fr

CARMAT reports its financial results for 2020, and confirms its 2021 prospects

Share post

CARMAT reports its financial results for 2020, and confirms its 2021 prospects

February 10th 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.

Top of page