CARMAT announces the first commercial implants of its Aeson® artificial heart outside the European Union

Paris, May 13, 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 “Centers for Medicare & Medicaid Services” (CMS) has approved coverage of the device and routine care items and services supplied to Medicare beneficiaries to be enrolled in the clinical feasibility study.

The approval confirms the Food and Drug Administration (FDA) Category B designation of the device, which refers to a non-experimental/investigational device for which initial questions of safety and effectiveness have been resolved. It enables the company to accelerate its discussions with the purchase departments, research contract offices and institutional review boards (IRB) at the 7 sites selected for the study. As a reminder, CARMAT has already obtained the conditional approval of two IRB.

The study aims to include 10 transplant-eligible patients, and the primary endpoint corresponds to patient survival at 180 days after the implant or a successful heart transplant within 180 days of the implant.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “This approval of CMS coverage marks a very important milestone for CARMAT, as it substantially supports its development in the United States. Indeed, hospitals will be able to receive payments for the device, routine care items and services during the clinical study. Given the ongoing discussions at the study centers, and subject to the positive evolution of the COVID-19 situation, we expect patient enrolment to begin in Q4 2020, as planned.

Paris, April 14, 2020 – 7.00 am 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, today announces the publication of a coverage initiation report by Ladenburg Thalmann, a leading international investment bank.

Ladenburg Thalmann will now cover the CARMAT share on the stock exchange and values the company at €381 million, i.e. €30.25 per share*.

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country.

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).