NeurAxis Achieves Critical Milestone; Secures Key Academic Society Guidelines Recommendation for Treatment of Functional Abdominal Pain (FAP) in IBS
- IB-Stim is one of only 4 therapies with the highest level of evidence in the treatment guidelines
- Only FDA-cleared treatment recommended in the guidelines for pediatric patients
- Large market opportunity with estimated $3 billion addressable market in US alone
- New Category I CPT code becoming effective January 1st, facilitating insurance coverage
- Recent FDA expanded clearances for IB-Stim strengthen market position
- Can be used as first-line therapy according to guidelines
- Product not available in European market
- Faces competition from three other highly recommended treatments (hypnotherapy, probiotics, and soluble fiber)
Insights
NeurAxis's PENFS technology inclusion in clinical guidelines represents a critical inflection point for reimbursement and commercial adoption.
The inclusion of NeurAxis's Percutaneous Electrical Nerve Field Stimulation (PENFS) technology in clinical practice guidelines represents a pivotal regulatory milestone with significant commercial implications. This recommendation from leading pediatric gastroenterology societies (NASPGHAN/ESPGHAN) positions IB-Stim as part of the standard treatment protocol for Functional Abdominal Pain (FAP) in pediatric IBS patients.
The guideline recommendation is particularly notable because:
- IB-Stim was recognized with the highest level of evidence as 1 of only 4 top-tier therapies in the treatment algorithm
- It's the only FDA-cleared treatment for this indication in the 8-21 year age group
- The technology now has three key commercial catalysts aligned: guideline inclusion, FDA clearances, and a Category I CPT code effective January 1st
From a market perspective, this recommendation substantially de-risks the reimbursement pathway. Clinical guidelines are a critical prerequisite for payers to establish coverage policies, potentially unlocking access to the
The GRADE methodology employed in these guidelines is particularly significant as it's supported by the WHO and represents the most rigorous approach to evidence evaluation. This level of validation not only strengthens the company's position with insurers but also provides clinicians with confidence to adopt the technology as a first-line therapy.
This type of guideline inclusion typically catalyzes a transition from case-by-case insurance approvals to systematic coverage policies, potentially accelerating revenue growth and reducing the sales cycle for medical device companies.
- Practice guidelines published in the Journal of Pediatric Gastroenterology & Nutrition (JPGN) name Percutaneous Electrical Nerve Field Stimulation (PENFS) as a recommended treatment option for FAP in IBS
- NeurAxis’s PENFS technology is the only FDA-cleared or approved treatment that is recommended in the guidelines for pediatrics, enabling momentum for large-scale insurance coverage for IB-Stim®
CARMEL, Ind., June 10, 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 its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology has been officially incorporated into newly released clinical practice guidelines issued by the leading pediatric academic society for the treatment of Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS). This inclusion represents a major catalyst for NeurAxis, unlocking the potential for large-scale insurance coverage for its flagship product, IB-Stim, and setting the stage for accelerated growth through evidence-based recommendations.
“We are thrilled that IB-Stim is now recognized as part of the standard of care for FAP in IBS,” said Brian Carrico, CEO of NeurAxis. “This milestone offers new hope to patients and reinforces the strength of our short and long-term growth strategy. Alongside our recent FDA expanded clearances for IB-Stim and our transformative, soon-to-be-effective on January 1st, Category I CPT code, we are now well-positioned to drive substantial top-line growth and operational leverage.” He added, “With the recent strengthening of our balance sheet and the expected rollout of more widespread insurance coverage, we are poised to accelerate our treatment option to the over 600,000 kids in the United States suffering from FAP. We estimate the addressable market for our product just in the US to be over 3 billion dollars. With these important achievements now completed, I expect that this achievement will lead to a significant expansion of insurance coverage and revenue generation.”
Dr. Adrian Miranda, practicing pediatric gastroenterologist and Chief Medical Officer of NeurAxis, commented: “Overall, consensus was reached by the committee on 25 therapies and PENFS with IB-Stim was 1 of 4 therapies that had the highest level of evidence and thus placed amongst the top in the treatment algorithm for FAP in IBS.” Dr. Miranda also added, “IB-Stim is not available in Europe, so the treatment algorithm was formulated to establish a framework for ‘shared decision making’ amongst the clinician and family, as opposed to a strict top to bottom approach. This gives clinicians the option to use IB-Stim as a first-line therapy and speaks to the overall certainty of the efficacy and safety supporting our technology. We couldn’t be more pleased with this result.”
Developing practice guidelines for FAP in IBS in children of 4–18 years was a collaborative effort of the European and North American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN and NASPGHAN). The guidelines followed the “Grading of Recommendations Assessment, Development and Evaluation” (GRADE) approach, which is supported by the World Health Organization (WHO). The highest GRADE therapies suggested in the guidelines include PENFS, hypnotherapy, lactobacillus rhamnosus (probiotic), and soluble fiber. This rigorous, evidence-based approach that incorporates PENFS as an important treatment option for children elevates NeurAxis’s profile within the healthcare industry and supports wider market adoption of IB-Stim.
Abdominal pain in IBS affects millions globally, creating a multi-billion-dollar market opportunity with limited effective treatment options. IB-Stim is the only pediatric treatment option that the FDA has cleared for FAP in IBS and abdominal pain in functional dyspepsia (to include nausea symptoms) for patients 8-21 years old. IB-Stim delivers gentle electrical impulses to cranial nerve bundles in the ear, offering a safe, non-invasive alternative to drug therapies often used off-label and many of which are not suggested in the practice guidelines from NASPGHAN / ESPGHAN.
For more information about NeurAxis, please visit www.neuraxis.com.
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, 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 more information, please visit http://neuraxis.com.
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 significance of NRXS's PENFS technology being included in clinical practice guidelines?
How large is the market opportunity for NeurAxis's IB-Stim?
What age group is NeurAxis's IB-Stim approved for?
What other treatments are recommended alongside PENFS in the new guidelines?
When will NeurAxis's new Category I CPT code become effective?
