Safe Orthopedics announces the first clinical benefits at 3 years


Safe Orthopedics Announces First 3-Month Clinical Benefits and Global Launch of Sycamore

  • 3-month follow-up result
  • 65% reduction in pain (ODI and VAS scales)
  • Global launch in early January 2022
  • 510k expected in 2022

Eragny-sur-Oise, France, December 20e, 2021 17:45 CET – Safe (FR0013467123 – ALSAF), a company specializing in the design, manufacture and marketing of single-use technologies for spine surgeries, delivering the safest treatment for urgently treated spine fractures, announces the end of the first evaluation of 3 months of the first case by the group of evaluating surgeons.

On May 24, 2021, Safe Orthopedics announced the CE marking of Sycamore, an implant designed to secure the treatment of vertebral fractures and reduce the risk of adjacent fractures.

In a previous biomechanical study on human vertebrae, a 40% increase in compressive strength was demonstrated between a vertebra instrumented with the Sycamore device and a vertebra that had only undergone a simple balloon kyphoplasty.

On December 18, 2021, the Franco-German surgeon evaluators of Sycamore met to comment on the evaluation of clinical benefits at 3 months and in particular the evaluation of pain reduction over several dozen surgeries. The evaluation group gave very satisfactory conclusions on the new product with a reduction in pain observed postoperatively by approximately 65% ​​according to the Owestry Disability Index (ODI) and Visual Analog Scale (VAS) pain scales.

Prof. Jean-Charles Le Huec, Orthopedic surgeon and traumatologist at the Polyclinique de Bordeaux Nord Aquitaine: For many years, I considered the treatments available for CVF fractures, especially in fragile bones, to be suboptimal. The literature shows that recompression with kyphoplasty is common and that sagittal balance can be lost. The Sycamore implant is designed to reduce this risk of re-compression and subsequent adjacent fractures by anchoring the implant, and therefore the fracture correction, in the strongest attachment point of the spine, the pedicle. From these early results with Sycamore we can see that the Safe Orthopedics team has developed a safe and effective product and I look forward to analyzing the longer term results ”.

Prof. Kevin Buffenoir, professor of neurosurgery at Nantes University Hospital, comments: “The Sycamore system was quickly adopted by my OR team, with the learning curve significantly shorter than expected. In this first round of patients, we treated a range of ages (27-80+), fracture types and fracture levels and found the Sycamore implant to perform extremely well. With the Sycamore balloon stopper, one can position the balloon for optimal height restoration and be sure that the cement will be held in place by the implant itself. This combination has the potential to provide real benefits to the patient over the long term, reducing the chances of future operations. As data collection continues, I look forward to reviewing these long term results for my patients ”.

Dr Ardeshir Ardeshiri, Head of the Spine Surgery Department at Itzhoe Clinic, Germany: Working closely with Safe Orthopedics’ clinical research and design teams, I have found that the Sycamore System has given very predictable results. Having now implanted 14 sycamore implants, my team and I found the instrumentation well designed and most importantly, using sycamore does not add much more time to the surgical procedure. In addition, I have found the Sycamore procedure to be highly reproducible, which allows me to achieve optimal results for each patient ”.

Pierre Dumouchel, Chairman and CEO of Safe Group, concluded : “Sycamore’s clinical pain tolerance and reduction results are in line with our expectations. In agreement with our evaluating surgeons, the commercial launch will take place at the beginning of January in all the countries where we are present then in the United States where we await regulatory approval in mid 2022. In parallel with this launch, we will continue to evaluate the effectiveness of Sycamore through an international clinical registry, with the objective of proving the medico-economic benefits of this new technology and convincing a large number of surgeons around the world ”.

Sycamore will be launched globally in January 2022, with the exception of the United States, where Food and Drugs Administration (FDA) approval for Sycamore is expected in the second half of the year.

About the Safe group
Safe Group is a French medical technology group which brings together Safe Orthopedics, a pioneer in ready-to-use technologies for spinal pathologies, and Safe Medical (formerly LCI Medical), a subcontractor of medical devices for orthopedic surgery. The group employs around 150 people.

Safe Orthopedics develops and manufactures kits combining sterile implants and single-use instruments, available to the surgeon at any time. These technologies are part of a minimally invasive approach aimed at reducing the risks of contamination and infection, in the interest of the patient and with a positive impact on the delays and costs of hospitalization. Protected by 18 patent families, SteriSpineTM kits are CE marked and FDA approved. Safe Orthopedics is headquartered in the Paris region (95610 Eragny-sur-Oise) and has subsidiaries in the United Kingdom, Germany, the United States and the Lyon region (Fleurieux-sur-l’Arbresle).

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Safe Medical produces implantable medical devices and ready-to-use instruments. It has an innovation center and two production sites in France (Fleurieux-sur-l’Arbresle, 69210) and Tunisia, offering many industrial services: design, industrialization, machining, finishing and sterile packaging. Supported by the French recovery plan in 2020, the company is investing in additive printing and will be operational in 2022 on this new technology.

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Francois-Henri Reynaud
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Ulysses Communication
Pierre-Louis Germain / +33 (0) 6 64 79 97 51 / [email protected]
Bruno Arabian / +33 (0) 6 87 88 47 26 / [email protected]


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