SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

Major Inclusion Criteria:

- Age 18 to 85 inclusive, currently receiving standard of care wound treatment for
chronic wounds or gangrene including as indicated: debridement, pressure offloading,
infection control, and/or maintenance of a moist wound environment.

- Diagnosis of advanced peripheral artery disease (PAD) with tissue loss (ulceration
and/or dry gangrene)

- Post intervention inclusion criteria include a successful open bypass grafting or
endovascular intervention of an infrapopliteal lesion(s) on the same leg that has
tissue loss without significant improvement in toe brachial index (TBI) post
intervention. The following will be accepted as demonstrating a lack of post
intervention toe brachial index (TBI) improvement:

- toe brachial index (TBI) ≤ 0.51

- Toe pressure < 50 mmHg with flat or dampened wave forms

- Skin Perfusion pressure < 40 mmHg at mid foot level

Major Exclusion Criteria:

- Previous major amputation of the leg to be treated or planned major amputation or
transmetatarsal amputation within the first month following enrollment.

- Only a short segment superficial femoral artery lesion - consistent with
Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A
or B category, and no infrapopliteal disease

- Staged or planned intervention in the index leg within 30 days after the index
procedure

- Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease

- Non-salvageable limb defined as major tissue loss and an unsalvageable foot;

- Clinical evidence of invasive infection in the index leg

- Inability to safely perform a revascularization procedure due to uncontrolled
diabetes or other medical condition.