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Enrollment in Phase III Clinical Trial for OMRIX's Thrombin Stand-Alone Product Has Been Completed.


NEW YORK -- --OMRIX's Thrombin thrombin: see blood clotting.  Being Developed for Use in General Surgery; Company on Track to File BLA BLA
abbr.
Bachelor of Liberal Arts
 in Q4 2006 --

OMRIX Biopharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: OMRI) announced today that patient enrollment in the multi-center, Phase III pivotal trial for the Company's Thrombin stand-alone product candidate has been completed. OMRIX's Thrombin stand-alone, which is derived from human plasma, is designed to provide effective hemostasis (control of bleeding) without the risk of adverse reactions associated with the use of bovine-sourced hemostats hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis . OMRIX's Thrombin will be available in a frozen liquid form making it ready for immediate use without the need for re-constitution. While the product will have a two year stability, it can be stored liquid in the operating room refrigerator for 30 days. Currently, the only stand-alone thrombin product available in the U.S. is a bovine-based lyophilized ly·oph·i·lize  
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).



[lyophil(ic) + -ize.
 product.

Robert Taub, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of OMRIX Biopharmaceuticals, Inc., stated, "Today's announcement is aligned with our strategy to build the most comprehensive and competitively differentiated franchise in biosurgery, particularly in the area of hemostasis. Together with, ETHICON, Inc., our distributor with whom we developed thrombin, we look forward to bolstering our leadership position in this growing area. Furthermore, we are pleased to be on track to file our BLA the fourth quarter of this year."

About the Study (A Comparative Evaluation of Human Thrombin versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (spine) and General Surgery Procedures)

The study is a Phase III pivotal, multi-center, prospective, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, controlled, double-blinded trial comparing thrombin topical (human) to bovine thrombin in achieving intra-operative hemostasis during cardiovascular, neurologic (spine) and general surgery procedures. A total of 304 patients were enrolled in the trial. The Company's target indication for this study is general hemostasis.

About OMRIX's Biosurgery Franchise: Defining the Marketplace

The Company's biosurgical franchise is comprised of three distinct commercial opportunities: liquid fibrin sealants (a type of surgical tissue adhesive whose ingredients interact during application to form a stable clot) used by surgeons as an adjunct to conventional surgical techniques; human thrombin (an enzyme that facilitates blood clotting by reacting with fibrinogen Fibrinogen

The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion
) often used by surgeons in combination with gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. , such as Ethicon Surgiflo(TM) or other passive hemostat hemostat /he·mo·stat/ (he´mo-stat)
1. a small surgical clamp for constricting blood vessels.

2. an antihemorrhagic agent.


he·mo·stat
n.
1.
 products in a tamponade tamponade /tam·pon·ade/ (tam?po-nad´)
1. surgical use of a tampon.

2. pathologic compression of a part.
 fashion; and the Biological Hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik)
1. causing hemostasis, or an agent that so acts.

2. due to or characterized by stasis of the blood.


he·mo·stat·ic
adj.
 Dressing, BHD BHD

In currencies, this is the abbreviation for the Bahraini Dinar.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
, (a convergence biological-device product that combines the efficacy of a biodegradable hemostatic mechanical barrier with the potency of human-derived biological components to promote the rapid formation of a clot at the site of a brisk bleeding wound).

About OMRIX Biopharmaceuticals, Inc.

OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and passive immunotherapy products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain of its biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX's novel and easy-to-use biological-device convergence products address unmet medical needs. For more information, please visit: www.omrix.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as ''anticipate,'' ''believe,'' ''continue,'' ''ongoing,'' ''estimate,'' ''expect,'' ''intend,'' ''may,'' ''plan,'' ''potential,'' ''predict,'' ''project'' or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking.

Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the sections entitled ''Risk factors'' and "Management's discussion and analysis Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
 of financial condition and results of operations" in the company's Prospectus as filed with the Securities and Exchange Commission on April 21, 2006. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this press release.

Unless required by law, the company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports the company will file from time to time with the Securities and Exchange Commission after the date of this press release.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 26, 2006
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