Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5
and 50% (inclusive) who require autografting will be considered for participation in this
study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device
will be applied over skin grafts meshed more widely than conventional autografting. Healing,
scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up
visits. Data concerning the clinical performance and safety of the ReCell device will be
collected. Safety will be evaluated in terms of treatment and serious related adverse events.

Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study
visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this
study at up to 15 institutions.

It is anticipated that enrollment will continue until PMA approval. Subject follow-up will
continue until the last enrolled subject completes the 24-week visit.

Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e.,
injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or
water).

2. The area of total burn injury is 5-50% TBSA inclusive.

3. Area(s) requiring skin grafting at least 320 square centimeters.

4. The subject is at least 5 years of age.

5. The subject (or family, for those under 18 years of age) is willing and able to
complete all follow-up evaluations required by the study protocol.

6. The subject is to abstain from any other treatment of the wound(s) for the duration of
the study unless medically necessary.

7. The subject agrees to abstain from enrollment in any other interventional clinical
trial for the duration of the study.

8. The subject and/or guardian are able to read and understand instructions and give
informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive
substances.

2. The subject is unable to follow the protocol.

3. The subject has other concurrent conditions that in the opinion of the investigator
may compromise patient safety or study objectives.

4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for
irrigation (Hartmann's) solution.

5. Pregnant or lactating women.