Summary: Neurent Medical’s PARAGON study showed positive six-month results for its Neuromark System, a radiofrequency ablation device for chronic rhinitis. The 80-participant trial demonstrated improvements in rhinitis symptoms, ear-related issues, and quality of life. Key findings include a significant reduction in Total Nasal Symptom Score (rTNSS), with 91% of participants achieving meaningful improvement. Ear symptoms associated with Eustachian tube dysfunction also improved. Both allergic and nonallergic rhinitis subgroups benefited similarly from the treatment. Results were published in Ear, Nose & Throat Journal.
Key Takeaways:
- Symptom Improvement: The Neuromark System demonstrated a statistically significant improvement in chronic rhinitis symptoms, with 91% of participants achieving a clinically important reduction in Total Nasal Symptom Score at six months.
- Enhanced Ear Symptom Relief: The study found that Neuromark also improved ear-related symptoms, such as ear ringing and muffled hearing, associated with Eustachian tube dysfunction.
- Consistent Results Across Subgroups: Both allergic and nonallergic rhinitis patients showed improvement in all outcome measures, with no notable differences between the two groups.
Neurent Medical, a company developing non-surgical interventions to treat chronic inflammatory sinonasal diseases, positive six-month results from the PARAGON study, demonstrating that treatment with Neuromark System, a radiofrequency ablation device indicated for chronic rhinitis, led to significant improvements in rhinitis symptoms, ear symptoms, and quality of life.
The results are published in Ear, Nose & Throat Journal.
The PARAGON Study, a prospective, multicenter, singe-arm trial, enrolled 80 participants. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at six-month follow-up.
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Additional assessments included Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). Subgroup analyses were performed for participants with allergic and nonallergic rhinitis.
Key Efficacy Findings:
- The primary endpoint was met with a statistically significant improvement from baseline to six months in the rTNSS.
- 91% of participants achieved the minimal clinically important difference of ≥1 point improvement in the rTNSS at six months.
- The ETDQ-7 score, which measures ear pressure, ear pain, clogged ears, ear problems with cold/sinusitis, crackling/popping, ringing in ears, and muffled hearing, was significantly improved at six months.
- The total NOSE score and all five subscores were significantly improved at all time points.
- The overall mini-RQLQ score and all domain scores demonstrated significant improvement at all follow-ups.
- Both allergic and nonallergic subgroups showed significant improvement in all outcome measures, with no significant differences between subgroups.
“This study provides significant evidence that the Neuromark System dramatically improves the symptoms of chronic rhinitis, especially runny nose and nasal congestion,” says lead investigator, Greg Davis, MD, in a release. “In addition, one of the exciting benefits of Neuromark, is that this procedure improves ear symptoms associated with Eustachian tube dysfunction. This is the first study to show that neuromodulation of the posterior nasal nerve improves these symptoms. I am proud of the research team and co-investigators, and look forward to seeing our long-term data in the future.”
Photo caption: Neuromark
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