Biostage has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, the Cellspan Esophageal Implant (CEI). Biostage filed its IND application to address an unmet medical need where patients requiring surgical treatment of esophageal disease currently face complication rates of over 50%, multiple surgeries, and a less than optimal quality of life. Biostage's technology has the potential to not only avoid multiple complex surgeries, but also improve the patient's quality of life compared to the current standard of care.
"The current esophageal reconstruction options result in high morbidity, meaning that even though patients are expected to live, they are likely to incur lifelong challenges, including eating, while facing the risk of multiple surgeries. Biostage believes the Cellspan implant is not only innovative, but could also potentially provide surgeons with a constructive alternative to treat these underserved patient populations," said CEO Jim McGorry.
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The Company's Cellspan technology combines a proprietary, biocompatible scaffold with a patient's own cells to create an esophageal implant that leverages the body's inherent capacity to heal itself. The CEI is a "living tube" that facilitates regeneration of esophageal tissue and triggers a positive host response resulting in a tissue-engineered neo-conduit that restores continuity of the esophagus.
"We believe our technology has the potential to dramatically improve the lives of patients suffering under current treatments,” McGorry said. “Today marks the culmination of concentrated pre-clinical and regulatory efforts led by Biostage's team of scientists, academics, surgeons, and partners, including a stringent review of the Company's application by a distinguished group of clinical and regulatory experts."
Biostage marks a major milestone with the filing of its IND to the FDA, including submission of pre-clinical and clinical evidence to support first-in-human clinical trials of its innovative technology platform.