BROOKLYN PARK, Minn., June 11, 2026
Airiver Medical has announced the successful treatment of the first patient in its pivotal RESTORE-2 U.S. clinical trial, evaluating the investigational ESSpand Sinus Drug Coated Balloon (DCB) for patients suffering from chronic rhinosinusitis (CRS). The milestone marks a significant advancement in the development of a novel therapy designed to improve outcomes following endoscopic sinus surgery by combining mechanical balloon dilation with localized drug delivery. The nationwide study is expected to enroll up to 300 patients and will assess the safety and efficacy of the ESSpand DCB as an adjunctive treatment aimed at reducing recurrence, preventing scarring, and maintaining long-term sinus drainage. If successful, the technology could offer a new treatment paradigm for millions of patients affected by chronic sinus disease who continue to experience symptoms despite conventional medical and surgical interventions.
RESTORE-2 Trial Evaluates Innovative Drug-Coated Balloon Technology
The first patient in the pivotal study was treated by Dr. Andrew Gould, a board-certified ear, nose, and throat specialist and director of research at Advanced ENT and Allergy in Louisville, Kentucky. The RESTORE-2 trial is designed to evaluate the investigational ESSpand Drug Coated Balloon when used alongside endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis both with and without nasal polyps. The technology combines standard balloon dilation, which mechanically opens blocked sinus drainage pathways, with a proprietary paclitaxel-coated surface that delivers medication directly to targeted tissue.
The localized drug delivery is intended to reduce post-surgical inflammation, limit scar formation, and prevent re-narrowing of sinus passageways. Researchers hope this dual-action approach will improve long-term symptom relief while reducing the need for repeat procedures and ongoing medical therapies. The study is expected to serve as the primary clinical evidence supporting a future FDA regulatory submission for commercialization in the United States.
Addressing a Major Unmet Need in Chronic Rhinosinusitis Care
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Chronic rhinosinusitis is one of the most common chronic health conditions worldwide and affects more than 14 million adults in the United States alone. The disease is characterized by persistent inflammation of the nasal passages and paranasal sinuses lasting at least three months despite treatment. Symptoms often include nasal congestion, facial pressure, reduced sense of smell, chronic drainage, and impaired quality of life. While many patients initially receive medical therapy, including corticosteroids, antibiotics, and saline irrigation, a substantial number eventually require surgical intervention. However, symptom recurrence remains a significant challenge, with many patients undergoing multiple procedures over time.
Airiver’s ESSpand technology seeks to bridge this treatment gap by providing a minimally invasive solution capable of delivering sustained benefits after surgery. Investigators believe that reducing post-operative tissue remodeling and maintaining sinus patency could significantly improve patient outcomes while decreasing reliance on oral steroids, biologic therapies, and repeat surgeries.
Airiver Expands Clinical Pipeline in Respiratory Disease Innovation
The launch of the RESTORE-2 trial represents another major milestone for Airiver Medical as it advances a broader portfolio of drug-coated balloon technologies targeting respiratory tract disorders. In addition to chronic rhinosinusitis, the company is currently conducting the OXYGEN-RCT pivotal U.S. study, evaluating its investigational Pulmonary Drug Coated Balloon for patients with central airway stenosis, a condition characterized by narrowing of the airways that can significantly impair breathing. That study has already treated multiple patients and continues enrollment across the United States.
Company leadership emphasized that the successful treatment of the first RESTORE-2 patient moves Airiver closer to delivering a potentially transformative therapy capable of providing long-term symptom relief with fewer interventions. As healthcare systems increasingly focus on improving outcomes while reducing treatment burden and healthcare costs, innovative technologies that combine mechanical intervention with targeted drug delivery may play an increasingly important role in the future management of chronic respiratory and sinus diseases.
Source: Airiver Medical press release
