Safe Orthopaedics: Strong Growth in Q3 2015 Revenue: +52.5%

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, presents its business update for the last 9 months at September 30, 2015.

"The buoyant increase in the number of surgical procedures performed during the first three quarters of 2015 allows us to confirm our annual objective of 2,200 surgeries announced at the time of our initial public offering. Our revenue grew by over 36% over the first nine months of the year to September 30, 2015, which reflects both our teams’ commercial dynamism and the increasing adoption of our products.” comments Yves Vignancour, Chief Executive Officer of Safe Orthopaedics.

Number of surgeries performed in line with the company’s growth strategy

The number of spine surgeries performed using Safe Orthopaedics products has reached a record 1,691 since the beginning of the year. In comparison, 610 surgical procedures were performed over the same period of 2014.

Given the performances recorded over the first three quarters of 2015, the company is confident in its ability to reach the target of 2,200 surgical procedures which was set at the time of its initial public offering.

In parallel, Safe Orthopaedics has been very active on the front of Product Development in the last few months:

• New Products launches:
  • Safe Orthopaedics has obtained the CE mark for its Fenestrated screw for patients suffering from osteoporosis and for its Trauma Screw to repair vertebral fractures. To date, more than 45 surgical procedures have been performed using those new implants.
  • The Company also obtained the FDA 510k approval for the Trauma Screw to correct and stabilize vertebral fractures, allowing the product launch in the United States.
• Clinical evidence: A retrospective study was issued in July in the US confirming the advantages of Safe Orthopaedics’ sterile single-use instrumentation.

In terms of revenue, the third quarter of 2015 show a growth of +52.5% to €628 thousand.

Revenue at September 30, 2015 was up +36.4% to €1,935 thousand (38% of which was realised in France). This record performance was achieved despite a negative base effect in the second quarter 2014, which benefited from substantial initial orders, and illustrates a dynamic upturn in sales during the third quarter of 2015.

At September 30, 2015, Safe Orthopaedics had a cash position of €7.6 million, compared with €6.0 million at June 30, 2015.

Safe Orthopaedics intends to continue implementing its growth strategy and commercial expansion, reinforced in the US by the recent approval of its innovations.

Upcoming scientific conference: NASS (Chicago), October 14-17

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 company’s CE-marked and FDA-approved SteriSpine^TM kits are already being marketed in 12 countries, in Europe and the United States. They are being rapidly adopted by surgeons throughout the world, with nearly 1,000 procedures performed in 2014 and 1,691 as of September 30, 2015. The company is based at Eragny-sur-Oise (France), and has 32 employees and a US subsidiary.

For more information, visit: www.SafeOrtho.com

Disclaimer

This press release contains certain forward-looking statements concerning Safe Orthopaedics and its business. Such forward-looking statements are based on assumptions that Safe Orthopaedics 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 Safe Orthopaedics registered by the French Financial Markets Authority (Autorité des marchés financiers) on January 12, 2015 under number I.15-003 (a copy of which is available on www.safeorthopedics.com) and to the development of economic conditions, financial markets and the markets in which Safe Orthopaedics operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Safe Orthopaedics or not currently considered material by Safe Orthopaedics. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Safe Orthopaedics to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Safe Orthopaedics shares in any country.

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