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FzioMed
Reports Preclinical Results Demonstrating Oxiplex/SP Adhesion Barrier
Gel for Spine Surgery Does Not Inhibit Bone Healing
SAN LUIS OBISPO, California - June 30, 2004 - FzioMed, Inc. today
announced the presentation of preclinical data showing that Oxiplex/SP
Adhesion Barrier Gel for Spine Surgery does not inhibit healing
in non-critical bone defects. The poster presentation is being
made at the 11th International Meeting on Advanced Spine Techniques
(IMAST) held in Bermuda from July 1 to July 3, 2004.
Oxiplex/SP Gel is a synthetic, bioabsorbable gel developed by
FzioMed to reduce epidural post-surgical adhesions following discectomy,
laminectomy, and laminotomy procedures in spine surgery. Oxiplex/SP
Gel is approved for sale in the European Union and in certain
countries outside the United States. The product is supplied to
these markets through FzioMed's distribution partners. A pivotal
clinical trial of Oxiplex/SP Gel is underway in the United States.
The study compares healing of a non-critical bone defect filled
with Oxiplex/SP Gel to that of a control group where the defect
is not filled with the gel. Results demonstrate that the presence
of Oxiplex/SP Gel at the site of a bone defect does not inhibit
healing at any time point. The results suggest further study of
Oxiplex/SP Gel for use in preventing epidural adhesions in spine
surgeries where bone fusion is desired. "This preclinical
study, and previous comprehensive work with Oxiplex/SP Gel, support
our goal to expand applications for FzioMed's technology in orthopedic
surgery," said Ronald Haynes, President and CEO of FzioMed.
FzioMed is a privately held medical company engaged in the development
and commercialization of synthetic, absorbable biomaterials based
on the company's patented Oxiplex technology. FzioMed is developing
products for the prevention of post-surgical adhesions, for tissue
healing and augmentation, and for the delivery of drugs. Oxiplex
is an innovative polymer technology with potential uses across
a wide variety of specialties including orthopedics, gynecology,
general surgery, cardiac, neurosurgery and aesthetic surgery.
FzioMed products include Oxiplex/SP, the leading adhesion barrier
for spine surgery, currently marketed outside of the United States.
Other FzioMed products are in various stages of development and
commercialization, and are directed towards high growth markets
in the rapidly growing field of biosurgery materials.
FzioMed® and Oxiplex®
are registered trademarks of FzioMed, Inc.
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