CARMAT announces updates in its governance

• CE marking in the bridge to transplant indication received in December 2020
• Operating expenses under control at €36m
• Financial resources including cash position of €36m at December 31, 2020, providing financial visibility until Q3 2021
• Company actively reviewing options to fund its development beyond Q3 2021

Paris, February 10, 2021 – 7 am CET

CARMAT (FR0010907956, ALCAR,), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces its annual results for the year ending December 31, 2020[1] and confirms its prospects for 2021.

Stéphane Piat, Chief Executive Officer of CARMAT, commented:

“I am very proud of all that has been accomplished at CARMAT in 2020, despite the global pandemic. 2020 opens a new chapter for CARMAT. The CE marking received on December 22 has paved the way to the commercialization of our artificial heart in Europe under the brand name Aeson®. This event materializes the efforts undertaken by all our employees and everyone involved in the CARMAT project since its inception. This unique device – the brainchild of Professor Carpentier – will become accessible to patients who currently have no therapeutic options.

CARMAT also achieved in 2020 many other major clinical and regulatory milestones. Firstly, in France, we obtained HAS approval to undertake EFICAS, a broad clinical study, two-thirds of whose costs will be covered by the French State. Secondly, the number of patients enrolled in the PIVOTAL study has increased to fifteen with the first implantation performed in Denmark and the resumption of implantations in France. Within this framework, our bioprosthesis has notably demonstrated a high level of reliability by providing a patient with 2 years of continuous support. Lastly, in the United States, thanks to the constructive talks undertaken with the FDA over the last year, we hope to soon perform the first implantations within the framework of an early feasibility study for which the CMS has approved the reimbursement of our product.

In 2021, we will continue this momentum by focusing our efforts primarily on the commercial launch of Aeson® in Germany during the second quarter of 2021, but also on the implementation of our clinical plan and the ramping up of production activity to accommodate long term demand. We have the financial resources we need to support this ramping up until the third quarter of 2021 and are exploring various options to extend our financial visibility beyond that horizon”.

[1] Annual accounts were approved by the Board of Directors on February 8, 2021. Audit procedures relative to these accounts have been carried out, and the auditor’s report is currently being prepared.

Paris, February 1, 2021 – 7:00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces the appointment of Professor Christian Latrémouille as Director of Surgical Affairs.
 
Doctor of Medicine specialized in Heart Surgery, Christian Latrémouille is a Professor at Paris University, formed by the recent merger of Paris-Descartes (Paris V) and Paris-Diderot (Paris VII) Universities.
 
Before joining CARMAT, Christian Latrémouille was, since 2017, Head of the Cardiovascular Surgery Department at the Georges Pompidou European Hospital in Paris. He began his career in 1993 as Senior Specialist Registrar within Prof. Alain Carpentier’s prestigious Cardiac Surgery department at the Broussais Hospital in Paris. Upon validation of a PhD in xenotransplantation, in 1995 he took charge of the heart transplant program. Initially Clinical Lecturer in 1995 and then University Lecturer in 2000, in 2004 he was appointed Associate Professor at Paris-Descartes University, university chair of Clinical Anatomy and hospital chair of adult Cardiac Surgery. Since then, he has been entrusted with the preclinical development phase of the CARMAT bioprosthetic total artificial heart.
 
Building on this experience, he performed the world’s first-in-man implantation of the CARMAT heart on December 18, 2013. He then became Principal Investigator of the CARMAT heart’s safety and feasibility study. Subsequently, during the PIVOTAL study, he continued as Proctor Principal, ensuring the training of all the new teams joining the project.
 
This career path makes him the only heart surgeon in the world to have participated in the CARMAT heart’s entire clinical assessment process.
 
“I particularly appreciate the trust put in me by allowing me to join CARMAT’s teams. The recent granting of CE marking and the prospect of soon performing the first human implants in the United States represent a major milestone in the development of CARMAT. Drawing on my experience, I am pleased to be able to take part in the final leg of this project in order to enable as many patients as possible to benefit from this innovative, ambitious and accomplished technology whose notion of quality of life remains the primary purpose”, says Prof. Latrémouille, CARMAT’s new Director of Surgical Affairs.
 
Stéphane Piat, Chief Executive Officer of CARMAT, adds: “It is an immense pleasure to welcome Christian Latrémouille to our management team. His arrival marks the completion of the structuring of our Management Committee with a view to preparing the launch of our Aeson device. His surgical expertise coupled with the unique experience he has acquired with CARMAT will be pivotal to the successful ramping up of our commercial launch. In his new role, Christian Latrémouille will accompany and oversee hospitals from the training phase through to patient treatment”.

• Addressable market in the bridge-to-transplant indication of more than 2,000 patients a year in Europe
• Company prepares for commercial launch in Q2 2021, with initial focus on Germany and France
• Robust clinical plan to support adoption and sales development
• Virtual conference with Stéphane Piat today at 5 pm CET

Paris, January 6, 2021 – 7 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today outlines the commercial and development plan for its total artificial heart. The Company holds a virtual conference in English today at 5 pm CET, for which you can register on this link.

2020, a defining year for CARMAT

In 2020, despite the COVID-19 situation, CARMAT has delivered on key objectives including:

• obtaining from the US Food & Drug Administration (FDA) the full approval to start an Early Feasibility Study (EFS) in the US, and successful training of three US centers in Q4 2020 in order to start implants in Q1 2021;
• securing a funding of €13m from the French state to start a new clinical trial (“EFICAS” study) in France in Q2 2021;
• receiving the CE Marking[1] which allows CARMAT to market its total artificial heart as a bridge-to-transplant in a large number of countries, including all European Union countries;
• resuming the PIVOTAL study in France, with 2 patients treated in December.

Commercial readiness, positioning and branding

Ahead of getting the CE marking, CARMAT had taken the necessary steps to be prepared to start selling its artificial heart from Q2 2021. This involves:

• accelerating the ramp-up of manufacturing activities;
• proactive customer targeting and early support to hospitals for reimbursement;
• product positioning and branding.

The Carmat artificial heart will be marketed under the Aeson® brand name.

In view of the 3 unique features of the product – pulsatility[2], autoregulation² and hemocompatibility[3] – CARMAT creates a new product category: the Physiologic Heart Replacement Therapy[4] (PHRT).

Commercial opportunity and plan

Significant market opportunity

The CE marking for the CARMAT heart as a bridge-to-transplant (BTT) represents a very significant market opportunity with a minimum of 2,000 patients currently on waiting lists for a heart transplant in five major European countries[5].  

Initial focus on Germany and France

In 2021, the Company’s plan is to focus on Germany and France, which together account for 55% of the mechanical circulatory support (MCS) market in the European Union[6]:

• Aeson® will be commercially launched in Germany in Q2 2021,
• the French market will initially be addressed through the EFICAS study.

In addition, the company might seize further sales opportunities in other countries recognizing the CE marking.

Strong market development approach

In parallel, CARMAT will continue to implement a very robust clinical plan which includes the EFICAS Study in France (52 patients), the completion of the ongoing PIVOTAL study (target of 20 patients)[7], along with a large post-market clinical follow-up which will include the first 95 patients treated in commercial setting, in order to generate further safety, performance and health-economics data. These data are expected to drive product adoption and support Aeson®’s value proposition (notably to obtain reimbursement of the product in France), and ultimately the obtention of the destination therapy (DT) indication for the product. While the BTT indication allows for temporary support by the device, this additional DT indication would allow CARMAT to target the patients who are not eligible to heart transplant who would remain under CARMAT’s device support in the longer term.

CARMAT confirms that its available resources[8] enable the company to fund its activities through to Q3 2021. The company is considering different options to finance its future development.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “2020 was a defining year for the company, culminating with the obtention of the CE Marking just before Christmas. Despite a very challenging environment, marked by the COVID-19, CARMAT has delivered on the vast majority of its objectives, and I would like to thank again the entire CARMAT team and all stakeholders who have made this possible. The bridge-to-transplant indication that we got as part of the CE Marking represents hope for patients and a very sizable market opportunity for the Company, as at least 2,000 patients are currently on waiting lists for a heart transplant in Europe, but only a fraction of them is fortunate enough to benefit from a donor graft. In 2021, our intention is to focus our efforts on Germany and France, which account for more than half of these patients. We might also address other countries recognizing the CE marking in a more opportunistic way. I am happy to confirm that we will be ready to start selling our product as early as Q2 2021. We will also continue to execute our strong clinical plan, in particular the EFICAS study that should start in Q2 2021, but also a post-market clinical follow-up of 95 implanted patients, which will have a significant impact on the adoption momentum of our prosthesis. Given its unique features demonstrated in clinical trials to date, Aeson® introduces a new way of treating end-stage heart failure, the Physiologic Heart Replacement Therapy, which aims to provide patients with significantly improved quality of life.”

[1] The CE marking was granted on December 22, 2020, to CARMAT’s total artificial heart system as a bridge-to-transplant (BTT) in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD (Left Ventricular Assist Device) and who are likely to undergo heart transplant in the 180 days following implantation.

[2] Bizouarn P et al.; Effects of pre-load variations on hemodynamic parameters with a pulsatile autoregulated artificial heart during the early post-operative period. J Heart Lung Transplant. 2018;37(1):161-3

[3] JACC 2017 Smadja, Bioprosthetic total artificial heart induces a profile of acquired hemocompatibility with membranes recellularization, July 2017:403-9

[4] The “PHRT” category has been created by CARMAT and differentiates form the “TAH” (total artificial heart) category by its unique combination of 3 features: pulsatility, autoregulation and hemocompatibility. The physiological heart replacement therapy can be either temporary (BTT – bridge to transplant) or for the long run (DT – destination therapy). The physiological nature of Aeson® is documented in the following publication: Richez U et al.; Hemocompatibility and safety of the CARMAT Total Artifical Heart hybrid membrane. Heliyon. 2019 Dec; 5(12): e02914. Published online 2019 Dec 8. doi: 10.1016/j.heliyon.2019.e02914

[5] statistics.eurotransplant.org: 9023P_2019; https://rams.agence-biomedecine.fr; Five major European countries: France, Germany, Italy, Spain and the UK.

[6] GlobalData: EU5 Cardiac Assist Devices Market Outlook To 2025 – Intra-Aortic Balloon Pumps, Mechanical Circulatory Support Devices And Short-Term Circulatory Support Devices (Report GDMECR1561DB)

[7] The initial inclusion target for this study was 20 patients, a figure that can be adjusted up or down during the course of the study. To date, 15 patients have been enrolled in the study.

[8] Including cash on-hand, €10m of ‘PGE’ Loan (loan guaranteed by the French State) drawn in November 2020, the last tranche (€10m) of the European Investment Bank Loan which can be drawn at any time until December 2021 (as drawdown criteria has already been met), and the non-dilutive financing of €13m granted by the French state to fund the EFICAS study (this amount will be perceived over the duration of the study); excluding the balance of the Kepler-Cheuvreux equity line, which can be used until September 27, 2021.

• CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant

• Virtual press conference scheduled on January 6, 2021

Paris, December 23, 2020 – 11 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has received the CE marking for its total artificial heart.

The CE marking was granted on December 22, 2020 to CARMAT’s total artificial heart system as a bridge to transplant in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD[1] and who are likely to undergo heart transplant in the 180 days following implantation.

The CE marking allows the company to market its total artificial heart system in all countries that recognize this certification, including all the countries of the European Union.

A virtual press conference with Stéphane Piat, Chief Executive Officer of the company, is scheduled on January 6, 2021 at 10 am. Further details will follow in due time.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “The CE Marking is great news for patients and a major milestone for CARMAT. As early as January, we will accelerate the ramp-up of our manufacturing activities and intensify discussions with our core target customers in order to achieve a   smooth commercial launch during the second quarter of 2021, and thus offer a solution to many patients waiting for a heart transplant. The CE marking definitely opens-up a new and very promising chapter for the Company. I am also particularly proud of our employees who have shown exceptional commitment and resilience during these very special times and of course of I would like to thank all our shareholders who have supported us for many years. I will be happy to share further details on our launch plan during a press-conference that will take place on January 6, 2021.”

Listing of the CARMAT share will resume at the opening of the stock market on December 24, 2020.

[1] LVAD: Left Ventricular Assist Device

• Three US centers successfully trained in November
• Commercial configuration of CARMAT prosthesis in final stage of approval by the FDA
• First enrolment in the study postponed to Q1 2021, and completion of the enrolment of the study still expected by end-2021

Paris, November 26, 2020 – 7 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides an update on its early feasibility study (EFS) in the United States.

The EFS was fully approved by the US Food and Drug Administration (FDA) in February 2020 and CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020.

In order to be able to use the “commercial configuration” of its artificial heart in the study, CARMAT submitted certain amendments to the FDA. The company believes that this latest version of the prosthesis should improve patient safety and quality of life. At this stage, thanks to a very constructive collaboration with the FDA, 8 amendments out of 9 have already been approved, and the last one should be approved in the coming weeks.

CARMAT is finalizing the study preparation with three US centers successfully trained in November at Pitt MIRM Centre for Preclinical Studies (Pittsburgh, Pennsylvania): VCU Health Pauley Heart Center (Richmond, Virginia), University of Louisville Jewish Hospital (Louisville, Kentucky), and Baylor University Medical Center (Dallas, Texas). All other steps necessary to start the EFS have already been taken.

In view of this, CARMAT now expects the first implants to be performed in Q1 2021 and the enrolment of the 10 patients to be completed by the end of 2021.

The Company confirms that its available resources[1] enable it to fund its activities through to Q3 2021.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “Despite the COVID-19 pandemic, we have been able to train the first three US centers selected for our Early Feasibility Study. They all went out of this experience very enthusiastic and committed to the success of this study. As we intend to use a new version of the CARMAT system, including features reinforcing the safety and the quality of life of patients, we had to submit amendments to supplement our initial dossier approved in February 2020. Based on ongoing discussions with the FDA, we expect to start to treat patients in the US with the new prosthesis in Q1 2021.”

[1] Including cash on-hand, €10m of ‘PGE’ Loan (loan guaranteed by the French State) drawn in November 2020, the last tranche (€10m) of the European Investment Bank Loan which can be drawn at any time until December 2021, and the non-dilutive financing of €13m granted by the French state to fund the EFICAS study (this amount will be perceived over the duration of the study); excluding the balance of the Kepler-Cheuvreux equity line, which can be used until September 27, 2021.

Paris, November 2, 2020 – 7 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has obtained, from a banking syndicate, a €10 million loan in the form of a State-Guaranteed Loan.

This loan is 90% guaranteed by the French State with an initial maturity of 12 months and an extension option enabling CARMAT to defer the reimbursement of the principal amount for an additional period of up to 5 years.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We would like to thank the French government and our partner banks for this non-dilutive financing that allows us to continue our activities with confidence. In an environment made uncertain by the COVID-19 crisis, this financial facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021”.

Paris, October 20, 2020 – 5.45 pm CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has obtained ANSM (French agency for the safety of medicines and health products) and CPP Ouest III (ethics committee) approval to perform implants of its device within the framework of the PIVOTAL study in France.

These approvals open up the possibility for French patients to receive the CARMAT device and for French hospitals to contribute to the completion of enrollment in the PIVOTAL study by the end of the first quarter of 2021.

To date, the number of implants performed within the framework of the PIVOTAL study stands at 13, including 10 in the first cohort, now closed, and 3 in the 2^nd cohort, which is currently enrolling patients.

As a reminder, the study protocol provides for the enrollment of a total of 10 patients in the 2^nd cohort, and the primary endpoint of the study is 6-month survival with the bioprosthesis or a successful heart transplant within 6 months of the device being implanted.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are delighted to be able to resume implants of the CARMAT heart in France. The enrollment pace, impacted by the COVID-19 situation in the centers in the Czech Republic, Denmark and Kazakhstan, could hence accelerate with the participation of highly specialized French centers to complete this key study. This is also very important in view of the future EFICAS study, insofar as the chosen French centers will thus be able to acquire valuable clinical experience before the launch of this broad study that is expected to begin in the second quarter of 2021. We are simultaneously working with centers in the United States to enable the US early feasibility study (EFS) to begin before the end of the year, as planned”.

Professor Jean-François Obadia, Head of the Cardiothoracic Surgery and Heart Transplant department at Louis Pradel hospital (CHU LYON) and the study’s national Principal Investigator, added: “Our participation in the PIVOTAL study will finally give us access to this innovative technology that meets an urgent clinical need for which we so far had no satisfactory solution. The prosthesis’ performances observed in the first patients already implanted abroad and our recent experience during the training of our teams in France are very encouraging. We are delighted to have this opportunity, particularly as our teams will subsequently participate in the EFICAS study, supported by the French Ministry of Health and Solidarity”.