NeurAxis Announces New Medical Policy Coverage with Two Health Insurers, Adding 700,000 Covered Lives

Rhea-AI Summary

NeurAxis (NYSE: NRXS) has secured medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology from two health insurers, adding 700,000 covered lives in Connecticut and Massachusetts. This brings their total national coverage to approximately 53 million members. The company's FDA-cleared IB-Stim device treats functional abdominal pain associated with IBS and Pediatric Functional Dyspepsia in patients aged 8-21 years through non-surgical electrical stimulation of cranial nerves. The technology has been included in pediatric academic society's treatment guidelines, and a Category I CPT code will become effective January 1, 2026, which is expected to improve reimbursement and adoption across children's hospitals.

Positive

• Expanded insurance coverage adding 700,000 new covered lives, reaching total coverage of 53 million members
• Inclusion in pediatric academic society's treatment guidelines for Functional Abdominal Pain in IBS
• Upcoming Category I CPT code activation on January 1, 2026, expected to improve reimbursement
• Only FDA-cleared treatment option for pediatric IBS and functional dyspepsia, with no FDA-approved drug alternatives

Negative

• Additional major payer decisions still pending
• Limited to specific age group (8-21 years old)

Insights

Medical Device Market Analyst

NeurAxis secures additional insurance coverage for its neuromodulation device, expanding market access and revenue potential ahead of CPT code implementation.

NeurAxis has secured an important expansion of insurance coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, adding approximately 700,000 covered lives through two health insurers in Connecticut and Massachusetts. This brings their total national coverage to roughly 53 million lives, with additional major payer decisions still pending.

The company's IB-Stim device, which delivers gentle electrical impulses to cranial nerve bundles in the ear, holds FDA clearance for functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in patients aged 8-21 years. This represents a significant market opportunity given there are currently no FDA-approved drug therapies for children with these conditions.

Three critical catalysts are converging to strengthen NeurAxis's market position: First, the recent inclusion of their PENFS technology in leading pediatric academic society's treatment guidelines for Functional Abdominal Pain in IBS - a crucial validation that typically drives insurance coverage decisions. Second, the upcoming activation of a Category I CPT code for PENFS effective January 1, 2026, which will establish standardized reimbursement values and incentivize adoption across children's hospitals. Third, the company reports a strengthened balance sheet, providing financial runway to capitalize on these developments.

This insurance expansion represents an important inflection point in NeurAxis's commercialization journey. By addressing the reimbursement barrier - traditionally the most significant hurdle for medical device adoption - the company is positioning its non-surgical alternative to gain market share in a treatment landscape currently dominated by off-label prescription medications that often lack efficacy evidence and carry side effect risks.

CARMEL, Ind., June 17, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), covering two health insurers, with approximately 700,000 total members in Connecticut and Massachusetts. This medical policy will bring our national total coverage for PENFS to roughly 53 million, with more decisions from major payers still pending.

NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia (Nausea Symptoms) in adolescents 8-21 years old. IB-Stim is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. Off-label, prescription drugs are often used to treat children despite poor evidence of efficacy and the potential for serious side effects.

“As we continue to execute, we remain focused on expanding insurance coverage for IB-Stim, which will make this much-needed therapy for abdominal pain associated with IBS and Pediatric Functional Dyspepsia more accessible and affordable to patients,” said Brian Carrico, CEO of NeurAxis. “This is an exciting inflection point for NeurAxis. Our proprietary PENFS technology was recently incorporated into the leading pediatric academic society’s treatment guidelines for Functional Abdominal Pain in IBS—a key milestone we expect will drive broad policy coverage and reimbursement. Additionally, the upcoming activation of the Category I CPT code for PENFS, effective January 1, 2026, will assign value to the PENFS procedure, improve reimbursement, and incentivize broader adoption across children’s hospitals. With a recently strengthened balance sheet, we are well-positioned to capitalize on the accelerating demand we see 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 adolescents 8-21 years old. 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.

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

FAQ

What new insurance coverage did NeurAxis (NRXS) secure for its PENFS technology?

NeurAxis secured coverage from two health insurers in Connecticut and Massachusetts, adding 700,000 covered lives and bringing their total national coverage to approximately 53 million members.

What is NeurAxis's IB-Stim device used to treat?

IB-Stim is FDA-cleared to treat functional abdominal pain associated with IBS and Pediatric Functional Dyspepsia (Nausea Symptoms) in adolescents aged 8-21 years old.

How does NeurAxis's PENFS technology work?

The IB-Stim device is a non-surgical treatment that delivers gentle electrical impulses into cranial nerve bundles in the ear.

When will the Category I CPT code for PENFS become effective?

The Category I CPT code for PENFS will become effective on January 1, 2026, which is expected to improve reimbursement and encourage broader adoption across children's hospitals.

Why is NeurAxis's IB-Stim significant in the pediatric treatment landscape?

IB-Stim is significant because there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction.