Additional Relevant Details Alternative endpoints considered included (i) Clinically Meaningful Endpoints such as Complete Wound/Ulcer Healing and the 6 Minute Walk Test, (ii) Patient Reported Outcome Measures such as Rest Pain and Quality of Life, and (iii) Surrogate Endpoints such as Ankle Brachial Index, Toe Brachial Index, Transcutaneous Oxygen Pressure, Hyperspectral Imaging, Skin Perfusion Pressure and Blood Oxygenation Level dependent MRI. In the supplement, the Company proposed Transcutaneous Oxygen Pressure (TcPO2) as a surrogate endpoint. TcPO2 is a non-invasive, clinically-accepted method for measuring the amount of oxygen diffused from capillaries through the skin, and reflects both the oxygen supply and the metabolic demand in a specific region. The Company believes that ample clinical evidence exists to support the claim that (i) TcPO2 predicts the risk of major amputation, (ii) endovascular interventions, including cell therapy, increase (improve) TcPO2 values, and (iii) cell therapy significantly reduces the risk of major amputation. The revised Phase III trial design will focus on the mean difference in TcPO2 measured at 12 months between a treatment arm and a control arm. The general design of the study will include 3:1 randomization, a 12 month follow-up program, and Rutherford category 5 CLI patients. The estimated sample size needed to successfully demonstrate safety and a statistically powered efficacy result is 148 patients (100 patients in the treatment arm, 33 patients in the control arm with a further 10% assumed to cover dropouts).