Biostage, Inc. announced that it officially activated the site with Mayo Clinic for its clinical trial as to severe esophageal disease, being its first clinical trial in the United States. The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus (including cancer, trauma or birth defects) at up to five hospitals in the U.S. The primary endpoint is the development of a continuous biological neo-conduit at three months following implantation.
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- Biostage, Inc. Activated Mayo Clinic as the First Site for Clinical Trial in Severe Esophageal Disease