Aerin Medical Announces FDA Clearance and 1-Year Evidence Supporting ENT Treatment for Patients with Chronic Rhinitis and Comorbid Migraine

The market leader in minimally invasive chronic rhinitis treatment is advancing therapies at the intersection of ENT and neurology

Mountain View, Calif., November 10, 2026 -Aerin Medical Inc., a leader in minimally invasive solutions for chronic ENT conditions, today announced significant milestones in its groundbreaking, minimally invasive chronic rhinitis (CR) and comorbid migraine program:

• FDA clearance in July: RhinAer® labeling now incorporates the company's SOOTHE study data on observed improvements in migraine-related outcomes in CR patients with comorbid migraine.¹
• 1-year evidence: Presentations at two recent otolaryngology society conferences shared multicenter data demonstrating significant, long lasting patient benefits from a single procedure.^2,3
• RhinAer is commercially available for the treatment of CR, with national commercial availability for comorbid migraine patients expected in early 2027.

"We believe our RhinAer technology and the results demonstrated in the SOOTHE study are a major advance in care that could help millions of patients," said Matt Brokaw, President and CEO of Aerin Medical. "Our focus on a CR and comorbid migraine program has been driven by world-class physicians, major investments, and our unique, proven, radiofrequency technology that precisely targets the posterior nasal nerves associated with shared CR and comorbid migraine symptoms." "

Migraine affects approximately 30 million US adults, so patients afflicted with CR and migraine are common in ENT clinics.⁴

The SOOTHE study is the first prospective, single-arm evaluation in this population treated with RhinAer. Results presented at two major society conferences in 2026 reported the following major findings:^2,3,5

• 81% migraine responder rate at three months (n=41).
• 70% reduction in monthly migraine days at three months (n=41).
• 69% reduction in acute medication use at three months (n=37).
• 77% reduction in severe migraine-related disability at three months (n=41).
• Sustained benefits were confirmed through one year.
• CR improvements were consistent with published literature.

"Our experience during the SOOTHE study made it clear this groundbreaking treatment may provide significant clinical improvement among patients who have few durable options. I've been impressed by the evidence and the company's thoughtful approach," said a SOOTHE Principal Investigator and leading migraine expert, Dr. Mark Mehle of Southwest General Medical Group in Ohio.

These advances build on Aerin's foundational approach with RhinAer, the market-leading device for ENT physicians treating CR patients. It is backed by 21 peer-reviewed publications, long-term data through three years, and more than 80,000 patients treated to-date.⁵ Aerin is advancing this novel treatment for patients with CR with the backing of leading physicians, including cross-specialty guidance from experts in both neurology and otolaryngology.

About RhinAer
RhinAer is a minimally invasive technology that uses patented, temperature- and impedance-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from chronic rhinitis. RhinAer features a thin, wand-like stylus that attaches to an Aerin console. The stylus is inserted via the nostril to deliver precise therapeutic benefits to the posterior nasal nerve (PNN) and soft tissue, while sparing surrounding tissues. RhinAer directly disrupts the 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 and congestion. The procedure can be performed with a local anesthetic during an office visit, with no incisions, and minimal downtime. RhinAer received FDA 510(k) clearance in December 2019 and CE Mark in 2020. For more information, visit www.RhinAer.com.

About Aerin Medical

Aerin Medical is a privately held, venture-backed company headquartered in Mountain View, California. Aerin's mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT conditions. Its products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, use Aerin's proprietary temperature-controlled radiofrequency technology to provide effective, minimally invasive alternatives to surgery. More than 200,000 patients have been treated with Aerin Medical products. For more information, please visit  www.aerinmedical.com  and follow Aerin Medical on Facebook, X, Instagram, LinkedIn and YouTube. 

Media Contact:
Kevin Knight
[email protected]

1. Aerin Medical Inc. RhinAer+TM Stylus Instructions for Use. Document IFU2274.B. Mountain View, CA: Aerin Medical Inc.; 2026.
2. Mehle M, Silvers S, Hoffmann KK, et al. Temperature-controlled posterior nerve ablation for the treatment of migraine in patients with chronic rhinitis and co-morbid migraine. Presented at COSM April 22-26, 2026. Phoenix, AZ.
3. Mehle M, Silvers S, Hoffmann KK, et al. Migraine Disability and Quality-of-Life Following Posterior Nasal Nerve Ablation in Patients with Rhinitis and Migraine. Presented at AAO-HNSF Annual Meeting October 18, 2026. Los Angeles, CA.
4. Cohen F, Brooks CV, Sun D, Buse DC, Reed ML, Fanning KM, Lipton RB. Prevalence and burden of migraine in the United States: A systematic review. Headache. 2024;64(5):516-532. doi:10.1111/head.14709
5. Stolovitzky JP, Ow RA, Silvers SL, et al. 3-Year Outcomes of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve in Patients With Chronic Rhinitis. Int Forum Allergy Rhinol. Published online April 4, 2025. doi:10.1002/alr.23577