Safe Orthopaedics Announces the European Launch of Its Range of Fenestrated Screws for Spine Surgery

Regulatory News :

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR / PEA PME eligible), a company developing and marketing an innovative range of sterile implants with associated disposable surgical instruments for spine surgery, announces the European launch of its new fenestrated screw and the success of the first six surgeries on patients with osteoporosis.

"The first surgeries have been a success. The Safe Orthopaedics fenestrated screw is very easy to use and allows us to save substantial time while reducing the risks to the patient”, comments Dr Gianluca Maestretti, orthopaedic surgeon at Fribourg cantonal hospital in Switzerland.

Having recently been granted CE marking, the Safe Orthopaedics fenestrated screw has lateral windows enabling cement to be injected into osteoporotic vertebra in order to strengthen the screw’s anchoring to the bone.

The innovation provided by Safe Orthopaedics is the combination of the fenestrated screw and its preassembled single-use instruments, thus eliminating the risk of cement leakage where the screw meets the instrument, resulting in optimal patient safety. Furthermore, the dosage of cement directly used in a cannula in the screwdriver’s handle makes it easier for surgeons to use and therefore reduces operating time. Lastly, the instruments preassembled on the implant reduce the cost of the procedure for hospitals.

Osteoporosis is characterized by a reduction in bone mass that makes bones more brittle. This illness affects a large number of people, notably people over 65 and postmenopausal women. The aging population in developed countries is thus driving the growth of the fenestrated screw market across Europe.

"We are delighted with these first surgeries using our fenestrated screw combined with its preassembled single-use instruments. This new screw is perfectly in line with our strategy of expanding our product offer for spine surgery. Safe Orthopaedics is continuing to innovate in order to provide greater safety for patients, to improve operating conditions for surgeons and to reduce costs for hospitals”, concludes Dominique Petit, founder, Chief Technical Officer and Chief Operations Officer of Safe Orthopaedics.

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 more than 1,000 procedures performed during the past 12 months. The company is based at Eragny-sur-Oise (France), and has 30 employees and a US subsidiary.

For more information, visit: www.SafeOrtho.com