NeurAxis, Inc. has achieved a historic milestone in gastroenterology by receiving FDA 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain associated with functional dyspepsia and related nausea symptoms in patients aged 8 years and older. This represents the first FDA clearance or approval for any treatment specifically addressing functional dyspepsia in adults.
Regulatory Breakthrough Addresses Critical Unmet Need
The FDA's comprehensive review included clinical literature supporting PENFS technology, encompassing randomized controlled trials and real-world evidence demonstrating safety and effectiveness in pediatric patients and individuals up to 21 years of age. Based on this evidence, the FDA extrapolated the data to support use in adult patients, expanding the indication to include patients aged 8 years and older.
"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."
Technology and Clinical Impact
NeurAxis' PENFS technology operates as a non-surgical device that delivers gentle electrical impulses into cranial nerve bundles in the ear. The technology addresses a significant gap in treatment options, as 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.
Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, emphasized the clinical significance: "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. 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."
Market Expansion and Commercial Implications
The expanded indication significantly increases NeurAxis' total addressable market by including adult patients with functional dyspepsia. The clearance will utilize the upcoming January 1, 2026, Category I CPT code for PENFS procedures, as it involves the same device and technology already approved for pediatric use.
Current treatment limitations highlight the importance of this approval. Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy. This positions NeurAxis' PENFS technology as a potentially safer alternative for patients suffering from functional dyspepsia.
Company Focus and Future Development
NeurAxis is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. The company is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its PENFS technology by the medical, scientific, and patient communities. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are currently underway.
