Total national coverage footprint for PENFS increases to roughly 100 million covered livesCARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage sp ...

Core Insights - NeurAxis, Inc. announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, increasing access to approximately 566,000 covered lives in Michigan, bringing total national coverage to about 55 million lives [1][3] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic conditions in both children and adults, with its proprietary IB-Stim technology FDA-cleared for treating functional abdominal pain associated with IBS and functional dyspepsia in patients aged 8 and older [2][4] - The IB-Stim device is non-invasive and stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and brain, addressing a significant unmet medical need as no FDA-approved drug therapies exist for pediatric patients with abdominal pain-related disorders [2][4] Market Strategy - The company is actively working to expand insurance coverage for IB-Stim, with discussions ongoing with several major insurers as they approach policy review cycles over the next eight months [3] - A Category I CPT code will take effect on January 1, 2026, which is expected to facilitate reimbursement and enhance revenue growth and margin expansion for NeurAxis [3] Clinical Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs, further solidifying its position in the market [4]

Core Insights - NeurAxis, Inc. announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with two health insurers, impacting approximately 700,000 members in Connecticut and Massachusetts, bringing total national coverage to about 53 million [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in adolescents aged 8-21 [2][4] Technology and Market Position - IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear, addressing a significant gap as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders [2] - The technology has been incorporated into treatment guidelines by a leading pediatric academic society, which is expected to enhance policy coverage and reimbursement [3] Future Developments - The activation of a Category I CPT code for PENFS, effective January 1, 2026, is anticipated to improve reimbursement and encourage broader adoption in children's hospitals [3] - NeurAxis is currently conducting additional clinical trials for PENFS across various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - NeurAxis, Inc. has announced that its PENFS technology is now included in clinical practice guidelines for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS), which is a significant milestone for the company [1][6] - The inclusion of IB-Stim in these guidelines is expected to enhance insurance coverage and drive growth, with an estimated addressable market exceeding $3 billion in the U.S. alone [2][3] - The guidelines were developed collaboratively by pediatric gastroenterology societies and emphasize evidence-based recommendations, positioning IB-Stim as a top-tier treatment option [2][6] Company Developments - NeurAxis's CEO highlighted the recognition of IB-Stim as part of the standard care for FAP in IBS, indicating a strong growth strategy and potential for substantial revenue generation [2] - The company has recently received FDA expanded clearances for IB-Stim and is set to implement a new Category I CPT code, further enhancing its market position [2] - The company aims to address the needs of over 600,000 children in the U.S. suffering from FAP, leveraging the new guidelines to expand treatment options [2][3] Market Context - The global market for abdominal pain in IBS presents a multi-billion-dollar opportunity, with IB-Stim being the only FDA-cleared pediatric treatment for FAP in IBS [3] - The guidelines recommend PENFS among other therapies, which elevates NeurAxis's profile and supports broader adoption of IB-Stim within the healthcare industry [2][6] - The rigorous GRADE approach used in developing the guidelines underscores the efficacy and safety of PENFS, enhancing its credibility as a treatment option [2][6]

Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].