Regulatory approval for the SteriSpine ranges secured in Australia and New Zealand
ERAGNY-SUR-OISE, France--(BUSINESS WIRE)--Regulatory News:
SAFE ORTHOPAEDICS (Paris:SAFOR) (Euronext: FR0012452746 – SAFOR), a company developing and marketing an innovative range of sterile implants combined with their single-use surgical instruments, is today announcing that the Australian regulatory authorities have approved its SteriSpine ranges and that it has entered into a distribution agreement with SSJ Health covering Australia and New Zealand.
The award of this approval for the SteriSpine ranges from the TGA (Therapeutic Goods Administration) in Australia will expand the company’s sales reach. The Australian market has been booming for the past 15 years and is now worth close to $140 million1 per year.
Pierre Dumouchel, Interim Chief Executive Officer of Safe Orthopaedics, said: “This approval is a major step forward for us because it marks the introduction of our technologies in the Asia-Pacific region, the world’s second-largest market, which is experiencing the highest growth rate in the world, estimated at 8.2% over the 2015-2020 period2. It is the product of a partnership with SSJ Health, and we aim to achieve rapid uptake of our SteriSpine PS and SteriSpine LC ranges in Australia and New Zealand.”
Thanks to its exclusive distribution agreement with SSJ Health, Safe Orthopaedics has a partnership in the region, which will serve as a platform for starting up its business activities in the Australian and New Zealand markets, the latter being estimated to $50 million2. SSJ Health is a leading supplier of spinal and orthopaedic products in Australia and New Zealand. The group works directly with surgeons and hospitals in the region, presenting them with the most advanced and innovative technologies from around the world.
Craig Setter, CEO of SSJ Health, added: “Safe Orthopaedics’ sterile, single use instruments and leading implants have the potential to revolutionise spinal surgery here. They will eliminate the risk of infection from the reuse of surgical instruments, cut hospital operating costs and facilitate increased reactivity to emergency surgeries. We believe these products will change the way surgeons and hospitals operate, disrupting and dominating the Australian & New Zealand spinal surgery market.”
Next publication: full-year 2015 results and first-quarter 2016 sales, Thursday April 28, 2016 (after the market closes)
About Safe Orthopaedics:
Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the SteriSpine™ Kits are CE-marked and FDA cleared. They are being rapidly adopted by surgeons with a strong growth of the number of surgical procedures performed between 2014 and 2015. The company is based at Eragny-sur-Oise (France), and has 33 employees.
For more information, visit: www.SafeOrtho.com
1 2016 Spinal implant market estimated by MILLENIUM RESEARCH GROUP
2 MILLENIUM RESEARCH GROUP