OMRIX Biopharmaceuticals Receives FDA Approval for General Hemostasis in Surgery Indication for Evicel Liquid Fibrin Sealant (Human)

NEW YORK--(BUSINESS WIRE)--Jan 10, 2008 - OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI) announced today that the U.S. Food and Drug Administration has granted an expanded indication for general hemostasis in surgery for EVICEL(TM) Liquid Fibrin Sealant (Human). EVICEL is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

"Although Fibrin Sealants have been commercially available in the U.S. since 1999, their potential remains largely unexplored. FDA approval of the clinical supplement and general hemostasis in surgery indication for EVICEL are important developments as they significantly expand the market potential for this product and bring us closer to our stated objective of creating a one-stop-shop for biological hemostats," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Ethicon, Inc., our marketing partner, will now actively promote EVICEL for a wide range of surgeries."

The approval of the general hemostasis in surgery indication is based on the submission of clinical data related to three pivotal studies conducted in three different surgical procedures with challenging bleeding. The pivotal study included in the last submitted clinical supplement is entitled: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding during Retroperitoneal or Intra-abdominal Surgery.

In this clinical study, EVICEL was shown to be superior to the control product (Surgicel(R), oxidized regenerated cellulose) in achieving hemostasis in less than 10 minutes. Superiority was also established at the secondary efficacy endpoints of 7 and 4 minutes.