Safe Orthopaedics announces first clinical benefits at 3 months and global launch of Sycamore
20 Dezember 2021 - 5:52PM
Safe Orthopaedics announces first clinical benefits at 3 months and
global launch of Sycamore
Safe Orthopaedics announces first clinical
benefits at 3 months and global launch of Sycamore
- 3-month follow-up result
- 65% pain reduction (ODI & VAS scales)
- Global launch in early January 2022
- 510k expected in 2022
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Eragny-sur-Oise, France, December 20th, 2021
17h45 CET – Safe (FR0013467123 – ALSAF), a company
specializing in the design, manufacturing and marketing of
single-use technologies for spinal surgeries, delivering the safest
treatment for spinal fractures urgently treated, announces the end
of the first 3-month evaluation of the first surgical cases by the
group of surgeon evaluators.
On May 24, 2021, Safe Orthopaedics 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 French-German surgeon
evaluators of Sycamore met to decide on the evaluation of the
clinical benefits at 3 months and in particular the evaluation of
the reduction of pain on several dozen surgeries. The evaluation
group gave very satisfactory conclusions on the new product with a
reduction of pain observed in post-surgery of about 65% according
to the pain scales Owestry Disability Index (ODI) and Visual Analog
Scale (VAS).
Pr Jean-Charles Le Huec, Orthopedic surgeon
and traumatologist at the Polyclinic of Bordeaux Nord
Aquitaine: "For many years I have considered the treatments
available for VCF fractures, especially in brittle bone, to be
sub-optimal. The literature shows re-compression with kyphoplasty
is common and sagittal balance can be lost. The Sycamore implant is
designed to reduce this chance of re-compression and subsequent
adjacent fractures by anchoring the implant, and thus the fracture
correction, in the strongest attachment point of the spine, the
pedicle. From these early results with Sycamore we can see the Safe
Orthopaedics team have developed a safe and effective product and I
look forward to analysing the longer term results”.
Pr Kevin Buffenoir, Professor of Neurosurgery
at the University Hospital of Nantes, comments: “The Sycamore
system has been adopted quickly by my operating room team with the
learning curve being substantially shorter than expected.
Over this early series of patients, we have treated a range of ages
(27-80+), fracture types and fracture levels and found the Sycamore
implant to be extremely capable. With the Sycamore balloon stop one
can position the balloon for optimum height restoration and be
confident that the cement will be held in place by the implant
itself. This combination has the potential to deliver real
advantages for the patient over the long term, reducing the chances
of future operations. As the data collection continues, I look
forward to examining these long-term results for my patients”.
Dr. Ardeshir Ardeshiri, Head of the Spine
Surgery Department of the Itzhoe Clinic, Germany: “Working
closely with the design & clinical research teams at Safe
Orthopaedics, I have found the Sycamore system has delivered very
predictable results. Having now implanted 14 Sycamore
implants, my team and I have found the instrumentation to be well
designed and, crucially the use of Sycamore does not add
significantly more time to the surgical procedure. What’s
more, I have found the Sycamore procedure to be highly reproducible
meaning I can achieve optimal results for every
patient”.
Pierre Dumouchel, Safe Group's Chairman and
CEO, concluded: "Sycamore's safety and pain reduction clinical
results are in line with our expectations. In agreement with our
evaluating surgeons, the commercial launch will take place in early
January in all countries where we are present and then in the
United States where we expect regulatory approval in mid-2022. In
parallel to this launch, we will continue to evaluate the efficacy
of Sycamore through an international clinical registry, with the
objective of proving the medico-economic benefits of this novel
technology and convincing a significant number of surgeons
worldwide”.
Sycamore will be launched globally in January
2022, with the exception of the U.S., where Food and Drugs
Administration (FDA) approval for Sycamore is expected in the
second half of the year.
About Safe GroupSafe Group is a French
medical technology group that brings together Safe Orthopaedics, a
pioneer in ready-to-use technologies for spine pathologies, and
Safe Medical (formerly LCI Medical), a medical device subcontractor
for orthopaedic surgery. The group employs approximately 150
people.
Safe Orthopaedics develops and manufactures kits
combining sterile implants and single-use instruments, available at
any time to the surgeon. 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 hospitalization times and costs. Protected by 18
patent families, SteriSpineTM kits are CE marked and FDA approved.
Safe Orthopaedics 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).
For more information:
www.safeorthopaedics.com
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 in Tunisia, offering numerous industrial services:
design, industrialization, machining, finishing and sterile
packaging. Supported by the French stimulus plan in 2020, the
companýinvests in additive printing and will be operational in
2022 on this new technology.
For more information: www.safemedical.fr
Contacts
Safe
Group
François-Henri Reynaud
Chief Financial and Administrative Officer
Tél. : +33 (0)1 34 21 50
00
investors@safeorthopaedics.com
Press RelationsUlysse
CommunicationPierre-Louis Germain / +33 (0)6 64 79 97 51
/ plgermain@ulysse-communication.com Bruno Arabian /
+33 (0)6 87 88 47 26 / barabian@ulysse-communication.com
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