Netherland-based ProFibrix has announced the completion of patient enrolment in pivotal Phase III trial with Fibrocaps (FINISH-3).
The multicentre, randomised, single-blind study enrolled around 718 surgical patients with mild to moderate surgical bleeding.
Phase III trial is designed to assess efficacy of Fibrocaps compared to gelatin sponge within four surgical indications and to confirm safety results from the Phase II Fibrocaps trials.
ProFibrix chief executive officer Jan said, "Based on the very positive response from the surgical community throughout our Phase III trial, we are confident that Fibrocaps will be able to rapidly capture a substantial share of the topical hemostat market, which is currently at US$ 1 billion and growing."
Fibrocaps formulated as a unique dry powder topical fibrin sealant constitutes two essential blood clotting proteins, fibrinogen and thrombin.
Final study results are expected in 2013.
