FDA approves Research Medical's fibrinogen trials:
This article was originally published in Clinica
Executive Summary
Research Medical has received permission from the US FDA to begin human clinical trials of its autologous fibrinogen delivery kit. The trials will comprise an initial 12-15 burn patient pilot study at the University of New York, Stony Brook, followed by an expanded, multi-centre clinical trial. The studies will evaluate the fibrinogen delivery kit as a means of achieving total haemostasis at a surgical site.