NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives
Rhea-AI Summary
NeurAxis (NYSE American: NRXS) announced new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (PENFS), adding approximately 45 million covered lives and bringing PENFS total national coverage to roughly 100 million covered lives.
The company’s FDA-cleared IB-Stim is approved for patients 8 years and older with functional abdominal pain related to IBS and functional dyspepsia. NeurAxis noted a Category I CPT code effective January 1, 2026, incorporation of PENFS into national clinical guidelines, and a strengthened balance sheet as positioning factors for expected revenue growth and margin expansion.
Positive
- Coverage adds approximately 45 million covered lives
- Total national coverage footprint reaches roughly 100 million covered lives
- IB-Stim is FDA-cleared for patients aged 8+ with functional abdominal pain
- Category I CPT code effective Jan 1, 2026
Negative
- New coverage is from a single major insurer to date, requiring additional payer wins
Key Figures
Market Reality Check
Peers on Argus 1 Down
NRXS was up 4.35% while the only momentum-scanned peer, ICU, was down 11.68%. Other close peers showed mixed moves, suggesting the reaction was more company-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 01 | Access expansion | Positive | -4.0% | VA Federal Supply Schedule contract adding IB-Stim access to VA system. |
| Nov 12 | Coverage expansion | Positive | +7.9% | New Michigan coverage adding 566,000 lives, lifting total to ~55 million. |
| Nov 11 | Earnings results | Positive | -5.9% | Q3 2025 revenue up 22% with higher units but wider operating loss. |
| Nov 04 | Earnings preview | Positive | -5.2% | Announcement of upcoming Q3 2025 results and business update call. |
| Oct 24 | FDA clearance | Positive | -8.6% | First FDA clearance for treating adult functional dyspepsia-related pain. |
Recent NRXS news has often been followed by negative price reactions even on seemingly positive milestones, with one notable positive reaction to a prior coverage expansion.
Over the last few months, NeurAxis has reported several commercial and regulatory milestones. On Oct 24, it gained FDA 510(k) clearance expanding PENFS indications to adults. Late October and November brought preliminary and then full Q3 2025 results, showing revenue growth but ongoing losses. The company also expanded coverage to about 55 million lives and secured a VA Federal Supply Schedule contract serving nearly 7 million patients. Today’s large coverage addition and move toward ~100 million covered lives builds directly on this access and reimbursement momentum.
Market Pulse Summary
This announcement highlights a major commercialization milestone, with PENFS coverage expanding by approximately 45 million lives and total access reaching about 100 million. It reinforces IB-Stim’s position as an FDA-cleared, non‑drug option for functional abdominal pain in patients aged 8 years and older, ahead of a Category I CPT code effective January 1, 2026. In context of prior coverage gains and FDA clearances, key watchpoints remain real-world utilization, payer uptake, revenue trends, and management’s execution on broader insurer contracting.
Key Terms
percutaneous electrical nerve field stimulation medical
neuromodulation medical
functional dyspepsia medical
category i cpt code technical
AI-generated analysis. Not financial advice.
Total national coverage footprint for PENFS increases to roughly 100 million covered lives
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.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com