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Mayo Clinic Chosen as Primary Clinical Trial Site for Biostage's Novel Approach to Severe Esophageal Disease

Wednesday, July 19, 2023

Biostage, Inc. (OTCQB: BSTG), a clinical-stage biotechnology company dedicated to developing organ regeneration technology for the treatment of severe diseases, including cancer, trauma, and birth defects, has officially activated the Mayo Clinic as its first clinical trial site in the United States. The trial will focus on treating severe esophageal disease using Biostage's innovative approach.

According to Jerry He, Chairman, and CEO of Biostage, the initiation of their first clinical study for the esophageal implant represents a significant milestone for the company. He emphasized that their technology has demonstrated promising results in preclinical studies, making it a potential effective platform for tubular organ regeneration. The company is eager to evaluate the efficacy and safety of the esophageal implant in clinical settings to understand its potential benefits for patients.

Dr. Shunfu Hu, VP of Operations and Business Development, expressed excitement about the clinical trial, emphasizing that after years of collaboration with Mayo Clinic, their innovative organ regeneration platform is now being evaluated for clinical use and patient recruitment in the United States.

The Phase 1 clinical trial, approved by the FDA, aims to assess both safety and efficacy in up to ten patients who require the removal of up to 6 cm of their esophagus due to conditions such as cancer, trauma, or birth defects. The primary endpoint of the study is the development of a continuous biological neo-conduit three months after the implantation of the esophageal implant.

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