Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes
mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United
States and in general worldwide. Foot ulceration is a serious complication of diabetes
mellitus associated with increased risk of infection, gangrene and amputation. These ulcers
are reported to be the leading cause of hospitalization among people with diabetes. Despite
existing ulcer therapies and technologies, there continues to be a great necessity for new
wound healing technologies that will further improve healing rates for these chronic ulcers
that remain a major source of morbidity, concern, and cost. This Phase 3 multinational,
multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell®
in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.

CureXcell® is a cell based therapy obtained from donated whole blood. The blood are
collected from healthy, young adult (age 18-40), the cells separated and then activated by
hypo-osmotic shock.

A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be
randomized to receive either CureXcell® or control.

The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study
biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to
demonstrate safety, tolerability and durability of CureXcell® compared to control.

The study has two phases: a core double-blind phase and a follow up phase.

Inclusion Criteria:

1. Males or females at least 18 years of age with diabetes type 1 or type 2;

2. Patients with HbA1c ≤ 12%;

3. Patients with at least one lower extremity (on or below the malleolus (ankle bone)),
at least full-thickness ulcer (penetrating through the whole layer of the skin),
which has been unresponsive to any treatment for at least 4 weeks;

4. Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free,
non-viable, hyperkeratotic and fibrotic tissue to the extent possible);

5. Ankle Brachial Index ≥ 0.65;

Exclusion Criteria:

1. Patients with more than two ulcers on the same foot or more than a total of three
chronic ulcers;

2. Patients with ulcers primarily caused by venous insufficiency;

3. Patients whose target ulcer has decreased > 25% in size from screening to baseline;

4. Malignancy within the past 5 years excluding successfully treated basal cell
carcinoma;

5. Significantly compromised immunity for any reason including radiation therapy,
chemotherapy or HIV;

6. Current clinical osteomyelitis;

7. Acute Charcot foot;

8. Current sepsis;