Implanet’s new JAZZ™ Standalone implant receives European marketing clearance (CE)

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 its new JAZZ™ Standalone implant has been granted approval by the European authorities and obtained the CE Mark.

JAZZ™ Standalone is an implant that further strengthens the Implanet’s freestanding, rod less fixation line, launched in 2016 with the JAZZ™ Lock implant. It is used in the treatment of adult degenerative bone disorders, the largest spine surgery market segment, representing $246 M¹ in Europe.

The JAZZ™ Standalone offers fast and simple freestanding posterior fixation to replace traditional fixation systems. Degenerative spine surgery is experiencing strong growth in Europe and the United States, driven by an aging demographic that demands functional restoration in a less invasive manner.

The JAZZ™ Standalone will be incorporated in the JAZZ product range without new investments in equipment or training for surgical teams.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “The result of our work with thought leading surgeons, the JAZZ™ Standalone is a new variant of our JAZZ technology devoted to treating degenerative pathologies. This implant utilizes the JAZZ™ Band platform and enables vertebral segments to be stabilized without the need for pedicle screws and rods. This is a fast, simple and safe surgical procedure that only requires limited surgical accessibility.”

Ludovic Lastennet, Implanet CEO, adds: “We are continuing to rigorously pursue our execution plan by regularly marketing new products and line extensions. The marketing approval of a major new component of the JAZZ™ Band platform in Europe is another key breakthrough in terms of expanding the range. Indeed, the JAZZ™ Standalone meets a major and persistent demand from surgeons regarding their need to continually simplify surgical procedures. It should rapidly be adopted by our partners, whether they be pediatric surgeons or surgeons specializing in adult degenerative disorders.”

IMPLANET will participate this week in two major Congresses:

• Global Spine Congress (degenerative surgery), Milano, Italy, 3 to 6 May 2017

• E-POSNA Congress (pediatric surgery), Barcelona, Spain, 3 to 6 May 2017

Next financial press release: Q2 2017 revenue, on July 18, 2017

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 48 staff and recorded 2016 sales of €7.8 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.

¹ Source : Company