Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments, is announcing today the commercial launch in Europe of a bone substitute for its Walnut cage for cervical surgeries.

This device, developed in conjunction with a specialist in synthetic bone substitutes, aims to promote bone growth and thus to make vertebral fusion safer.

“This bone substitute is an ideal fit for the Walnut cage,” commented Dr. Antonio Faundez, orthopedic surgeon at the Hôpital de La Tour Geneva-Meyrin hospital in Switzerland and a member of Safe Orthopaedics’ Scientific Advisory Board. “It dovetails perfectly with Safe Orthopaedics’ strategy of offering effective solutions, while providing the surgeon with flexibility in how to use it.”

In parallel, the SteriSpineCC range (Walnut cage and associated single-use ancillary) has also received (510k) marketing approval from the US Food and Drug Administration (FDA). Although it is not commercialized in the United States, this technology will gain more rapid approval in certain countries such as in Latin America and the Asia-Pacific region.

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, added: “This bone substitute will help us to meet growing demand from surgeons, and we are delighted to be able to offer it in conjunction with our Walnut cervical cage.”

Next Financial release

Fourth-quarter 2016 revenue: Thursday, January 19, 2017 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com