Pluristem Therapeutics Inc. announced that the U.S. Food & Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX-PAD cell treatment in patients with Critical Limb Ischemia (CLI). EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need. As part of the program, Pluristem’s PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the U.S. who are unsuitable for revascularization and cannot take part in the Company’s ongoing Phase III clinical study, which is currently enrolling patients in the U.S. and Europe. The Company’s PLX-PAD program has already been selected for accelerated approval pathways in both regions, including the FDA’s Fast Track Designation and the European Medicines Agency’s (EMA) Adaptive Pathways program. CLI is an advanced stage of peripheral artery disease where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Patients with CLI have a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options. Pluristem’s PLX-PAD cell therapy utilizes placental cells to secrete a range of therapeutic proteins that trigger the body’s own repair mechanisms, allowing it to grow blood vessels, bring oxygenated blood to damaged tissue, and heal itself faster.