September 12, 2017
BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:
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 technologies.
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.
Régis 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 (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), 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.
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