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FzioMed
Receives Expanded Label Claims For Oxiplex® In Spine Surgery
SAN LUIS OBISPO, Calif. - Feb. 11, 2003 - FzioMed, Inc. announced
today that it has received approval in Europe to expand the label
claims for its Oxiplex®/SP Gel for use in spine surgery to
include the reduction of pain and radiculopathy.
Oxiplex®/SP Gel is a bioabsorbable gel that is applied during
spine surgery as a barrier to reduce the formation of post-surgical
adhesions, a leading complication of many surgical procedures.
The product, currently sold throughout Europe, is indicated for
use in laminectomy, laminotomy and discectomy surgeries. The expanded
labeling, based on results from the company's clinical trial,
now includes indications for the reduction of pain and radiculopathy.
"The use of Oxiplex®/SP Gel in spine surgeries offers
the potential for improved patient outcomes," said Ronald
Haynes, President and CEO of FzioMed. "We are very pleased
to report this expansion of label claims. The patient benefits
of reducing pain and radiculopathy will be the subject of an article
in an upcoming issue of Spine."
FzioMed is a privately held biomedical company engaged in the
development and commercialization of advanced, absorbable biosurgery
products based on the company's patented Oxiplex® platform
technology. Oxiplex® is an innovative polymer that is formulated
for a variety of medical indications and markets. Products in
development include those for the prevention of post-surgical
adhesions, drug delivery and hemostasis. FzioMed products are
at various stages of clinical and pre-clinical development, and
are directed towards high growth markets in the rapidly growing
field of biosurgery.
Oxiplex® is a registered trademark
of FzioMed, Inc.
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