A Randomized Study Confirms the Benefits of Safe Orthopaedics’ Products in a Leading French Teaching Hospital

Regulatory News:

Safe Orthopaedics (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, is today announcing the presentation of a randomized study confirming the benefits of its single-use instruments for spine surgery.

This 1:1 randomized study of 40 surgeries was conducted by teams at CHU Bicêtre, one of France’s leading teaching hospitals. It was led jointly by Dr. Sylvie Raspaud, who oversaw the pharmaceutical aspects, and Prof. Charles Court, orthopedic surgeon and Head of the Orthopedics service.

The study ran from April 2014 to May 2015 following CHU Bicêtre’s adoption of Safe Orthopaedics’ products and compared the operative and logistics times (pre- and post-operative) for traditional renewable instruments and Safe Orthopaedics’ single-use instruments in lumbar spine fusion surgeries (lumbar arthrodesis).

Pre-and post-operative times cut by 80%

This study showed a spectacular reduction of 81% in average logistics times from 176 to 33 minutes on average by switching over to single-use instruments since the hospital and its staff no longer had to perform various procedural steps (transport, labor, sterilization).

100% availability: logistics incidents eliminated thanks to immediate availability

At the same time, no logistical incidents were observed with Safe Orthopaedics’ instruments. With reusable instruments, an incident rate of 15% was recorded (unavailability of instruments set, lack of screws and sterilization problems).

Strictly defined operative times would have also been shortened by 14 minutes (from 190 to 176 minutes on average), even though the CHU Bicêtre surgeons were novice users who had received guidance from a Safe Orthopaedics trainer only during their first surgery.

Prof. Charles Court, orthopedic surgeon and Head of the CHU Bicêtre Orthopedics service, said: "Our study brought to light the major savings achieved by using Safe Orthopaedics’ products for scheduled vertebral fusion surgeries. I am tremendously proud of the work that our teams did.”

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, added: "The results of this study highlight the substantial efficiency improvements that can be harnessed by using our products. We now plan to add further weight to these findings by conducting a larger study to demonstrate that the gains achieved by a large hospital facility with integrated services, such as the Bicêtre teaching hospital, could be even bigger in smaller institutions, with direct benefits for the hospital and its medical teams.”

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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. The company is based at Eragny-sur-Oise (France), and has 34 employees.

For more information, visit: www.SafeOrtho.com

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