OsteoBiologics, Inc. Receives 510(k) Clearance From
FDA to Market and Distribute its PolyGraft(TM) TCP Bone Graft Substitute
FDA to Market and Distribute its PolyGraft(TM) TCP Bone Graft Substitute
SAN ANTONIO, Aug. 30 /PRNewswire/ -- OsteoBiologics, Inc. ("OBI"), an innovator in tissue repair technologies, announced that it has received 510(k) Premarket Notification from the Food and Drug Administration to market and distribute its newest formulation of composite bone void filler device called PolyGraft(TM) TCP Bone Graft Substitute. The porous PolyGraft(TM) TCP material is composed of a patented blend of polylactide-co-glycolide, tricalcium phosphate and polyglycolide fibers. The PolyGraft(TM) TCP material can be fabricated into products such as granules, blocks, wedges and other preformed shapes and is indicated to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft(TM) TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis), and these defects may be surgically created osseous defects or bone defects due to traumatic injury to the bone. "OBI has developed another composite bone void filler in which the ceramic portion resorbs slower to enhance strength retention," stated Fred Dinger, President and CEO of OBI. "The availability of this technology platform gives OBI the opportunity to continue our rapid product line expansion and enables us to provide solutions for the body to heal itself for a broader range of unmet clinical needs." About OsteoBiologics, Inc. OBI, located in San Antonio, Texas, is a private company that develops and manufactures bioabsorbable polymeric scaffolds, films, and related instrumentation for the repair and replacement of bone, soft tissue and cartilage. Its products are based on proprietary and patented technologies covered by U.S. and foreign patents. The Company is focusing on commercializing and further developing its platform technologies in arthroscopy and sports medicine. Additionally, OBI is actively forming strategic alliances with companies serving other areas of medicine such as spine, trauma, general orthopedics, and wound care to leverage its technologies into those markets. Certain statements made in this press release are forward looking statements as such term is defined in the Private Securities litigation Reform Act of 1995. For more information, please contact Daniel Lee, Director of Marketing at (210) 690-2131.
SOURCE OsteoBiologics, Inc.
Web Site: http://www.obi.com