If the request is granted, Holliston, Mass.-based Biostage, formerly know as Harvard Apparatus Regenerative Technology, would win 7 years of market exclusivity after FDA approval, plus tax credits and an exemption from the federal safety watchdog’s drug registration fees.
“This submission is the 1st 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 studies during Q3 and into Q4,” CEO Jim McGorry said in prepared remarks. “Our plan and goal is to file an investigational new drug application with the FDA by the end of the current year. Assuming approval on a normal time-frame, we believe that by this time next year our Cellspan esophageal implant should be in a human clinical pilot study.”
In May, Biostage floated $5 million worth of common stock to fund its R&D efforts. The pre-revenues company reported a net loss of -$2.5 million for the 1st quarter of 2016 and quarterly R&D expenses of $1.4 million. Its cash holding were worth $4.8 million.
The post Biostage files for orphan drug designation for Cellspan artificial esophagus appeared first on MassDevice.
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