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.”
About IMPLANET
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.
About TFS
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
through www.tfscro.com