Neurent Medical Announces 510(k) Clearance of its Next Generation NEUROMARK® System

Developed in Collaboration with Leading ENT Experts, the Enhanced NEUROMARK® System Reflects Meaningful Innovation and Delivers Real-Time Feedback to Improve Patient Care

GALWAY, Ireland, June 11, 2025 /PRNewswire/ -- Neurent Medical, a leader in pioneering non-surgical solutions for chronic sinonasal inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Next Generation NEUROMARK^®  System, marking a major milestone in advancing care for patients suffering from Chronic Rhinitis. This latest advancement in the NEUROMARK platform delivers a new level of control, confirmation, and confidence for otolaryngologists.  

The new system is designed to optimize the treatment of posterior nasal nerves by providing real-time feedback, guiding proper electrode placement, and confirming successful treatment delivery. The flexible shaft and atraumatic leaflets conform to patient anatomy, enabling physicians to reach challenging areas in the nasal cavity while maximizing treatment coverage. The NEUROMARK System delivers impedance-controlled, low-power radiofrequency (RF) energy to disrupt the parasympathetic nerve signals, addressing key symptoms of Chronic Rhinitis such as persistent nasal congestion and rhinorrhea (runny nose).

"We have just completed a highly successful commercial validation phase, positioning the NEUROMARK system at the forefront of Chronic Rhinitis care," said Brian Shields, CEO of Neurent Medical. "During this phase, we have collaborated with leading General ENT and Rhinology specialists across both private practice and academic settings. Their insights were instrumental in shaping this next-generation system. I am incredibly proud of how their feedback translated into meaningful technological improvements. This milestone highlights our continued commitment to innovations that empowers ENTs to treat patients with greater confidence."

"I have worked closely with the Neurent Medical team from the beginning and continue to be impressed by their dedication to ENT surgeons and our patients." said Dr. Marc Dubin, Chief Medical Officer, ENT Specialty Partners. "The latest generation of the NEUROMARK System reflects this commitment, incorporating usability enhancements and real- time feedback capabilities to support precise treatment delivery."

This FDA clearance paves the way for broader U.S. availability of the NEUROMARK System as Neurent Medical continues its mission to redefine the standard of care for Chronic Rhinitis, affecting nearly 1 in 4 Americans¹.

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.neuromark.com.

1. Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34

SOURCE Neurent Medical