Our most advanced program is exploring the treatment of ischemic stroke, which represents the leading cause of serious disability in the United States, Europe, Japan, China and many other regions around the world. The potential for MultiStem to treat ischemic stroke is currently being evaluated in a registrational trial in Japan by a collaborative partner, HEALIOS K.K., and in a pivotal Phase 3 clinical trial being conducted by us primarily in North America and Europe under an FDA Special Protocol Assessment, or SPA. In addition, this program received the Fast Track designation, as well as the Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA. These designations are designed to accelerate the development, regulatory review and subsequent commercialization of product candidates like MultiStem cell therapy for ischemic stroke, if the clinical evaluation demonstrates appropriate safety and therapeutic effectiveness.
In recent years, we have advanced several MultiStem programs to the clinical development stage and have also established many preclinical programs through our internal efforts and a broad network of collaborations, where we have worked with investigators at over 30 institutions across the U.S. and Europe.