Clinical Development

The hemostatic effects of Fibrocaps™ have been investigated in a number of animal models. Preclinical studies have included liver biopsies and liver resection in pigs. The porcine model has been widely used in the evaluation of new hemostatic treatments and is considered predictive for outcomes in human clinical trials.

The efficacy of Fibrocaps was assessed by determining the time to hemostasis in  surgical wound bleedings. 




A proof-of-concept Phase-II study in a number of patients undergoing liver resection was recently concluded at several hospitals in the Netherlands. The main objectives were to assess the safety of Fibrocaps and to monitor its effectiveness, which is measured as the time required to achieve hemostasis. The data showed efficacy and safety profiles, as well as performance of the delivery device for mild and moderate bleeding during liver surgery.

A subsequent Phase-III pivotal trial in several hundred patients is scheduled to start in 2010 in Europe and/or the United States. In this trial Fibrocaps will be used in a number of surgical indications. Results from the pivotal trial are expected in 2011, and are expected to suffice for regulatory filings in both the U.S. and the EU.