Positive Three-Year Follow-Up Results Confirm Long-Term Benefits of RhinAer

Aerin Medical Inc. is reporting study results that further supports the use of its device (RhinAer) to treat chronic rhinitis. Published in the International Forum of Allergy & Rhinology (IFAR), the RHINTRAC trial evaluated the safety and efficacy of temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) using RhinAer.

RHINTRAC’s results further strengthen the clinical evidence supporting RhinAer’s long-term benefits, including sustained symptom relief, decreased medication use, and meaningful improvements in quality of life.

“We’re encouraged by the consistent improvements seen at three years in patients treated with RhinAer,” said Pablo Stolovitzky, M.D., adjunct associate professor, Department of Otolaryngology, Emory University; CEO of ENT of Georgia North, Atlanta; and principal RHINTRAC trial investigator. “The long-lasting and significant reduction in chronic rhinitis symptoms reinforces RhinAer as a durable, minimally invasive treatment that can meaningfully improve patients’ lives.”

The quality of life impact of chronic rhinitis symptoms is substantial and can rival other chronic illnesses such as asthma, angina, and myocardial infarction; patients who do not respond to medical therapy have limited treatment options. In this study, treatment with TCRF ablation of the PNN led to sustained and meaningful symptom relief. At three years, 80% of patients reported significant, lasting improvements, including a 57% reduction in rTNSS scores and a 54% improvement in MiniRQLQ quality-of-life measures. Improvements encompassed key symptoms such as nasal congestion, postnasal drip, and cough, contributing to enhanced daily functioning. The durability of these results reinforces RhinAer as a clinically effective option for patients with persistent, medication-refractory disease, according to Aerin Medical.

Related: Study: One RhinAer Treatment Offers Long-Term Improvement of Chronic Rhinitis

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 PNN that triggers excessive mucus production, treating an underlying cause of chronic rhinitis. RhinAer provides ENT physicians with a comprehensive solution for treating 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 U.S. Food and Drug Administration 510(k) clearance in December 2019 and CE Mark in 2020.

Additional key study findings:

• Consistent benefit in patients who had previously failed medical therapy
  • 72.9% of patients had severe symptoms at baseline despite prior medication use
• Sustained improvement in nasal symptom scores
  • 57% reduction in mean reflective total nasal symptom scores (rTNSS)
• Meaningful relief from postnasal drip and cough
  • PND scores improved from 2.5 to 1.4
  • Cough scores improved from 1.5 to 0.7
• Stable and consistent safety profile
  • No serious adverse events reported
  • No new events reported between 24 and 36 months

“These results further validate RhinAer as a safe, minimally invasive, and durable solution for those significantly affected by chronic rhinitis,” Aerin Medical CEO Matt Brokaw stated. “As the market leader with the most published clinical evidence supporting RhinAer PNN ablation technology, this publication in IFAR provides even more clinical evidence surrounding use of this therapy. IFAR’s extensive reach allows us to broadly share information about the lasting improvements in symptoms, quality of life, and reduced reliance on medication—all underscoring the real-world benefit that ENTs are delivering to their patients with this technology every day.”

Aerin Medical is a privately held, venture-backed company, headquartered in Mountain View, Calif. Aerin’s aims to expand access to meaningful relief for chronic ENT conditions. Its 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 150,000 patients have been treated with Aerin Medical products to date.