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FDA Clears Pluristem’s Expanded Access Program to Initiate Treatments of Critical Limb Ischemia Outside of Ongoing Phase III Study


HAIFA, ISRAEL, January 9, 2018 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food & Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLXPAD 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

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. “This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem and its shareholders. It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study,” said Yaky Yanay, Co-CEO and President of Pluristem. “We are hopeful that the FDA may also allow us to be compensated for the costs of treatment, which can support our work developing effective cell therapies for millions of patients worldwide.” 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.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion
technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.


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