New Data Supports Aerin’s RhinAer for the Treatment of Chronic Rhinitis

Aerin Medical RhinAer
The RhinAer platform [Image from Aerin Medical]

Aerin Medical today announced the release of positive results from a 12-month study of its RhinAer platform.

Results of the Sunnyvale, California-based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum for Allergy & Rhinology (IFAR)showed that symptoms of chronic rhinitis continued to improve up to 12 months after RhinAer treatment.

The findings build on previous data demonstrating superiority and safety with RhinAer compared to a sham procedure control, including last month’s two-year data supporting temperature-controlled radio frequency (RF) technology designed to disrupt nerve signals that cause chronic rhinitis symptoms, including a constant runny nose and post-nasal drip.

Rhintrac enrolled 117 patients seeking treatment for symptoms of chronic rhinitis lasting at least six months. Patients were randomly assigned to active treatment with RhinAer or to a control group where patients received a sham procedure that replicated RhinAer without releasing RF energy.

After three months, the trial arm assignments were revealed and qualified sham patients were given the option to switch and receive RhinAer treatment, with 12-month data reporting follow-up results from 72 patients in the original active treatment arm and six months of follow-up for the 25 patients who chose to cross.

Aerin said in a press release that the percentage of patients who responded in the active treatment arm continued to improve over the 12 months (67.5%, 75.0% and 80.6% at 3, 6 and 12 months, respectively). Responders are defined as patients with a ≥30% improvement in symptoms from baseline prior to the procedure.

The magnitude of symptom relief also improved, with statistically significant improvements in symptoms of rhinorrhoea, nasal congestion, itchy nose and sneezing compared to baseline. Patients also had significant improvements in post-nasal drip and cough symptoms that lasted for 12 months, while crossover patients experienced similar benefits compared to those in the initial active treatment arm.

Aerin added that RhinAer treatment was well tolerated, with patients reporting low post-procedural pain scores and no post-procedural headache. To date, no serious adverse events related to the device or procedure have been reported in any treatment group.

“Publishing these data in such an esteemed journal really underscores the validity of the study and its results, and the results align well with our previously published multi-year data on the safety and efficacy of RhinAer,” founder and CMO of Aerin, dr. Scott Wolf said in the edition. “We are grateful to our physician partners for their tireless efforts in building the clinical body of evidence for RhinAer—evidence that helps ENT physicians make treatment decisions for their allergic and non-allergic patients with chronic rhinitis.”

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