Regenera

Spinal cord injuries, mostly of traumatic origin, affect around 250,000 people each year worldwide, often resulting in permanent neurological impairments, while current therapies fail to address their complex, multifactorial nature. Regenera tackles this challenge with SpinoSave, a proprietary biomaterial hosting autologous stem cells, designed to intervene within the first 24 hours after injury and counteract the cascade of events that follows the lesion.

The European Medicines Agency’s Committee for Advanced Therapies (EMA CAT) has classified SpinoSave as an Advanced Therapy Medicinal Product (ATMP) under the subclassification of Tissue Engineered Product (TEP) (classification no. EMA/CAT/12870/2023, 16.02.2023), and the European Medicines Agency’s Committee for Orphan Medicinal Products (EMA COMP) has granted it orphan designation (classification no. EU/3/24/2909, 16.04.2024). Regenera also received a “Seal of Excellence” from the European Commission as part of the European Innovation Council (EIC) Accelerator Programme.