- Development of cord blood stem cell therapies in Europe/USA for the treatment of various forms of Pediatric brain injury based on autologous human mononuclear cells. The treatment was developed for but is not limited to the pediatric population.
EMA Committee for Advanced Therapies (CAT)
- Our product was granted ATMP-TEP Classification
EMA Small and medium size enterprise office (SME)
- SME Qualification was first granted on August 20, 2015 (EMA/SME/357/15)
EMA Committee for Medicinal Products for Human use (CHMP)
- Scientific Advice sought in 2017
Food and Drug Administration (FDA)
Department of Health & Human Services
Office of Orphan Products Development
- Request for Orphan drug designation filed.
EMA Committee for Orphan Medicinal Products (COMP)
Orphan Medicinal Products applications were filed in 2016
- After COMP Hearing, a positive opinion was adopted by the Committee and Orphan Drug Designation was granted by the European Commission/EMA on October 14, 2016 for