Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance

The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of
small scars pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars.

In Part A of the study, subjects will have their abdominoplasty site mapped to accommodate a
series of excisions depending on pannus size. All excisions to be treated with SLI-F06 will
be on one side of the mapped area (i.e., left side or right side) and vehicle treated
excisions will be on the other side of the mapped area. At time of abdominoplasty the
excision site will be harvested and processed.

In Part B of the study, subjects who complete Part A will be randomly assigned to receive
injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and
control injections along the other half. The subject will undergo routine wound care and will
attend study follow-up visits following abdominoplasty. The entire incision will be treated
post-operatively in precisely the same manner.

Duration of study-approximately 15 months.

Inclusion Criteria:

1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of
childbearing potential must have a negative UPT at Visit 1a and 1b and practice a
reliable method of contraception throughout the study.

2. Seeking or scheduled for standard elective abdominoplasty.

3. Willing to undergo directed excisions and follow-up prior to abdominoplasty and to
undergo all follow-up visits after abdominoplasty.

4. Willing to undergo directed excisions under local anesthetic

5. Be able to follow study instructions and likely to complete all required visits.

6. Sign the IRB-approved ICF (which includes the Photographic Release Form and HIPAA)
prior to any study-related procedures being performed.

Exclusion Criteria:

1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and
not practicing reliable birth control.

2. Known hypersensitivity or previous allergic reaction to any constituent of the IP.

3. History of diabetes mellitus or an HgB A1C greater than 5.7 percent.

4. Morbid obesity (i.e., BMI >40).

5. History of prior abdominal surgery.

6. History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat
reduction procedures in or near the anterior abdomen within 12 months of baseline.

7. History of poor or delayed wound healing such as a prior wound dehiscence, chronic
wound or leg ulcer.

8. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome.

9. Operating Physician unable to design an abdominoplasty incision area of at least 25 cm
wide by 12 cm tall at the center of the fusiform.

10. The presence of any abnormality of the skin within the area of the proposed
abdominoplasty that, in the opinion of the Principal Investigator (PI), could
interfere with the excision process or grading of the resultant surgical scar.

11. Use of any restricted concomitant medications/procedures or tobacco/inhaled nicotine
products within a restricted time period.

12. Allergy to or intolerance of local anesthetics.

13. Medical or psychiatric conditions that may increase the risk associated with study
participation or may interfere with interpretation of study results or compliance of
the subject and, in the opinion of the PI, would make the subject inappropriate for
study entry.

14. Any personal, familial, employment or financial situation that could impede the
subject's ability to attend all study visits and successfully complete the entire
clinical study.

15. Clinically significant alcohol or drug abuse, or history of poor cooperation or
unreliability.

16. Exposure to any other investigational drug/device within 30 days prior to study entry.