Airiver Medical has announced the first patient treatment in its RESTORE-2 pivotal clinical trial evaluating its ESSpand drug-coated balloon (DCB) for chronic rhinosinusitis (CRS).
The U.S. study will enroll up to 300 patients with CRS, with and without nasal polyps, and is designed to assess the device’s safety and effectiveness when used alongside endoscopic sinus surgery.
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The technology uses a balloon-based dilation system that delivers a paclitaxel drug coating directly to sinus tissue, aiming to maintain symptom relief, reduce scarring, and prevent re-narrowing of sinus drainage pathways after surgery.
Airiver says results from the trial are intended to support a future FDA regulatory submission and potential U.S. commercialization. The company is also running a separate clinical program in central airway stenosis, following FDA IDE approval and breakthrough device designation.
CEO Paul Vajgrt called the milestone a key step toward improved long-term treatment options, saying:
“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.”
Clinician investigator Dr. Andrew 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.”
The first patient treatment marks an important step in Airiver’s effort to develop longer-lasting, minimally invasive solutions for chronic sinus disease.
