PARAGON Study Shows NEUROMARK® Treatment Benefits Allergic and Nonallergic Rhinitis Patients
Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced the publication of positive six-month results from the PARAGON clinical study in Ear, Nose & Throat Journal. The study demonstrates that treatment with Neurent Medical's NEUROMARK® System, a radiofrequency ablation device indicated for chronic rhinitis, led to significant improvements in rhinitis symptoms, ear symptoms, and quality of life.
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 6-month follow-up. 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 6 months in the rTNSS (p < .0001).
91% or participants achieved the minimal clinically important difference (MCID) of ≥1 point improvement in the rTNSS at 6 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 6 months (p < .0001).
The total NOSE score and all 5 subscores were significantly improved at all time points (p < .0001).
The overall mini-RQLQ score and all domain scores demonstrated significant improvement at all follow-ups (p < .0001).
Both allergic and nonallergic subgroups showed significant improvement in all outcome measures (rTNSS, ETDQ-7, NOSE, and mini-RQLQ) (p < .001), with no significant differences between subgroups.
Lead investigator, Dr. Greg Davis said, "This study provides significant evidence that the NEUROMARK System dramatically improves the symptoms of chronic rhinitis, especially runny nose and nasal congestion." He continued, "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."
"We are very pleased with the results from the PARAGON study, which underscore the effectiveness of our NEUROMARK System in providing significant relief for patients suffering from chronic rhinitis, including patients with both allergic and nonallergic rhinitis" said Brian Shields, CEO of Neurent Medical. "This data reinforces our commitment to developing innovative, minimally invasive solutions that enhance patients' quality of life and address the growing need for more effective treatments for chronic sinonasal diseases."
The NEUROMARK® System is a groundbreaking, minimally invasive treatment option designed to target the underlying drivers of chronic rhinitis. With these promising clinical outcomes, Neurent Medical continues to pave the way for non-surgical interventions in sinonasal care.
For more information about the PARAGON study the full publication can be accessed online at: https://journals.sagepub.com/doi/epub/10.1177/01455613241285134
About the NEUROMARK® System
The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radio frequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The system is engineered to gently apply controlled low-power RF energy to target regions of the nasal cavity to disrupt the parasympathetic nerve signals in order to reduce the inflammatory response, thereby reducing core symptoms such as congestion and rhinorrhea.
About Neurent Medical
Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neurentmedical.com.