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

Tuesday, April 24, 2007

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

CLEVELAND, April 24 /PRNewswire/ -- 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 approved its 510(k) application to permit marketing of the InterPlate(TM) Vertebral Body Replacement System for use without supplemental fixation. The new indication will allow RSB Spine to market the product as an anterior fusion device, without the need for additional posterior implant support. Submissions for cervical and lumbar interbody indications will follow, as well as new product designs based on the InterPlate platform.
The InterPlate(TM) VBR is a unique spinal implant designed to facilitate rapid fusion and is used in conjunction with graft material to fuse two or more vertebrae together. Spinal fusion is one of the most common procedures performed by neurosurgeons and orthopedic spine surgeons.

Robert S. Bray Jr., M.D., is the inventor of the InterPlate(TM) and has performed over 7,500 spine surgeries. He is the director of St. Johns Spine Institute in Santa Monica, CA, and the Founding Director and CEO of D.I.S.C., a state-of-the-art outpatient surgery center in Marina del Rey, CA. Dr. Bray said: "This will allow the InterPlate(TM) VBR to be used in those patients where a less invasive, anterior approach is selected, in conjunction with a standalone implant. Compared to use with posterior supplemental fixation, the patient will recover more rapidly, and hospitals will realize significant cost savings. I am excited about a dynamic, low profile device with screw back out prevention being available for this application." Dr. Bray has invented a number of other commercially successful medical devices.

John A. Redmond, Chief Executive Officer of RSB Spine, added: "The response to this product has been tremendous, and we are in negotiations with several top distributors who are very anxious to start selling the InterPlate(TM) and the new devices we are developing based on the InterPlate(TM) platform. We expect to show a very steep sales ramp starting in June, when we will have enough inventory to meet demand. We also expect to introduce two additional products later this summer."

Source: RSB Spine, LLC 
CONTACT: John Redmond of RSB Spine, LLC, +1-216-241-2804
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