January 28, 2019

Biostage touts results from 2017 operation in advance of FDA filing

Photo | Courtesy
Biostage CEO Jim McGorry.

Holliston biotech Biostage is planning U.S. regulatory filings to begin marketing its esophagus-regenerating implants after a single-patient case in 2017 proved the company's technology works.

Dennis Wigle, chair of thoracic surgery at Mayo Clinic in Minnesota, spoke about the case at the Society of Thoracic Surgeons TechCon 2019 meeting last week.

An elderly, terminally-ill patient previously had a tumor removed from his chest, leaving behind a damaged esophagus. Biostage's technology includes a synthetic tubular scaffold seeded with the patient's stem cells to repair the tissue.

That scaffold was removed three months after surgery, leaving behind a continuous esophageal tube.

After the man died due to an unrelated stroke, an autopsy showed a portion of the esophagus was successfully reconstructed.

Building on that study and backing by the Mayo Clinic and Wigle -- both of which have financial interests in the technology -- Biostage plans an investigational new drug application with the U.S. Food and Drug Administration sometime this year.

The company is seeking to expand its work into the pediatric arena to treat a condition in which infants are born without a complete esophagus.


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