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 received 510(k) regulatory clearance from the Food & Drug Administration (FDA) in the United States removing the intended the use of the JAZZ Band™ platform with the Implanet Spine System. JAZZ may be used with other posterior thoraco-lumbar fixation systems (screws, rods, hooks) available on the market.
Ludovic Lastennet, CEO of Implanet, says: “We had been eagerly awaiting this latest clearance, which represents a major milestone in our development. Surgeons may now utilize their posterior fixation system of choice when incorporating JAZZ into their hybrid constructs. On a clinical level, this clearance will also allow us to initiate extensive multicenter prospective studies in the United States. It sends a strong signal less than a month from the start of major spine surgery conferences, the SRS and NASS annual meetings, and we are confident that this latest clearance will enable us to accelerate our technology’s regulatory process in other countries with substantial market potential.”
This latest FDA clearance follows that obtained in June for the expanded JAZZ Band range, allowing the Company to respond to all surgeon requests through the offer of a comprehensive range covering various diameters.
Next financial press release: revenue for the 3rd quarter of 2015, on 27 October 2015.
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 45 staff and recorded 2014 sales of €7.0 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.
Ticker: IMPL - ISIN code: FR0010458729
|Participation in major upcoming international conferences dedicated to spine surgery|
|30 Sept.-3 Oct. SRS - Scoliosis Research Society Minneapolis, US|
|14-17 Oct. NASS - North American Spine Society Chicago, US|
|28-31 Oct. SILACO - Congreso Iberoamericano de Columna Vertebra Lima, Peru|