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

Inclusion Criteria:

1. Pediatric subjects aged ≥28 days (≥1 month) to <18 years, requiring non-emergentopen hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgicalprocedures; i) A minimum of 4 subjects to be enrolled will be aged ≥28 days to <1year

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

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

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

Exclusion Criteria:

1. Subjects with known intolerance to blood products or to one of the components of thestudy 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 otherinvestigational 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 maypreclude conduct of the study procedure

7. Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery orscheduled to receive COVID-19 vaccine within the 30-day follow-up period

8. Subject with TBS in an actively infected field (Class III Contaminated or Class IVDirty or Infected)

9. TBS is from large defects in arteries or veins where the injured vascular wallrequires repair with maintenance of vessel patency and which would result inpersistent exposure of EVARREST to blood flow and pressure during healing andabsorption of the product

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

11. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bonyconfine.