CARMAT confirms the submission of a “Forfait Innovation” dossier in France and its eligibility with observations received from the French National Authority for Health (HAS)

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).

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CARMAT reports its 2019 annual results and confirms its 2020 objectives

  • 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 12th 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.

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CARMAT announces FDA full approval to initiate US clinical feasibility study of its total artificial heart

  • 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.”

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2020 Financial Calendar

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.

Event

Date

2019 Full-Year Results

Wednesday, February 12, 2020

Shareholders’ Meeting

Monday, March 30, 2020

2020 Half-Year Results

Friday, September 18, 2020

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CARMAT resumes enrollment in the PIVOTAL study in the Czech Republic

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.”

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CARMAT granted authorization to resume the PIVOTAL study in Kazakhstan

  • 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.”

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CARMAT appoints Alexandre Eleonore as Director of Manufacturing

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.”

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CARMAT granted authorization to resume the PIVOTAL study in the Czech Republic

  • 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.”

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