OMRIX receives FDA approval for its liquid fibrin sealant, Evicel, for use in vascular surgery
New York, USA – 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).