CARMAT provides an update on the ongoing receivership procedure – resumption of trading

Paris, February 25, 2021 – 7:00 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 announced the publication of the Company’s 2020 Universal Registration Document for the year ended December 31, 2020.

The document, filed with the French stock-market authority (Autorité des Marchés Financiers) on February 24, 2021, is available to the public free of charge upon request, as per current legal regulations; and on the Company’s website under the section Investors / Documentation / Regulated information, as well as on that of the AMF (www.amf-france.org).

It notably includes the2020 annual financial report, the report on corporate governance, the required information in relation to the share repurchase program, as well as the auditors’ reports and information on the fees paid to the statutory auditors in 2020.

First enrollment in the study expected in Q1 2021

Paris, February 10, 2021 – 5.45 pm 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 FDA has granted CARMAT approval to use the new version of its artificial heart in the EFS. This new version includes certain improvements in the prosthesis and the wearable system based on clinical experience gained in the PIVOTAL study. The company believes that this latest version should further improve patient safety and quality of life.

In view of this, the Company confirms that it expects the first enrolments in the EFS in Q1 2021.

As a reminder, 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.

Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are pleased to provide this new version of our artificial heart, which is similar to our CE-marked product, to the US study centers. Despite the Covid-19 pandemic, we were able to train and initiate three of them before the end of 2020. These centers are now ready to enroll patients. We also intend to pursue the training and initiation of additional selected centers.”

• 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”.