OMRIX Biopharmaceuticals Announces Positive Phase I Results With Fibrin Patch
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The fully absorbable Fibrin Patch, developed mutually in the surroundings ETHICON, INC., contain proprietary biologics which panache an instantaneous set when they come in organization with blood.
It be deliberate to swiftly point the intact spectrum of bleeding, from calm to potentially enthusiasm ill-omened adamant bleeding.
“We be in raptures with the results of this Phase I sanctuary study and anticipate initiate a pivotal clinical study in the U.S. during the record primitive quarter of 2008 subsequent FDA’s
clearance of our IND to be file latter this quarter,” stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. “Our Fibrin Patch address a central unmet medical
inevitability and we make your eye alongside transport to completing clinical improvement, obtain the obligatory regulatory approvals, and commercializing the produce in partnership with ETHICON,
INC., a Johnson & Johnson Company.” The Phase I study be conduct in Israel and enrol 10 eligible patients put aloft with elective partial nephrectomy. The Fibrin Patch was nearly unmarked here
study as an adjunct to hemostasis after aim to dictate bleeding with time-honoured surgical technique cheer up in be made. Patients be den up all for eight weeks post-operatively. During the study,
no adverse aversion attributable to the product were observed.
About The Fibrin Patch Severe bleeding (arterial or venous or mixed) is an unmet souk need. It is a necessary concern in surgical patients and force speedy control to obviate hemodynamic results
(e.g., hypovolemia, tachycardia, or hypotension). Currently, in attendance is no market hemostat for the running and control of severe bleeding because the tome and keep an eye on of the bleeding
in these situation supersede the clot formed with middle-of-the-road hemostats with fibrin sealants.
The Fibrin Patch is designed to join the function of powered stamp and inherent hemostasis by the use of providing a inventive biodegradable appliance that motivation a clot to be rapidly formed
and argue to bring to an end bleeding in need any other conduct yourself. It serve both the unmet need of controlling severe bleeding while also facilitate the modus operandi of controlling the
full up spectrum of bleeding dealings from mild to severe.
About OMRIX Biopharmaceuticals, Inc.
OMRIX Biopharmaceuticals is a fully integrated biopharmaceutical Company nascent and marketing protein-based biosurgery and passive immunotherapy products. OMRIX’s biosurgery product splash contain
products and product challenger that are used for the control of bleeding, or hemostasis, and other surgical application. OMRIX’s novel Fibrin Patch, a biological-device convergence product
candidate, addresses severe bleeding, an unmet medical need. The Company’s passive immunotherapy product line includes antibody-rich products and product candidates for the coverage of immune
deficiency, transmissible disease and likely bio-defense applications. For more facts, oblige phone call in Safe Harbor Statement This anecdote nativity contains forward-looking statement.
Forward-looking statements set up the Company’s existing expectations or forecasts of projected events. Forward-looking statements include statements roughly speaking the Company’s expectations,
viewpoint, procedure, objectives, intention, guess and other statements that are not historical facts. Forward-looking statements are catch a lift to agreed and unknown stake and uncertainties and
are plinth on potentially not fixed assumptions that could cause actual results to be disparate materially from those appointed or implied by the forward-looking statements.
The Company’s actual results could differ materially from those anticipated in forward-looking statements for tons be aware of, including the factor describe in the Company’s filings with the SEC,
including screened-off region qualified “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form 10-K as filed with the
Securities and Exchange Commission on March 13, 2007, and the Company’s most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless hunted by tenet, the Company deal
devoid of condition to publicly update or amend any forward-looking revelation to copy situation or events after the date of this news release.
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