Safe Orthopaedics announces CE mark for Sycamore
24 Mai 2021 - 8:34AM
Safe Orthopaedics announces CE mark for Sycamore
- Novel treatment for osteoporotic
fractures
- Very dynamic market segment
- Launch of a multi-centric study in France and
Germany
- Worldwide commercialization expected in
2022
Éragny-sur-Oise, France, On May 24, 2021
à 8:35 CET – Safe Orthopaedics (FR0013467123 –
ALSAF), a 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
orthopedic medical devices, today announces the CE mark for
Sycamore, a new treatment for the management of patients with one
or more osteoporotic fractures.
Osteoporotic fracture is a global clinical
issue. Driven by the aging population and the dynamic lifestyle of
those 50 years and older, the number of vertebral fractures has
increased significantly over the past two decades.
Developed with the help of a dozen European
surgeons, Sycamore is a minimally invasive, ready-to-use technology
that improves the first treatment of one or more fractures and
reduces the risk of recurrence in osteoporotic patients.
In the laboratory, Safe Orthopaedics has
demonstrated the potential clinical benefit of this new technology
on human vertebrae, increasing the strength of a
cementoplasty-reconstructed vertebra by more than 30%, reducing the
risk of post-operative vertebral collapse and thus the patient's
re-operation.Prof. Jean-Charles Le Huec, surgeon at the polyclinic
Bordeaux Nord Aquitaine and former professor at the Bordeaux
University Hospital, France comments: “Studies have shown
that 25% of patients over 50 years of age have a risk of vertebral
fracture and 20% of women may suffer an adjacent level fracture
within 12 months. With an ageing global population, the
treatment of these pathologies is a real challenge over the coming
years. In collaboration with Safe Orthopaedics, we have designed
and tested in human vertebrae at the biomechanical lab a new
solution. The Sycamore implant is based on a new mechanical concept
that has shown it can significantly reinforce a fractured vertebra
and has the potential to reduce long-term risk of loss of
correction commonly seen with some devices. I’m delighted to
see the CE mark of the technology and will participate in the
evaluation of Sycamore in clinical practice”.
Dr. Ardeshir Ardeshiri, surgeon at the Itzehoe
Clinic, Germany adds: “Like many surgeons, I continuously look
to improve the treatment and outcomes for the increasing number of
fracture surgeries that I operate on, seeking options that are
minimally invasive, reproducible and efficient. Along with the
other evaluation centers, I am proud to participate in the
evaluation of the Sycamore implant with Safe Orthopaedics to
demonstrate the clinical benefits of the device. Like all Safe
Orthopaedics products that I have used, the ready-to-use
instrumentation of Sycamore, and the implant design, has the
potential to help streamline the surgical process for the entire
operating room team whilst also bringing tangible benefits to my
patients”.
Safe Orthopaedics, which recently obtained CE
Mark approval for Sycamore, is launching a multi-centric study of
the technology in France and Germany and expects Sycamore to be
marketed worldwide by 2022. Designed by Safe Orthopaedics and
manufactured by Safe Medical, Sycamore is a 100% French technology,
which comes in a ready-to-use kit including minimally invasive
instrumentation and sterile implants.
“Motivated by the clinical challenges expressed
by surgeons, our research team is committed to finding simple and
effective solutions. We are proud to announce the launch of this
new technology called Sycamore and to complete our range of
SteriSpineTMVA products for the management of patients with
vertebral fractures” explains Pierre Dumouchel, Chairman and CEO of
Safe Group. "In accordance with the new European Medical Devices
Regulation (MDR), we are launching a multi-center study in several
French and German centers and preparing for the global launch of
Sycamore in 2022. Sycamore is the first project resulting from the
consolidation of our Safe Group, designed by Safe Orthopaedics and
produced by Safe Medical and is part of our plan to accelerate
innovation and double-digit commercial growth”.
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
Safe Medical (formerly LCI Medical) produces
implantable medical devices and ready-to-use instruments. It has an
innovation center and two production sites in France and Tunisia,
offering a wide range of industrial services: design,
manufacturing, machining, finishing and sterile packaging.
Supported by the French stimulus plan in 2020, the company is
investing in additive printing and will be operational in 2022 on
this new technology.For more information: www.safemedical.fr
Contacts
Safe
Orthopaedics
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 61 / plgermain@ulysse-communication.com Bruno
Arabian / +33 (0)6 87 88 47 26 /
barabian@ulysse-communication.com
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