Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to
compare HemoStyp with Surgicel® in the management of bleeding during surgery.

Inclusion Criteria:

1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular
surgery);

2. At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding
present at target bleeding site after primary standard conventional surgical
hemostatic methods are proven to be ineffective or impractical;

3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age
or older; and

4. Subjects or parent or legal guardian of the subject who are willing and able to sign
consent.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation;

2. Indications for emergency surgery;

3. Pre-operative laboratory findings of a hematologic disorder;

4. Subjects with history of moderate to severe allergies;

5. Subjects undergoing minimally invasive laparoscopic surgery;

6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery;

7. Subjects who are pregnant or breast-feeding at the time of surgery; or

8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery,
warfarin or Xa inhibitors not withheld per standard protocols for the management of
anticoagulants pre-operatively.