NeurAxis, Inc. (NRXS), a growth-stage medical technology company developing neuromodulation therapies to address chronic and debilitating conditions in children and adults, announced the publication of clinical practice guidelines recommending percutaneous electrical nerve field stimulation (PENFS) as a treatment option for functional abdominal pain associated with irritable bowel syndrome (FAP/IBS).

NeurAxis’s IB-Stim device employs PENFS technology and is the only FDA-cleared treatment recommended in the new guidelines for pediatrics. The guidelines were published in theJournal of Pediatric Gastroenterology & Nutrition by the European and North American Societies for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN and NASPGHAN), the leading pediatric academic societies.

After evaluating the benefits and harms of the treatment, the Guideline Development Group noted that pain intensity reduction achieved with auricular PENFS was among the highest across all studied treatment options, leading to its inclusion as part of the standard of care for FAP/IBS. The committee evaluated a total of 25 therapies, with PENFS rated as one of the top four with the highest levels of evidence. The guidelines followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach, which is supported by the World Health Organization. In addition to PENFS, highly-rated therapies for FAP/IBS include hypnotherapy, the lactobacillus rhamnosus probiotic, and soluble fiber.

Clinicians now have the option of using IB-Stim as first-line therapy, confirming the efficacy and safety supporting PENFS technology and backing wider market adoption of IB-Stim.

In light of the fact that several large payers require published academic society guidelines to aid their coverage determinations, we expect the new guidelines to function as a significant catalyst for broader insurance coverage, facilitating treatment access for the majority of affected children in the U.S. while accelerating revenue generation for NeurAxis. NeurAxis management expects the number of covered lives to double from the current 51 million to around 100 million by year-end.

We reiterate our Buy rating on the stock and have raised our target price to $5.50, from $4.75, based on an increase in 2026 forecast revenue from $8.0 to $11.0 million.

First Treatment Ever Cleared by the FDA Related toFunctional Dyspepsia; Sales Team Will Leverage Existing Reimbursement and Provider Infrastructure; Reiterate Buy Rating

Shares of NeurAxis, Inc. (NRXS), a growth-stage medical technology company developing neuromodulation therapies to address chronic and debilitating conditions in children and adults, gained 76% yesterday after the company received FDA510(k) clearance for its IB-Stim device for Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia (indigestion) and Functional Dyspepsia-related Nausea Symptoms. The clearance covers patients 8-21 years of age and is the first treatment ever cleared by the FDA related to functional dyspepsia.

The label expansion – IB Stim was already cleared for Functional Abdominal Pain associated with Irritable Bowel Syndrome in patients aged 8-21 years - is thought to nearly double the company’s pediatric addressable market. The company’s sales team will be targeting the same base of pediatric gastroenterologists for the new indication, leveraging the same CPT code and insurance coverage. Commercial rollout for the new indication will begin immediately, and in light of the fact that NeurAxis will be using the same provider call points as for the existing IBS indication, we expect a seamless and capital-efficient launch process.

Publication of academic society guidelines recommending IB-Stim as standard of care and first-linetherapy for pediatric functional abdominal pain (FAP) remains NeurAxis’s next milestone, expected bythe end of May 2025. In addition to the Category I CPT code going into effect on January 1, 2026, we expect these guidelines to function as a significant catalyst for broader insurance coverage, facilitating treatment access for the majority of affected children in the U.S.

Given the earlier than expected FDA label expansion, we have increased our revenue forecast for the second half of 2025, from $2.25 million to $2.75 million, and from $8 to $11 million for FY 2026. We reiterate our Buy rating on the stock.

Shares of NeurAxis, Inc. (NRXS), a growth-stage medical technology company developing neuromodulation therapies to address chronic and debilitating conditions in children and adults, gained 16% after the company reported financial results for the first quarter ended March 31, 2025.

Revenues increased 39% year-over-year, to $895,655, exceeding Kingswood Capital’s estimate of $725,000 by 23.5%. EPS of ($0.33) fell short of our estimate of ($0.24) mainly due to a one-time legal settlement in the amount of $750,000.

Considering NeurAxis’s third consecutive quarter of double digit revenue growth, we have adjusted our FY 2025 revenue forecast from $3.66 to $4.06 million but are leaving our FY2026 revenue estimate and price target unchanged.

In our view, NeurAxis is significantly de-risked on the product development side and has mainly become a commercial execution story with multiple near-term milestones driving growth and creating forward momentum. We reiterate our Buy rating on the stock.