CARMEL, Ind., May 22, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE:NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the first quarter 2024 for the period ended March 31, 2024. Recent Operational Highlights Expanded total covered lives to approximately 22.5 million covered lives, an increase of 400% compared to 4.5 million covered lives as of May 1, 2023. Recent medical policy coverages include: BCBS licensee in Florida covering over 6 million lives. BCBS licensee in North Dakota covering over 310,000 people. BCBS plan in the mid-Atlantic region, providing coverage for approximately 7 million covered lives. Medical Policy with a BCBS licensee covering approximately 1 million covered lives BCBS plan in the mid-Atlantic with approximately 3.5 million covered lives. The Company remains committed to clinical research in the pediatric space with a total of 15 peer-reviewed published studies using NeurAxis' PENFS technology. Thirteen of those studies were carried out in US children's hospitals and included children with disorders of the gut-brain interaction (DGBIs). This level of evidence puts NeurAxis in a great position to continue expanding payor coverage and increase adoption of the technology. Announced the results of the largest multicenter, prospective registry in pediatric DGBIs. It evaluated outcomes of pediatric patients (8-18 years) following a 4-week course of IB-Stim in a real‐world clinical setting. Seven large tertiary care centers enrolled patients with pain-associated DGBIs. Patients were asked to fill out validated pediatric questionnaires, including the abdominal pain index (API). Data was collected weekly during therapy and then every 3 months up to 1 year. Compared to baseline scores, there were significant improvements in abdominal pain (API) after 4 weeks of IB-Stim treatment at every time point, including 6 months (p<0.001) and 12 months (p<0.001).          Announced the results of a retrospective study led by the Cincinnati Children's Hospital Medical Center comparing and reviewing the records of 101 adolescent patients with DGBIs treated with IB-Stim™ therapy or standard-of-care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). The comparative analysis noted: At follow-up, IB-Stim™ therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034). In a comparison of outcomes between groups, IB-Stim™ was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); and Disability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim™ (p=0.21). Signed an exclusive option agreement with the University of Michigan for the right to license its' innovative rectal expulsion device (RED). RED redesigns the balloon expulsion testing workflow to simplify anorectal function testing. FDA clearance is expected in the fourth quarter of 2024. In addition to securing $3.0 million in committed convertible note financing from affiliates of Inspire Health Alliance on November 8, 2023, the Company also closed an additional $3.1 million in committed financing from various investors, including affiliates of Inspire Health Alliance, with identical terms in the first quarter of 2024, with the majority of such financing expected to be paid in monthly amounts through the first quarter of 2025. The Company further strengthened its balance sheet and liquidity position this week by signing documents for an additional $3.0 million in convertible notes from a reputable healthcare focused fund. Management Commentary Brian Carrico, Chief Executive Officer of NeurAxis, commented, "We are pleased with the continued execution of our commercialization strategy for IB-Stim™, our FDA cleared device for functional abdominal pain associated with irritable bowel syndrome in adolescents 11-18 years old. IB-Stim™ is based on our proprietary technology known as Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, which targets nerves to alter pain transmission at the CNS level. The demand for our product is at record levels and continues to increase and as the payer coverage continues to expand, we expect to see continued revenue growth. We remain focused on leveraging the strong data from our studies, which we expect will lead us to wider insurance acceptance from the 22.5 million lives we have under coverage today to a projected 50 million lives by the end of 2024. In recent weeks, we received verbal approval for our first state Medicaid program and written approval for a managed Medicaid in South Carolina. As such, we expect continued revenue growth in 2H24 as hospitals put the proper billing processes in place and begin purchasing the product." "Further contributing to our growth acceleration in 2H24 will be the commercialization of RED, our option to licensed innovative rectal expulsion device, a self-inflating balloon expulsion test that allows for point-of-care testing to effectively identify patients with an evacuation disorder, such as pelvic floor dysfunction. We expect the device to receive FDA clearance in the fourth quarter of 2024" Mr. Carrico continued. Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, commented, "Our robust research studies are integral and have resulted in gaining industry acceptance and insurance coverage. Thus far there have been 15 published studies using PENFS technology, including the most recent "real-world" registry data that shows the sustainability of the improved response in children and adolescents. Mr. Carrico concluded, "We remain steadfast in executing on our near-term goals to further commercialize our lead pediatric indication for IB-Stim. In addition, we are advancing our development pipeline for a number of new indications leveraging our unique neuromodulation therapy, including Functional Dyspepsia, Cyclic Vomiting Syndrome, Post-concussion Syndrome, and more. I anticipate growth in 2024 to be driven by our expanding insurance coverage, and the commercialization of RED. With a strengthened balance sheet through a key investment from Inspire Health Alliance and long-term investors who understand the medical space well, I believe we are well positioned to execute our business plan in 2024." First Quarter 2024 Financial Results Revenues in the first quarter of 2024 were $646.6 thousand, down 19.7% compared to $805.1 thousand in the first quarter of 2023. The decrease was primarily due to fewer shipments to certain customers as they manage through the insurance reimbursement process, partially offset by an increase in volume to our patient assistance customers that receive devices at a discount. While we have made great strides in recent months in gaining coverage, note that there is a lag between insurance coverage and order placement due to billing and coding implementation processes unique to each ...