Biostage's Cellspan Implant an Orphan Drug for restoration of esophagus

|By:, SA News Editor

The FDA designates Biostage's (BSTG +30%) Cellspan Esophageal Implant an Orphan Drug for restoring the structure and function of the esophagus due to cancer, injury or congenital abnormalities.

Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.

The regenerative implant is based on the company's Cellframe technology in which a patient's stem cells, taken from a biopsy of fat tissue, are grown in the lab on a biocompatible scaffold and then implanted at the injury site.

The company expects to file its IND in Q3 2017 followed by the start of a Phase 1 study in Q4.

Shares are up a whopping 44x surge in volume.