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

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   

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.”