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Evicel™
We have been developing our next generation fibrin sealant, Evicel™,
in collaboration with Ethicon. Evicel™ differs from Quixil®
in that it does not contain an antifibrinolytic stabilizing agent
in the Biologically Active Component. The presence of this agent
resulted in Quixil® being contraindicated for surgical procedures
involving direct contact with Cerebro Spinal Fluid and/or Dura Mater.
Evicel™ has been submitted to the European Authorities for
its approval for a general hemostasis indication in July 2007.
Fibrin Patch
In collaboration with Ethicon we are currently developing an innovative
fibrin patch that builds on our Evicel™ technology. This next
generation product combines mechanical and biological action and
is designed for rapid control of bleeding, including severe or brisk
bleeding, and for use on active bleeding sites.
Brisk bleeding is a serious concern in surgical patients. This
type of bleeding is difficult to control and is characterized by
fast flow and high pressure. There is no surgical sealant currently
available to induce the rapid formation of a clot at a brisk bleeding
site because the volume and pressure of the bleeding in these situations
displaces the clot made by other surgical sealants. Currently, the
successful closure of such wounds depends solely on the skill and
speed of the surgeon. Our fibrin patch is designed to address this
unmet clinical need.
Our fibrin patch is comprised of our Biologically Active Component
and thrombin embedded in a biodegradable matrix. The biodegradable
matrix acts as an immediate physical barrier to stop bleeding, while
the biological components generate a rapid response resulting in
the formation of a clot. The matrix degrades over a period of approximately
2 months.
We have conducted several successful pre-clinical tests in laboratory
animals with our fibrin patch and have completed a Phase I safety
study in Israel in partial nephrectomy procedures with no particular
safety concerns raised with relation to the product.
To view a wet lab demonstration of the Fibrin Patch being used in
pre-clinical studies please click
here.
ADHEXIL™
We are currently developing our ADHEXIL product for prevention of
adhesions. A phase I/II clinical trial has been initiated to evaluate
safety and efficacy of Adhexil in preventing and/or reducing post-operative
adhesions in patients undergoing gynecological surgery.
Adhexil is delivered in a kit containing a human, fibrin-based, absorbable,
adhesion barrier. Adhexil can be sprayed on surfaces most at risk
for adhesions at the end of the surgical procedure. The product produces
a fibrin coating that is naturally degraded by endogenous fibrinolytic
enzymes within 14 days.
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