Aerin Medical, a US-based company that focuses on offering non-invasive solutions for Ear, Nose and Throat (ENT) conditions, has reported positive results from the RHINTRAC clinical trial.
The randomised sham-controlled trial assessed the safety and efficacy of RhinAer in treating chronic rhinitis.
RhinAer is a temperature-controlled radiofrequency (RF) technology developed to disrupt nerve signals that trigger chronic rhinitis symptoms, such as a constant runny nose and postnasal drip.
It features a thin, wand-like stylus that can be inserted through the nostril to deliver therapeutic benefits. The solution secured US Food and Drug Administration (FDA) 510(k) clearance in December 2019.
Aerin Medical CEO Matt Brokaw said: “The publication of results from RHINTRAC and a number of other significant clinical studies underscores Aerin’s dedication to providing high-level clinical evidence that helps otolaryngologists make treatment decisions for their patients.
“We are thankful for the physician investigators who have led research demonstrating the benefits of our products and confirming a role for non-invasive procedure options for patients.”
RHINTRAC multicentre trial enrolled 117 patients randomising them in treatment and control arms.
The study met its primary endpoint and patients in the treatment group exhibited clinically significant and superior responder rate at the end of three months.
The data also confirms that the study met its secondary endpoint with patients reporting a significant reduction in symptoms. During the procedure, no serious device or procedure-related adverse events occurred.
The company will continue to follow up with patients for two years.