New Hope for Chronic Rhinitis: NEUROMARK Trial Validates New Treatment
- 73.3% responder rate in the active treatment group vs. 35.0% in the sham group at 90 days (p < 0.001).
- 31242 CPT code established by CMS in 2024, enabling insurance coverage.
- FDA 510(k) clearance for the NEUROMARK System in 2021 and 2025.
Experts conclude that the NEUROMARK System provides clinically validated, superior relief for chronic rhinitis by targeting the underlying neural cause, supported by rigorous RCT evidence and regulatory approvals.
New Hope for Chronic Rhinitis as Landmark Trial Validates NEUROMARK System
GALWAY, Ireland – February 24, 2026 – For the tens of millions of people worldwide trapped in a cycle of constant sniffles, congestion, and postnasal drip, the term “chronic rhinitis” is an understatement. It's a persistent, quality-of-life-draining condition that often leaves patients frustrated with the limited relief offered by daily nasal sprays and pills. Today, a significant breakthrough offers new, evidence-backed hope.
Neurent Medical, a Galway-based medical device innovator, has announced the publication of overwhelmingly positive results from a major clinical trial for its NEUROMARK® System. The study, featured in the prestigious International Forum of Allergy & Rhinology, provides the highest level of clinical proof to date that the company's minimally invasive technology is a superior treatment for chronic rhinitis sufferers.
The Science of Lasting Relief
At its core, many cases of chronic rhinitis are driven by overactive nerves in the nasal cavity, primarily the posterior nasal nerve. These nerves send continuous signals that trigger the body to produce excess mucus and cause inflammation, leading to the familiar symptoms of a perpetually runny or stuffy nose. While medications can temporarily mask these symptoms, they don't address the underlying neural cause.
The NEUROMARK® System is designed to do just that. It is a non-surgical device that empowers otolaryngologists (ENTs) to perform a procedure called posterior nasal nerve ablation. Using a slender, specialized probe inserted into the nasal cavity, the system delivers precise, low-power radiofrequency (RF) energy to the target nerve region. This energy gently disrupts the hyperactive nerve pathways, significantly reducing the signals that cause chronic symptoms.
What sets the NEUROMARK technology apart is its use of a unique multipoint probe and impedance-controlled energy delivery. This allows the physician to treat a broader area of the nerve region with high precision while receiving real-time biofeedback from the device. This feedback confirms that the treatment has been delivered effectively, providing a new level of confidence and control for the clinician and a more tailored treatment for the patient. The procedure is typically performed in a doctor's office in under 30 minutes with minimal downtime.
Gold-Standard Evidence Confirms Superiority
The newly published study was a prospective, multicenter, single-blind, randomized controlled trial (RCT)—the gold standard for proving a medical treatment's effectiveness. The trial enrolled 132 participants who were randomly assigned to receive either the active NEUROMARK treatment or a sham (placebo) procedure.
The results were definitive. The primary goal was to measure the “responder rate” at 90 days, defined by a significant reduction in the reflective Total Nasal Symptom Score (rTNSS). In the group that received the active treatment, a remarkable 73.3% of patients were classified as responders. This stood in stark contrast to the sham group, where only 35.0% of patients saw similar improvement. The statistical significance of this finding (p < 0.001) unequivocally demonstrated the superiority of the NEUROMARK System.
The benefits extended across a wide range of debilitating symptoms. Patients treated with NEUROMARK reported significantly greater improvements not only in their overall nasal symptoms but also in postnasal drip, chronic cough, and nasal obstruction. Furthermore, their quality of life, measured through standardized questionnaires like the mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), showed dramatic improvement compared to the control group.
"These results provide high-level clinical evidence supporting posterior nasal nerve ablation with impedance controlled radiofrequency energy as an effective treatment option for patients suffering from chronic rhinitis," said Mas Takashima, MD, the trial's Principal Investigator and lead author. "The significant improvements observed across both symptom-based and quality-of-life measures highlight the meaningful impact this therapy can have for patients whose symptoms persist despite medical management."
Paving the Way for Widespread Patient Access
Strong clinical data is only one part of the journey to bringing a new medical technology to patients. Regulatory clearance and insurance coverage are equally critical hurdles. Here, Neurent Medical has also achieved major successes that, combined with this new study, position the NEUROMARK System for broad adoption.
The device first received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2021, with a next-generation version cleared in 2025. A pivotal moment came on January 1, 2024, when the Centers for Medicare and Medicaid Services (CMS) established a specific Category I CPT code (31242) for the procedure. This standardized the billing process, removing a significant barrier for physicians wanting to offer the treatment.
Following this, major private insurers have begun to update their policies. In late 2025, industry giants like UnitedHealthcare and Cigna removed posterior nasal nerve ablation from their lists of experimental procedures, opening the door for millions of their members to access the treatment. These policy changes are often a direct response to the growing body of high-quality clinical evidence, such as the newly published RCT.
Brian Shields, Chief Executive Officer of Neurent Medical, commented on the milestone. "The publication of this randomized controlled trial represents another major milestone for Neurent and reinforces our commitment to evidence-based innovation," he stated. "Demonstrating superiority versus sham in a rigorous RCT underscores the clinical value of the NEUROMARK System and strengthens the foundation for broader adoption of posterior nasal nerve ablation in the treatment of chronic rhinitis."
For patients who have struggled for years with the limitations of existing therapies, this convergence of powerful clinical validation, regulatory support, and expanding insurance coverage marks a pivotal turning point. The validation of this minimally invasive, office-based procedure offers a durable solution that targets the root cause of their symptoms, promising a future with far more clear-breathing days ahead.
