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 been granted further regulatory approvals for its products by the Australian health authorities (TGA - Therapeutic Goods Administration).
Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “On the large Australian market, which accounted for 11% of the Group’s 2014-15 sales, we are continuing our development, and these additional approvals bode well for our future activity. Beyond the innovative nature of our prostheses, these results were made possible by the work of our teams, in particular from our local subsidiary, Amplitude Australia Pty, created in 2013.”
Following the registration of the Score prosthesis, the Integrale stem and the Saturne cup in 2007 followed by the Uniscore prosthesis in 2014, Amplitude Surgical has just received the following approvals from the TGA:
- its entire Novastep foot product range on September 24, 2015. Marketing will be carried out through an exclusive Australian distributor as soon as the prosthetic reimbursement codes are obtained;
- its Anatomic knee on August 3, 2015. This product range was commercially pre-launched at the AOA (Australian Orthopedics Association) congress in Brisbane in early October 2015, in order to initiate a two-year clinical trial among a group of eight surgeons. The aim of this trial is to assess the prosthesis’ performance in order to set a reimbursement price for private hospitals approved by Australian mutual health insurance companies. Following the first knee replacement carried out by Dr. MacDessi at Canterbury Hospital in early August, over 40 additional joint replacements have already been undertaken.
Next event: Shareholders’ Meeting, Wednesday December 9, 2015
Next financial press release: H1 2015/16 sales, Wednesday February 3, 2016
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. On June 30, 2015, Amplitude Surgical had a workforce of 248 staff and recorded sales of 71.1 million euros and an EBITDA margin of close to 19%.