Athersys, Inc. announced that the Company has been granted a clinical Type B meeting with the U.S. Food & Drug Administration (FDA). The Company was previously granted Regenerative Medicine Advanced Therapy (RMAT) and fast track designations for the use of MultiStem in the treatment of ischemic stroke. These designations enable sponsors to work closely with the FDA and receive its guidance on expediting advancement of designated programs. In the Type B meeting with the FDA, scheduled for late March, the Company intends to discuss proposed modifications to the ongoing pivotal Phase 3 MASTERS-2 clinical trial, which is under special protocol assessment (SPA) agreement.

During the upcoming Type B meeting, the Company will bring forward proposed modifications to the MASTERS-2 trial, with the intent of establishing primary and secondary outcomes that best reflect the potential benefit of MultiStem treatment with ischemic stroke patients. The decision to request this meeting was made following data analysis from the Phase 2 MASTERS-1 trial and the more recent Phase 2/3 TREASURE ischemic stroke trial completed by Healios in Japan. Athersys also considered guidance from clinical key opinion leaders on the evolving practices in standard of care for acute ischemic stroke treatment and engaged expert statisticians to confirm the potential of the proposed protocol amendments.

The Company will be hosting a business update call later this morning, February 14th at 11:00 a.m. ET, during which more details will be provided.