Fibrocaps: Phase II data

The single-blind, U.S. Phase II FC-002 US trial in 70 patients undergoing spinal, peripheral vascular or general surgery showed that topical Fibrocaps followed by the Gelfoam absorbable gelatin sponge met the primary endpoint of reducing mean time to hemostasis vs. Gelfoam alone (1.9 vs. 4.8 minutes, p<0.001). Fibrocaps followed by the Gelfoam also met the secondary endpoints of significantly reducing the incidence of hemostasis at 3, 5 and 10 minutes vs. Gelfoam alone (p<0.001, p=0.001 and p=0.003, respectively). Fibrocaps was safe with no adverse events attributed to the product. ...