Development of a full innovative range of implants for lumbar discopathies,
US commercial launch aimed for the end of 2021 and obtaining of CE-marking in 2022
First collaborative project industrialized in the Integrated Manufacturing Company of Safe Group in Fleurieux-sur-l’Arbresle
Éragny-sur-Oise, France, on 10 February 2021, 17h35 CET – Safe Orthopaedics (FR0013467123 – ALSAF), holding of the Safe Group (composed of Safe Orthopaedics, a company specializing in the design, manufacturing and marketing of single-use technologies for spinal surgeries, and Safe Medical (Ex-LCI medical), integrated subcontractor for orthopaedic medical devices, today announces the signature of a technological co-development agreement with the American company SpineUp Inc.
The treatment for lumbar discopathies is constantly evolving : miniaturization of incisions, multiple surgical approaches, PEEK machined or titane printed implants… and the surgeons wish to have the best options to best treat their patients. Since several quarters, Safe Orthopaedics works on the extension of its SteriSpine LC range, in order to offer a maximum of ready-to-use options.
“3 years ago I decided to begin using Safe Orthopaedics’ ready-to-use products in order to enhance the efficiency of my OR team and improve the outcomes for my patients. In collaboration with the Safe Orthopaedics team, I have seen the benefits that the ready-to-use concept can bring to my practice and have been delighted with the clinical results. Surgeons need different options for the disc diseases treatment and I’m proud to collaborate in order to develop their portfolio of products, to expand their SteriSpineLC range and bring the benefits of the ready-to-use model to many more treatment pathways.” explains Dc John Choi…
The co-development strategy is a way to minimize conception costs, and to accelerate the commercial launch and clinical evoluation today requested by the new european regulation.
SpineUp, a manufacturer of medical devices for spinal surgery established in Florida, already customer of Safe Medical, shares the same interest as Safe Orthopaedics. Together, both companies aim a commercial launche and several other strategical territories by the end of 2021, the achievement of a clinical evaluation, necessary for the CE-marking, in 2022, and any other international homologations.
This co-development is perfectly in line with the strategy of Safe Group, which places at disposal its Integrated Manufacturing Company. Funded by the Recovery Plan and by BPIFrance on its innovation projects, Safe Medical continues extension of its French site, where additive manufacturing and sterile packaging of medical device will be conducted, in addition to machining and finishing.
“This partnership between manufacturers is an innovation accelerateur. By mutualizing our research and development efforts, our companies, SpineUp and Safe Group, will quickly have a large innovative range of implants for the treatment of lumbar discopathies, while keeping our unique indentities on instrument technologies. For this reason, Safe Orthopaedics works closely on its ready-to-use instrument technologies SteriSpine LC with a group of international surgeons in order to respond to different surgical approaches”, Pierre Dumouchel, President and Chief Executive Officer of Safe Group, explains.
About Safe Group
Safe Group is a French medical technology company, composed of Safe Orthopaedics, pioneer of ready-to-use technologies for spinal diseases and Safe Medical (ex-LCI medical), subcontractor of medical devices for orthopaedics surgery. The Group employs around 150 employees.
Safe Orthopaedics develops and manufactures kits combining sterile implants and single-use instruments, available at any time for the surgeon. These technologies enable minimally invasive approach, reducing the risk of
cross contamination and infection, in the interest of the patient with a positive impact on hospitalization durations and costs. Protected by 17 patent families, the SteriSpineTM PS are CE marked and FDA approved.
Safe Orthopaedics has its headquarters close to Paris (95610 Eragny-sur-Oise - France) and subsidiaries in the UK, Germany, United States and in the Lyon area where the manufacturing company is located.
For more information: www.SafeOrthopaedics.com
Chief Financial and Administrative Officer
Tél. : +33 (0)1 34 21 50 00