Aerin Medical Inc., a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, today announced the publication in Allergy and Rhinology of positive two-year results from a trial evaluating the safety and efficacy of RhinAer® in patients with chronic rhinitis.
Data from the trial demonstrated that treatment with RhinAer to the posterior nasal nerve (PNN) is safe and provides significant, durable symptom improvement for both chronic non-allergic and allergic rhinitis patients.
“This long-term data confirms that RhinAer enables us to effectively provide lasting relief to our patients who suffer from chronic rhinitis,” said V. Vasu Kakarlapudi, MD, Advanced ENT and Allergy, New Albany, Indiana. “Treatment of the PNN using RhinAer has been shown to be an effective, patient-friendly option to treat both chronic allergic and non-allergic rhinitis. It’s exciting that otolaryngologists have a safe, non-invasive treatment option that can be performed in the clinic under local anesthesia and that provides long-term benefits for our patients.”
RhinAer is an innovative, temperature-controlled radiofrequency (RF) technology used to disrupt nerve signals that cause chronic rhinitis symptoms, such as constant runny nose and post-nasal drip. The study was an extension of a prospective, multi-center, single-arm trial, designed to collect long-term outcomes for 34 patients who had undergone a single treatment on the PNN with RhinAer 24 months prior. The results of the study showed that at 24 months, 88.2% of the patients responded to treatment, independent of rhinitis subtype. Patients with allergic, non-allergic and rhinitis of unknown origin all exhibited a durable improvement in rhinitis symptoms. Specifically, two years following the treatment with RhinAer, data showed that:
Clinically and statistically significant reduction (65.5%) in symptoms using the reflective total nasal symptom (rTNSS) score, which measures rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing.
Both post-nasal drip and chronic cough improved from baseline through 24 months (i.e., post-nasal drip improved from a mean of 4.1 to 2.1 and chronic cough improved from 3.2 to 0.9 (p <.001 for both measures)).
Patients reported a higher quality of life in terms of sleep quality (including less difficulty falling asleep, less fatigue and less irritability), well-being, and lower feelings of embarrassment/self-consciousness about their condition.
At 24 months, patients reported using fewer oral and nasal medications to control their rhinitis symptoms than they were using at the beginning of the study.
Patient-reported satisfaction remained high through the course of the study.
There were no serious adverse events related to RhinAer treatment in the 24-month period.
“We appreciate the commitment of physician investigators to providing their peers with highly anticipated long-term results showing both lasting outcomes and a corresponding significant improvement in quality of life for chronic rhinitis patients,” said Matt Brokaw, CEO of Aerin Medical. “RhinAer provides ENTs a compelling alternative with lasting benefits for appropriate chronic rhinitis patients whether they suffer from allergic or non-allergic rhinitis.”
Rhinitis, or inflammation of the mucous membrane of the nose, can include symptoms such as runny nose, congestion, itching, sneezing, coughing, and post-nasal drip. Chronic rhinitis, when symptoms last more than four consecutive weeks, can be challenging to treat. Otolaryngologists, or ENTs, use RhinAer to directly interrupt nerve signals and help reduce chronic rhinitis symptoms.
About RhinAer: Using temperature-controlled, radiofrequency technology, RhinAer features a thin, wand-like stylus that is inserted via the nostril to deliver precise therapeutic benefits, while sparing surrounding tissues. RhinAer directly disrupts the posterior nasal nerve (PNN) that triggers excessive mucus production, treating an underlying cause of chronic rhinitis. RhinAer provides ENT physicians with a comprehensive solution for the treatment of chronic rhinitis, addressing sources of rhinorrhea (runny nose) and congestion. The procedure can be performed with a local anesthetic during an office visit, with no incisions, minimal to no downtime and little discomfort. RhinAer received FDA 510(k) clearance in December 2019 and CE Mark in 2020.