Tuesday, June 16, 2015

News: Implanet Enrolls First Patient in a Major Multi-Center Clinical Study Led by the Ohio State University

BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News :

Image result for implanetIMPLANET (Paris:IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has enrolled the first patient in a major multicentric clinical protocol designed to study the medical value provided by the JAZZ Band™ in the treatment of instrumented thoracic and lumbar arthrodesis (osteo-degenerative bone pathologies).

Ludovic Lastennet, CEO of Implanet, says: “We are pleased to announce that the first patient has been enrolled in a multicenter study led by principal investigator H. Francis Farhadi, MD, PhD of The Ohio State University. The study, entitled Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Jazz System, will examine the JAZZ Band as an adjunct to spinal fusion in adult scoliosis and adult degenerative surgeries.”

Dr. Farhadi comments: “At Ohio State, we are always in search of innovative technologies to advance the treatment of complex spinal pathologies. We are excited to have started the Jazz Band study and look forward to analyzing the potential clinical and economic benefits of sublaminar band technology in complex spinal fusions.”

Patient recruitment will continue, with additional centers joining the study in 2H 2015.

Initiation of this new multi-center study is consistent with Implanet’s focus on the documentation of clinical and economic outcomes with the JAZZ Band. Continued growth in the US market has been supported by multiple strategic development initiatives, most notably:

  • Signing of 7 new sales partners (32 vs. 25 as of December 31, 2014) along with strengthening of the Sales Management Team (4 Directors);
  • CE mark and FDA clearance for new JAZZ diameters - Extension of the JAZZ Band™ technological platform from a single 5.5 mm diameter implant to the market’s most comprehensive range of sublaminar implants;
  • Successful exhibition at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting, the world's largest conference dedicated to orthopedics, which brought together more than 15,000 orthopedic surgeons from around the world;
  • Sponsorship and participation in the POSNA (Pediatric Orthopaedic Society of North America) Annual Meeting.

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

Ludovic Lastennet, Tel.: +33 (0)5 57 99 55 55
Investor Relations
Florent Alba, Tel.: +33 (0)1 44 71 94 94
Press Relations
Nicolas Merigeau, Tel.: +33 (0)1 44 71 94 98

Published at Business Wire

No comments:

Post a Comment