CARMAT

Continuing Progress in Line with the Objective of Obtaining CE Marking in 2019 - Seite 2

CARMAT has received the necessary regulatory authorizations to conduct this study in France and three other countries: Kazakhstan, the Czech Republic, and Denmark. This broadening of the study to include leading international facilities in the conduct of clinical trials on circulatory support devices targeting the European market has helped significantly accelerate patient enrollment in the study.

To date, the number of implantations already performed represents 30% of the study’s planned total.

The surgical procedure boasts a 100% success rate, and operating time has been cut by approximately 21% compared with the first implantations, showing both a substantial improvement in surgical teams’ learning curve and good reproducibility of the surgery as the study progresses.

The patients treated in the PIVOTAL study have a more stable clinical profile than those involved in the feasibility study, as illustrated by the 100% survival rate at 1 month compared with 75% previously.

In order to further accelerate the implantation rate, CARMAT is planning to expand the network of investigation centers to 3 additional countries and is expecting to end PIVOTAL study implantations this year.

• Major progress in the CE marking process

The CE marking process undertaken by CARMAT with certification body DEKRA aims to validate the CARMAT heart’s compliance with European regulatory requirements. Within this framework, in 2017 CARMAT delivered more than half of the CE marking dossier’s modules, notably those concerning all the technical aspects. The Company is continuing to supplement the dossier with reliability data from prostheses operating continuously on test benches.

Following the PIVOTAL study, the clinical results will complete the final module of the CE marking dossier that will be submitted to DEKRA for validation, aiming to obtain CE marking in 2019.

• Industrialization and market-access strategy

CARMAT has opened its new, automated assembly plant in Bois-d’Arcy, near Paris. This site will meet the demands of industrial-pace production and the Company will launch, once the technical teams have been transferred, the manufacturing of prostheses to accompany the ramping up of enrollment in the PIVOTAL study. The opening of this automated site is perfectly in line with CARMAT’s strategic transformation process into an industrial company. This complex project is being steered by a dedicated team and aims to implement best industrial practices in terms of organization, processes, and IT systems for maximum efficiency and quality.