“Receiving RMAT designation is a significant milestone for NG01 and, most importantly, for the MS patient community,” said Tal Gilat, CEO, NeuroGenesis Bio. “Secondary Progressive MS is a debilitating condition with a profound unmet need for therapies that go beyond merely slowing decline. This designation validates our substantial human data collected from over 120 patients and allows us to work closely with the FDA to accelerate delivery of NG01 to patients who desperately need therapies that can promote repair and improve function”.

Dr. Andrew Goodman, Professor of Neurology at the University of Rochester, NY, and world-renowned key opinion leader in MS care, added: “The clinical data for NG01 demonstrates comprehensive benefit across multiple outcomes. By bypassing the blood-brain barrier via intrathecal delivery, we are seeing not only stabilization and reduction in critical neurodegenerative biomarkers, but also functional improvement. This RMAT designation recognizes the strong scientific foundation of this novel approach.”