Biostage receives FDA orphan drug designation for Cellspan Esophageal Implant
Biostage announced that its Cellspan Esophageal Implant was granted Orphan Drug Designation by the U.S. FDA to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities. The company recently provided a regulatory update of its Cellspan esophageal implant following its substantive pre-IND meeting with the FDA. The feedback provided by the FDA to Biostage's proposed clinical protocol for its esophageal implant provided clarity for a clinical path forward for its intended Investigational New Drug application and the advancement into Phase 1 human clinical studies. The company expects to file its IND in the third quarter of 2017 and commence its Phase 1 first-in-human clinical study in the fourth quarter of 2017.