09 Jun CE Marking Renewed into 2024 for IMPLANET MADISONTM Knee Prosthesis and JAZZ® Spine Ranges
BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:
IMPLANET (Euronext Growth : ALIMP, FR0013470168, eligible for PEA-PME equity savings plans) (Paris:ALIMP), a medical technology company specializing in vertebral and knee-surgery implants, announces that the European authorities have extended the CE marking on its entire range of MADISONTM knee prostheses for a further four years.
Implanet is continuing to invest in innovation and the clinical validation of its two product ranges, Spine with JAZZ® and Knee with MADISONTM, in order to be able to meet customer’s requirements and ensure the long-term continuance of CE and FDA regulatory clearance. Thanks to this substantial and important initiative, Implanet now has excellent regulatory visibility through May 2024. This will allow the Company to obtain clearance more comfortably for its product ranges under the new European MDR (Medical Device Regulation) by 2024.
Ludovic Lastennet, CEO of Implanet, comments: “We are delighted to announce that we have met this key regulatory milestone and secured all our CE marking into 2024. Despite the challenges associated with the Covid-19 pandemic and increasingly stringent regulations covering medical devices, Implanet has remained mobilized and provided the authorities with all the elements demonstrating the clinical quality of its product ranges. Moreover, we are still involved in exclusive negotiations to sell our Knee range, the development of which is further enhanced thanks to this CE marking renewal. Our next objective is to accelerate our growth and devote ourselves 100% to the treatment of spinal disorders to establish our positioning as a powerful player in this sector, both in France and abroad”.
Upcoming financial events:
– H1 2020 revenue, on July 7, 2020, after market
– H1 2020 results, on September 15, 2020, after market
Founded in 2007, Implanet is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its activity revolves around two product ranges, the latest generation JAZZ® implant, designed to improve the treatment of spinal pathologies requiring vertebral fusion surgery, and the MADISON implant designed for first-line prosthetic knee surgery. Implanet’s tried-and-tested orthopedic platform is based on product traceability. Protected by four families of international patents, JAZZ® and MADISON have obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States, the CE mark as well as the ANVISA authorization in Brazil. Implanet employs 36 staff and recorded 2019 sales of €7.4 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, Implanet established a US subsidiary in Boston in 2013. Implanet is listed on Euronext™ Growth market in Paris.
The Company would like to remind that the table for monitoring the equity line (OCA, OCAPI, BSA) and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel.: +33(0)5 57 99 55 55
Tel.: +33 (0)1 44 71 94 94
Tel.: +33 (0)1 44 71 94 94
SOURCE: Business Wire, 9th June 2020