Peytant Solutions Inc. is sharing positive pre-clinical results of its AMStent Tracheobronchial Covered Stent System, the first and only stent covered with decellularized human amniotic membrane (DCAM) to receive U.S. Food and Drug Administration (FDA) DeNovo clearance.

During the recent 2025 American Association for Bronchology and Interventional Pulmonology (AABIP) Annual Meeting, Roy Joseph Cho, M.D., associate professor of interventional pulmonology at the University of Minnesota, presented the pre-clinical outcomes demonstrating superior results compared to a commercially available synthetic polymer-covered stent. Additionally, Ashutosh Sachdeva, M.D., associate professor of medicine, director of the interventional pulmonology program, and fellowship director in the Division of Pulmonary and Critical Care at the University of Maryland, featured the AMStent in his presentation “The Future: Novel Airway Stents.”  

The AMStent device is designed to maintain airway patency and restore structure and function of the trachea or bronchial tree in patients with cancerous obstructions while addressing challenges of synthetic-covered stents, which can cause a foreign body response and resulting complications. When compared to a commercially available synthetic-covered stent in a pre-clinical study, the AMStent device demonstrated superior results: It was associated with significantly less mucus buildup, integrating with airway tissue as early as day seven and achieving full integration by day 90. In comparison, 33% of the control stents were fully occluded and showed significant airway complications throughout the study. The AMStents showed no stent migration while the control stents showed frequent migration, caused significantly less inflammation, and restored the epithelial layer’s structure and function. The results were obtained over a 90-day period in a porcine model.

The AMStent is an implantable airway prosthesis, delivered through a minimally invasive catheter system. The expandable tubular device is made of nitinol covered in a decellularized human amniotic membrane (DCAM), made from human amnion using Peytant’s proprietary Zymeric process. Unlike synthetic coverings made of forever chemicals such as expanded polytetrafluoroethylene (ePTFE) or thermoplastic polyurethanes (TPUs), DCAM contains naturally occurring structural proteins like collagen, keratin, fibronectins, and laminins.

“We’re on a mission to fundamentally transform the treatment of luminal diseases using patented, foundational biomaterial technology,” Peytant Solutions Co-Founder/CEO/Board Chair John Schorgl stated. “These results reinforce our belief that the AMStent system has the potential to set a new standard of care.”

Having secured FDA De Novo clearance, Peytant now is preparing to commercially launch the AMStent System in the United States later this year. Future research will explore its potential for other luminal applications, including vascular, gastrointestinal, neurological, and urological systems.

Peytant Solutions is a Minneapolis-based medical technology company focused on improving patient outcomes for luminal blockages. Its AMStent System—combining a human amnion derived covered stent with a minimally invasive catheter delivery system—is the first step in a platform technology with potential applications across multiple specialties.