Pluristem Ltd. entered into an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech for the use of Pluristem's PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), specifically in two indications: the treatment of Critical Limb Ischemia (CLI), and Intermediate Claudication (IC) in South Korea. Under the terms of the agreement, Cha will perform and fund multiple clinical trials in South Korea for treating CLI and IC using PLX-PAD under the supervision of the Korea Food & Drug Administration (KFDA). Upon the first regulatory approval for a PLX product in South Korea, Pluristem and Cha will establish a joint venture (JV) co-owned by the parties.

The purpose of the JV will be to commercialize PLX cell products in South Korea. According to market research firm Clearstate, 1 million people in South Korea have PAD and the growth forecast for the number of people diagnosed and treated in the country is moderate-to-high. While Cha will bear the costs of conducting the clinical trials for the agreed upon indications, Pluristem will continue to retain rights to its proprietary manufacturing technology and cell-related intellectual property.

Additionally, Pluristem will be able to use the data generated by Cha to pursue the development of PLX product candidates outside of South Korea. The agreement contemplates adding products for indications beyond CLI and IC by mutual agreement and is intended to serve as the foundation of a broad based long-term partnership.