#United States #Chronic Rhinosinusitis #Brooklyn Park #Airiver Medical #Drug Coated Balloon

Airiver Medical's Pivotal Breakthrough in Chronic Rhinosinusitis Treatment

Brooklyn Park, Minn. – December 9, 2025 – Airiver Medical, a pioneering clinical stage company focused on innovative technologies for respiratory conditions, has made a significant leap toward revolutionizing treatment for chronic rhinosinusitis (CRS). With the recent approval from the U.S. Food and Drug Administration (FDA) to conduct a pivotal clinical trial for its Airiver ESSpand Sinus Drug Coated Balloon (DCB), the company aims to change the lives of many suffering from this debilitating condition.

Chronic rhinosinusitis is defined as ongoing inflammation of the nose and paranasal sinuses, persisting for at least three months and affecting millions across the globe. Sufferers often endure severe symptoms ranging from persistent nasal congestion to facial pain, and many resort to surgery when medication fails. However, these surgical solutions only provide temporary relief, and symptoms frequently return, leading to additional procedures.

The Study and Its Importance

The upcoming study will enroll up to 300 patients with CRS, encompassing cases both with and without nasal polyps. Spanning multiple locations across the United States, this trial will assess the safety and efficacy of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The innovative design of the ESSpand DCB features a specialized paclitaxel drug coating, delivered concurrently with standard balloon dilation, aimed at maintaining long-term relief by preventing scarring and re-narrowing of the sinus passages.

Lixiao Wang, the visionary founder and CEO of Airiver Medical, expressed excitement about this major advancement: “Securing IDE approval for this study means we are one step closer to being able to offer chronic rhinosinusitis patients a treatment option that has the potential to finally give them the long-term relief they've been waiting for with fewer treatments.” Wang’s commitment to transforming the landscape for CRS patients reflects the urgent need for effective long-term solutions in a field often characterized by inadequate results.

A New Era for CRS Management

The impact of this study holds the promise for a major shift in managing chronic rhinosinusitis. The ESSpand DCB represents an exciting advance that could provide sustained openness in the sinus pathways, contributing to improved patient outcomes. If successful, the findings from this pivotal study will lay the groundwork for regulatory submission to the FDA and the eventual availability of the ESSpand DCB in the United States market.

The Airiver DCB remains an investigational device at this time, which means it has not yet received marketing authorization from the FDA and is still unavailable for sale in the U.S. However, as regulatory pathways are pursued, the implications for patients suffering from chronic rhinosinusitis could be profound.

About Airiver Medical

Founded with the mission to enhance care for patients with respiratory conditions, Airiver Medical is dedicated to developing groundbreaking technologies that redefine treatment possibilities. The company’s focus on chronic rhinosinusitis and central airway stenosis aims to fill gaps in current therapeutic approaches, providing patients with real hope for better health outcomes.

In summary, Airiver Medical's receipt of FDA IDE approval marks not just an achievement for the company, but a critical moment in the journey towards more effective interventions for CRS. The full-scale clinical trial is set to usher in a new era of possibilities for patients who have long suffered in silence. For more information on Airiver Medical and its innovative approaches, please visit www.airiver.com.