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Advanced Biomaterial Systems Receives FDA Clearance to Market ABS’s Symphony™ VR Radiopaque Bone Cement For Use in Vertebroplasty or Kyphoplasty Procedures
 
CHATHAM, NJ, January 14, 2005
Advanced Biomaterial Systems, Inc. (ABS) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) today to market ABS’s Symphony™ VR Radiopaque Bone Cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

“This FDA clearance now allows ABS to market its Plexis™ mixing and delivery system together with ABS’s Symphony™ VR radiopaque bone cement as a complete and controlled solution to spine physicians for stabilizing spinal compression fractures for use in either vertebroplasty or kyphoplasty procedures,” said Pete Carr, President and Chief Executive Officer of ABS. “ABS’s proprietary Symphony™ VR bone cement comes premixed with a radiopacifier and provides the spine physician with longer working time and lower exothermic temperature while using less monomer than other products currently on the market. The Plexis™ bone void filling system utilizes a patented mixing and delivery technology that ensures an optimal and consistent material mix and provides a precise, metered delivery for maximum control by the surgical professional. ABS continues to develop and deliver products to the market that advance procedure outcomes and patient safety.”

ABS will be exhibiting its products at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Washington, DC in February, the Society of Interventional Radiology (SIR) annual scientific meeting in New Orleans, LA in March, and the American Association of Neurological Surgeons (AANS) annual meeting in New Orleans, LA in April.

About Advanced Biomaterial Systems, Inc.

Advanced Biomaterial Systems (www.advbiomat.com) develops and markets proprietary biomaterials and delivery systems designed to advance procedure outcomes and patient safety for site specific treatments used by orthopaedic surgeons, neurosurgeons, interventional radiologists and neuroradiologists. ABS’s products include: twistOR PrePack™ - a patented mixing and delivery system prepackaged with ABS’s proprietary CONCERT® Bone Cement used for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures; Plexis™ Bone Void Filling System – a mixing and delivery system based on patented technology used for delivering biomaterials to site specific locations in minimally invasive procedures; ABS Symphony™ VR Radiopaque Bone Cement – a proprietary material used for the fixation of pathological fractures of the vertebral body in either vertebroplasty or kyphoplasty procedures; and CONCERT® Cranioplast - a proprietary radiopaque resinous material used for repairing cranial defects.


 
 
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