Recon

Implanet Announces FDA 510(k) Clearance for the MADISON Total Knee Prosthesis

October 29, 2019

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received 510(k) clearance from FDA for the cemented version of its Madison total knee prosthesis. This is the first step towards targeted clearance of complete Total Knee Replacement (TKR) range.

Robust clinical results, including data collected over 7 years and 17,000 implants, supported the clearance. This milestone further establishes Implanet as a leading global med device player and one of the few French companies in this sector granted 510(k) clearance for its knee prostheses.

Obtaining this marketing clearance also represents a key component of the partnership and distribution contract with KICo (Knee Innovation Company) signed and announced in November 2018.

Ludovic Lastennet, CEO of Implanet, commented: “This clearance is another key milestone for Implanet and further validates four proprietary MADISON proprietary technology. With more than 17,000 knee prostheses implanted to date, we have demonstrated the clinical value of our products. This clearance is fully in line with the strategic development of our partnership with KICo that aims to target, for Implanet’s knee division, the high-potential markets of Australia and the United States through KICo’s Florida-based subsidiary. The United States is the world’s largest market, with 760,000 primary knee operations, annual growth of 4% and a market worth close to 4 billion dollars*”.

*Source: Millenium Research Group 2015

Upcoming conferences Implanet will attend:

– SOFCOT (French Society of Orthopaedic & Traumatological Surgery Congress), November 11th to 13th, 2019, Paris, France
– DWG German Spine Congress, November 28th to 30th, 2019, Munich, Germany

Next financial press release: 2019 annual revenue, on Tuesday January 21st, 2020 (after market)

About Implanet

Founded in 2007, Implanet is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Implanet’s tried-and-tested orthopedic platform, which is based on perfect control over the traceability of its products, provides it with a proven ability to promote this innovation. 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 and the CE mark. Implanet employs 38 staff and recorded 2018 sales of €6.7 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

Disclaimer

This press release contains forward-looking statements concerning IMPLANET and its activities. Such forward looking statements are based on assumptions that IMPLANET considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of IMPLANET registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 16, 2018 under number D.18-0337 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which IMPLANET operates. The forward-looking statements contained in this release are also subject to risks unknown to IMPLANET or that IMPLANET does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by IMPLANET that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for IMPLANET shares in any country.

Contacts

Implanet
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel.: +33(0)5 57 99 55 55
investors@Implanet.com

NewCap
Investor Relations
Sandrine Boussard-Gallien
Tel.: +33 (0)1 44 71 94 94
Implanet@newcap.eu

NewCap
Media Relations
Nicolas Merigeau
Tel.: +33 (0)1 44 71 94 94
Implanet@newcap.eu

Print Friendly, PDF & Email
Tags

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button
Close