries, namely Germany, Italy, Spain, and Poland – and, of course, in France as part of the EFICAS study.
The first “User Meeting” we organized in November 2024, which brought together nearly 100 experts in cardiology to share their experience with Aeson®, was a tremendous success. It should prompt many European hospitals to either take the step of performing a first implant of our artificial heart or integrate it more broadly into their clinical practice.
All this, combined with the strong momentum in our EFICAS study in France, makes us optimistic about the future trajectory of our implants, and allows us to anticipate doubling our sales in 2025, at the very least.
A well-structured supply chain, calibrated to meet the demand, distribution agreements already in place in nine countries, a “field” team providing best-in-class support to hospitals, and key scientific publications on Aeson® outcomes planned in 2025, will support this momentum. We are therefore very well-positioned to continue and accelerate our development in the coming months and progressively establish Aeson® as a benchmark in the treatment of advanced heart failure.”
[1] Excluding the United States, where 9 hospitals are trained as part of the EFS (Early Feasibility Study) clinical trial, and France, where 10 centers are taking part in the EFICAS study.
[2] Unaudited data.
CARMAT optimizes its financial structure by buying-back, for a symbolic sum of one euro, 2 million shares from Matra-Défense (Airbus group) which will be allocated to the repayment of its financial debt
Paris, December 23, 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”), announced today that it has bought-back 2 million shares from Matra-Défense (Airbus group) (“Airbus”), for a symbolic sum of one euro, which will be used to repay the Company’s financial debt, via their use in the ongoing equitization of the first tranche of its loan contracted with the European Investment Bank (EIB).
Airbus to reduce its stake in CARMAT
A founder of CARMAT in 2008, alongside Professor Alain Carpentier, Airbus has since supported the Company, particularly from a technical point of view, throughout the research and development process, and then the industrialization of the Aeson® artificial heart.
As CARMAT is now well engaged in the commercialization of Aeson®, and Airbus has no expertise in medical devices, the two companies agreed for Airbus to reduce its stake in CARMAT, in which Airbus was still holding about 6.1%[1] of the shares.
In order to support CARMAT’s development through this transaction, Airbus has proposed to sell the vast majority of its CARMAT shares (i.e. 2 million out of a total of 2.67 million shares) to the Company for a symbolic sum of 1 euro, so that these shares could then be used as part of the ongoing equitization of the loan contracted with the European Investment Bank[2], and thus contribute directly to the Company’s debt reduction.
CARMAT buys back 2 million Airbus shares for a symbolic sum of 1 euro
On December 20, 2024, Airbus sold to CARMAT, by way of an off-market block sale, the full ownership of 2 million CARMAT shares, valued at €1.998 million[1], for a symbolic sum of one euro.
At the same time, Matra Défense resigned from CARMAT’s board of directors.
Shares bought-back by CARMAT to be used in the on-going equitization of the loan contracted with the EIB, thus enabling partial repayment of such loan
As a reminder, in order to reduce the repayment in cash, due under the loan contracted by CARMAT with the EIB, CARMAT and the EIB, on June 13, 2024, launched an equitization of the first tranche of this loan, consisting in its gradual conversion into CARMAT shares, via a management trust[1].
As part of this operation, the trustee regularly exercises share subscription warrants (the “Warrants”) issued to it free of charge by CARMAT, by way of offsetting receivables. The trustee then gradually sells on the market, the new shares issued as a result of these exercises, and the net proceeds of these sales are then transferred to the EIB in repayment of its loan.
The management trust agreement regulating this equitization, and the terms of the Warrants were amended on December 20, 2024, in order to allow CARMAT to deliver to the trustee either newly issued shares or existing shares.
In practice, CARMAT now intends to deliver in priority the existing shares bought-back from Airbus upon exercise of the Warrants, until these existing shares are exhausted.
The use of the shares bought-back from Airbus will therefore enable CARMAT to partially repay the loan contracted with the EIB as part of the on-going equitization, while significantly limiting the dilution associated to it.
Stéphane Piat, Chief Executive Officer of CARMAT, comments : “This friendly reduction in stake by AIRBUS, one of CARMAT’s founders and an industrial partner closely linked to our company’s identity, is an important and very natural step. It is indeed thanks to Airbus’ technological know-how that the Aeson® artificial heart imagined by Professor Alain Carpentier could turn into reality and gradually become a therapy that now saves the life of patients suffering from advanced heart failure. It is also thanks to Airbus group’s financial support that we have been able to go through pivotal periods of our project, and thus become an industrial and commercial company, now well set on a growth trajectory. Actually, the reduction in Airbus’ stake testifies to our ability to now “stand on our own two feet”, and to carry-on with the support of our other key shareholders, particularly LOHAS (Pierre Bastid) and Sante Holdings, who are very much involved in the strategic management of CARMAT.
I would like to reiterate my gratitude to Airbus group for its invaluable contribution to the creation and development of CARMAT over the last 20 years; and to thank them for enabling us, through the very favorable terms of the reduction of their stake in our capital, to repay part of our financial debt, while avoiding any cashout, and with no dilutive effect for our existing shareholders. All this fully reflects our long-standing relationship based on support, respect and trust.”
Marie-Pierre Merle-Beral, Director representing Airbus Group on CARMAT Board of Directors, comments : “Airbus is proud to have been able to contribute, through its know-how and financial support, to the CARMAT adventure since its inception, thus enabling the emergence of a world leader in artificial heart technologies. We wish CARMAT and its management team every success in addressing challenges ahead, and in bringing this innovation to patients worldwide.”
Paris, November 26, 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”), announces the success of its first “Aeson® European User Meeting”, held on 21 and 22 November 2024 in Chantilly, near Paris.
Strong and promising interest in Aeson® from the French and international medical community
The forum brought together more than 100 European leaders in cardiology (cardiologists, surgeons, anaesthetists, intensivists, nurses, specialized distributors, etc.), representing 41 hospitals and 10 countries (France, Germany, Italy, Spain, Poland, the Netherlands, Serbia, Slovenia, Macedonia and Israel), demonstrating an extremely strong interest from the medical community in the Aeson® artificial heart.
Thorough and constructive exchanges among peers, based on growing experience of using Aeson®
Following a summary of the clinical experience and results of Aeson® by Dr Piet Jansen, Medical Director of CARMAT, the different thematic sessions were led by a number of European physicians who have already used Aeson®, enabling them to share their experience with their peers (including those who have not yet implanted Aeson®).
Discussions focused in particular on:
Strong intent to use Aeson® among participants
Out of the 41 hospitals represented, around half of them had already performed at least one Aeson® implant, which provided a wealth of information to the twenty or so centers trained and present at the conference, which had not yet done so.
In this context, drawing on his experience of 7 Aeson® implants at the Lille University Hospital (France), Professor Vincentelli and Dr Moussa shared their approach and advice for a successful initiation and development of an Aeson® programme in a hospital, stressing in particular the need for close collaboration between all key stakeholders (hospital administration, cardiologists, surgeons, anaesthetists, nurses, etc).
When asked about their intent to carry-on or start implanting Aeson®, all the hospitals taking part in the meeting, confirmed that they were planning to implant the device in 2025, which paves the way for a strong growth in sales over the coming months.
Ultimate goal: Secure “destination therapy” status
Building on its growing and extremely encouraging experience in the bridge-to-transplant indication, CARMAT continues to ultimately aim for the “destination therapy” (“DT”) indication, which would enable patients to live sustainably on Aeson® support without subsequent heart transplant. Destination therapy was mentioned several times by participants in the forum, as a natural and anticipated therapeutic development for Aeson®.
To this end, CARMAT confirms that it plans to resume its PIVOTAL study in Europe in the second half of 2025, on a cohort of patients not eligible for transplant.
Approval in “DT” would be a decisive step in meeting the critical challenge of graft shortage, given that only 5% of patients in need of a transplant can actually benefit from it. As such, the DT indication represents the largest addressable market opportunity in cardiology. CARMAT anticipates that securing this indication could take a few years.
Stéphane Piat, Chief Executive Officer of CARMAT, comments : “I’m delighted with the success of this first User Meeting organized by CARMAT. Over and above the high number of participants, which in itself, is exceptional, it is really the quality of the discussions and the enthusiasm and commitment of the healthcare professionals behind our Aeson® heart that make me very optimistic about the deployment of our artificial heart.
The experience shared by the physicians during the meeting confirms a real need for our therapy, a very wide range of patients who could benefit from Aeson®, and our high-quality clinical results. All this feedback leads me to believe that the number of implants is going to grow in centers already using Aeson®, and that many of the 30 or so trained hospitals, that have not yet carried out their first implant, will take the plunge in the near future.
Combined, our clinical results, state-of-the-art production facilities and strong support of the medical community, position us well to become the leader in the fast-growing advanced heart failure market.
I would like to thank all the participants in this conference, especially the physicians who have led the various workshops, and the CARMAT teams who have organized this event. More than ever, I believe that together, we can make Aeson® the reference treatment for advanced heart failure.”
[1] ECMO = Extracorporeal membrane oxygenation
• 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.
• 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.
