The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding US Study

This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness
of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for
which standard methods of achieving hemostasis are ineffective or impractical.

Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively
through discharge and at 30 days (+/-14 days) post-surgery.

Enrollment will be staggered by age. The first group will include 31 subjects ≥1 years to <18
years of age and the subsequent group will include 4 subjects from 1 month (≥ 28 days from
birth) to <1 years of age. Ongoing safety assessment will ensure adequate safety monitoring
occur during the staged enrollment.

At least thirty-five (35) qualified pediatric subjects with an appropriate mild or moderate
bleeding TBS will be enrolled in this study.

Inclusion Criteria:

1. Pediatric subjects aged ≥28 days (≥1 month) to <18 years, requiring non-emergent open
hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical
procedures; i) The first 31 subjects to be enrolled will be subjects aged ≥1 years to
<18 years.

ii) The next 4 subjects to be enrolled will be subjects aged ≥28 days to <1 year.

2. The subject's parent/legal guardian must be willing to give permission for the subject
to participate in the trial, and provide written Informed Consent for the subject. In
addition, assent must be obtained from pediatric subjects who possess the intellectual
and emotional ability to comprehend the concepts involved in the trial. If the
pediatric subject is not able to provide assent (due to age, maturity and/or inability
to intellectually and/or emotionally comprehend the trial), the parent/legal
guardian's written Informed Consent for the subject will be acceptable for the subject
to be included in the study.

3. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma
Target Bleeding Site (TBS) identified intra-operatively by the surgeon;

4. Ability to firmly press trial treatment at TBS until 4 minutes after TBS
identification.

Exclusion Criteria:

1. Subjects with known intolerance to blood products or to one of the components of the
study product or is unwilling to receive blood products;

2. Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;

3. Subject is currently participating or plan to participate in any other investigational
device or drug study without prior approval from the Sponsor;

4. Subjects who are known, current alcohol and/or drug abusers

5. Subjects admitted for trauma surgery

6. Subjects with any pre or intra-operative findings identified by the surgeon that may
preclude conduct of the study procedure.

7. Subject with TBS in an actively infected field (Class III Contaminated or Class IV
Dirty or Infected)

8. TBS is from large defects in arteries or veins where the injured vascular wall
requires repair with maintenance of vessel patency and which would result in
persistent exposure of EVARREST to blood flow and pressure during healing and
absorption of the product;

9. TBS with major arterial bleeding requiring suture or mechanical ligation;

10. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
confine.