New Two-Year Results Show Sustained Improvement in Chronic Rhinitis Symptoms Following a Single Procedure with Aerin Medical’s RhinAer®

29 Feb 2024
www.biospace.com
Clinical ResultDrug Approval
Durable results are consistent with other studies of RhinAer MOUNTAIN VIEW, 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 the publication of positive 24-month results from RHINTRAC, a randomized, sham-controlled clinical trial, in the International Forum of Allergy & Rhinology (IFAR). These results demonstrate the durable treatment effect of RhinAer® for treating chronic rhinitis, showing a significant improvement in symptoms through two years. These findings build on the previously published results of two separate studies that also demonstrated significant, sustained improvement with RhinAer treatment.1,2 This press release features multimedia. View the full release here: Results of the RHINTRAC randomized controlled trial published in the International Forum of Allergy & Rhinology (IFAR) confirmed that treatment with RhinAer® resulted in a significant improvement in chronic rhinitis symptoms through two years. RhinAer uses temperature-controlled radiofrequency energy to provide long-term relief from chronic rhinitis. (Photo: Business Wire) “Chronic rhinitis treatment has been a longstanding challenge due to the limitations of medical therapy and the historical lack of minimally invasive, comprehensive procedure options,” said Pablo Stolovitzky, M.D., Adjunct Assistant Professor, Department of Otolaryngology, Emory University; CEO of ENT of Georgia North, Atlanta; and principal investigator of the RHINTRAC trial. “It is significant to add high-level evidence reinforcing the efficacy and durability of RhinAer, which provides a well-studied solution for those enduring the burdens of chronic rhinitis.” ENTs use RhinAer to directly interrupt overactive nerve signals which contribute to symptoms that can be difficult to treat with medications alone in patients suffering from chronic rhinitis. RHINTRAC, a multi-center randomized study, enrolled 117 patients with chronic rhinitis symptoms of at least six months duration, commonly with a poor response to medical therapy. This publication reports patient outcomes through two years, including treatment response, chronic rhinitis symptom burden, quality of life, medication use and adverse events for all treated patients. More than 87% of patients responded to treatment and patients showed sustained improvement in chronic rhinitis symptoms at two years. Additional findings published in IFAR included: Eighty-one percent of patients reported improvements in quality of life, as assessed by the Mini-Rhinoconjunctivitis Quality of Life questionnaire, compared to baseline. Patient treatment response, including symptom reductions, improved through two years, with a 64.6% improvement over baseline in reflective total nasal symptom score (rTNSS). All individual symptom scores (runny nose, congestion, sneezing and nasal itching) were significantly improved over baseline through two years. “Three separate studies have consistently shown long-term benefit from a single procedure with RhinAer,” said Scott Wolf, M.D., co-founder and Chief Medical Officer of Aerin Medical. “We sincerely thank the dedicated physicians who have significantly advanced understanding of RhinAer’s treatment effect on behalf of the otolaryngology community.” Rhinitis, or inflammation of the mucous membranes 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 and may significantly lower a person’s quality of life. 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 initially received FDA 510(k) clearance in December 2019 and CE Mark in 2020. For more information, visit . About Aerin Medical Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT 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 unique technologies that are appealing alternatives to invasive surgery. More than 100,000 patients have been treated with Aerin Medical products to date. For more information, please visit and follow Aerin Medical on Facebook, X, Instagram, LinkedIn and YouTube. 1 Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy & Rhinology. (2022);13. doi:10.1177/21526575221096045. 2 Lee, J.T., Abbas, G.M., Charous, D.D., Cuevas, M., Göktas, Ö., Loftus, P.A., Nachlas, N.E., Toskala, E.M., Watkins, J.P. and Brehmer, D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. The Laryngoscope. (2023) .
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