Newswise — GALWAY, Ireland , June 6, 2024 /PRNewswire/ — Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced the publication of positive 12-month results from the CLARITY clinical trial in Laryngoscope Investigative Otolaryngology. This study demonstrates that treatment with Neurent Medical’s radiofrequency (RF) ablation device, the NEUROMARK® system, is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up.
Dr. Reh added, “The CLARITY study results provide compelling evidence of sustained symptom relief for patients.”
Key Findings:
- Symptom Reduction: All 5 Visual Analog Scale Nasal Symptom Score (VAS NSS) items demonstrated significant improvement (p<.0001) over baseline at all 3 time points (6, 9, and 12 months). The reflective Total Nasal Symptom Score (rTNSS) improved from baseline at all 3 time points (p<.0001). A total of 91% of participants achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point for the rTNSS at 12 months.
- Clinical Safety: The procedure showed a consistent safety profile, with no serious adverse events related to the RF ablation device observed throughout the study.
- Quality of Life Improvement: The total mean mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) significantly improved from baseline at all 3 time points (p<.0001). A total of 86% of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ at 12 months.
Brian Shields, CEO of Neurent Medical, overviewed the significance of these findings, “This publication further validates the efficacy of our algorithm-driven patented technology for the treatment of chronic rhinitis. The publication of our device’s long-term efficacy and safety data in Laryngoscope Investigative Otolaryngology reaffirms our commitment to building strong clinical evidence to support the continued adoption of our innovative solutions that significantly improve outcomes and patient quality of life.”
Lead investigator Dr. Douglas D. Reh added, “The CLARITY study results provide compelling evidence of sustained symptom relief and enhanced quality of life for patients suffering from chronic rhinitis. This important research better elucidates the neurovascular component of chronic rhinitis and underscores the potential of Neurent Medical’s RF ablation device as a transformative treatment option with durable relief.”
The publication of this study further represents a noteworthy advancement in the field of sinonasal treatment options. The long-term data presented in the CLARITY study not only informs healthcare providers’ treatment decisions but also paves the way for future potential payor coverage considerations. As Neurent Medical continues to innovate, the company remains committed to improving the standard of care for chronic rhinitis patients nationwide.
The full publication may be accessed online here: https://onlinelibrary.wiley.
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 Radio Frequency (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.
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