NeurAxis Secures FDA Clearance for Treating Pediatric FAP and FD

NeurAxis, Inc., a prominent medical technology firm specializing in neuromodulation therapies, has achieved a significant milestone with the FDA's clearance for its IB-Stim™ device. The approval extends its use for treating Pediatric Functional Abdominal Pain linked to Functional Dyspepsia and associated nausea symptoms for individuals aged 8 to 21 years. This marks an expansion from its previous clearance for Functional Abdominal Pain related to Irritable Bowel Syndrome. With no prior treatments approved by the FDA for functional dyspepsia, this development is set to broaden NeurAxis' influence in the realm of non-invasive neuromodulation therapies for pediatric patients.

The newly acquired clearance is anticipated to substantially increase NeurAxis' market reach, leveraging existing CPT codes and insurance frameworks similar to those for IBS treatment. This strategic alignment facilitates a seamless market introduction, enhancing the company's ability to generate revenue without extensive capital expenditure. As the commercial launch of the expanded indication begins, NeurAxis aims to strengthen its hold in the medical field.

Brian Carrico, President and CEO of NeurAxis, underscores the importance of this achievement in the company's expansion goals. By venturing into treatments for Pediatric Functional Dyspepsia and its associated nausea, NeurAxis not only extends its clinical impact but also sets the stage for significant revenue augmentation through a cost-efficient rollout strategy. The decision is backed by solid clinical evidence supporting their PENFS technology, which is gaining acceptance among healthcare providers and insurers. The recent approval of a new CPT Category I code by the American Medical Association is expected to become effective in January 2026, further supporting this growth trajectory.

Chief Medical Officer Dr. Adrian Miranda highlights the debilitating nature of functional dyspepsia, which can result in severe abdominal pain and nausea in adolescents, often leading to secondary issues such as fear of eating and considerable dietary restrictions. The FDA's decision offers hope to many families who previously faced limited treatment options.

IB-Stim™, NeurAxis’ proprietary device, employs Percutaneous Electrical Nerve Field Stimulation (PENFS) technology. It is a non-surgical method delivering mild electrical impulses to cranial nerves in the ear, addressing functional abdominal pain associated with both IBS and functional dyspepsia in young patients. This device stands out, particularly as there are currently no drug therapies approved by the FDA for treating abdominal pain-related disorders of the gut-brain interaction in children. Pharmaceuticals used off-label can present serious side effects and lack robust scientific validation of their effectiveness.

NeurAxis, Inc. remains committed to progressing its neuromodulation treatments for chronic and debilitating conditions across pediatric and adult populations. By focusing on evidence-based advancements, the company strives to promote its IB-Stim™ therapy among medical and patient communities. Ongoing clinical trials aim to explore further applications of PENFS technology across various conditions with significant unmet medical needs.

This FDA clearance provides NeurAxis with a platform to potentially transform pediatric care in the field of functional dyspepsia and related ailments, offering a new therapeutic avenue backed by science and innovation.