Amplitude Surgical Announces That is Has Been Granted Approval to Market Its Anatomic® Total Knee Prosthesis in the United States
January 20, 2017
VALENCE, France–(BUSINESS WIRE)–Regulatory News:
Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces that it has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its Anatomic® implant, addressing degenerative knee disorders.
Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “This is a major milestone for Amplitude Surgical; it rewards the work of an entire team, from creative surgeons to engineers and all members of staff who have contributed to the development of this implant and the drafting of the FDA marketing approval file. Our Anatomic® knee has been a real success, with more than 20,000 surgeries carried out to date. This approval provides us with access to the US market, worth over 4 billion dollars. It illustrates the high quality of our implant, which is unquestionably suited to American standards, and will enable our US subsidiary, Amplitude Orthopedics Corp., to launch its commercial activity.”
Amplitude is currently the leading French manufacturer of hip and knee implants, with more than 50,000 implants inserted every year. With a market share of close to 15% in knee implants, the Company ranks no. 2 in France just behind ZimmerBiomet, and well ahead of the other major international players such as De Puy (J&J), Stryker and Smith&Nephew. The American competitive environment is fairly similar to that observed in countries in which the Group is established, and will require the setting up of a high-quality dedicated team for the marketing of our Anatomic® knee on this continent.
Next financial press release: H1 2016-17 sales, Wednesday February 15, 2017, after market.
About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.
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