NeurAxis, Inc. Announces Inclusion of PENFS Technology in Pediatric Gastroenterology Guidelines for Functional Abdominal Pain Treatment

NeurAxis (NRXS) announced that its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, specifically the IB-Stim device, is now included in clinical practice guidelines for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS) for pediatric patients. This inclusion, driven by leading pediatric gastroenterology societies, is expected to enhance insurance coverage for IB-Stim, the only FDA-cleared pediatric treatment recommended, and positions NeurAxis for significant growth within the estimated $3 billion U.S. market. Several institutional investors have recently adjusted their positions in NRXS, with CREATIVE PLANNING significantly increasing its stake while BANK OF MONTREAL /CAN/ and CITADEL ADVISORS LLC reduced theirs.

Analysis

NeurAxis, Inc. (NRXS) has achieved a significant milestone with its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, being incorporated into new clinical practice guidelines by leading pediatric gastroenterology societies for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS) among pediatric patients. This inclusion is particularly noteworthy as IB-Stim is the only FDA-cleared treatment recommended in these guidelines for this demographic, aged 8-21. The company anticipates this development will substantially enhance insurance coverage, a critical catalyst for penetrating an estimated $3 billion U.S. addressable market where over 600,000 children suffer from FAP. Further bolstering its growth prospects are recent FDA expanded clearances for IB-Stim and a new Category I CPT code effective January 1st, expected to facilitate broader adoption and drive top-line growth, as stated by CEO Brian Carrico. While PENFS with IB-Stim was one of four therapies recognized for the highest level of evidence, positioning it favorably, the company acknowledges that IB-Stim is not yet available in Europe, potentially limiting global expansion. Additionally, the presence of other therapies with similar evidence levels in the guidelines suggests a competitive landscape. Institutional investor activity in Q1 2025 was mixed, with five funds increasing positions (notably CREATIVE PLANNING adding 551,668 shares) and five decreasing (including BANK OF MONTREAL /CAN/ reducing by 23.4% and CITADEL ADVISORS LLC by 43.0%, and BLACKROCK, INC. exiting its position), indicating varied sentiment among larger investors despite the positive company-specific news highlighted by a strongly positive sentiment score of 0.75 for the article.

Key Decisions for Investors

• Investors should assess the significant revenue growth potential for NeurAxis stemming from IB-Stim's inclusion in pediatric FAP guidelines, which is expected to boost insurance coverage and market adoption, further supported by a new CPT code.
• It is prudent to monitor the competitive landscape, as IB-Stim, while the only FDA-cleared recommended option, coexists with other highly-evidenced therapies, and to track the company's U.S. commercial execution and any future European expansion plans.
• Investors should weigh these positive catalysts against the current lack of European market access, the inherent risks of forward-looking statements common in medical technology companies, and the mixed Q1 2025 institutional investment activity which signals a need for thorough individual due diligence.