OsteoBiologics, Inc. Receives 510(k) Clearance From FDA to Market and Distribute its PolyGraft(TM) TCP Bone Graft Substitute

OsteoBiologics, Inc. Receives 510(k) Clearance From
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

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