^aResults shown are from the major surgery trial, which included 13 previously treated adolescent and adult subjects. On the day of their respective surgeries, patients received 1 infusion of Rebinyn^® 80 IU/kg. Postoperatively, subjects received infusions of Rebinyn^® 40 IU/kg at the investigator’s discretion for up to 3 weeks after surgery. Across 13 surgical procedures (9 major)—which included 9 orthopedic, 1 gastrointestinal, and 3 oral cavity procedures—the hemostatic effect during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good hemostasis.

^bIn the surgery study, mean FIX activity following an initial preoperative Rebinyn^® 80 IU/kg dose in 13 procedures was assessed by one-stage assay with product-specific standard. At 8 and 24 hours, one subject who had no FIX activity measurement obtained was excluded. At 48 hours, 2 subjects who had no FIX activity measurement obtained were excluded and 4 subjects re-dosed prior to the second day after surgery for whom FIX activity at 24 hours were 84%, 112%, 131%, and 134%. The FIX activity at 48 hours reflects a measurement on the second day after surgery (range 47-57 hours).

^cRange shaded represents the normal population FIX activity range of 50% to 150%.