Biostage, Inc. (Nasdaq:BSTG) just issued a press release on June 29th stating they have just filed for FDA orphan drug designation for Cellspan™ Esophageal Implant. The Orphan Drug Act of 1983 provides a range of incentives to encourage research and development investment in treatments for rare medical conditions. These incentives include seven-year market exclusivity commencing on product approval; tax credits; assistance in regulatory proceedings – fast-track registrations; and full exemption from the FDA's drug registration fees.
CEO Jim McGorry commented, "This submission is the first step in our effort to secure orphan status for our Cellspan esophageal implant, which we believe has the potential to be a valuable option in the treatment of esophageal cancer. The Biostage team is executing on the key initiatives required to advance into human clinical trials for our esophageal implant product candidate, and we remain on track with our plan to conclude its pre-clinical development, to publish our large-animal study results and to execute our related Good Laboratory Practices (GLP) studies during Q3 and into Q4." Read the full press release here: http://ir.biostage.com/2016-06-29-Biostage-Fi...al-Implant