Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns

This Phase 1 Study is a 2 cohort, open-label, non-randomized trial, to assess the safety and
tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full
thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive
wound closure.

Subjects who meet eligibility criteria and provide informed consent will receive placement of
Xeno-Skin™ on a single burn wound site.

Inclusion Criteria:

1. The subject or, when applicable, the subject's legally authorized representative,
provides written informed consent to participate in this study

2. Age greater than 18 years old

3. Male or female of non-childbearing potential. Females must be:

a. Naturally postmenopausal defined as ≥1 year without menses and: i. ≥55 years, or
ii. <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L; or iii. Surgically
sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation.

4. Total Burn Surface Area (TBSA) <30% to include deep partial thickness or full
thickness burn wound

5. Burn injury requiring excision

6. Burn injury requiring temporary allograft coverage of wound based on clinical
judgement prior to definitive wound closure with autologous skin grafts

7. Sufficient area of burn wound for Xeno-Skin™ placement, not previously treated with
allograft, and not located on face or hands.

Exclusion Criteria:

1. Pregnant or lactating women

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

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

4. Known allergy to penicillin, aminoglycosides (such as streptomycin) or amphotericin B.

5. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation
in the past 5 years. Non-metastatic basal or squamous cell carcinoma of the skin and
cervical carcinoma in situ are allowed

6. Use of any experimental or investigational drugs within 30 days prior to placement of
Xeno-Skin™

7. Previously received a porcine or other xenogeneic tissue product, including but not
limited to:

glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and
glutaraldehyde fixed porcine dermal matrix

8. BMI > 40 kg/m2

9. HbA1c ≥ 7.0%

10. Treatment with systemic corticosteroids within 30 days before screening (not including
inhaled steroids)

11. Electrical or chemical burns

12. History of chronic end stage renal disease defined as an MDRD CrCl < 15 mL/min, or
receiving chronic dialysis

13. History of chronic liver disease or cirrhosis (Child-Pugh Score C). Evidence of acute
or chronic hepatitis B infection based on documented HBV serology testing

14. Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum,
Cytomegalovirus, herpes or varicella zoster Note: Successfully treated hepatitis C
patients without evidence of end stage liver disease is allowed. If HCV antibody
reactive, then HCV RNA must be undetectable.

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

16. Presence of venous or arterial vascular disorder directly affecting the area of burn
wound

17. Pre-existing haemolytic anemia

18. Chronic malnourishment as determined by Investigator

19. Significant pulmonary compromise

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

21. Documented evidence of wound infection prior to treatment

22. Evidence of sepsis and/or end organ damage

23. Acute lung injury

24. Life expectancy of less than 180 days