The Phase I study was conducted in Israel and enrolled 10 eligible patients undergoing elective partial nephrectomy. The fibrin patch was used in this study as an adjunct to hemostasis after attempts to control bleeding with conventional surgical techniques had been made. Patients were followed up for eight weeks post-operatively. During the study, no adverse reactions attributable to the product were observed. The fully absorbable fibrin patch, developed together with Ethicon, contains proprietary biologics which form an instant clot when they come in contact with blood. It is intended to rapidly manage the whole spectrum of bleeding, from mild to potentially life threatening severe bleeding.
Robert Taub, president and CEO of Omrix, said: “We are pleased with the results of this phase I safety study and anticipate initiating a pivotal clinical study in the US during the first quarter of 2008 pending FDA’s clearance of our IND to be filed later this quarter. Our fibrin patch addresses a significant unmet medical need and we look forward to completing clinical development, obtaining the necessary regulatory approvals, and commercializing the product in partnership with Ethicon, a Johnson & Johnson Company.”