Clinical Development
The hemostatic effects of Fibrocaps™ are under development in many areas. 
Fibrocaps is being developed under the general FDA guidelines that support marketing of fibrin sealant products manufactured for commercial use (FDA Guidance for Industry, “Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use”, Center for Biologics Evaluation and Research, May 1999) and CHMP Guidelines on the clinical investigation of plasma-derived fibrin sealants. The clinical safety and efficacy of Fibrocaps have been evaluated in two Phase 2 studies in surgical indications where adjuncts to hemostasis are required to control bleeding: Study FC-002 US enrolled subjects undergoing spinal surgery, peripheral vascular surgery (i.e., peripheral arterial bypass surgery and arteriovenous graft formation for hemodialysis access) and general surgery, while Study FC-002 NL enrolled subjects undergoing major hepatic resections. A single, pivotal, international Phase 3 trial consisting of four different individually-powered surgical indications has been designed. ProFibrix plans to conduct an international, multi-center, pivotal Phase 3 study entitled “A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis (FINISH-3)”.
