Airiver Medical Treats First Patient in Pivotal Clinical Study of the Airiver Drug Coated Balloon for Patients with Chronic Rhinosinusitis

The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the nasal passageways with drug delivery designed to maintain symptom relief

BROOKLYN PARK, Minn., June 11, 2026 /PRNewswire/ -- Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, today announced the successful treatment of the first patient with chronic rhinosinusitis (CRS) in its RESTORE-2 U.S. pivotal clinical trial of the Airiver ESSpand Sinus Drug Coated Balloon (DCB).

The first patient was treated by Dr. Andrew Gould, board-certified ENT and director of research at Advanced ENT and Allergy in Louisville, Ky. Dr. Gould has been enrolling patients in clinical trials over the past 25 years.

"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," said Dr. Gould. "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 landmark study is enrolling up to 300 patients suffering from CRS with and without nasal polyps and is being conducted across the U.S. to assess the safety and efficacy of the investigational ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The ESSpand DCB is designed to maintain symptom relief and prevent scarring and renarrowing of drainage passageways by applying a thin layer of a proprietary paclitaxel drug coating to the targeted tissue contemporaneously with balloon dilation of the restricted sinus drainage passageways. The study is intended to serve as the basis for Airiver Medical's regulatory submission to the FDA and eventual commercialization of the ESSpand DCB in the U.S.

"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," said Paul Vajgrt, CEO of

Airiver Medical. "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."

CRS is defined as long-term (present for a minimum of three months despite intervention) symptomatic inflammation of the nose and paranasal sinuses. CRS is one of the most common chronic medical conditions in the world, with more than 14 million U.S. adults suffering from the condition. Four million of these patients cite challenges finding relief through traditional medical treatments, as medication alone is sometimes not enough, and they may choose to undergo surgery. Despite this initial surgery, symptoms often return and many patients undergo at least one additional surgery.

In addition to the RESTORE-2 clinical trial, Airiver Medical is also enrolling patients in the OXYGEN-RCT U.S. pivotal clinical study, assessing the safety and efficacy of the investigational Airiver Pulmonary DCB in patients with central airway stenosis. This trial has currently treated 21 patients and will enroll up to 200.

The Airiver DCB is an investigational device. The Airiver DCB has not received marketing authorization from the FDA and is not available for sale in the United States.

About Airiver Medical

Airiver Medical is a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions. The company aims to improve the current standard of care for central airway stenosis and chronic rhinosinusitis. Airiver Medical's Drug Coated Balloon could offer a new solution for these conditions, potentially creating sustained patency, better outcomes and fewer treatments.

For more information, please visit www.airiver.com.

Media Contact:
Shelli Lissick
[email protected]
(651) 276-6922

SOURCE Airiver Medical