NeurAxis announces new insurance coverage for its FDA-cleared IB-Stim device, addressing pediatric abdominal pain related to IBS and FD.
Quiver AI Summary
NeurAxis, Inc. announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, from a major national health insurer, which will benefit approximately 45 million health plan members across multiple states. IB-Stim, FDA-cleared for treating functional abdominal pain related to irritable bowel syndrome (IBS) and functional dyspepsia in patients aged 8 and older, addresses significant unmet medical needs for pediatric patients, as there are currently no FDA-approved drug therapies for their condition. The coverage reflects the growing recognition of IB-Stim as a necessary evidence-based therapy for gastrointestinal disorders in children. NeurAxis is optimistic about securing further coverage from additional insurers, highlighting potential for significant revenue growth with a new Category I CPT code effective January 1, 2026.
Potential Positives
- NeurAxis has secured significant new medical policy coverage for its IB-Stim technology from a major national health insurer, potentially benefiting approximately 45 million health plan members.
- The FDA-cleared IB-Stim device addresses a significant unmet medical need for pediatric patients suffering from functional abdominal pain, with no FDA-approved drug therapies currently available for this condition.
- The announcement of a Category I CPT code effective January 1, 2026, positions NeurAxis for potential revenue growth and margin expansion.
Potential Negatives
- The mention of significant unmet medical needs and the reliance on off-label prescription drugs indicate a gap in available treatments, which may suggest that NeurAxis is entering a competitive and uncertain market.
- Forward-looking statements include various risks and uncertainties that could significantly impact the company's future business, strategy, and financial performance.
- Dependence on the approval of additional national insurers for coverage may pose a risk to financial stability and revenue growth if those approvals do not materialize as anticipated.
FAQ
What is NeurAxis, Inc. known for?
NeurAxis, Inc. specializes in medical technology, focusing on neuromodulation therapies for chronic conditions in children and adults.
What is the new medical policy coverage for PENFS?
The new coverage extends to approximately 45 million health plan members across multiple states for Percutaneous Electrical Nerve Field Stimulation.
How does the IB-Stim device work?
IB-Stim is a non-invasive device that stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and brain.
What conditions does IB-Stim treat?
IB-Stim is FDA-cleared for treating functional abdominal pain, specifically associated with irritable bowel syndrome and functional dyspepsia.
When does the new CPT code for IB-Stim take effect?
The new Category I CPT code for IB-Stim will take effect on January 1, 2026.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
CARMEL, 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 spans multiple states and represents approximately 45 million health plan members.
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 (FD) including 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 to functional dyspepsia, 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.
“We are extremely pleased to see medical policy coverage for PENFS from one of the nation’s leading health insurers, and we are working aggressively to secure additional large national insurers,” said Brian Carrico, Chief Executive Officer of NeurAxis. “This milestone demonstrates the growing clinical and payer recognition of IB-Stim as a necessary, evidence-based therapy for pediatric gastrointestinal disorders. With a Category I CPT code taking effect January 1, 2026, and our proprietary PENFS technology incorporated into leading national society clinical practice guidelines, NeurAxis is well positioned for significant revenue growth and margin expansion. Supported by a strengthened balance sheet, the Company is prepared to capitalize on the accelerating demand ahead.”
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 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) and functional dyspepsia 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.
Contacts:
Company
NeurAxis, Inc.
[email protected]
For contraindications, precautions, warnings, and IFU, please see:
https://ibstim.com/important-information/
.
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
[email protected]