Biostage tries to fast track throat regrowth implants
Holliston biotechnology firm Biostage has filed for a designation that would allow it to fast-track registrations for its Cellspan esophageal implants and gain a full exemption from the U.S. Food & Drug Administration's registration fees.
The Orphan Drug Act of 1983 provides incentives to encourage research to treat rare medical conditions. These include even-year market exclusivity commencing on product approval, tax credits and assistance in regulatory proceedings. To receive orphan drug designation, a company must demonstrate that the condition addressed by the drug or biologic impacts less than 200,000 persons in the U.S.
Biostage is a biotechnology company developing bioengineered organ implants to treat cancers. The Holliston company, formerly known as Harvard Apparatus Regenerative Technology, announced in May that it has already successfully regenerated a segment of esophagus in a study of the implants conducted with the Mayo Clinic using Yucatan pigs.
If regulatory proceedings go as scheduled, human testing of the technology could take place by summer of 2017, Biostage CEO Jim McGorry said in a statement.
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