FDA approves BioStage’s esophageal device investigational new drug application

March 25, 2020 By Danielle Kirsh Leave a Comment

Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval.

The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue.

Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was implanted in a 75-year old male patient who had a life-threatening cancerous mass in his chest.

“FDA’s approval of Biostage’s first IND is an extremely important milestone for Biostage as it will transition Biostage into a clinical-stage company. In addition, establishing a safety profile for the CEI in adults will facilitate and support the use of the CEI in Esophageal Atresia patients,” chairman Jason Jing Chen said in a news release. “Esophageal Atresia (EA) is a congenital condition in infants who are born with an incomplete esophagus and are unable to receive oral nutrition. We believe the CEI will be a significant advancement for EA and will provide a treatment option that will hopefully change the standard of care for these infants.”

The approval will allow the company to investigate the safety and feasibility of the implant in adult patients.

“The use of the CEI is an organ saving approach that reserves the esophagus while treating conditions that would otherwise require the use of other organs to repair the diseased tissue,” chief scientific officer William Fodor said. “Our next goal is focused on ‘clinical readiness’ and to build upon our expertise in the clinical application of tissue-engineered and cell-based products,” Fodor said. “This is an exciting time for Biostage to establish itself as a leader in the clinical application of the regenerative medicinal products, such as the CEI, where the product provides the stimulus and the foundation for the body to heal itself.”

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