Implanet granted regulatory clearance in the U.S. (510k) and Europe (CE) for its new Jazz Lock® implant
Major breakthrough that extends the Jazz Band® platform range of indications to the cervical spine
BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News:
IMPLANET (Paris:IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has been granted 510k clearance in the United States and the CE mark in Europe to market its new Jazz Lock® implant.
Jazz Lock® is the first of an innovative range of band products designed for degenerative spine disorder surgery. This new implant expands the JAZZ technological platform and allows Implanet to broaden its activity to the cervical spine, estimated at over $200 million worldwide1. Based on the polyester sublaminar braid platform, Jazz Lock® eliminates the mechanism’s locking screw and connecting rod, thanks to a proprietary fastening locking system. Implanet thus offers surgeons a new implant with an optimized and reproducible surgical technique.
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “Constant innovation is the essential component in maintaining our technological advantage. Over the last two years, we have focused our efforts on finalizing our range of Jazz Band implants, notably with the market’s most extensive range of connectors, to ensure compatibility with all existing posterior fixation systems. A result of collaboration with leading surgeons, Jazz Lock represents a major breakthrough: an innovative, IP protected design offering surgeons a fusion device that no other company currently can.”
Ludovic Lastennet, CEO of Implanet, adds: “Obtaining regulatory clearances to market this new major component of our Jazz Band platform is a significant milestone in terms of product range expansion. Already established in the major spinal deformity segment, we are now accelerating our presence in the degenerative bone disorder segment, which is three times larger2. Jazz Lock is the first component of an innovative range of band products for degenerative spine disorder surgery targeted for launch in the near future, in line with our execution plan. Jazz Lock’s commercial launch is underway and further expands the breadth of our product offering.”
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 2015 sales of €6.7 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 Compartment C of the Euronext™ regulated market in Paris.
This press release contains forward-looking statements related to Implanet and its activities. Implanet estimates that these forward-looking are based on reasonable assumptions. No guarantee is given as to these forecasts being achieved, which are subject to risks, including those described in Implanet Reference Document registered with the French Autorité des marchés financiers on April 28, 2015 under number R.15-023 (a copy of which is available on www.implanet-invest.com), and to the development of economic conditions, the financial markets and the markets in which Implanet operates. Forward-looking statements included in this press release are also subject to risks unknown for Implanet or not considered by Implanet as significant as of today. The Company's future performance, the Company’s financial position, results, cash-flows and developments in the sector may differ materially due to the realization of one of those risk factors.
1 Source: i-Data
2 Source: i-Data for 2010
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