NeurAxis Receives New FDA 510(K) Clearance for IB-Stim, Expanding its Addressable Market

Rhea-AI Summary

NeurAxis (NYSE American: NRXS) has received a new FDA 510(k) clearance for IB-Stim™, expanding its addressable market by approximately 75%. The clearance extends the age range for use from 11-18 to 8-21 years old and increases the treatment protocol from 3 devices over 4 weeks to 1 device per week for 4 weeks. IB-Stim, a non-surgical neuromodulation device, treats functional abdominal pain associated with IBS by sending gentle electrical impulses to cranial nerve bundles in the ear. The company expects increased revenue and margin growth due to expanded payer coverage and a new CPT Category I code effective January 2026.

Positive

• Addressable market expansion of approximately 75%
• Extended age range approval from 11-18 to 8-21 years old
• Increased treatment protocol from 3 to 4 devices per patient
• New CPT Category I code established, effective January 2026
• Expanded payer coverage

Negative

• None.

Insights

Medical Research Analyst

This FDA clearance significantly expands IB-Stim's market potential in two important ways. First, broadening the age range from 11-18 to 8-21 years represents a 75% increase in the addressable patient population. Second, the new protocol allowing weekly device changes over 4 weeks, versus the previous 3-device limit, increases revenue potential per patient by 33%.

The lack of FDA-approved drug alternatives for pediatric functional abdominal pain gives IB-Stim a unique market position. The non-invasive nature and established safety profile through published research strengthen its competitive advantage. The upcoming Category I CPT code implementation in 2026 should streamline reimbursement processes and boost adoption among healthcare providers.

Market Research Analyst

For a micro-cap company with an $18.8M market cap, this regulatory win is strategically significant. The expanded indication directly addresses two key revenue drivers: larger patient pool and increased per-patient device utilization. The CPT Category I code upgrade from January 2026 typically leads to better insurance coverage and higher reimbursement rates compared to temporary codes.

The timing aligns well with growing market awareness of non-pharmacological solutions for pediatric pain management. With no FDA-approved drug alternatives, IB-Stim could capture significant market share in this underserved segment, potentially driving substantial revenue growth in upcoming quarters.

Clearance expands indication for use from 11-18 year olds to 8-21 year olds; and from 3 devices, not to exceed 4 weeks, to 1 device per week for 4 weeks

CARMEL, Ind., Nov. 04, 2024 (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 that it received a new 510(k) clearance for IB-Stim™ Nonimplanted Nerve Stimulator for functional abdominal pain relief. The new indication expands IB-Stim’s addressable market and overall devices per patient. NeurAxis leveraged its robust published data to receive this new indication.

“We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “Furthermore, we expect devices per patient to increase, as this new FDA clearance states on label use of four devices per patient. All of this has been achieved due to the strong body of published research, which has resulted in the increased acceptance of our PENFS technology. This includes ongoing expansion of payer coverage, as well as the recent establishment of a new CPT Category I code by the American Medical Association, effective January 2026. Our recent achievements in our commercialization strategy have set the stage for increased revenue and margin growth in the upcoming quarters.” Mr. Carrico concluded.

NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) 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. Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy.

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 the 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) 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.

For contraindications, precaution, warnings, and IFU, please see:

https://ibstim.com/important-information/.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

FAQ

What is the new age range approved for NeurAxis (NRXS) IB-Stim device?

The new FDA 510(k) clearance expands the age range for IB-Stim from 11-18 years to 8-21 years old.

How many IB-Stim devices are now approved per patient under the new FDA clearance?

The new clearance allows for 1 device per week for 4 weeks, increased from the previous 3 devices not exceeding 4 weeks.

When will the new CPT Category I code for NeurAxis (NRXS) IB-Stim become effective?

The new CPT Category I code established by the American Medical Association will become effective in January 2026.

By what percentage did the addressable market expand with the new FDA clearance for NRXS?

The new FDA 510(k) clearance expands IB-Stim's addressable market by approximately 75%.