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Implanet Receives TGA Clearance for the MADISONTM Total Knee Prosthesis in Australia

  • Recognition of the range of implants developed by Implanet to address a high potential market
  • New milestone in the commercialization of the MADISONTM prosthesis in partnership with KICo

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 the clearance of its MADISONTM total knee prosthesis by the Therapeutic Goods Administration (TGA) for marketing in Australia.

logo couleur IMPLANET

This approval is an integrated part of the distribution agreement concluded with KICo in November 2018 for the marketing of the MADISONTM knee prosthesis, specifically covering the United States and Australia. This new milestone completes the eight international licenses covering the MADISONTM knee prosthesis range, the FDA 510(k) clearance granted for marketing in the US as well as the CE marking obtained in Europe.

Ludovic Lastennet, CEO of Implanet, states: “This new clearance from the Australian Health Authority reinforces the clinical value of our proprietary technology for knee surgery and ensures the development of our business in one of the highest-potential markets. In line with our strategy to expand into new countries, this clearance follows the 510(k) from FDA and the CE marking that runs until May 2024, and paves the way for the Group to achieve new structural milestones.”

Upcoming financial event:

Q1 2021 revenue

on Tuesday April 20, 2021

About Implanet

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 29 staff and recorded 2020 sales of €6.0 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

Contacts

IMPLANET
Ludovic Lastennet, CEO

David Dieumegard, CFO

Tel.: +33 (0)5 57 99 55 55

[email protected]

NewCap
Investor Relations

Mathilde Bohin

Nicolas Fossiez

Tel.: +33 (0)1 44 71 94 94

[email protected]

NewCap
Media Relations

Nicolas Merigeau

Tel.: +33 (0)1 44 71 94 94

[email protected]

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