AmnioStent - Combining nitinol scaffold with amnion tissue to create a novel airway stent technology for tracheobronchial applications

Peytant Solutions is developing a human amnion tissue cover scaffold, called the AmnioStent™, for the treatment of malignant airway strictures.  The goal of this grant is to conduct sterilization and biocompatibility validation testing of AmnioStent per the FDA Guidance for Premarket Notifications of Esophageal and Tracheal Prostheses and preparation of the FDA 510k application.