SUNNYVALE, Calif.– Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, today announced the publication of positive results from the RELIEF clinical trial in the American Journal of Rhinology & Allergy. RELIEF demonstrated that treatment yielded a clinically significant improvement in all chronic rhinitis symptoms and quality-of-life (QoL) at three- and six-months following RhinAer® treatment. Additionally, the study demonstrated that the procedure was well-tolerated by patients.
“Chronic rhinitis can be a frustrating condition for patients as the symptoms are often poorly controlled with current treatments like nasal sprays and other medications,” said Elina Toskala, M.D., Ph.D., MBA, Professor, Rhinology and Skull Base Surgery, Department of Otolaryngology – Head and Neck Surgery, Thomas Jefferson University in Philadelphia, and investigator of the RELIEF clinical trial. “This new international, multi-center study demonstrates that treatment with a temperature-controlled radiofrequency device shows a sustained improvement in chronic rhinitis symptoms, cough and post-nasal drip as well as quality-of-life measures through 6 months. The procedure was shown to be well-tolerated with no post-procedural headaches reported.”
RELIEF, a prospective, single-arm, multi-center study, enrolled 129 adults with chronic rhinitis at 16 centers in the United States and Germany and evaluated clinical outcomes and QoL in those who were treated with RhinAer. The RELIEF study met its primary and secondary endpoints, demonstrating that treatment of the posterior nasal nerve (PNN) area with RhinAer was safe and significantly reduced major chronic rhinitis symptoms at three- and six-months following treatment. Findings included:
- Symptom Improvement: There was a 62.8% improvement over baseline at six months and 53.8% improvement at three months (p<0.001 comparing each follow up to baseline) in reflective total nasal symptom score (rTNSS) subscores (runny nose, nasal congestion, itching and sneezing). Post-nasal drip and chronic cough scores were significantly improved at three months and further improved at six months.
- Responder Rates: 83.5% of patients positively responded to treatment in the six-month analysis and 76.2% at three months, defined as a ≥30% improvement in symptoms compared to baseline.
- Quality-of-Life Improvement: At six months, 87.7% of participants reported a minimal clinically important difference (MCID) of ≥0.4-point improvement in the mini rhinoconjunctivitis quality-of-life questionnaire (MiniRQLQ) score; that percentage was 80.3% at three months. This is the first time this QoL instrument — which measures the disease-specific, health-related QoL functional impairments considered most troublesome to patients because of their rhinoconjunctivitis — has been used to report outcomes of the technology.
- Safety: The RhinAer treatment was well-tolerated, with no headaches or significant pain-related adverse events reported. No serious device- or procedure-related adverse events occurred.
“Aerin Medical is committed to providing high-quality evidence to support appropriate use of our novel technology, with 10 significant peer-reviewed publications delivered to our otolaryngology community in the last year,” said Matt Brokaw, CEO of Aerin Medical. “Publication of these study results validates the benefits that patients are experiencing after receiving treatment with RhinAer, and we are grateful to the physicians and patients who participated in this study.”
Rhinitis, or inflammation of the mucous membrane 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. ENTs use RhinAer to directly interrupt nerve signals and help reduce chronic rhinitis symptoms.
