CARMAT announces its 2023 annual results and provides an update on its progress and prospects for 2024

With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France

Paris, April 6, 2020 – 5.45 pm CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the French National Authority for Health (HAS) has given its definitive approval to initiate a clinical study of the CARMAT device within the framework of the Forfait Innovation program^[1].

Through this definitive approval, the HAS confirmed its positive opinion regarding the financing by special exemption of the CARMAT total artificial heart within the framework of the EFICAS study, a prospective, multicenter, non-randomized study, to be undertaken in France. The design of the study, which includes 52 patients to be implanted with the CARMAT heart as a bridge to a heart transplant, has been adjusted in accordance with the observations expressed by the HAS in the conditional approval received by CARMAT in February 2020. The primary endpoint of the study is the survival rate at 180 days after implantation without a disabling stroke or a successful cardiac transplantation within 180 days post-implant.

CARMAT has already received approval from the French National Agency for Medicine and Health Product Safety (ANSM) and the Île-de-France Patient Protection Committee (CPP) to undertake such a study.

The Company will now initiate budget discussions with the Ministry of Health and Solidarity.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are delighted with this positive opinion from the HAS, received within a particularly complex context. The definitive eligibility of our device to the Forfait Innovation program now enables us to open budgetary discussions pertaining to the EFICAS study aimed at facilitating the access of French patients suffering from end-stage biventricular heart failure to our cutting-edge technology”.

^[1] The Forfait Innovation is granted by the Ministry of Health and Solidarity, following an initial eligibility assessment by the HAS (https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation).

Paris, March 30, 2020 – 5.45 pm CEST  

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, informs its shareholders that the annual general meeting (AGM) of March 30, 2020 was able to deliberate, quorum having been reached.

Given the ongoing restrictions associated with the COVID-19 context, CARMAT’s Shareholders’ Meeting was held behind closed doors and streamed online. This AGM approved all the resolutions tabled, with the exception of the 30^th resolution, which was rejected on the recommendation of the Board of Directors. 

Mr. André Muller is appointed as an Independent Director

The Company’s shareholders notably ratified the appointment of Mr. André Muller as an Independent Director. Mr. Muller will bring his extensive experience within the health sector as a Chief Financial Officer, Director and investor to CARMAT’s Board of Directors. He was notably Chief Financial Officer of Actelion, a Swiss biotechnology company acquired by American pharmaceutical group Johnson & Johnson for USD 30 billion in 2017. He also contributed to the creation, and led the IPO, of Idorsia Ltd, the spin-off comprising Actelion’s clinical R&D activities.

The Board of Directors thus now consists of 10 members, 6 of them independent.

At this stage, the impact of the COVID-19 pandemic is expected to be limited

Within the context of the COVID-19 pandemic, CARMAT has implemented measures to protect its employees and has adapted its work organization in order to guarantee business continuity while complying with the guidelines and restrictions imposed by the government.

At this stage, the Company does not expect the pandemic to have a significant impact on its operational activity or its 2020 schedule:

• Manufacturing: the new procedures put in place in 2019 enable greater fluidity and the ramping up of its production capacity. Particular attention is being paid to supplier relations in order to guarantee continuous production, which has not been impacted so far.
• PIVOTAL study: due to ongoing international travel restrictions and hospital medical staff having to focus entirely on fighting COVID-19, CARMAT’s teams are currently unable to access implant centers. 3 new patients corresponding to the criteria of the study are thus currently waiting to receive the CARMAT heart. The Company estimates that, if the pandemic is resolved by the end of the second quarter of 2020, the impact on its clinical schedule will be limited, given the time required to complete enrollment in the study (estimated at 4 to 5 months). To date, 12 patients in the PIVOTAL study have been implanted and the prosthesis has achieved individual support of 25 months.
• “Forfait Innovation”: as indicated in the press release of February 17, 2020, CARMAT has submitted, to the French National Authority for Health (HAS), the protocol for a clinical study within the framework of the Forfait Innovation program (EFFICAS study). At this stage, the Company is not expecting the COVID-19 crisis to have an impact on the timetable of its discussions with HAS.
• Feasibility study in the United States: talks are ongoing with the FDA, the CMS (Centers for Medicare & Medicaid Services) and the ethical committees of the selected centers, and the objective is still to treat a first patient during the fourth quarter of 2020.
• CE marking: the discussions currently taking place with DEKRA have not been affected at this stage.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “I would like to thank all of our shareholders for their commitment and support in this highly unusual context. We are delighted that Mr. André Muller is joining our Board of Directors, to which he will bring his financial expertise and his knowledge of the health sector. Last but not least, I would like to pay tribute to the commitment of our teams during this unprecedented health emergency. Thanks to their efforts, our activities are continuing in line with our objectives. We will keep the public informed of our project’s progress and outlook in light of the evolution of the COVID-19 situation.”

Paris, March 17, 2020 – 5.45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, notifies its shareholders and the financial community as a whole of the procedures for participating in and voting at its Annual Shareholders’ Meeting within the context of the ongoing coronavirus (Covid-19) epidemic.
Following the measures announced by the French government aimed at minimizing the impact of the epidemic, the Annual Shareholders’ Meeting of CARMAT, initially due to take place at the Business Center Edouard VII in the 9th arrondissement of Paris at 10 am on Monday March 30, 2020, can no longer take place in person.
This Shareholders’ Meeting will therefore now be held as a web conference at the same time, 10 am on March 30 (only in French). You will receive a link to log in to the conference via a separate release as soon as possible.
You will be able to follow the management presentation thanks to this web conference and ask any questions you may have via the web platform during the Q&A session, but online voting will not be possible during this conference.
Therefore, if you are a CARMAT shareholder and wish to vote on the resolutions, you are invited to:
• either send a proxy to the Company
• or vote by correspondence
by using the voting form available on the CARMAT website, in accordance with the terms indicated in the Notice of Meeting published in the BALO official journal on February 24, 2020.
We apologize for these changes, which are due to factors beyond our control.
All the documents pertaining to this Shareholders’ Meeting are available on request from the Company, and can also be found on its website: go to Investors / Documentation / Regulated Information and choose Shareholders’ Meeting.

Paris, March 10, 2020 – 5.45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces that it has reached a major milestone by achieving record individual support of 2 years with its bioprosthesis within the framework of the PIVOTAL study.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “This is major news today for CARMAT. Indeed, within the context of the clinical development, we assess both the efficacy and the safety of our bioprosthesis, of which the durability is a decisive factor for patients. Passing two-year period of individual functioning is very encouraging, and confirms the capacity of our device to provide long-term support, which is one of our two key objectives along with that of being a bridge to a heart transplant.”

Paris, February 17, 2020 – 6.00 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart (TAH), aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the French National Authority for Health (HAS) has deemed the CARMAT TAH eligible with observations to start a clinical study in France as part of the Forfait Innovation program.

The Forfait Innovation[1] is a program that facilitates the early access of patients to innovative technologies in the early clinical development phase. According to the HAS, the CARMAT TAH meets the criteria of novelty linked to the use of biological materials in contact with blood, its capacity of auto-regulation and the lighter and quieter external equipment. Moreover, the HAS considers that the device is likely to bring a significant clinical benefit addressing an insufficiently met medical need and that the proposed clinical study allows to collect the missing data needed to assess the improvement of the care provided to transplant-eligible patients suffering from biventricular heart failure.

CARMAT has submitted a prospective multi-center non-randomized study that aims to evaluate the survival rate at 180 days after implantation without a disabling stroke or until a successful cardiac transplantation. CARMAT has obtained the approval to conduct such a clinical study by the French National Agency for Medicines and Health Products Safety (ANSM) and is awaiting the Ethics Committee final approval (CPP). CARMAT is committed to respond to the observations of HAS on the study protocol within the timelines foreseen by the Forfait Innovation program. Upon final approval of the study, CARMAT will initiate budget discussions with the ministers responsible for Health and Social Security.

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “We are delighted with this positive opinion from the HAS, which demonstrates a real need for more effective and safer management of heart failure patients in France. Following the recent FDA approval to initiate a feasibility study of our device in the United States, this is another major milestone of our project to make our technology rapidly available to patients eligible for heart transplant.”

[1] The Forfait Innovation is granted by the ministers responsible for Health and Social Security, after the initial eligibility deemed by the HAS (https://www.has-sante.fr/jcms/c_2035788/fr/forfait-innovation).

• Operating expenses under control in a context of intensifying the European market access strategy
• Strong cash position of €55.5 million at December 31, 2019, providing financial visibility until mid-2021
• Full FDA approval for a clinical feasibility study in the United States, with enrollment expected to begin in the fourth quarter of 2020

Paris, February 12, 2020 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today reports its annual results for the year ending December 31, 2019[1], and presents its 2020 development prospects.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “2019 was a crucial year for CARMAT, as we were able to successfully strengthen all strategic pillars of our project: the manufacturing system, the quality of the bioprosthesis that is continuing to fulfill its role within the PIVOTAL study in line with expectations, and the Company’s financial structure. Firstly, we completed the transfer of all our manufacturing activities to the Bois-d’Arcy site, where the production of prostheses resumed in May following the implementation of the final technical adjustments. This had a direct effect on the PIVOTAL study that was then able to gradually resume thanks to the approvals received from the health authorities in Denmark, the Czech Republic and Kazakhstan. The 12^th patient of the study was thus able to benefit from the new prosthesis in December, enabling us to reach over 7 years of cumulative support to date within the framework of the study. At the same time, we continued our very constructive discussions with the FDA that led, in September, to the conditional approval being granted to undertake a feasibility study in the United States. Since then, we have responded to all remaining questions and recently obtained the full approval of the FDA that will enable us to accelerate discussions with the 7 chosen American medical centers, but also with the Centers for Medicare & Medicaid Services (CMS) to obtain coverage of the costs of the study, for which enrollment could begin during the fourth quarter of 2020. Lastly, we significantly strengthened our financial structure through a €60 million private placement with investors who share our long-term vision. These funds have provided us with a financial visibility through to mid-2021 and the necessary resources to continue achieving various milestones of our project, notably including our key objective of obtaining CE marking in 2020.”

[1] Annual accounts were approved by the Board of Directors on February 10, 2020. Audit procedures relative to these accounts have been carried out, and the auditor’s report is currently being prepared.

• CARMAT has responded to all remaining questions from the conditional approval
• Number of subjects to be enrolled in the study extended to 10 patients

Paris, February 5, 2020 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the US Food and Drug Administration (FDA) has fully approved the Company’s Investigational Device Exemption (IDE) application to start a US Early Feasibility Study (EFS) of its total artificial heart.

The amended EFS protocol includes 10 transplant-eligible subjects limited to a network of 7 US renowned institutions. The primary endpoint of the study is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.

CARMAT also obtained conditional approval from two Institutional Review Boards (IRB) and this full FDA approval enables the company to accelerate the discussions with the other IRB and research contract offices at the 7 sites. The company is also working closely with the Centers for Medicare & Medicaid Services (CMS) to obtain a coverage of the costs of the trial, with the objective to start patient enrolment in Q4 2020.

CARMAT will present the EFS protocol at the 2020 symposium on mechanical support for the heart and lung of the American Association for Thoracic Surgery (AATS) on February 14, 2020, in Houston (Texas).

Stéphane Piat, Chief Executive Officer of CARMAT, said: “The full approval to initiate a US study marks another milestone for CARMAT and confirms the trust of the FDA in our ability to conduct the feasibility study of the first bioprosthetic artificial heart in the United States. Considering the ongoing approval procedures with the Institutional Review Boards at the selected centers and discussions on the potential reimbursement of the treatment costs, we expect patient enrolment to start in Q4 2020.”