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Reimbursement / Regulatory

Implanet Receives Regulatory Approval to Market JAZZ Band in Brazil -

Implanet received ANVISA approval to market the JAZZ Band™ platform in Brazil. JAZZ is the company's flagship product, intended for the treatment of spinal pathologies that require vertebral fusion. 

The JAZZ fixation system received it initial FDA clearance in 2012, and was recently granted additional clearance for its use with any thoraco-lumbar fusion system. 

While the U.S. remains Implanet's principal market (comprising 59% of revenue in 3Q15), the company notes that Brazil accounts for 83% of a Latin American vertebral fusion market that is valued at €139MM (~$152MM). Procedures are reported to be evenly split between cervical and thoraco-lumbar fusions, suggesting significant opportunity for Implanet. 

Source: Implanet

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