CAMBRIDGE, Mass., April 27 /PRNewswire/ -- ETEX Corporation, a leading orthopaedic biomaterials company, announced today FDA 510k clearance of 1cc and 2.5cc sizes of Beta-bsm(TM) Injectable Paste and Gamma-bsm(TM) Moldable Putty to complement the existing 5cc and 10cc sizes. Both products are bone substitute materials based on ETEX's proprietary nanocrystalline calcium phosphate technology.
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Beta-bsm(TM) and Gamma-bsm(TM) set hard to provide an optimal osteoconductive scaffold that mimics the nanocrystalline structure of human bone. Smaller sizes were developed in direct response to the needs of the small bone market. Both hand and foot/ankle surgeons requested user friendly moldable and injectable materials that set fast, are drillable, provide high compressive strength and remodel into bone over time.
Beta-bsm(TM) Injectable Paste and Gamma-bsm(TM) Moldable Putty are intended for use in filling bone voids or defects of the skeletal system (including extremities, pelvis, and spine) that are not intrinsic to the stability of the bone structure. ETEX's rapidly expanding product portfolio, including EquivaBone(TM), a hard-setting, certified osteoinductive product, is marketed through a growing independent distribution network.
Brian Ennis, CEO of ETEX Corporation, comments, "ETEX is proud of our product development approach, driven by direct customer input. We are excited to offer state of the art bone graft substitutes, formulated for optimal performance and patient outcomes, in sizes complimentary to extremity surgery."
About ETEX Corporation
Established in 1989, ETEX Corporation develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes. A leader in bioresorbable bone substitute materials, ETEX focuses on expanding applications through combinations with cells, biologics, or therapeutic agents delivered in minimally invasive and easy to use systems. For more information, visit www.etexcorp.com.
CONTACT: Shane Doyle of ETEX Corporation, +1-617-577-7270
Web site: www.etexcorp.com/