Biostage, Inc. announced that it initiated start-up activities for its first clinical trial. 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.
Harvard Apparatus Regenerative Technology Inc.
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- Biostage Initiates Study Start-Up Activities for Clinical Trial in Severe Esophageal Disease