Airiver Medical, a clinical stage company developing technologies to help patients with certain respiratory tract conditions, announced on Thursday the successful treatment of the first patient with chronic rhinosinusitis (CRS) in its RESTORE-2 US pivotal clinical trial of the Airiver ESSpand Sinus Drug Coated Balloon (DCB).

The study will enrol up to 300 patients suffering from CRS with and without nasal polyps, and is being conducted across the United States 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 re-narrowing 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 commercialisation of the ESSpand DCB in the US.

In addition to the RESTORE-2 clinical trial, Airiver Medical is also enrolling patients in the OXYGEN-RCT US 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 enrol up to 200.

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