| 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.
|