The first patient received treatment for chronic rhinosinusitis (CRS) in its RESTORE-2 U.S. pivotal clinical trial. It evaluates the Brooklyn Park, Minnesota-based company’s Airiver ESSpand sinus DCB. Dr. Andrew Gould treated the first patient in Lousville, Kentucky.
Airiver expects its study to enroll up to 300 patients with CRS, with and without nasal polyps. It assesses the safety and efficacy of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS).
Airiver designed its DCB to maintain symptom relief and prevent scarring and re-narrowing of drainage passageways. It applies a thin layer of a proprietary paclitaxel drug coating to the targeted tissue contemporaneously with balloon dilation of the restricted sinus drainage passageways.
The company expects its study to serve as the basis for a regulatory submission to the FDA, followed by U.S. commercialization.
Airiver concurrently has a trial ongoing for treating central airway stenosis (airway narrowing). In August 2025, the company received FDA investigational device exemption (IDE) for the DCB, enabling the launch of that pivotal trial. The company then announced FDA breakthrough device designation and the first patient treated in that trial in March.
Commentary from Airiver officials and investigators
Paul Vajgrt, CEO of Airiver Medical, said:
“This is an important milestone as we’re one step closer to providing patients suffering from CRS and physicians with our novel treatment option that has the potential for long-term relief with fewer treatments, which is a significant gap in current treatment options. We thank Dr. Gould and his team, the patients and health care providers participating in the clinical trial, and our team for their dedication to bringing this therapy to patients who are seeking a long-term option.”
Dr. Gould added:
“We’re thrilled to have treated the first patient in this important study and very hopeful that this will provide meaningful improvements in outcomes for endoscopic sinus surgery. If the RESTORE-2 trial is successful, this technology could help patients avoid further surgeries, oral steroids, and expensive biologic therapy – a huge potential win for patients and the healthcare system.”
