FDA Clears NeurAxis’ Self-Inflating Balloon Device

NeurAxis Inc. has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its Rectal Expulsion Device (RED), designed for testing and evaluating patients with chronic constipation due to pelvic floor dyssynergia and who are unlikely to improve with increased laxative use.

NeurAxis will begin the process of commercially marketing RED and expects a soft launch this quarter with a full launch expected in Q2. Management believes that providers will bring this technology to their practice immediately, given its clinical need and total addressable market of roughly $1.5 billion. There is currently a Category I CPT code assigned to the procedure and it is covered by Medicare and most commercial insurance companies.

RED is a proprietary, self-inflating balloon that evaluates a patient’s ability to expel contents from the rectum. “For many patients with chronic constipation, traditional laxative therapy does not work well because the problem is not related to colon motility, but rather with the neuromuscular function of the pelvic floor,” NeurAxis Chief Medical Officer Dr. Adrian Miranda said. “Without proper testing, these patients can be missed and continue to suffer with inadequate treatments.”

RED can also be used as a qualitative test for rectal hypersensitivity. It will help identify patients who have an exaggerated urge to defecate, which also changes the treatment algorithm for patients with constipation.

“The RED 510(k) clearance is another important achievement as we continue to build and expand our Gastroenterology business and accelerate meaningful revenue growth towards our goal of cash flow breakeven,” NeurAxis President/CEO Brian Carrico stated. “I am excited by our multiple avenues of revenue and profitability growth, driven by the expansion of insurance coverage and age indication of our IB-Stim product for pediatric FAP/IBS and our commercial launch of RED. Looking out beyond 2025, we are excited to pursue expanded indications with the FDA, using our PENFS technology, including adult FAP/IBS and pediatric/adult Functional Dyspepsia.”

NeurAxis Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive the adoption of its IB-Stim therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.