OMRIX Biopharmaceuticals Receives Food and Drug Administration (FDA) Approval for Liquid Fibrin Sealant, Evicel(TM), For Use in Vascular Surgery
- Category: Proteins and Peptides
- Published on Wednesday, 16 May 2007 04:00
- Hits: 2138
NEW YORK, NY, USA | May 15, 2007 | OMRIX Biopharmaceuticals, Inc. (“OMRIX” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, announced that on May 9, 2007, the U.S. Food and Drug Administration, or FDA, approved its supplemental Biologics License Application, or sBLA, to market its liquid fibrin sealant, Evicel(TM), in vascular surgery.
“We are expanding the commercialization potential of our hemostasis franchise with Evicel’s expanded indication in vascular surgery, stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. “We are also one step closer to obtaining a general hemostasis in surgery indication for Evicel, and reaching our stated objective of creating a one-stop-shop for biological hemostats.”
Ethicon, Inc., the Company’s marketing partner, will actively promote Evicel’s vascular indication to surgeons for procedures where a vascular anastomosis or reconstruction is performed. Specifically, in addition to liver surgeons, Evicel will be marketed to peripheral vascular surgeons, cardiac surgeons (specifically for vascular components), plastic surgeons performing microvascular anastomoses, transplant surgeons (when blood vessels are connected), and trauma surgeons performing vascular repair.
The Company believes that the vascular surgery market is approximately twice the size of the market previously addressed with Evicel’s indication in liver surgery. The approval of Evicel with a general hemostasis in surgery indication is expected in the first quarter of 2008 (1Q08).
About EVICEL* Fibrin Sealant (Human)
Evicel is safe, effective, and the only commercially available bovine, and aprotinin-free, fibrin sealant. It is fast (ready to use in less than one minute after thawing) and forms a clear, stable clot that anchors firmly to the bleeding site. Evicel is currently indicated as an adjunct to hemostasis for use in patients undergoing liver or vascular surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.
About OMRIX Biopharmaceuticals, Inc.
OMRIX Biopharmaceuticals is a fully-integrated biopharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. OMRIX’ biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. OMRIX' 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 treatment of immune deficiencies, infectious diseases and potential bio-defense applications. For more information, please visit: www.omrix.com.
Safe Harbor Statement
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. 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 company’s filings with the SEC, including sections entitled "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 required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this press release.
SOURCE: OMRIX Biopharmaceuticals, Inc.