BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News:
IMPLANET (Paris:IMPL) (OTCQX:IMPZY)(Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received European regulatory clearance through the CE Mark to market the new JAZZ® Passer.
Following 510(k) marketing clearance from the FDA in September for the US market, Implanet has just received the CE Mark for its new JAZZ® Passer product line.
This new milestone will allow Implanet to offer its latest technological development in the world’s second largest spine surgery market, worth an estimated $800 million1.
Ludovic Lastennet, CEO of Implanet, says: “This innovation will accelerate the adoption of JAZZ® technology by new European surgeons. This highly dynamic market is driven by France and Germany, regions where we are active, notably in the high potential adult degenerative bone disorder segment. At the recent Eurospine conference in Dublin, we saw enthusiasm for our solution from health professionals and surgeons. We were able to show, during a thematic evening with more than 50 participants and throughout this conference, how easy to use our latest innovations are.”
As a reminder, JAZZ® Passer is a compatible solution with the JAZZ® Platform, providing new options in terms of accessing and working around anatomical structures.
IMPLANET will participate in the following
scientific conventions in Q4-2017
NASS in Orlando, October 25 to 28, 2017
SOFCOT in Paris, November 6 to 9, 2017
ICEOS in San Diego, November 15 to 17, 2017
Next financial press release: 2017 annual revenue, on January 16, 2018 (before market)
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.
1 Source : Global Data