Availability of the 2024 Universal registration document

Paris, January 31, 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 completion of its global offering for a total gross amount of €9.7 million, of which €8.6 million was subscribed by specialized investors as defined below and €1.1 million by retail investors via the PrimaryBid platform (the “Global Offering“).

Stéphane Piat, Chief Executive Officer of CARMAT, stated: “I am happy with the success of this capital increase, achieved in a tough environment, which gives us the means to pursue our growth trajectory. I would like to thank all existing and new shareholders, and more particularly our two main shareholders, who have once again strongly confirmed their commitment to our company. Backed by this support, we are determined to successfully achieve the many value-creating milestones that lie ahead of us in the first quarter. Given the sales momentum observed at the beginning of the year, we are also confident in our ability to double our sales this year compared to 2024. Meanwhile, we will continue our efforts to extend our cash runway over the longer term and thus allow for an even wider adoption of our unique therapy, for the benefit of patients suffering from advanced heart failure.”

• Global Offering composed of a reserved offering for qualified investors and a public offering for retail investors via the PrimaryBid platform
• Issue price for new shares set at 0.77 euro per share
• Closing of the PrimaryBid Offer on January 30, 2025 at 11:00 pm CET and of the Reserved Offering on January 31, 2025 before market opening, subject to early closure
• Cash runway extended to mid-May 2025 post-global offering
• Estimated residual financing need over the next 12 months, post-global offering, of between €30 to 35 million

Paris, January 30, 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 announces the launch of a global offering of approximately €10 million, through the issuance of new shares at a fixed price of 0.77 euro per share, targeting both qualified investors (as defined below) and retail investors via the PrimaryBid platform (the “Global Offering”).

Stéphane Piat, Chief Executive Officer of CARMAT, states: “As Aeson® artificial heart is gaining traction across Europe, in offering a real solution for patients suffering from advanced heart failure, and as our commercial outlook for 2025 and beyond is highly promising, we are launching today a share capital increase, with the strong and renewed support of our two largest shareholders, Lohas (Pierre Bastid) and Sante Holdings.

With 42 Aeson® implants performed in 2024 across five European countries, including France, and sales of €7 million – 2.5 times higher than in 2023- we are demonstrating that Aeson® addresses a real and growing need among physicians and provides a tangible alternative for patients with advanced heart failure.

Today, 60 hospitals across 17 countries have been trained in Aeson®, and nearly half of them have already performed their first implant. The strong attendance at our inaugural “Aeson® European User Meeting” in late 2024, which gathered over 100 leading experts in cardiology, reflects the growing adoption of our therapy. We are already seeing the impact of this momentum in early 2025, and we anticipate that it will translate into a significant increase in our sales. This is why we approach 2025 with strong confidence in our ability to at least double our sales vs 2024, especially as several publications in leading scientific journals – expected in the first quarter – should provide clinical evidence of Aeson®’s performance.

These commercial and operational achievements have also sparked interest from new investors. In this context, we are also pursuing discussions with several financial players who could commit to supporting CARMAT significantly and in the long-run. Should these discussions conclude in a positive way, CARMAT could benefit from substantial financial backing, enhancing our financing runway and strengthening our financial position. This would position us ideally to execute our strategic roadmap and carry-on progressing towards profitability.

In the short-term, the global offering launched today will enable us to strengthen our cash position and pursue our growth trajectory, while continuing our efforts to secure other longer-term financing. At this crucial moment in our journey, we are delighted to be able to open this global offering to both professional and individual investors, whose support has never wavered.”

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 1^st half of 2025.

• Over 90 patients have received the Aeson® artificial heart since the first implant in 2013, including 42 in 2024.
• 2024 Sales of €7 million (a 2.5-fold increase vs 2023).
• Cash burn reduced by over 20% vs 2023.
• 50 hospitals trained in Aeson® implants internationally^[1].
• Successful first “Aeson® User Meeting” and increasing engagement from trained hospitals, supporting the anticipation of a strong implants momentum in 2025.
• CARMAT expects to at least double its sales in 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
 

• Buy-back by CARMAT of 2 million shares from Airbus for a symbolic sum of 1 euro.
• The shares so bought-back will be allocated to the repayment of the Company’s financial debt, via their use in the ongoing equitization of the loan contracted with the European Investment Bank, thus reducing the dilution associated with this equitization.

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.”

• More than 100 healthcare professionals from 41 hospitals and 10 countries rallied to share their experiences of the Aeson® artificial heart

• All hospitals taking part in the event confirmed their intent to introduce or expand the use of Aeson® in their clinical practice

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:

• Patient selection and case studies: numerous real-life cases of Aeson® implants were presented, demonstrating the device’s ability to meet the needs of a wide range of patient profiles, including those who had been placed under ECMO[1] prior to the implantation.

• Anatomical fit and post-operation recovery: discussions confirmed the high degree of anatomical fit of the device, as well as the rapid recovery of a majority of patients, enabling them to get discharged from hospital, on average 56 days after the implantation, and then to proceed with a heart transplant in optimal conditions.

• Surgical techniques: detailed feedback on the key steps of the implantation and explantation procedures enabled participants to better anticipate the management of the specificities of such surgeries.

• Patient management: several sessions were also devoted to sharing in-depth experience on patients’ management, from a psychological, physical and medication standpoints, before, during and after implant.

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