CARMAT completes enrolment in the EFICAS clinical study and receives approval from French authorities for 21 additional Aeson® implants, while awaiting potential reimbursement of the device in France

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, January 7, 2020 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces its indicative financial calendar for 2020.

This preliminary agenda may be modified. Each publication will be released before market opening.

Paris, December 9, 2019 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that a 12th patient of the PIVOTAL study has been implanted in the Czech Republic.

This implant was performed by the team headed by Prof. Ivan Netuka, Chair of the Department of Cardiovascular Surgery at the Institute of Clinical and Experimental Medicine (IKEM) in Prague and Principal Investigator of the second part of the PIVOTAL study.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are very pleased to announce the resumption of implants in Prague. The surgical procedure was performed satisfactorily a few days ago, and the patient is continuing his gradual recovery. We noticed, both at the Prague center and in Nur-Sultan, an increased flow of eligible patients, which should enable the medical teams to enroll patients at a faster pace than for the first cohort, in line with our aim of obtaining CE marking in 2020.”

• The Company has received the approval of the Kazakhstan health authority and the ethics committee of the National Research Center for Cardiac Surgery in Nur-Sultan, which has substantial experience with the CARMAT device
• The study can now be conducted simultaneously in 3 countries

Paris, December 2, 2019 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that it has received authorization to resume the PIVOTAL study in Kazakhstan.

The implants will be performed at the National Research Center for Cardiac Surgery in Nur-Sultan (formerly called Astana), where the teams, led by Professor Yuri Pya, have successfully implanted the CARMAT device during the first part of the PIVOTAL study. Furthermore, several bridge-to-transplant surgeries conducted in this center demonstrated the ability of its surgical teams to successfully manage the explant procedure of the device as a donor heart becomes available. With authorizations in Kazakhstan, the Czech Republic and Denmark, the Company aims to complete enrollment of the second cohort of patients in the PIVOTAL study in order to obtain CE marking in 2020.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are pleased to announce that we have been given the approval to enroll new patients in Kazakhstan. Together with the teams in Nur-Sultan, we are actively preparing for upcoming implants. With this approval, we reach our objective to resume the study at a center experienced both with device implantation and explant for transplant-eligible patients.”

Paris, November 27, 2019 – 07.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the appointment of Mr Alexandre Eleonore as Director
of Manufacturing.

Alexandre Eleonore is a confirmed industry expert with a strong background in operational management. He graduated from the Sevenans Polytechnic Institute, now UTBM (Université de Technologie Belfort-Montbéliard), and spent the first part of his career in leading automotive equipment manufacturers such as Faurecia and Plastic Omnium. After 10 years in this sector, he joined the Sorin group in 2009, which became Microport CRM, one of the world’s leading players in the treatment of cardiac rhythm disorders. He became Vice President Operations & Customer Service and implemented cost improvement plans, thanks to his knowledge of lean manufacturing and industrial process automation.

“Joining CARMAT and its teams is obvious to me. Following the excellent work done with the first prostheses, it is now a matter of preparing the large-scale production of one of the most complex medical devices ever invented. It is both a technical and a human challenge to establish the right industrial processes that will enable us to meet market demand,” said Alexandre Eleonore, Director of Manufacturing of CARMAT.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “We are very pleased to welcome Alexandre Eleonore to our management team. As Director of Manufacturing, his role will be to develop the processes related to the ramp-up of the Bois-d’Arcy site, while working on reducing the production costs of the prosthesis, in line with the continued transformation of CARMAT into an industrial and commercial company. His dual expertise in major industrial sectors such as automotive and health will be a key advantage for the commercial phase, which will require the production of several hundred prostheses per year with a high level of quality.”

• The Company has received the approval of the Czech health authority and the ethics committee of the IKEM center in Prague, which has substantial experience with the CARMAT device
• CARMAT is in advanced talks to also resume the study in Kazakhstan

Paris, November 19, 2019 – 5.45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that it has received authorization to resume the PIVOTAL study in the Czech Republic.

The implants will be performed at the Institute of Clinical and Experimental Medicine (IKEM) in Prague, whose teams have benefited from a major learning curve acquired through implanting the CARMAT device during the first part of the PIVOTAL study. The screening for the second patient cohort, who will receive the new prostheses produced at the Bois-d’Arcy site, is already underway. The Company is also in advanced talks with the Kazakhstani health authorities regarding the resumption of the study at the National Research Center for Cardiac Surgery in Nur-Sultan (formerly called Astana). With authorizations in these strategic countries, given the experience they have acquired to date with the CARMAT artificial heart, and Denmark, the Company is aiming to intensify enrollment in the PIVOTAL study in order to finalize it as soon as possible and obtain CE marking in 2020.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are pleased to announce that we have been given approval to enroll new patients in the Czech Republic. In close collaboration with the teams of the IKEM cardiac center in Prague, we are already preparing for upcoming implants. This approval was eagerly expected, as our will was to resume the study at an experienced center before including other facilities. Following this key authorization for our project, we also expect a rapid resumption in Kazakhstan.”

Paris, November 14, 2019 – 6.00 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced its participation in the Jefferies Healthcare Conference to be held on November 20-21, 2019 in London.

Stéphane Piat, Chief Executive Officer of CARMAT, will participate in investors meetings and present the company during a plenary session on Wednesday, November 20, at 5.20 pm (London time).

The presentation of CARMAT will be accessible live via the link:

http://wsw.com/webcast/jeff123/alcar.pa/