ANVISA regulatory approval granted in Brazil to market the JAZZ BandTM platform
IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received regulatory approval from the Brazilian National Health Surveillance Agency (ANVISA) to market its JAZZ BandTM platform.
With almost 27,000 operations carried out in 2015, and anticipated annual growth of +7.5%, Brazil accounts for 83% of a Latin America vertebral fusion market estimated to be worth 139 million euros. There is a balanced split in fusion surgery between cervical fusion procedures and thoraco-lumbar fusion procedures, representing significant opportunity for Implanet, the only player to offer a truly comprehensive range of braided implants.
Alvaro Tadeus, CEO of Importek, Implanet’s commercial partner, comments: “We are delighted to strengthen a partnership started 5 years ago. Having the JAZZ platform approved by ANVISA is a major step forward for Implanet in our territory. The combination of Implanet’s disruptive technology and our in-depth knowledge of the spine market and our network of influential opinion leaders should enable us to perform the first JAZZ surgeries in the coming weeks.”
Ludovic Lastennet, CEO of Implanet, adds: “With this latest approval in one of the most promising spine surgery markets for our JAZZ technological platform, we have reached another major milestone in our international expansion plan. Dynamic growth in the United States, our principal market, driven by the fast- growing rate of adoption and the recent 510K clearance from FDA to use JAZZ with 100% of thoraco-lumbar fixation systems, is helping speed the approval process in Latin American markets. With its market size and strong pricing, Brazil is a real growth engine on this continent, and this opens the way for additional milestones to be reached.”
IMPLANET will participate in the following Q4 2015 scientific congresses:
SOFCOT, in Paris from 10 to 12 November 2015.
CBOT, in Sao Paulo from 19 to 21 November 2015
MATSS Technical Courses, in Ribeirao Preto (Brazil) from 27 to 28 November 2015. IPOS, in Orlando, Florida from 9 to 12 December 2015.