Safe Group and the american company SpineUp announce the signature of a technological co-development agreement
10 Februar 2021 - 5:35PM
- 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 ofcross 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
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 61 / plgermain@ulysse-communication.comBruno
Arabian / +33 (0)6 87 88 47 26 /
barabian@ulysse-communication.com
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