Critical Limb Ischemia

In the United States, there are approximately 1.8 million people living with limb loss and more than 110,000 lower extremities are amputated annually. A majority (82%) of new amputations are performed each year due to complications of the vascular system, especially from diabetes. Lower-limb amputations (LEA) accounts for 97% of all dysvascular limb loss discharges. The rate of dysvascular-related LEA continues to rise. Current surgical procedures to prevent amputation include vascular bypass and non-coronary artery angioplasty.

Arteriocyte is currently conducting pre-clinical studies to assess the potential benefit of ACY001 and ALO212 in lower extremity ischemia. By increasing the blood flow in patients' lower limbs, the Company expects these products may eventually provide benefit to those patients with critical limb ischemia and reduce the risk of amputation. Arteriocyte is compiling necessary data to submit an IND for the FDA in order to evaluate ACY001and ALO212 clinically in this patient population. Plans for phase I clinical safety trials are in development.