A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES® (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)

• Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury.

• The patient has a thermal burn injury that is:

‣ ≤ 30% TBSA (exclusive of superficial areas) and

⁃ ≤ 10% of the burn injury TBSA is a full-thickness burn.

• The Index Burn must be a clean partial-thickness burn injury \> or = to 160 cm2 and between 2-20% BSA (inclusive).

• The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas).

• The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.

• The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary.

• The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.

• In the opinion of the investigator, the patient and/or parent/guardian must be able to:

‣ Understand the full nature and purpose of the study, including possible risks and adverse events,

⁃ Understand instruction, and

⁃ Provide voluntary informed written consent/assent as appropriate for study participation.