Michael Barbella, Managing Editor02.27.24
Aerin Medical Inc. is extolling positive two-year clinical trial results that indicated a single procedure with RhinAer—a temperature-controlled, radiofrequency technology—resulted in sustained improvements in chronic rhinitis symptoms, including post-nasal drip and chronic cough, and quality of life through two years, as well as a substantial decrease in chronic rhinitis medication usage.
The prospective, single-arm RELIEF study, conducted across 16 centers in the United States and Germany, enrolled 129 patients seeking relief from chronic rhinitis symptoms. The targeted treatment area focused on the posterior nasal nerve (PNN) using RhinAer. Patients were asked to report post-nasal drip and chronic cough symptoms, quality of life evaluation and medication usage. Key findings of the study highlight the longevity of RhinAer’s treatment effect in all areas of measurement through two years, including:
“Medications are commonly prescribed for chronic rhinitis, but unfortunately often have limited effectiveness,” said Daniel D. Charous, M.D., Arizona Desert Ear, Nose & Throat Specialists and RELIEF study investigator. “This study’s results reinforce existing evidence that a single procedure with RhinAer offers durable symptom relief and also reduces medication use for my patients.”
Rhinitis, or inflammation of the nose's mucous membrane, 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. ENTs use RhinAer as a non-invasive alternative to surgical interventions to directly interrupt nerve signals and help reduce chronic rhinitis symptoms.
“Publication of more peer-reviewed evidence reinforces Aerin Medical’s commitment to supporting the interests of otolaryngologists and their patients,” Aerin Medical CEO Matt Brokaw stated. “Chronic rhinitis is one of the most common conditions presenting to ENTs, and we’re grateful to physician investigators who have contributed to RhinAer’s body of evidence as the only radiofrequency device with established multi-year durability.”
Results of the RELIEF study add to Aerin Medical’s body of clinical evidence that supported a Category I Current Procedural Terminology (CPT) code application established by the Centers for Medicare and Medicaid Services that took effect Jan. 1. The new code—for endoscopic destruction of the PNN using radiofrequency ablation—describes the procedure performed by ENT physicians when treating overactive nerves that drive chronic rhinitis symptoms with 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 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.
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 chronic ENT conditions. The company’s products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology that allow ENT physicians to improve patients’ symptoms. More than 100,000 patients have been treated with Aerin Medical products to date.
The prospective, single-arm RELIEF study, conducted across 16 centers in the United States and Germany, enrolled 129 patients seeking relief from chronic rhinitis symptoms. The targeted treatment area focused on the posterior nasal nerve (PNN) using RhinAer. Patients were asked to report post-nasal drip and chronic cough symptoms, quality of life evaluation and medication usage. Key findings of the study highlight the longevity of RhinAer’s treatment effect in all areas of measurement through two years, including:
- A significant improvement in reflective total nasal symptom score (rTNSS) sustained over two years.
- Significant improvement in chronic cough and post-nasal drip from baseline.
- A clinically relevant increase in quality of life for 77.4% of patients at the two-year mark as assessed by the mini rhinoconjunctivitis questionnaire.
“Medications are commonly prescribed for chronic rhinitis, but unfortunately often have limited effectiveness,” said Daniel D. Charous, M.D., Arizona Desert Ear, Nose & Throat Specialists and RELIEF study investigator. “This study’s results reinforce existing evidence that a single procedure with RhinAer offers durable symptom relief and also reduces medication use for my patients.”
Rhinitis, or inflammation of the nose's mucous membrane, 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. ENTs use RhinAer as a non-invasive alternative to surgical interventions to directly interrupt nerve signals and help reduce chronic rhinitis symptoms.
“Publication of more peer-reviewed evidence reinforces Aerin Medical’s commitment to supporting the interests of otolaryngologists and their patients,” Aerin Medical CEO Matt Brokaw stated. “Chronic rhinitis is one of the most common conditions presenting to ENTs, and we’re grateful to physician investigators who have contributed to RhinAer’s body of evidence as the only radiofrequency device with established multi-year durability.”
Results of the RELIEF study add to Aerin Medical’s body of clinical evidence that supported a Category I Current Procedural Terminology (CPT) code application established by the Centers for Medicare and Medicaid Services that took effect Jan. 1. The new code—for endoscopic destruction of the PNN using radiofrequency ablation—describes the procedure performed by ENT physicians when treating overactive nerves that drive chronic rhinitis symptoms with 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 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.
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 chronic ENT conditions. The company’s products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology that allow ENT physicians to improve patients’ symptoms. More than 100,000 patients have been treated with Aerin Medical products to date.