Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

Inclusion Criteria:

1. The subject, or the subject's legally authorized representative (LAR), provideswritten informed consent to participate in this study

2. Males or females age greater than or equal to 18 years old

3. Total Burn Surface Area (TBSA) <50% to include mixed depth and full-thickness burnwounds as defined as "primarily full-thickness (FT) and deep-partial (DPT) thermalburns (e.g. >60% of the total burn area should be FT and DPT) before debridement",and full-thickness burns for which surgical intervention is clinically indicated

4. Having a mixed depth thermal burn wound including full thickness requiring skingrafting

5. Biological females must have a negative serum pregnancy test at Screening and mustnot be nursing

6. All subjects must agree to use a protocol-approved method of contraception for aminimum of 3 months following realSKIN placement, which includes a barrier methodplus one or more of the following:

• Hormonal contraceptives (e.g., birth control pills, skin patches, vaginalrings, and the Depo-Provera shot)

• Intrauterine device (IUD)

• Male or female condoms with spermicide

• Diaphragm with spermicide

• Permanent tubal occlusive birth control system

7. Sufficient area of burn wound for realSKIN and comparator autograft placement to notbe located on face or hands or having a target graft site centered on high-impactareas such as joints, weight-bearing areas (e.g. soles of feet), or the inguinalregion, per Investigator's judgment

Exclusion Criteria:

1. Pregnant or lactating women

2. Documented history of infection with human immunodeficiency virus (HIV) or othercondition(s) that in the opinion of the Investigator may compromise patient safetyor study objectives

3. Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (>10mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine,tacrolimus), anti- proliferative agents, and other immunomodulators

4. Active malignancy, including those requiring surgery, chemotherapy, and/or radiationin the past 5 years; non-metastatic basal or squamous cell carcinoma of the skin andcervical carcinoma in situ are allowed

5. Use of any experimental or investigational drugs within 30 days prior to placementof realSKIN

6. Previously received a porcine or other xenogeneic tissue product, including but notlimited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valvereplacements and glutaraldehyde fixed porcine dermal matrix (e.g., EZ Derm)

7. Patients with advanced or unstable/uncontrolled comorbid conditions, such asadvanced renal disease, diabetes mellitus and liver disease

8. Patients with HbA1c ≥ 10.0%; specimen must be obtained for screening purposes ifcurrent (within past 3 months) value is not available

9. Patients with a history of chronic end stage renal disease defined as MDRD CrCL < 15mL/min or receiving chronic dialysis

10. Patients with a history of chronic liver disease or cirrhosis (Child-Pugh Score C);evidence of acute or chronic hepatitis B infection based on documented HBV serologytesting

11. Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum,Cytomegalovirus, herpes or varicella zoster; note: Successfully treated hepatitis Cpatients without evidence of end stage liver disease is allowed; if HCV antibodyreactive, then HCV RNA must be undetectable

12. Recent (within 3 months prior to study enrollment) MI, unstable angina leading tohospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting,cerebrovascular accident, transient ischemic attack, endovascular procedure, orsurgical intervention for peripheral vascular disease or plans to undergo a majorsurgical or interventional procedure (e.g., PCI, CABG, carotid or peripheralrevascularization)

13. Presence of venous or arterial vascular disorder directly affecting the area of burnwound

14. Pre-existing haemolytic anemia

15. Chronic malnourishment as determined by Investigator

16. Inhalation injury as determined by bronchoscopic exam if available, or diagnosis atthe time of screening

17. Systemic anticoagulation at the time of treatment or INR > 2

18. Documented evidence of wound infection at Screening

19. Evidence of sepsis at Screening