NeurAxis Unlocks GI Care with Landmark Reimbursement Code for IB-Stim

CARMEL, Ind. – January 08, 2026 – Medical technology company NeurAxis has achieved a pivotal commercial milestone as a Category I Current Procedural Terminology (CPT®) code for its innovative pain management therapy officially goes into effect today. The new code covers Percutaneous Electrical Nerve Field Stimulation (PENFS), the technology behind the company's flagship IB-Stim® device, establishing a permanent, nationally recognized pathway for reimbursement and signaling a new era of access for patients with chronic gastrointestinal disorders.

This development is poised to significantly streamline the billing process for healthcare providers and create a predictable payment environment with Medicare, Medicaid, and commercial insurers. For countless children and adults suffering from debilitating conditions like Irritable Bowel Syndrome (IBS) and functional dyspepsia (FD), this change represents a crucial step toward accessing a proven, non-pharmacological treatment option.

A Commercial Breakthrough for Neuromodulation

The activation of a Category I CPT code is far more than a procedural update; it is a declaration of clinical validation from the American Medical Association (AMA). Unlike temporary Category III codes assigned to emerging technologies, a Category I designation signifies that a therapy has met rigorous criteria for broad clinical acceptance, widespread utilization, and established efficacy. This move effectively de-risks the adoption of IB-Stim for both hospitals and private clinics, which have historically faced uncertainty in securing payment for the therapy.

“Achieving this long-awaited milestone significantly strengthens the foundation of our business,” said Brian Carrico, Chief Executive Officer of NeurAxis, in a statement. “With a Category I CPT code now in effect, we have greater commercial clarity due to a consistent and recognized code, improved payer alignment, and enhanced scalability across health systems. We believe this will accelerate access to care for patients in need, and in turn, support additional coverage expansion, and drive long-term revenue growth.”

The financial implications are substantial. NeurAxis estimates the addressable market for its PENFS technology in the United States alone exceeds $3 billion. The new code provides the company with a durable reimbursement model and a more predictable commercial trajectory. This is particularly vital in the competitive neurological device market, which is projected to grow from $12.5 billion in 2023 to nearly $21 billion by 2033. IB-Stim now has a distinct advantage as a non-drug alternative, especially for pediatric patients where many pharmacological options are used off-label and carry risks of side effects.

Expanding Access for Patients with Chronic GI Pain

Behind the regulatory and financial news is a story of profound human impact. Functional abdominal pain disorders like IBS and functional dyspepsia can devastate a person's quality of life, particularly for the pediatric population. The conditions are characterized by chronic pain, nausea, and fear of eating, often leading to significant weight loss and social isolation. For many young patients, the journey to find relief is a frustrating cycle of failed treatments.

IB-Stim offers a novel approach. The small, non-invasive device is worn behind the ear, where it delivers gentle electrical impulses to cranial nerve bundles. These impulses target areas of the brain involved in processing pain, effectively re-regulating the communication pathway between the gut and the brain. The therapy is FDA-cleared for patients aged 8 and older for functional abdominal pain associated with IBS, as well as for functional dyspepsia and its related nausea symptoms—the first device ever cleared for FD.

Robust clinical evidence underpins the therapy's effectiveness. A landmark randomized, double-blind, sham-controlled trial demonstrated that after three weeks of therapy, 81% of patients using IB-Stim reported overall symptom improvement, compared to just 26% in the placebo group. Furthermore, 59% of patients in the active treatment group experienced at least a 30% reduction in their worst pain scores. The long-term benefits are also promising, with a multicenter registry study of 292 pediatric patients showing that significant improvements in abdominal pain were sustained at six and twelve months post-treatment. Notably, 92% of these patients had already failed previous medication therapies, with 61% having tried four or more different drugs without success.

Validating a Non-Pharmacological Standard of Care

The new CPT code serves as the capstone on a growing mountain of evidence supporting PENFS as a legitimate and essential tool in modern pain management. This achievement is expected to accelerate a critical shift in payer policies, moving IB-Stim from being classified as “experimental” or “investigational” to being recognized as a medically necessary standard of care.

Several Blue Cross Blue Shield plans had already begun to cover the therapy under specific conditions, often requiring patients to have failed multiple medication categories. The establishment of a national Category I code is anticipated to standardize and broaden this coverage across the country. While Medicare does not yet have a National Coverage Determination for PENFS, the new code opens the door for Medicare Advantage Organizations to establish their own positive coverage policies based on the therapy's validated evidence base.

The therapy's standing was further cemented when it was included as a recommended treatment option for functional abdominal pain in IBS within practice guidelines published in the Journal of Pediatric Gastroenterology & Nutrition. This endorsement from the medical community, combined with the AMA's CPT code approval, provides a powerful one-two punch for driving adoption in major health systems.

As NeurAxis prepares to present at the Lytham Partners Healthcare Investor Summit on January 15, the message to the market is clear: IB-Stim has transitioned from a promising innovation to an established, reimbursable therapy. This milestone not only solidifies the company's commercial future but also marks a significant victory for the broader field of bioelectronic medicine and the ongoing search for effective, non-pharmacological solutions to chronic disease.