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September 6,2000
Confluent Surgical, Inc. Begins SprayGelT Adhesion Barrier
System Clinical Trial
BOSTON, Nov. 30 /PRNewswire/ - -Confluent Surgical Inc. announced
today that the Company has begun a clinical trial for the
SprayGelT Adhesion Barrier System.
SprayGel is designed to reduce or eliminate
adhesions after gynecological surgery. Adhesions are a leading
cause of pain, infertility, and other complications following
such surgery. The study is being conducted at two clinical
sites in Europe, and will include up to 50 patients undergoing
surgery for removal of uterine fibroid tumors (myomectomy).
The clinical endpoint of the clinical trial will be the reduction
or elimination of adhesions to the uterus.
"We are pleased to have attained this
important milestone in the development of what promises to
be first truly effective therapeutic approach for the prevention
of post-surgical adhesions" said Amar Sawhney, Ph.D.,
Founder, President, and CEO of Confluent.
Based on proprietary hydrogel technology,
SprayGel consists of two synthetic liquids that when mixed
together rapidly cross-link to form an absorbable biocompatible
hydrogel in situ, at the application. The polymerization occurs
very rapidly (within seconds) with no heat evolved and no
external energy source required (e.g., light or heat source).
SprayGel is sprayed onto tissues using an air-assisted sprayer
that can be used in either laparoscopic or open procedures.
The hydrogel forms a flexible adhesion barrier that is tightly
adherent to tissue, remains intact for about a week, and is
then absorbed. This allows surgically injured tissues to heal
without forming a scar or adhesion with surrounding organs.
"SprayGel is a breakthrough in adhesion
barriers because it can be easily applied laparoscopically
and remains on the tissues where it is applied during the
critical wound healing period." Said Dr. Alain J.M. Audebert,
Gynecologic Surgeon, Institut Robert B. Greenblatt, Bordeaux,
France
Confluent Surgical, Inc. is a privately
held medical device company formed in 1998, that is focused
on developing in-situ polymerized biomaterials to address
unmet or under served clinical needs associated primarily
with the prevention of Post Surgical Adhesions.
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