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FzioMed,
Inc. Announces Initiation of Clinical Trial for Adhesion Prevention
Product in Spine Surgery
SAN LUIS OBISPO, California - February 5, 2001 - FzioMed, Inc.
announced today that it has initiated a clinical trial of the
company's Oxiplex/SP spine surgery product. The U.S. Food
and Drug Administration (FDA) recently approved FzioMed's Investigational
Device Exemption (IDE) application to conduct a multi-center clinical
pilot study of the new product. Oxiplex/SP is a bioresorbable
material that is applied within the surgical site during lumbar
surgery and designed to reduce post-operative peridural scarring,
also known as post-surgical adhesions. Post-surgical adhesions
are a leading complication of many surgical procedures. Over 400,000
patients undergo lumbar surgery in the United States each year.
Ronald Haynes, President and CEO of FzioMed, Inc. said, "The
start of this, our second Oxiplex clinical trial, is a key
milestone in expanding the market potential for FzioMed technology.
There is a great unmet need for an effective anti-adhesion product
in spine surgery and we believe that Oxiplex/SP can be an
important tool for surgeons."
FzioMed is a privately-held biomedical company engaged in the
development and manufacture of bioresorbable products based on
the company's patented Oxiplex technology. Oxiplex
is a unique polymer technology that is formulated for a variety
of targeted medical indications and markets. Products in development
using Oxiplex include those for the prevention of post-surgical
adhesions, hemostasis during surgery, osteoarthritis and drug
delivery. 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 products.
Oxiplex is a registered
trademark of FzioMed, Inc.
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