BioArctic receives regulatory approval in Finland for a clinical study in patients with Complete Spinal Cord Injury
Stockholm, Sweden, July 10, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by Fimea, the Finnish Medicines Agency, and Valvira, the Finnish authority for medical device, as well as the local ethics committee for inclusion of Finnish patients in BioArctic’s ongoing clinical Phase 1/2 study with SC0806. The candidate product is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with complete spinal cord injury. This approval means that BioArctic has received approvals in all the countries