IMPLANET Receives FDA Clearance for Its New Hybrid Fixation System Jazz Spinal SystemTM

Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral implants for orthopedic surgery and the distribution of technological medical equipment, today announced the Food and Drug Administration (FDA) 510(k) clearance of its new hybrid fixation system Jazz Spinal System^TM.

As a result of the technological partnership established in November 2022 between IMPLANET and Sanyou Medical, this brand new and unique hybrid fixation system Jazz Spinal System^TM encompasses the full range of technological expertise and R&D capabilities of both groups. It features a comprehensive solution of pedicle screws, combined with the most relevant Band implant range on the market, JAZZ. Jazz Spinal System^TM incorporates the latest developments and innovations in spinal surgery, including a complete system for the treatment of pediatric deformity as well as a comprehensive range of solutions for the treatment of adult spinal pathologies, including minimally invasive approaches. Designed for both traditional open surgery of the thoracolumbar spine and minimally invasive percutaneous fixation, this innovative system also meets the needs of surgeons treating complex deformities.

Ludovic Lastennet, IMPLANET’s Chief Executive Officer, stated: «Following the technological partnership signed two years ago, we are proud to announce the clearance of a groundbreaking and innovative hybrid fixation system Jazz Spinal System^TM in the United States. This milestone demonstrates the full potential of the synergies provided by our partnership with Sanyou Medical. Implanet America's sales teams, revitalized by the implementation of new management at the beginning of the year, will be able to launch the commercialization of this new solution during the summer of 2024. This represents a significant milestone in our development plan in the United States, the leading market for spinal surgery globally, aimed at strengthening our offering in this strategic market. »

Upcoming financial event:

- 2024 Half-Year Revenue, July 9, 2024, after market

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery and distributing medical technology equipment. Its activity revolves around a comprehensive innovative solution for improving the treatment of spinal pathologies (JAZZ) complemented by the product range offered by Orthopaedic & Spine Development (OSD), acquired in May 2021 (thoraco-lumbar screws, cages and cervical plates). Implanet’s tried-and-tested orthopedic platform is based on the traceability of its products. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States, the CE mark in Europe and ANVISA approval in Brazil. In 2022, IMPLANET entered into a commercial, technological and financial partnership with SANYOU MEDICAL, China's second largest medical device manufacturer. IMPLANET employs 43 staff and recorded a consolidated revenue of €7.4 million in 2023. Based near Bordeaux in France, IMPLANET opened a US subsidiary in Boston in 2013. IMPLANET is listed on the Euronext Growth market in Paris.
For further information, please visit www.Implanet.com.

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The Implanet Stock at the time of publication of the news with a raise of +10,22 % to 0,124EUR on Lang & Schwarz stock exchange (13. Mai 2024, 17:28 Uhr).