Natural Vascular Scaffold (NVS) Therapy

This is a prospective, non-randomized, multi-center, open label Phase 1 study to assess the
safety, pharmacokinetics (PK), and preliminary efficacy trends of applying NVS Therapy to de
novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA)
during percutaneous transluminal angioplasty (PTA) in patients with life-style limiting
claudication due to obstructive SFA and proximal popliteal artery atherosclerosis. Each
investigator will receive supervised training for each procedure.

Eligibility to participate in the study is determined during the screening period and prior
to the index procedure. Once a subject has been determined to be suitable for a peripheral
intervention and all general eligibility criteria are met, angiographic eligibility will be
evaluated at the time of the index procedure. Subjects then undergo the procedure with the
NVS Therapy. Study data will be analyzed through the Day 365 follow-up visit.

Inclusion Criteria:

- Subject is at least 18 years of age.

- Subject (or legal guardian) understands the study requirements and the treatment
procedure and provides written informed consent before any study-specific tests or
procedures are performed.

- Subject is eligible for PTA.

- Subject is willing to comply with all protocol required follow-up evaluations.

- Subject has documented Rutherford Classification 2 to 4 (see Appendix 3).

- Subject has laboratory test results that are within clinically acceptable limits.

- In Investigator's opinion, subject is hemodynamically stable at the time of the index
procedure.

- Subject has a life expectancy of ≥1 year in the opinion of the Investigator.

Exclusion Criteria:

- Subject had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within
the past 3 months prior to enrollment.

- Subject has any permanent neurologic defect that may cause non-compliance with the
protocol.

- Subject had an MI within last the 3 months prior to enrollment.

- Subject is pregnant, planning to become pregnant, breastfeeding or planning to
breastfeed in the next 365 days.

- Subject is currently receiving oral or intravenous immunosuppressive therapy (ie,
inhaled steroids are not excluded).

- Subject has known life-limiting immunosuppressive or autoimmune disease (eg, human
immunodeficiency virus, systemic lupus erythematosus, but not including diabetes
mellitus).

- Subject has local or systemic thrombolytic therapy within 48 hours prior to index
procedure.

- Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban,
apixaban, or dabigatran etexilate.

- Subject has known allergies or sensitivities to heparin, aspirin (ASA), or other
anticoagulant/antiplatelet therapies.

- Subject has an allergy to contrast media that cannot be adequately pre-treated prior
to the index procedure.

- Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.

- Subject has documented or suspected liver disease, including laboratory evidence of
hepatitis.

- Subject has renal failure or chronic kidney disease with glomerular filtration rate
(GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation
result of ≤ 30 mL/min per 1.73 m2.

- Subject has white blood cell (WBC) count < (3,000 cells/mm3) within 7 days prior to
index procedure.

- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 ≤ 7 days
pre-procedure.

- Subject has been diagnosed with bleeding diatheses or hypercoagulable state.

- Subject has known or suspected active systemic infection evidenced by WBC > 14.0
(14,000/mm3).

- Subject is currently participating in another investigational drug or device study.

- Subject intends to participate in another investigational drug or device study within
365 days after the index procedure.

- Subject has any surgical procedure or intervention performed within the 30-day period
prior to index procedure.