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 granted 510(k) clearance in the United States and the CE Mark in Europe to market the new Jazz Claw®.
Jazz Claw is an unmatched hybrid implant providing autostable posterior fixation, replacing traditional hook-and-screw fixation systems. Jazz Claw is designed to treat complex degenerative pathologies in adults (kyphosis), a growing indication driven by the aging population. Jazz Claw compliments Implanet’s growing product portfolio devoted to degenerative pathologies, which represent the largest spine surgery market segment. In addition, its autostable characteristics aid in the treatment of adolescent scoliosis with hybrid fixation.
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “Jazz Claw is Implanet’s response to the complex issue of securing the top of constructs in adolescent scoliosis and adult degenerative deformities. This biomechanically challenging area was traditionally treated with pedicle screws or hooks, with inherent drawbacks that the Jazz Claw eliminates. The result of a collaboration with prominent surgical teams, Jazz Claw is a new hybrid solution that provides ease of use, versatility and the power of sublaminar band reduction in a high demand location.”
Ludovic Lastennet, CEO of Implanet, adds: “We continue to execute our business plan and product-launch schedule in a timely fashion. Jazz Claw is a major new component of our Jazz Band® platform, an implant that supplements our product offering for major deformities and meets a major market demand. In this respect, it should rapidly be adopted by our partners, whether specializing in pediatric or adult degenerative indications.”
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 (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.