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 of positive results from the RHINTRAC clinical trial in OTO Open. Three-month data from the randomized sham-controlled trial demonstrated that treatment with RhinAer is safe and provides significant symptom improvement superior to control for patients with chronic rhinitis. 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 postnasal drip. The RHINTRAC study reinforces RhinAer safety and efficacy established by recently published one-year pivotal study results.

“RhinAer is a significant advance for ENT physicians who have historically had limited options to treat chronic rhinitis patients who don’t respond to medical therapy,” said Masayoshi Takashima, M.D., co-principal investigator who is Chair of the Department of Otolaryngology – Head & Neck Surgery at Houston Methodist Hospital. “This study provides one of the highest levels of clinical evidence supporting the benefits of this safe and well-tolerated technique that can be performed in-office.”

The multi-center trial enrolled 117 patients seeking treatment after at least six months of chronic rhinitis symptoms, randomizing them to in-office treatment and control arms. Patients assigned to the control arm received a sham procedure that replicated the treatment without delivering RF energy.

The study met its primary endpoint with patients in the treatment group demonstrating a clinically significant and superior responder rate at three months. The study also met its secondary endpoint with patients in the treatment group experiencing significant symptom reduction. No serious device or procedure-related adverse events occurred. The study will continue follow up with patients through two years, but three-month results were shown to be predictive of long-term outcomes in the RhinAer pivotal study.

“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,” said Matt Brokaw, CEO of Aerin Medical. “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.”

Rhinitis, or inflammation of the mucous membrane of the nose, affects an estimated 30% of the American population.1 Symptoms include 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. ENTs use RhinAer to directly interrupt nerve signals and help reduce chronic rhinitis symptoms.

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 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 a routine 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.

Source: Company Press Release