Full Press Release Details
CARMEL, Ind., April 22, 2026 (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 four additional health insurers with medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), representing approximately 1.25 million covered lives. These medical policies expand incremental access to IB-Stim treatment for beneficiaries in West Virginia, New Hampshire, South Carolina, Virginia, and Florida.
“Momentum in expanding insurance coverage for IB-Stim remains strong as we work to make this therapy more accessible and affordable to patients nationwide through written policy coverage on a national scale with all payers,” said Brian Carrico, CEO of NeurAxis. “Payers across the country are increasingly recognizing the efficacy of IB-Stim due to the Category I CPT code now being effective and our PENFS technology included in leading clinical guidelines. Backed by a solid balance sheet, we are prepared to expand the commercial footprint in parallel to increased payer coverage and capitalize on accelerating demand.”
NeurAxis’ proprietary PENFS technology, IB-Stim, is FDA-cleared for the treatment of functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia, and FD associated nausea symptoms, in patients 8 years and older. IB-Stim is a non-invasive neuromodulation device that gently stimulates cranial nerve bundles in the ear to help regulate pain signaling between the gut and the brain. Currently, no FDA-approved drug therapies exist for pediatric patients with abdominal pain-related disorders of gut-brain interaction (DGBIs), a significant unmet medical need. In the absence of approved options, off-label prescription drugs are often used, despite limited efficacy data and potential safety concerns—underscoring IB-Stim’s unique position as the only FDA-cleared therapy specifically designed for this large and underserved pain related patient population.
The Company advises that its audited consolidated financial statements for the fiscal year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2026, contain an audit report of the Company’s independent registered public accounting firm that includes an explanatory (emphasis-of-matter) paragraph regarding substantial doubt about the Company’s ability to continue as a going concern. This disclosure is made to satisfy Section 610(b) of the NYSE American Company Guide. This disclosure does not amend, modify, or restate the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or any other previously filed disclosure.
About NeurAxis, Inc.
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 adoption of IB-Stim®, 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), functional dyspepsia (FD), and FD-related nausea symptoms in patients 8 years and older. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.
For more information, please visit http://neuraxis.com.
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
The Company advises that its audited consolidated financial statements for the fiscal year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2026, contain an audit report of the Company’s independent registered public accounting firm that includes an explanatory (emphasis-of-matter) paragraph regarding substantial doubt about the Company’s ability to continue as a going concern. This disclosure is made to satisfy Section 610(b) of the NYSE American Company Guide. This disclosure does not amend, modify, or restate the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or any other previously filed disclosure.
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.
Tags
Irritable Bowel Syndrome
Medical Policy Coverage