Airiver Medical, a clinical stage company developing technologies for respiratory tract conditions, has won investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to being a pivotal clinical trial of its Airiver pulmonary drug-coated balloon (DCB) to treat central airway stenosis.

Central airway stenosis (or airway narrowing) can be associated with prolonged intubation, tracheostomy, stenting, tuberculosis, or lung transplant. There are about 100,000 tracheo-bronchial stenting and dilation procedures done in the U.S. each year.

The Airiver DCB combines standard balloon dilation to open the respiratory tract with delivery of a proprietary drug that’s designed to maintain symptom relief and prevent recurrence. The trial, which will enroll up to 200 patients with central airway stenosis, will test the Airiver DCB against standard of care balloon dilation.

The study will be the basis for the company’s regulatory submission to the FDA, and subsequent commercialization in the U.S.

“As it stands, there is no optimal treatment of recurrent airway stenosis available as part of today’s treatment paradigm,” said Lixiao Wang, founder, CEO, and chief technology officer for Airiver Medical. “Securing IDE approval for this study is extremely exciting because the Airiver DCB has the potential to establish a new minimally invasive and durable treatment option preventing recurrence for patients suffering from this serious condition, which has not yet been accomplished.”