SUNNYVALE, Calif.--(BUSINESS WIRE)--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 that the American Journal of Rhinology & Allergy has published positive one-year results from a trial evaluating the safety and efficacy of RhinAer® in patients with chronic rhinitis. RhinAer is an innovative, temperature-controlled, radiofrequency technology used to disrupt nerve signals that cause chronic rhinitis symptoms. Following a single treatment with RhinAer, symptom severity significantly decreased in the first two weeks and remained low through the one-year follow-up.
“The outcomes of this study demonstrate the robust and durable benefits of RhinAer, and they reinforce the effectiveness of targeting the posterior nasal nerve area with temperature-controlled radiofrequency to treat chronic rhinitis,” said V. Vasu Kakarlapudi, M.D., MBA, of Advanced ENT and Allergy in Louisville, Kentucky, and principal investigator of the study. “RhinAer offers patients a lasting, non-invasive option to effectively treat their condition without complex surgery.”
The prospective, single-arm, multi-center study enrolled 50 adult patients with moderate to severe rhinitis symptoms based on the 4-point reflective Total Nasal Symptoms Survey (rTNSS), which rates symptoms including runny nose, congestion, itching and sneezing. Patients were monitored at 2, 4, 12, 26, and 52 weeks following treatment with RhinAer and completed a satisfaction questionnaire.
The study met its primary endpoint, demonstrating that patients who were treated with RhinAer experienced clinically significant reductions in chronic rhinitis symptoms three months following treatment, with lasting symptom improvements out to one year. Findings included:
- Mean rTNSS scores improved from 8.5 at baseline to 3.6, a 57.6% improvement (p<0.001). Similar outcomes were achieved with rTNSS subscores (runny nose, nasal congestion, itching and sneezing), postnasal drip and chronic cough scores.
- 80.9% of patients experienced symptom improvement of at least 30% relative to baseline at one year.
- 100% of patients experienced at least one rTNSS point improvement relative to baseline, showing that all patients experienced some measurable symptom relief.
Treatment was well-tolerated, with no serious device- or procedure-related adverse events occurring. The authors noted that no device- or procedure-related headaches were reported throughout the trial. Subgroup analysis data also showed that RhinAer was effective in providing symptom relief to patients who presented with allergic as well as non-allergic rhinitis.
“Historically, options have been limited for the large percentage of chronic rhinitis patients unresponsive to medication,” said Matt Brokaw, CEO of Aerin Medical. “RhinAer provides otolaryngologists an effective, non-invasive solution for appropriately selected chronic rhinitis patients who have been challenging to treat, and fits seamlessly into any practice setting.”
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 postnasal 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.
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 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.
About Aerin Medical
Aerin Medical is a privately held, venture-backed company, with U.S. offices in Sunnyvale, California and Austin, Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal conditions. The company’s products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with in-office procedures performed with local anesthetic. More than 40,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Twitter and LinkedIn.
1 Roland LT, et al, The cost of rhinitis in the United States: a national insurance claims analysis. Int Forum Allergy Rhinol. 2021; 11(5):946-948. https://doi.org/10.1002/alr.22748
