Safe Orthopaedics Announces the Release of the Auto-Adjust Pedicle Screw System for Repairing Traumatic Spine Injuries

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, today announces the first use of its new Auto-Adjust pedicle screw in surgical procedures to repair thoracic and lumbar spine fractures.

Auto-Adjust is a novel, highly-innovative patented pedicle screw that gives Safe Orthopaedics access to the spinal trauma market, estimated at €800m worldwide. This implant is designed to simplify surgical repair of vertebral fractures and facilitate the restoration of sagittal balance.

Auto-Adjust is a multi-axial screw that helps position the rods but operates like a fixed-head screw to realign the spine. This system provides gradual and automatic fracture reduction, with a surgical procedure identical to that of standard spinal fusion.

Mainly caused by a trauma, spinal fractures require swift surgical treatment. The new Auto-Adjust pedicle screw, combined with its single-use sterile instruments, is ready for use at all times and thus eliminates unnecessary delays.

To date, 8 surgeries have been performed in France and the Netherlands, two of them through a percutaneous approach.

Dr. Hervé Vouaillat, Orthopaedist surgeon at Echirolles Clinique des Cèdres (France), said: "For the first time, we have been using a new type of pedicle screw in Trauma that allows an easy reduction of the vertebral fracture through a percutaneous approach. This implant from Safe Orthopaedics provides reproducibility and therefore secures fracture reduction. Furthermore, the single-use instruments guarantee permanent availability.”

Dr. Jasper Wolfs, Neurosurgeon at Leidschendam Medical Center (Netherlands), added: "The Auto-Adjust Screw has the advantages of a polyaxial and a monoaxial screw. In traumatic spine injury in particular, this screw has the amazing ability to realign the spine and restore the sagittal balance. Many spine surgeons had been waiting for just such an implant.”

Yves Vignancour, CEO of Safe Orthopaedics concluded: "The abilities of our new Auto-Adjust implant are very promising: not only does it make surgery safer, it also optimizes it and thus delivers greater benefits to the patient. With Auto-Adjust, Safe Orthopaedics is continuing to innovate by providing unequalled and patented solutions to help spine surgeons. After Europe, we expect to make Auto-Adjust available in the US before the end of the year.”

Next financial press release:

Revenue for the 2^nd quarter of 2015 will be published on Wednesday July 15, 2015 (after market)

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 550 in the first quarter of 2015 alone. The company is based at Eragny-sur-Oise (France), and has 33 employees and a US subsidiary.

For more information, visit: www.SafeOrtho.com

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