IMPLANET Receives FDA Clearance for Its New Hybrid Fixation System Jazz Spinal SystemTM
May 13 2024 - 12:00PM
Business Wire
Regulatory News:
IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for
PEA-PME equity savings plans), a medical technology company
specializing in vertebral implants for orthopedic surgery and the
distribution of technological medical equipment, today announced
the Food and Drug Administration (FDA) 510(k) clearance of its new
hybrid fixation system Jazz Spinal SystemTM.
As a result of the technological partnership established in
November 2022 between IMPLANET and Sanyou Medical, this brand new
and unique hybrid fixation system Jazz Spinal SystemTM encompasses
the full range of technological expertise and R&D capabilities
of both groups. It features a comprehensive solution of pedicle
screws, combined with the most relevant Band implant range on the
market, JAZZ®. Jazz Spinal SystemTM incorporates the latest
developments and innovations in spinal surgery, including a
complete system for the treatment of pediatric deformity as well as
a comprehensive range of solutions for the treatment of adult
spinal pathologies, including minimally invasive approaches.
Designed for both traditional open surgery of the thoracolumbar
spine and minimally invasive percutaneous fixation, this innovative
system also meets the needs of surgeons treating complex
deformities.
Ludovic Lastennet, IMPLANET’s Chief Executive Officer,
stated: «Following the technological partnership signed two years
ago, we are proud to announce the clearance of a groundbreaking and
innovative hybrid fixation system Jazz Spinal SystemTM in the
United States. This milestone demonstrates the full potential of
the synergies provided by our partnership with Sanyou Medical.
Implanet America's sales teams, revitalized by the implementation
of new management at the beginning of the year, will be able to
launch the commercialization of this new solution during the summer
of 2024. This represents a significant milestone in our development
plan in the United States, the leading market for spinal surgery
globally, aimed at strengthening our offering in this strategic
market. »
Upcoming financial event:
- 2024 Half-Year Revenue, July 9,
2024, after market
About IMPLANET Founded in 2007, IMPLANET is a medical
technology company that manufactures high-quality implants for
orthopedic surgery and distributing medical technology equipment.
Its activity revolves around a comprehensive innovative solution
for improving the treatment of spinal pathologies (JAZZ®)
complemented by the product range offered by Orthopaedic &
Spine Development (OSD), acquired in May 2021 (thoraco-lumbar
screws, cages and cervical plates). Implanet’s tried-and-tested
orthopedic platform is based on the traceability of its products.
Protected by four families of international patents, JAZZ® has
obtained 510(k) regulatory clearance from the Food and Drug
Administration (FDA) in the United States, the CE mark in Europe
and ANVISA approval in Brazil. In 2022, IMPLANET entered into a
commercial, technological and financial partnership with SANYOU
MEDICAL, China's second largest medical device manufacturer.
IMPLANET employs 43 staff and recorded a consolidated revenue of
€7.4 million in 2023. Based near Bordeaux in France, IMPLANET
opened a US subsidiary in Boston in 2013. IMPLANET is listed on the
Euronext Growth market in Paris. For further information, please
visit www.Implanet.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240513147791/en/
IMPLANET Ludovic Lastennet, CEO David Dieumegard, CFO
Tél. : +33 (0)5 57 99 55 55 investors@Implanet.com
NewCap Investor Relations Nicolas Fossiez Tél.: +33 (0)1
44 71 94 94 Implanet@newcap.eu
NewCap Media Relations Arthur Rouillé Tél.: +33 (0)1 44
71 94 94 Implanet@newcap.eu
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