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Orthopedic and Dental Industry News Complete Archive »

FDA Approves Medtronic's INFUSE For Certain Oral Maxillofacial and Dental Applications BY ARIELLA P. GOLOMB, MD, MARCH 14, 2007

Medtronic announced yesterday that they received FDA approval to market INFUSE for oral maxillofacial and dental regenerative bone grafting procedures. This news follows the FDA Dental Products Advisory Panel recommendation for approval last fall. INFUSE has already been FDA approved for use in certain lumbar spine fusion and tibial fracture repair procedures. The Company looks to the somewhat "cash and carry" nature of the new indication's market as a means of diversifying their payor base and estimates that the US market size for this new indication is ~$250M.

Medtronic is building a specialty sales force to support this new indication. Chief Operating Officer and soon-to-be CEO Bill Hawkins was quoted recently as stating that "We are aggressively scouting the market for new opportunities." Whether those new opportunities include building out their dental portfolio is still TBD.

Medtronic's press release included a quote from Daniel Spagnoli, Ph.D., DDS, an oral and maxillofacial surgeon, who stated "INFUSE Bone Graft encourages bone growth to make it possible for [patients] to have the corrective dental work that gives my patients a chance to have confidence, to feel good about their smile, to function well and to be able to enjoy a meal." Such corrective work could include dental implants - and the availability of INFUSE for these applications could create more opportunities for dental implant procedures.

Medtronic also announced yesterday that they will be expanding their Medtronic Spinal and Biologics Memphis facility- doubling it in size and making room for distribution, customer service and administrative functions. It's a sign that the Company is anticipating much demand to come.

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