BIOCORP announces the CE marking of SoloSmart®, an accessory medical device for SANOFI Solostar® pens at the occasion of EASD

• Obtaining regulatory approval opens the door to the availability of SoloSmart^® in the European Union

Regulatory News:

BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company specialized in the design, development, and manufacturing of innovative medical devices, and SANOFI announced the completion of the development of SoloSmart^® today, on the opening of the EASD (European Association for the Study of Diabetes) annual meeting in Stockholm, Sweden. SoloSmart^® is fully compatible with the pharmaceutical group's SoloStar^® injection pens.

The result of the collaboration initiated in 2019 between the two companies is presented as an accessory to the Sanofi SoloStar^®/ DoubleStar^® insulin pens, which records information about the insulin dose, time and date of each injection and transmits it via Bluetooth to a compatible mobile application. The SoloSmart^® device automatically and accurately records injected doses, eliminating the need for manual logbooks and possibly allows for adapting to new patient uses of continuous glucose monitoring systems or connected BGM.

Developed by BIOCORP's R&D department, SoloSmart^® meets the latest requirements of the new European medical device regulation. Its commercial launch will begin early 2023 in the distribution networks approved by SANOFI and its partners. This partnership strategic step validates a substantial milestone - more details will be given on September 29^th (half year results).

Eric Dessertenne, CEO of BIOCORP, said: "The expertise we have developed with Mallya leads us to improve and develop a new device by miniaturizing it, keeping data reliability. We are today very proud of developments achieved by our respective R&D and to present them today at the EASD, which brings together an international diabetes community. The strength of this industrial and commercial partnership has resulted in a technological achievement which will allow people living with diabetes, users of SoloStar^® pens, to benefit from a solution that improves their daily life thanks to a presentation that is very compact but still secure and accurate.”

ABOUT BIOCORP

Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 70 employees. BIOCORP is listed on Euronext since July 2015 (FR0012788065 – ALCOR).

For more information, please visit www.biocorpsys.com.

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