FDA clearance granted in the US for the new system devoted to posterior
fixation in spine surgery, compatible with all JAZZ? Platform implants
BORDEAUX, France & BOSTON(BUSINESS WIRE)
IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible)
(Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in
vertebral and knee-surgery implants, today announces that it has
received FDA clearance to market the new JAZZ? Passer.
JAZZ? Passer comprises new passer instruments and a variation of the
JAZZ? Band braid, the JAZZ? Passer Band. The latter is 100% compatible
with all JAZZ? platform implant connectors, and replicates the
mechanical performances of the innovative JAZZ? Band braid, highlighted
in numerous scientific publications.
JAZZ? Passer facilitates placing the band around anatomical structures,
representing a breakthrough in terms of flexibility and ease of use.
This simplified system should drive surgeon adoption of JAZZ? band
This comprehensive system was designed in direct response to surgeon
feedback. Implanet addresses an ever-expanding list of therapeutic
indications, given the characteristics and performance of the JAZZ?
Platform. By effectively covering all degenerative, scoliosis-deformity
and trauma-tumor pathologies in adolescents and adults, the Company
competes in a market segment estimated at over 2 billion dollars.
Rgis Le Couedic, Implanet's Product Development & Manufacturing
Director, says: This project's challenge lay in the need to retain
our JAZZ? technology's proprietary performance characteristics. Our goal
was also to develop simple instrumentation that provides the surgeon
tactile feel when passing the braid around bony structures. Our valued
surgeon advisors confirm that this twofold objective has been achieved,
with the combination of the new braid and passers making it even easier
to use JAZZ?, notably in the areas of degenerative and complex spine
surgery, which account for most spine operations.
Regarding this new product launch, Nicolas Marin, Implanet's Chief
Marketing Officer, adds: The JAZZ? Passer systems enables us to
reach a new milestone in the adoption of our technology and the
frequency of its use by surgeons. With 20% market share in pediatric
deformity surgery in France, we feel that the use of JAZZ? band
technologies has become standard of care and will be part of the
therapeutic arsenal of many surgeons in the rest of the world. JAZZ?
Passer represents the most appropriate response to the various problems
encountered by spine surgeons that only our technology makes it possible
to truly address, illustrated by the conversion of new user surgeons,
particularly in the United States.
Next financial press release: H1 2017 results, on September 19,
2017 after market closes
Founded in 2007, IMPLANET is a medical technology company that
manufactures high-quality implants for orthopedic surgery. Its flagship
product, the JAZZ? latest-generation implant, aims to treat spinal
pathologies requiring vertebral fusion surgery. 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 and the CE mark. IMPLANET employs 48 staff and recorded 2016
sales of ?7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in
Boston in 2013. IMPLANET is listed on Euronext? Growth market in Paris.
This press release contains forward-looking statements concerning
Implanet and its activities. Such forward looking statements are based
on assumptions that Implanet considers to be reasonable. However, there
can be no assurance that the anticipated events contained in such
forward-looking statements will occur. Forward- looking statements are
subject to numerous risks and uncertainties including the risks set
forth in the registration document of Implanet registered by the French
Financial Markets Authority (Autorit des marchs financiers (AMF)) on
April 26, 2016 under number R.16-035 and available on the Company's
and to the development of economic situation, financial markets, and the
markets in which Implanet operates. The forward-looking statements
contained in this release are also subject to risks unknown to Implanet
or that Implanet does not consider material at this time. The
realization of all or part of these risks could lead to actual results,
financial conditions, performances or achievements by Implanet that
differ significantly from the results, financial conditions,
performances or achievements expressed in such forward-looking
statements. This press release and the information it contains do not
constitute an offer to sell or to subscribe for, or a solicitation of an
order to purchase or subscribe for Implanet shares in any country.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170911006099/en/
Ludovic Lastennet, +33 (0)5 57 99 55 55
Florent Alba, +33 (0)1 44 71 94 94
Nicolas Merigeau, +33 (0)1 44 71 94 98
Pascal Nigen, +1 917 385 21 60