Devices Orthopaedic Neurosurgery FDA

 News Release - August 24, 2006

RSB Spine Announces 510(k) Approval to Market the InterPlate(TM) Vertebral Body Replacement Implant System

CLEVELAND, Aug. 24 (HSMN NewsFeed) -- RSB Spine, LLC, a privately held medical device company focused on developing innovative spinal implants, announced today that the U.S. Food and Drug Administration has conditionally approved its 510(k) application to permit marketing of the InterPlate(TM) Vertebral Body Replacement System. Submissions for cervical and lumbar interbody indications will follow.

The InterPlate(TM) is a unique spinal implant designed to facilitate rapid spinal fusion and is used in conjunction with graft material to fuse two or more spinal vertebrae together. Spinal fusion is one of the most common spinal procedures performed by neurosurgeons and orthopedic spine surgeons.

Robert S. Bray Jr., M.D., a neurosurgeon who has performed over 7,500 spine surgeries, is the director of St. Johns Spine Institute in Santa Monica, CA, and inventor of the InterPlate(TM), said: "The InterPlate(TM) is a next- generation device incorporating the best features of plate and interbody designs without the drawbacks. I believe its innovative design and unique features will appeal to spine surgeons and that it will soon become the implant of choice for single-level spinal fusion." Dr. Bray has invented a number of other commercially successful medical devices.

John A. Redmond, chief executive officer of RSB Spine, added: "Based on the overwhelmingly positive response from surgeons who have seen the InterPlate(TM), we believe it could rapidly become a major revenue generator and change how spinal fusions are viewed. The approval of the InterPlate(TM) is another step in a series of advances supporting our strategy of developing unique implants that are attractive acquisition candidates for spinal implant companies with good distribution muscle."

In 2004 and 2005, respectively, RSB Spine sold its surgical instrument line to Jarit, an Integra Lifesciences Holding Corp. company (IART), and its cervical plate system to Nuvasive (NUVA).

Source: RSB Spine

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