Biostage Initiated Study Start-up Activities for Clinical Trial in Severe Esophageal Disease

HOLLISTON, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, today 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.

Further details of the study are posted on clinicaltrials.gov.

“Every day counts. We have been working at an unprecedented pace together with our partner IQVIA biotech to accelerate the activation of first site for the trial,” said Jerry He, Chairman of the Board and Chief Executive Officer, “We believe our regenerative solution could provide profound benefits for patients in critical need of new treatment options. We look forward to advancing this exciting platform technology and bringing new treatments to the market.”

In April 2023, the Company announced a $6 Million financing to advance the clinical trial and accelerate the development of new pipeline.

About Biostage.

We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.

We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Denis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.