Healthcare Industry News: thrombin
News Release - July 10, 2006
OMRIX Biopharmaceuticals Receives FDA Approval for Second Generation Fibrin Sealant, Evicel(TM), For Use in Liver SurgerySubmits Evicel Phase III Study to FDA for Expanded Indication in Peripheral Vascular Surgery
Company Advances Expanded General Hemostasis Surgery Indication and Leadership Position in Surgical Hemostasis Market
NEW YORK--(HSMN NewsFeed)--July 10, 2006--OMRIX Biopharmaceuticals, Inc. ("OMRIX" or "The Company") (NASDAQ: OMRI ), a commercial-stage biopharmaceutical company that develops and markets biosurgical and passive immunotherapy products, announced today that it has been granted marketing clearance from the U.S. Food and Drug Administration (FDA) for its second generation fibrin sealant, Evicel(TM), to control bleeding (hemostasis) during liver surgery. Evicel differs from OMRIX's first generation fibrin sealant, CrossealŽ, in that Evicel does not contain a stabilizer, and therefore will not have the neurosurgical contraindication required of Crosseal.
The Company also announced that it submitted a Prior Approval Supplement (PAS) to the FDA containing the results of a prospective, randomized multi-center Phase III controlled study comparing the hemostatic efficacy of Evicel to standard-of-care in peripheral vascular surgery in 150 patients. The first subject was randomized on June 9, 2005 and the last subject completed the study on March 29, 2006. OMRIX submitted this PAS in order to expand the indication of Evicel to include vascular surgery.
"Together with our distributor, ETHICON, Inc., we are re-defining the hemostasis market," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Uncontrolled surgical bleeding is a severe clinical issue. We are poised to provide today's market with the safest and most technically superior products that address the need for effective and quick hemostasis."
Mr. Taub continued, "An indication for general hemostasis requires the completion of at least three pivotal clinical studies, of which we have now completed two -- liver and peripheral vascular surgery. A 150 patient study in kidney surgery is currently underway. The achievement of today's strategically important milestones provides a foundation on which to expand the commercialization potential of our hemostasis franchise, and brings us one step closer to a general hemostasis label of Evicel, our liquid fibrin sealant. We look forward to announcing additional validating events for Evicel and our other biosurgical products: thrombin and Biological Hemostatic Dressing, or BHD."
Evicel's Competitive Advantages
Evicel is unique in its ease of use, immediate availability to the surgeon and in its bovine-free formulation. It provides for important hemostasis support when conventional surgical techniques (i.e., suture, ligature, and cautery) prove to be inefficient, ineffective or impractical. When compared to the already successful Crosseal, Evicel does not require the addition of the stabilizing agent Tranaxemic Acid.
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.
Safe Harbor Statement
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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 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.
Source: OMRIX Biopharmaceuticals
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