Biostage, Inc. announced the publication of paper establishing the basis for using its product to treat birth defects in the esophagus in babies. The piglets gained weight steadily over the course of the study and eventually tripled their size, showing that the regenerated esophagus grows with the patient. The paper states that current techniques for repairing birth defects in the esophagus, "have significant costs, complication rates, lengthy hospital stays, and significant morbidities.

Therefore, the development of novel approaches that bridge a primary long gap…are highly desired." Dr. Christine Finck, Surgeon in Chief, Connecticut Children's Medical Center, who performed the surgeries, said "this technology has the potential to provide a novel therapy for some of their must fragile patients." Biostage has previously reported on the first-in-human regeneration of an esophagus in an adult cancer patient, performed at Mayo Clinic and published in JTO Clinical and Research Reports in August 2021. That paper concluded that the Biostage Esophageal Implant would have, "considerable clinical use." The FDA has already approved a 10-patient, phase 1/2 clinical trial for repair of the esophagus in adults. The FDA has indicated a willingness to consider expanding the current clinical trial to include pediatric subjects once the safety of the implant is shown in adults.

Hence, they expect the repair of birth defects in the esophagus to be an additional indication for which Biostage will seek FDA approval.