BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News:
IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible) (Paris:IMPL), a medical technology company specialized in vertebral and knee-surgery implants, announces the commencement of a prospective and multicenter clinical study, designed to document the outcomes of the JAZZ Band in adult degenerative and adult deformity indications.
Implanet has partnered with TFS International, a professional CRO (Contract Research Organization), to help ensure a scientifically robust study design and execution.
Ludovic Lastennet, CEO of Implanet, states: “We are pleased to announce this important first step in the establishment of our prospective multicenter US study, partnering with a highly reputable CRO to initiate and manage the project with the highest standards of quality and rigor. The JAZZ Band has tremendous potential as a tool for surgeons to augment spinal fusion in complex adult surgery. As the global leader in Band based technologies, we are excited to take a leadership position in both rapidly expanding our product portfolio and documenting clinical and economic outcomes.”
In addition to the partnership with TFS International, Implanet is finalizing agreements with eminent US spine centers with strong expertise in complex adult degenerative surgery and a deep interest in developing innovative spinal implant technology platforms.
Daniel Spasic, CEO of TFS International, adds: “We are very pleased with Implanet’s decision to partner with TFS on this multicenter US study. TFS will now, together with some of the most renowned medical centers in the country, work diligently to ensure the execution of a successful study and help to position Implanet as an innovator in complex spine surgeries.”
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 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.
TFS International is leading global mid-size clinical Contract Research Organization (CRO). Founded in 1996 in Sweden, TFS currently operates in over 20 countries throughout Europe, North America and Japan and employs more than 750 professionals. Through two business areas, TFS DevelopTM and TFS PeopleTM, TFS provides services worldwide as end-to-end solutions or tactical functional services. Detailed information about TFS, its business offerings, global locations and recent press releases can be obtained throughwww.tfscro.com
Tel. : +33 (0)5 57 99 55 55
Florent Alba, Tel. : +33 (0)1 44 71 94 94
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
Pascal Nigen, Tel.: +1 917 385 21 60
Published at BusinessWire