NeurAxis Signs Option Agreement with UMich for Gastrointestinal Device

NeurAxis Inc. has forged an exclusive option agreement with the University of Michigan to license its rectal expulsion device (RED). During the option agreement period, NeurAxis intends to evaluate RED’s market potential.

“We are thrilled to announce this exclusive agreement with the University of Michigan as it potentially expands and fuels NeurAxis’ adult GI focus,” NeurAxis President/CEO Brian Carrico said. “RED offers a significant market opportunity for NeurAxis as it has a Category I CPT Code and established reimbursement in place and targets the same clinical call points as IB-Stim. Working with the University of Michigan, we plan to submit RED for FDA clearance under a 510(k) process with a target commercialization in 2024 and we expect to see meaningful revenues from RED beginning in 2024.”  

The RED redesigns the balloon expulsion testing workflow to directly simplify anorectal function testing downstream to any gastroenterologist’s office.   
 
“Chronic constipation aligns well with NeurAxis’ focus and expertise in the field of disorders of the gut-brain interaction,” NeurAxis Senior Vice President of Science and Technology/Chief Medical Officer Dr. Adrian Miranda said. “The economic impact of adult chronic constipation in the U.S. is significant, with an estimated 2.5 million physician visits annually. Like IBS, chronic constipation also negatively impacts health-related quality of life, including psychological and social consequences. RED is a highly sensitive screening tool for evacuation disorders that will effectively and efficiently identify the underlying cause of symptoms allowing clinicians to tailor treatment and minimize unnecessary testing with a point-of-care test.”
 
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. IB-Stim is cleared by the U.S. Food and Drug Administration 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.