Biostage has applied to the U.S. Food and Drug Administration for a new esophageal implant, the Holliston bioengineering firm announced Wednesday.
The company’s investigational new drug application follows what Biostage says was pre-clinical and clinical evidence supporting first-in-human clinical trials.
The proposed new product, the Cellspan esophageal implant, attaches a biocompatible scaffold with a patient’s own cells to create an esophageal implant to potentially be used to treat pediatric esophageal atresia and other conditions impacting the esophagus.
Current options for those with esophageal disease include surgery with high rates of complication and less-optimal quality of life including challenges eating, Biostage said.Â
