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NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE:NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it has received FDA 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation (PENFS) technology for the treatment of functional abdominal pain (FAP) associated with functional dyspepsia (FD), and FD related nausea symptoms, in patients aged 8 years and older. The FDA reviewed the clinical literature supporting the use of NeurAxis' PENFS technology, including randomized controlled trials and real-world evidence demonstrating the device's safety and effectiveness in pediatric patients and individuals up to 21 years of age. Based on this comprehensive review, the FDA extrapolated the data to adults, supporting the use of PENFS in patients aged 8 years and older. This expanded indication marks a historic milestone, the first FDA clearance or approval for a treatment specifically addressing functional dyspepsia in adults.
"This latest FDA clearance represents a pivotal milestone for NeurAxis as it is the first ever FDA approved or cleared treatment in the adult market for functional dyspepsia which also includes related nausea symptoms," said Brian Carrico, President and Chief Executive Officer of NeurAxis. "By reaching this goal, it will not only broaden our clinical impact but also positions us to drive substantial revenue growth throughout the GI space in all patients 8 years of age and older. Our upcoming January 1st, 2026, Category I CPT Code for PENFS procedures will also apply to this new adult indication, as it is the same device and same technology. This important approval positions NeurAxis as the leader in minimally invasive neuromodulation therapies."
"Functional dyspepsia can include severe abdominal pain and nausea. In both adolescents and adults, the condition can significantly impact quality of life, leading to food avoidance, unintentional weight loss, and restrictive eating behaviors," said Dr. Adrian Miranda, Chief Medical Officer of NeurAxis. "We are thrilled by the agency's decision, which gives us the opportunity to offer the benefit of treatment to thousands of adult patients who have had limited options—until now."
NeurAxis' PENFS technology is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction (DGBIs) and no approved drug therapies for adults for pain with functional dyspepsia. Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy.
Posted In: NRXS
