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CARMAT to provide a business update and host a videoconference on April 9, 2025

Please register to the videoconference by clicking on one of the following links:

 

Videoconference in French at 6:00 pm CEST

Videoconference in English at 8:00 pm CEST

 

Paris, March 31, 2025 – 6:30 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”), will publish a business update and host a videoconference on Wednesday, April 9, 2025 after the market closes.

The videoconference will be held in French at 6:00 pm (CEST) and then in English at 8:00 pm (CEST).

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

  • Stéphane Piat, Chief Executive Officer
  • Pascale d’Arbonneau, Deputy Chief executive Officer & Chief Financial Officer
  • Francesco Arecchi, Director of Global Market Development
  • Christian Latrémouille, Director of Surgical Affairs

 You will have the opportunity to submit your questions via the videoconferencing platform throughout the presentation.

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Paris, March 27, 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”), announces the implementation of a flexible equity financing line with IRIS Capital Investment (“IRIS”), for a maximum of 9,000,000 shares (i.e., approximately 15% of its current share capital), over a 24-month period.

 

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “I am very pleased with the implementation of this financing line with IRIS Capital Investment, which, based on our current share price, provides us with a potential total financing amount of approximately €7.9 million over the next 24 months, and thus offers substantial room for manoeuvre that we can start benefitting from immediately. In parallel, we are actively working on securing additional funding to ensure the long-term development of our Company and our sales growth. Following a strong start this year, we are determined to progressively establish Aeson® as a reference solution for patients suffering from advanced biventricular heart failure — today in Europe, and within a few years in the United States.”

 

Pursuant to the terms of the agreement signed on March 26, 2025 between the Company and IRIS, the latter has undertaken to subscribe up to 9,000,000 new ordinary shares of the Company, over a 24-month period, at its own initiative and subject to the conditions set out in the appendix to this press release.

 

The main purpose of this financing is to strengthen CARMAT’s equity and to contribute to the funding of its working capital requirements, particularly to support the development of its sales and the completion of its EFICAS clinical trial in France.

 

Based on the current share price[1], the Company could receive a total gross amount of €7.9 million should it make full use of this financing line (although this amount is not guaranteed).

 

The financing line has been structured via the issuance of warrants giving the right to subscribe new ordinary shares of the Company (the “Warrants”), exclusively for the benefit of IRIS[2]. This issuance was decided by the Board of Directors of the Company on March 26, 2025, pursuant to the delegation granted by the combined shareholders’ meeting of the Company held on December 30, 2024, under its 6th resolution, and in accordance with the provisions of Article L. 225-138 of the French Commercial Code. The main characteristics of the Warrants (in particular their exercise conditions) are described in the appendix to this press release.

 

CARMAT controls the exercise schedule of the Warrants, having the option to suspend, reactivate or terminate this financing agreement at any time without penalty, but also the right to set a maximum number of Warrants that can be exercised over a given period. In addition, the number of new shares issued upon exercise of the Warrants during each calendar quarter cannot exceed 15% of the volume of CARMAT shares traded on the Euronext Growth market of Euronext Paris during that quarter, unless expressly agreed by the Company.

 

The issuance of the Warrants does not give rise to the publication of a prospectus subject to the approval of the French Financial Markets Authority (AMF) nor to the publication of an information document subject to filing with the AMF.

 

The number of shares issued and admitted to trading under this agreement will be disclosed on the Company’s website.

 

The flexible equity financing line implemented with IRIS only partially finances CARMAT’s estimated funding needs over the next 12 months, amounting to c. €35 million based on its current business plan. In this context, the Company is actively exploring various additional financing options and is particularly holding discussions with several financial stakeholders which could support it over the long term. However, it should be noted that, to date, there is no guarantee that such discussions will ultimately lead to any financial support for the Company, regardless of the amount, nor that they will materialize before the end of the Company’s current cash runway, i.e. end of May 2025[3].

 

[1] Closing price on March 26, 2025, i.e., €0.879.

[2] The latter being part of the category defined by the combined shareholders’ meeting of the Company held on December 30, 2024, under its 6th resolution, namely: “natural persons, companies or investment funds, French or foreign, whether shareholders or not of the Company, investing on a regular basis, or having invested more than €1 million over the past 36 months prior to the issue concerned, in the life sciences or technology sectors.”

[3] Cash runway excluding the equity financing line entered into with IRIS, the proceeds of which by the end of May 2025 cannot be determined with certainty.

 

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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   

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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.”

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  • 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.”

 

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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.

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