NeurAxis, Inc. (NYSE American: NRXS) is a medical technology company specializing in neuromodulation therapies aimed at treating chronic and debilitating conditions in both pediatric and adult populations. Established in 2012 and headquartered in Carmel, Indiana, NeurAxis is committed to advancing its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology to address disorders of gut-brain interaction (DGBIs). The company's mission is to improve lives by creating safe and effective treatments that alleviate suffering among children, aiming to establish a new standard of care for patients aged 8-21 years with functional abdominal pain associated with irritable bowel syndrome (IBS).
Key Strategic Focus
NeurAxis concentrates on developing and commercializing targeted neuromodulation therapies for pediatric and adolescent patients suffering from DGBIs. The company's core objectives include expanding the adoption of its IB-Stim™ therapy, enhancing insurance coverage, and conducting clinical trials to broaden the indications for its PENFS technology. By leveraging evidence-based research, NeurAxis aims to drive acceptance of its therapies within the medical and scientific communities.
Financials and Funding
In the fourth quarter of 2024, NeurAxis reported revenues of $761,000, marking a 43% increase compared to the same period in 2023. The operating loss improved by 10% year-over-year, and the cash balance stood at $3.7 million as of December 31, 2024. Throughout 2024, the company secured $6.1 million in committed financing from various investors, including affiliates of Inspire Health Alliance, to support its growth initiatives and strengthen its balance sheet.
Pipeline Development
NeurAxis's flagship product, IB-Stim™, is FDA-cleared for treating functional abdominal pain associated with IBS in adolescents aged 8-21 years. The company is actively pursuing FDA clearance for expanded indications, including functional dyspepsia in children, with submissions expected in 2025. Additionally, NeurAxis received 510(k) clearance from the FDA for its Rectal Expulsion Device (RED), designed to simplify anorectal function testing, with commercialization efforts underway and initial revenues anticipated in the second quarter of 2025.
Technological Platform and Innovation
NeurAxis's proprietary PENFS technology underpins its IB-Stim™ therapy, offering a non-invasive neuromodulation solution for DGBIs. The company has a robust portfolio of 16 peer-reviewed publications supporting the efficacy of its technology, positioning it as a leader in the field. The recent FDA clearance of the RED device further demonstrates NeurAxis's commitment to innovation in medical technology.
Leadership Team
- Brian Carrico, Chief Executive Officer: Under his leadership, NeurAxis has achieved significant milestones, including expanded insurance coverage and FDA clearances.
- Dr. Adrian Miranda, Chief Medical Officer: He has been instrumental in advancing the company's clinical research initiatives, contributing to the publication of multiple peer-reviewed studies.
Competitor Profile
Market Insights and Dynamics: The neuromodulation therapy market is experiencing growth, driven by increasing prevalence of chronic conditions and demand for non-invasive treatment options.
Competitor Analysis: NeurAxis faces competition from companies developing neuromodulation devices for gastrointestinal disorders. Key competitors include firms offering alternative therapies for IBS and related conditions.
Strategic Collaborations and Partnerships
NeurAxis has engaged in strategic collaborations to enhance its product offerings. Notably, the company signed an exclusive option agreement with the University of Michigan for the right to license the RED device, aiming to simplify anorectal function testing and expand its product portfolio.
Operational Insights
NeurAxis's strategic focus on evidence-based research has led to significant insurance coverage expansions, now encompassing approximately 51 million lives. This positions the company favorably against competitors, as broader coverage facilitates increased adoption of its therapies.
Strategic Opportunities and Future Directions
Looking ahead, NeurAxis plans to submit for FDA clearance for functional dyspepsia in children, potentially doubling its addressable market in the pediatric segment. The company also anticipates the implementation of a new CPT Category I code for PENFS procedures effective January 1, 2026, which is expected to drive further adoption and reimbursement of its therapies.
Contact Information
- Website: neuraxis.com
- Investor Relations: ir.neuraxis.com
- LinkedIn: linkedin.com/company/neuraxis-inc
- Twitter: twitter.com/NeurAxisInc
- Facebook: facebook.com/NeurAxisInc
NeurAxis continues to advance its mission of improving patient outcomes through innovative neuromodulation therapies, leveraging its technological expertise and strategic initiatives to address unmet medical needs.
