A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

A prospective, multi-center, single arm, study of BiZact™ on children and adolescents
undergoing tonsillectomy.

Study Visits:

- Screening/Baseline

- Surgery, Day 0

- Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments)

- Post-Op Follow-up Day 28 (Office Visit)

Inclusion Criteria:

- Children and adolescent subjects 2-21 years of age at the time of the procedure,
inclusive

- Scheduled to undergo tonsillectomy

- The Subject or (if the subject is a minor) Subject's Parent/Legally Authorized
Representative (LAR) is willing to participate and consents to participate, as
documented by signed informed consent form and/ or assent form (as applicable)

Exclusion Criteria:

- Subjects undergoing:

1. Tonsillectomy as a result of cancer

2. Unilateral tonsillectomy

- Subjects with:

1. Known bleeding disorders

2. Current peritonsillar abscess

3. Craniofacial disorders

4. Down's syndrome (Trisomy 21)

5. Cerebral palsy

6. Major heart disease (including but not limited to; right-sided heart failure,
left-sided heart failure, congestive heart failure, coronary artery disease,
arrhythmias, chronic heart failure, acute heart failure, etc.)

7. Current tobacco use

- Subjects unable to comply with the required study follow-up visits

- Female subjects pregnant at time of procedure.

- The subject has comorbidities which, in the opinion of the Investigator, will not be
appropriate for the study or the subject has an estimated life expectancy - The
subject is participating or has participated in any drug or device research study
within 30 days of enrollment.