Half of enrolments targeted in the EFICAS study reached by CARMAT

• 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.

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.”

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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:

• Equitization of the first tranche of the EIB loan will reduce its repayment in cash and optimize the Company’s cash position
• Set-up of a trust and issuance of share warrants to the trustee, enabling it to subscribe shares of the Company to be then sold on the market, the proceeds of which being allocated to the repayment of the tranche
  

Paris, June 13, 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”), today announces the equitization of the first tranche of its loan contracted with the European Investment Bank (EIB) by the set-up of a trust and issuance of share warrants to the trustee.

This implementation is part of the final agreement reached on March 22, 2024 by CARMAT with its financial creditors^[1], including the EIB, on new repayment terms for its bank loans. The terms of the equitization are in all respects similar to those described when the agreement was announced.

Stéphane Piat, CEO of CARMAT, comments: “The equitization of the first tranche of the loan contracted with the EIB is part of the agreement we reached last March with all our financial creditors on the rescheduling of our bank loans and their new  repayment terms.

The effective start of this equitization is an important step and very good news, since it will enable us to significantly reduce the cash repayment of our debt, thereby contributing to contain our funding requirements.

As our cash runway currently extends to mid-August 2024, we continue to work on several options to strengthen our equity and cash position over the coming months; and remain fully mobilized to pursue the commercial development of our therapy, which at this stage is very encouraging.”

[1] Press release March 22, 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.

• In compliance with regulations, the implementation of this modification gives rise to the publication of a “field safety notice”.
• Its roll-out will begin over the next few days.

Paris, December 28, 2023 – 5:45 pm (CET)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announced a software enhancement which significantly improves the safety profile of its Aeson® artificial heart.

The prosthesis software will now be able to detect on a real time basis, signals of possible Aeson® malfunctions. The software will then immediately adapt the control of the prosthesis so that its performance is not affected, and the patient’s support is not impacted.

These changes, developed and tested by CARMAT’s research teams, will first be deployed on all hearts currently implanted in patients, as part of a software update for which a field safety notice is published[1]. It will then be embedded into the Aeson® production process, after getting the appropriate regulatory approvals.

Stéphane Piat, Chief Executive Officer of CARMAT, declares: “In all industries, electronic components are potentially subject to failure, because perfection of their manufacturing is almost impossible to achieve. It was important to be able to manage such risks in the case of our device, and I’m therefore very proud of the feat achieved by our software engineers: from now on, for many of the potential malfunctions linked to the prosthesis’s electronic components, Aeson® software will automatically “correct” these faults by adapting the prosthesis’s performance in an appropriate manner, so that the patient’s support remains unaffected. For me, this is a major and immediate step forward for all the patients who benefit and will benefit from our therapy; but also in the long term, when it comes to obtaining the destination therapy indication for Aeson®, as this improvement significantly strengthens the safety profile and therefore the potential durability of the prosthesis.”

[1] In France, publication is made on the ANSM health authority website.