BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News:
IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has been given the green light by the American and European authorities, through FDA 510k clearance and CE marking, to market its new Jazz Frame® implant.
JAZZ Frame® is a system of connectors, the final link in the JAZZ Band® technological platform dedicated to the hybrid surgical technique. Implanet now offers surgeons the possibility of defining and optimizing a global strategy to reduce major deformities, thus maximizing long-term clinical outcomes.
“Since we have been using sublaminar braid implants to reduce and stabilize scoliotic deformities, we have been able to show significantly greater reductions than we previously obtained with our all-screw or hook-and-screw assemblies”, says Professor Keyvan Mazda, MD, Ph.D, Robert Debré Hospital, APHP, adding: “Using the JAZZ Frame® facilitates the restoration of both frontal and sagittal balance, thanks to the simultaneous reduction of both thoracic curves. This is most notable in the case of the most complex deformities where shoulder imbalance is common. The result of years of clinical experience and of close collaboration with Implanet, JAZZ Frame® allows us to be even more efficient and quick for the sole benefit of patients.”
Ludovic Lastennet, CEO of Implanet, adds: “We continue to strictly adhere to, and execute our business plan. The rapid marketing clearance in Europe and the United States is a real source of satisfaction, innovation that maximizes the clinical value of our technology. Optimized for implementation of the “frame” technique, we expect this implant to be rapidly adopted by our partner surgeons, pediatric and adult deformity specialists alike. The marketing release of JAZZ Frame® in our various markets is scheduled for the first quarter of 2017.”
Next financial press release: 2016 annual results, on March 28,
Implanet will participate in the Invest Securities Biomed Event, on January 26 in Paris.
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 Compartment C of the Euronext™ regulated market in Paris.