Postponement of the publication of the 2025 interim financial report

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   

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.”

————————

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.

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 2^nd half of 2024:

• 2023 sales of €2.8 million, i.e. 17 Aeson® implants, including 11 in the last quarter
• 2024 sales forecast of around €14 million
• Active exploration of financing options to extend, in the short-term, the Company’s financial horizon beyond May 2024.
• 12-month financing requirements estimated at around €45 million

Paris, April 24, 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 reports its annual results for the year ending December 31, 2023, and provides an update on its progress and prospects for 2024.

The annual financial statements were approved by the Board of Directors on April 22, 2024, on a going concern basis. On April 30, 2024, the Company will publish its 2023 Universal Registration Document, including the annual financial report and the statutory auditor’s report, whose audit procedures are being finalized.

Readers’ attention is drawn to the fact that the Company’s cash runway extends to mid-May 2024. Should the financings anticipated by the CARMAT not materialize by that date, the Company would then have to make significant adjustments to his annual financial statements.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “In many respects, 2023 has been a structuring year for CARMAT, crowned in December by the symbolic milestone of 50 CARMAT heart implants since the start of our clinical experience, and by the opening of a second production building in Bois-d’Arcy.

Backed by a first-class industrial tool, sized to support our growth, we can now look forward with confidence to the commercial deployment of our therapy. The momentum in Aeson® sales that began in the last quarter of 2023, with 11 implantations, has continued since the start of 2024, at an average rate of around 3 implants per month.

To date, we are on track with our targets for the training of additional hospitals, and implants as part of the EFICAS study. Our geographical deployment is continuing, and 25 of the 39 hospitals trained to commercial implants have already referred patients to CARMAT, confirming the medical community’s strong interest in our therapy and its potential. All these advances enable us to anticipate a substantial gradual growth in our sales over the coming months, and revenue of around €14 million for 2024.

I would like to thank all our teams for their resilience, particularly over the past two challenging years. I would also like to express my gratitude to our shareholders, both historical and more recent, whose trust enables us to make progress towards our goal of making CARMAT a leading player in the treatment of advanced heart failure.”

Paris, April 4, 2024 – 6:00 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”), announces today its participation in the following scientific and investor conferences during the second quarter of 2024:

Scientific Conferences

• 44^th ISHLT Annual Meeting

April 10 to 13, 2024 (Prague, Czech Republic)

Scientific Conference of the International Society of Heart and Lung Transplantation (ISHLT); one of the largest events dedicated to the treatment of advanced heart and lung diseases. The CARMAT team will be present on stand 36.

For more information, click here.

• Mechanical Circulatory Support (MCS) Master-Class 2024

June 7 to 8, 2024 (Turin, Italy)

International Society for Mechanical Circulatory Support (ISMCS) event dedicated to training in implantation techniques for mechanical circulatory support systems. CARMAT proctors will present the Aeson® heart implantation procedure during hands-on sessions.

For more information, click here.

• EACTAIC ECHO Course 2024

June 15 to 18, 2024 (Milan, Italy)

The European Association of Cardiothoracic and Vascular Anesthesia and Intensive Care (EACTAIC) ECHO 2024 course features innovations to enhance the learning experience and promote skills development.

For more information, click here.

Investor Conferences

• Gilbert Dupont Société Générale MidCap Forum

May 16, 2024 (Paris, France)

Investor forum organised by Gilbert Dupont (Société Générale Group), a leading player in the intermediation and financial operations in the French small and mid-cap segment.

• Portzamparc BNP Paribas Mid & Small Caps Seminar

June 12, 2024 (Paris, France)

Mid & Smallcaps conference organised by Portzamparc, BNP Paribas investment banking partner specialising in French small and medium-sized companies.