The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.

Autologous MSC-NTF cells have received Orphan Drug designation status from the US FDA and the EMA for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm has completed a Phase III pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989).

The USA-based company has also completed, under an investigational new drug application, a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).