CARMAT reports its 2020 half-year results and issues an update on its activities and outlook

  • Cash position of €45.3 million at June 30, 2020, covering the next major stages of its project
  • Despite the COVID-19 crisis, CARMAT still on track to meet key deadlines:
    • CE marking expected by the end of 2020, allowing a commercial launch in 2021
    • Implants within the framework of the feasibility study in the United States expected to begin by the end of 2020
  • Videoconference with Stéphane Piat at 6.30 pm Paris time today

 

Paris, September 9, 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, today reports its results for the first half of the year to June 30, 2020[1] and issues an update on its activities and development prospects.

 

Stéphane Piat, Chief Executive Officer of CARMAT, said:The first half of 2020 was unusual because of the COVID-19 pandemic that affected healthcare systems around the world. For CARMAT, the impact was insofar limited as our activities in France continued with limited hindrances and in strict compliance with the health and safety measures imposed by the authorities. During the first half of the year, we continued our work to ramp up production and enhance the reliability of production processes at our Bois-d’Arcy plant, with a particular emphasis on securing supplies with a view to the commercial phase. On a clinical level, with the gradual easing of restrictions in Europe from mid-May 2020, Rigshopitalet in Denmark was able to perform its first implantation of our device, thus taking the total number of patients in the PIVOTAL study to 13. Given the persistence of the COVID-19 situation and the resulting procurement problems encountered by certain suppliers, CARMAT is now expecting to complete enrollment in the PIVOTAL study by the end of the first quarter of 2021. This delay does not jeopardize the timeframe of the submission and review of the CE marking dossier making it possible for this CE marking to be granted by the end of 2020. We are also continuing to hold discussions with the FDA and various stakeholders in the U.S. feasibility study to enable patient enrollment to begin before the end of 2020 as planned, subject to the public health emergency improving. The “Forfait Innovation” dossier was definitively approved by the French National Authority for Health (HAS) in April, budgetary discussions initiated with the Ministry of Health and Solidarity have entered their final phase and official notification of the decision should be published in the coming weeks. Today, given what we have achieved in recent months and despite the ongoing pandemic context, we are confirming our development strategy and, with a cash position of €45.3 million, have the necessary resources to meet our project’s key milestones.”

[1] First-half accounts were approved by the Board on September 7, 2020 and have been the subject of a limited review by the statutory auditors. The 2020 half-year financial report was published today and is available on the Company’s website.

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CARMAT announces the publication of the bridge-to-transplant experience in the Journal of Heart and Lung Transplantation

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CARMAT announces the first implantation of its total artificial heart in Denmark

Paris, May 25, 2020 – 6.30 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, announces the first implantation of its bioprosthetic artificial heart in Denmark.

 

The implant procedure was performed by the team of Dr. Peter Skov Olsen, cardio-thoracic surgeon at the Heart Center of Rigshospitalet in Copenhagen. It is the first Danish hospital to implant the CARMAT total artificial heart and the third international medical center contributing to the PIVOTAL study, together with the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, and the National Research Center for Cardiac Surgery in Nur-Sultan, Kazakhstan.

 

Finn Gustafsson, MD, PhD, Professor of Advanced Heart Failure and Transplantation at the Heart Center and principal investigator of the study, comments: “We are excited to gain clinical experience with the CARMAT artificial heart and to contribute to the PIVOTAL study. With its hemocompatibility, autoregulation and silent operation, the CARMAT TAH could become a real alternative treatment to heart transplantation for patients suffering from end-stage heart-failure.”

 

Stéphane Piat, Chief Executive Officer of CARMAT, adds: “Rigshospitalet has developed a strong expertise in treating advanced heart failure and has participated in front-line clinical studies with innovative medical therapies and devices in this field. I am delighted that such an internationally recognized site becomes the third international center to implant our device. With the recent release of certain COVID-19 pandemic-related restrictions, CARMAT’s teams and proctors were able to prepare and participate in the surgical procedure and early post-operative follow up. To date, 13 patients have received our device in the PIVOTAL study and, subject to the progressive ramp-up in recruitments across our three active study centers, we estimate that 4-5 months are needed to complete enrollment and reach the total of 20 patients.”

 

In accordance with good clinical practice and subject to regulatory obligations or specific circumstances, CARMAT will not provide individual updates on patients’ implantations or their health condition. However, it is planning to communicate when major milestones in the PIVOTAL study are reached, such as the opening of new centers and the overall progression of patient recruitment.

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CARMAT obtains approval for the reimbursement of its total artificial heart during the US clinical feasibility study

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.

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The U.S. investment bank Ladenburg Thalmann initiates the coverage of CARMAT with a “Buy” recommendation

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.

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CARMAT confirms the definitive approval of its "Forfait Innovation" dossier by the French National Authority for Health (HAS)

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).

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CARMAT announces that the Shareholders’ Meeting has approved all the resolutions supported by the Board of Directors and issues an update on its activities within the context of the COVID-19 pandemic

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 30th 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.”

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Annual Shareholders’ Meeting of March 30, 2020: online login details

Paris, March 19, 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 of how they can log in to and follow the Annual Shareholders’ Meeting of March 30, 2020 via Internet.

The Company’s shareholders are invited to log in via the following link at 10 am CET on March 30, 2020:

https://event.onlineseminarsolutions.com/wcc/r/2232014-1/9105729AE81D4AA764374641104C8729

• this link allows shareholders to preregister for the web conference right away if they so wish;
• at any time during the presentation, shareholders will be able to send their questions via the web conference platform. These questions will be answered during the Q&A session;
• the presentation slideshow (in French), visible during the web conference, will also be available on CARMAT’s website after the meeting.

As indicated in our last press release, online voting will not be possible during the web conference.
Shareholders who wish to vote on the resolutions are therefore 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.

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.

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