NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pediatric FAP/Functional Dyspepsia (FD) and Associated Nausea Symptoms
- First-ever FDA clearance for functional dyspepsia treatment, establishing market leadership
- Expected to double the company's total addressable market
- Leverages existing CPT code and insurance coverage for efficient market rollout
- New CPT Category I code approval effective January 2026
- Non-invasive treatment alternative where no FDA-approved drug therapies exist
- None.
Insights
FDA clearance for pediatric functional dyspepsia treatment doubles NeurAxis's market with immediate rollout using existing infrastructure.
NeurAxis has secured a groundbreaking FDA 510(k) clearance for IB-Stim to treat functional abdominal pain (FAP) associated with functional dyspepsia (FD) and related nausea in patients aged 8-21. This marks the first-ever FDA clearance for any functional dyspepsia treatment, positioning NeurAxis as a pioneer in this therapeutic area.
The expanded indication is expected to nearly double the company's total addressable market, representing a significant revenue opportunity. What's particularly impressive is the implementation strategy - NeurAxis can leverage their existing CPT code, insurance coverage, and provider relationships for an immediate and capital-efficient commercial rollout.
This development builds on the company's momentum in non-invasive neuromodulation for pediatric conditions. Their Percutaneous Electrical Nerve Field Stimulation (PENFS) technology delivers gentle electrical impulses to cranial nerve bundles in the ear, offering a non-pharmacological approach for conditions that currently lack FDA-approved drug therapies.
The market opportunity is compelling as functional dyspepsia presents significant challenges for pediatric patients, including fear of eating, weight loss, and dietary restrictions. With the American Medical Association's recent approval of a Category I CPT code for IB-Stim (effective January 2026), reimbursement pathways are strengthening, which typically accelerates clinical adoption and revenue growth for medical devices.
• Significantly expands IB-Stim’s total addressable market
• Clearance covers patients aged 8–21
• Seamless go-to-market strategy with existing reimbursement and provider infrastructure
CARMEL, Ind., May 20, 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 that it has received FDA 510(k) clearance for IB-Stim™ for the treatment of Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and FD related Nausea Symptoms, in patients aged 8 to 21 years. This clearance is the second successful expanded FDA indication for IB-Stim, following its initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS). The new indication represents the first treatment ever cleared or approved by the FDA related to functional dyspepsia. It is expected to nearly double the Company’s total addressable market, reinforcing NeurAxis’ leadership in non-invasive, pediatric-focused neuromodulation.
The indication leverages the same CPT code, insurance coverage, and provider call points as the existing IBS indication, supporting a seamless and capital-efficient go-to-market strategy. Commercial rollout for this expanded important indication will begin immediately.
“This latest FDA clearance represents a pivotal milestone in NeurAxis’ growth strategy,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “Expanding into the treatment of Pediatric Functional Dyspepsia pain that includes related nausea symptoms, not only broadens our clinical impact but also positions us to drive significant revenue growth through a capital-efficient rollout. This progress is fueled by a robust body of clinical evidence supporting our PENFS technology, which continues to gain traction among providers and payers. Notably, we are seeing expanded insurance coverage and, most recently, the American Medical Association’s approval of a new CPT Category I code for IB-Stim, which will take effect in January 2026.”
“Functional dyspepsia can cause severe abdominal pain and nausea, and in adolescents, it often leads to serious secondary issues like fear of eating, weight loss, and significant dietary restriction,” said Dr. Adrian Miranda, Chief Medical Officer of NeurAxis. “We are thrilled by the agency’s decision, which gives us the opportunity to offer real hope to thousands of patients and their families who have had limited options—until now.”
NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia 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 (DGBI’s). 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 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, the results of the shareholder vote to enable the issuance of the Preferred Stock, 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, Precautions, 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 FDA clearance that NeurAxis (NRXS) received for IB-Stim?
How will the new FDA clearance impact NeurAxis's (NRXS) market potential?
What is IB-Stim and how does it work?
When will the new CPT Category I code for NeurAxis's (NRXS) IB-Stim take effect?
What age group can be treated with NeurAxis's (NRXS) IB-Stim device?
