Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis
RhinAer™ Procedure Promises Lasting Relief for Millions of Americans Suffering from Common Chronic Condition
AUSTIN TX., March 5, 2020: Aerin Medical, a company focused on minimally invasive solutions for chronic nasal conditions, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the company’s second product, the RhinAer™ Procedure, an innovative non-surgical treatment for chronic rhinitis.
Over 30 million Americans suffer from non-allergic rhinitis.[1] Patients with the condition suffer from bothersome symptoms such as runny nose, post-nasal drip, congestion and chronic cough. For many of these patients, management with medications and sprays is inadequate. The RhinAer procedure provides lasting relief by directly disrupting the signals that cause symptoms. The procedure can be performed under a local anesthetic in an ENT physician’s office with no incisions and minimal discomfort.
“Chronic rhinitis is a condition that can significantly affect quality of life, impacting daily activities and even leading to feelings of isolation and depression,”[2] said Adil A. Fatakia, M.D., a rhinologist at West Jefferson Medical Center in Marrerro, La. “RhinAer’s compelling clinical results, including its high responder rate, clean side effect profile and tolerability, make it a highly attractive option for my patients.”
Clinical results from the prospective, multi-center pivotal clinical trial of RhinAer demonstrated meaningful benefits to patients. In the study, 96% of patients treated with RhinAer reported an improvement in their rhinitis symptoms at six months, with symptoms improving on average by 61%. There were no serious device-related adverse events, and the procedure was generally well-tolerated. Notably, significant improvements were demonstrated for the most bothersome chronic rhinitis symptoms, runny nose and post-nasal drip.
“The FDA clearance and launch of our second nonsurgical innovation for ENT physicians and patients is a significant milestone for Aerin Medical,” Fred Dinger, president and CEO. “More than 13,000 patients have now been treated with the Aerin® Console and the VivAer procedure to treat nasal obstruction. With the launch of the RhinAer procedure, Aerin now offers ENT physicians an efficient platform solution that can be used to improve the lives of the millions of patients suffering from chronic rhinitis as well.”
Both RhinAer and VivAer rely on Aerin’s proprietary temperature-controlled technology, which has been developed and optimized for the nasal airway to provide a precise therapeutic effect while minimizing risk to surrounding tissue.
About Aerin Medical
Aerin Medical is a privately held, venture-backed company with offices in Austin, Texas and Sunnyvale, Calif. Aerin’s mission is to provide ENT physicians with minimally invasive procedures for the treatment of chronic nasal airway conditions. The company’s FDA-cleared products, the VivAer® Stylus for nasal airway obstruction and the RhinAer™ Stylus for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with a nonsurgical procedure under local anesthetic in their office.
[1] Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009; 2(3):20-25. doi:10.1097/WOX.0b013e3181990aac.
[2] Roxbury, et al in The Journal of Allergy and Clinical Immunology: In Practice
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