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It's like Medtronic for gastrointestinal neurostimulation.

Think of it as Boston Scientific, but focused on neurostimulation for chronic gut conditions like IBS.

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• Portable Neuromodulation Stimulator (PoNS®) Device: A non-invasive medical device that stimulates the brain through the tongue, designed to improve gait and balance deficits when used with physical therapy for conditions like multiple sclerosis and mild-to-moderate traumatic brain injury.

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Neuraxis (NRXS) primarily sells its Relivion system to **individuals**, specifically patients suffering from migraine and other headache disorders. The company employs a hybrid commercialization model that includes direct-to-patient marketing and engagement with healthcare providers (neurologists, headache specialists, and pain management clinics) who prescribe the device. According to its recent SEC filings (e.g., the 10-K report for the fiscal year ended December 31, 2023), no single customer accounted for 10% or more of its total revenue, indicating a broad customer base among individual patients rather than reliance on a few large corporate buyers.

The categories of individual customers Neuraxis serves include:

• Individuals diagnosed with migraine or other primary headache disorders: These are patients seeking effective, non-invasive, and non-pharmacological treatment options to manage their conditions and improve their quality of life. They often struggle with chronic or severe headaches and are looking for new solutions.
• Patients seeking drug-free or adjunctive therapies: This category includes individuals who may be looking for alternatives to pharmaceutical treatments due to side effects, contraindications, or a desire to reduce medication reliance. It also includes those who wish to complement their existing headache management regimen with a non-pharmacological device.
• Proactive patients engaged with innovative medical technologies: These are individuals who, in consultation with their healthcare providers, are open to adopting FDA-cleared medical devices like the Relivion system as part of a modern, comprehensive approach to managing their chronic headache conditions, demonstrating an interest in advanced therapeutic options.

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• Varex Imaging Corporation (NASDAQ: VREX)

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Brian Carrico, President, Chief Executive Officer and Director

Brian Carrico was appointed CEO of NeurAxis in January 2018. He joined the company in 2012 and has held various leadership positions, including Vice President of Sales and President. Carrico played a key role in developing the company's strategic direction, securing start-up capital, and bringing its technology to market. Prior to NeurAxis, he worked in sales for Bard Medical and St. Jude Medical.

Timothy H. Henrichs, Chief Financial Officer and Principal Accounting Officer

Timothy Henrichs became Chief Financial Officer of NeurAxis on February 5, 2024. He previously served as a member of the NeurAxis Board starting August 8, 2023. His experience includes serving as Chief Financial Officer of Renovo Home Partners since 2022, and Executive Vice President and Chief Financial Officer of Follett Corporation from 2008 to 2022. He also held the position of Global Controller for General Electric Company's Healthcare Clinical Systems division from 2005 to 2008 and had leadership roles at Federal Signal Corporation and Ernst & Young LLP. Henrichs brings over 20 years of global leadership experience across diverse industries.

Dr. Adrian Miranda, Senior VP of Science & Technology and Chief Medical Officer

Dr. Adrian Miranda is a Professor of Pediatrics and a board-certified Pediatric Gastroenterologist. He obtained his medical degree from the Medical College of Wisconsin and completed his residency and subspecialty training in Pediatric Gastroenterology at Children's Hospital of Wisconsin (CHW). He contributes a strong background in research and clinical expertise to his role.

Dr. Thomas Carrico, Chief Regulatory Officer and Compliance & Privacy Officer

Dr. Thomas Carrico has over 40 years of experience in the healthcare field, with 30 years prior to joining NeurAxis in 2012. He has extensive involvement in the study and application of techniques and treatments affecting the autonomic nervous system. His background also includes working with attorneys on state and national boards, which supports his regulatory responsibilities at NeurAxis.

Dr. Christopher Robin Brown D.D.S., Founder, Director of Innovation and Director

Dr. Christopher Robin Brown is a co-founder of NeurAxis, established in 2011. He was responsible for developing clinical protocols, initial practice guidelines, designing and implementing the practitioner certification program, and personally financing the company's first two years. He also authored and designed the initial studies that established the neurovascular and tissue energy transfer theories underpinning the company's devices.

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Key Risks to Neuraxis (NRXS)

1. Financial Instability and Unprofitability: Neuraxis faces substantial financial challenges, evidenced by consistently negative profitability ratios, including an alarming EBIT margin of -272.6% and a deeply negative net income. The company has reported significant net losses and is not projected to achieve profitability within the next three years. Additionally, Neuraxis is rapidly depleting its cash reserves, with some analyses indicating less than one year of cash runway. This financial distress is further highlighted by substantial operating cash flow deficits and a large negative return on assets, suggesting inefficiencies in generating profit from existing assets.
2. Regulatory and Payer Coverage Dependence: As a medical technology company specializing in neuromodulation therapies, Neuraxis is highly dependent on regulatory approvals for its devices and the expansion of their indications. While the company has achieved some FDA clearances, the process of obtaining and maintaining these approvals, along with evolving treatment standards, presents ongoing challenges. Crucially, securing widespread insurance coverage and positive reimbursement policies from both government and commercial payers is vital for market adoption and revenue growth. Changes in healthcare budgets and insurance reimbursement policies could significantly impact the company's financial performance.
3. Market Dependence and Competitive Pressures: Neuraxis's business model relies on a few key products, such as IB-Stim and the Rectal Expulsion Device (RED), for a significant portion of its revenue. This reliance makes the company vulnerable to market acceptance of these specific products. Furthermore, Neuraxis operates within a highly competitive medical technology industry, facing competition from both established companies and emerging startups specializing in neuromodulation devices and diagnostic imaging solutions. Maintaining and growing market share amid this competition is a continuous risk.

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Emerging Threats for Neuraxis (NRXS):

• Disruption from Advanced Point-of-Care (POC) and At-Home Diagnostic Technologies: The diagnostic landscape is rapidly shifting towards more convenient, immediate, and accessible testing solutions. Emerging technologies, including advanced rapid tests, CRISPR-based diagnostics, and sophisticated at-home testing kits, are enabling accurate results to be obtained at the point of care or by individuals in their homes, reducing the reliance on traditional centralized laboratories for sample processing. This technological shift poses a clear threat to Neuraxis's core business model, similar to how Netflix's streaming model disrupted Blockbuster's physical rental business or how the iPhone's integrated experience threatened BlackBerry's specialized devices.
• Intensifying Competition in New Clinical Diagnostic Verticals: As Neuraxis attempts to pivot and diversify its service offerings beyond COVID-19 testing into other clinical areas such as pharmacogenomics, women's health, and toxicology, it faces significant emerging threats from well-established, larger diagnostic companies (e.g., LabCorp, Quest Diagnostics) and a growing number of specialized startups. These incumbents possess vast resources, economies of scale, existing physician networks, and established payer relationships, making it challenging for a smaller player like Neuraxis to gain market share and achieve profitability in these highly competitive sectors. This mirrors the challenge faced by traditional taxi services when Uber entered the market with a more agile and digitally integrated business model.

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Neuraxis (symbol: NRXS) focuses on neuromodulation therapies, with its main product, IB-Stim, being a Percutaneous Electrical Nerve Field Stimulation (PENFS) system. IB-Stim is FDA-cleared for functional abdominal pain associated with Irritable Bowel Syndrome (IBS) in adolescents aged 8-21 years, and the company is also developing it for adult indications and other pediatric conditions.

The addressable markets for Neuraxis's products and services can be considered within the broader Irritable Bowel Syndrome (IBS) treatment market and the Neuromodulation market.

Irritable Bowel Syndrome (IBS) Treatment Market

• The global irritable bowel syndrome (IBS) treatment market was valued at approximately USD 8.28 billion in 2025 and is projected to reach USD 35.18 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 15.6%.
• Other estimates for the global IBS treatment market indicate a value of around USD 3.5 billion in 2024, expected to reach USD 8.4 billion by 2034 with a CAGR of 9.1% (global).
• North America is a dominant region in the IBS treatment market, holding the largest share, with the U.S. alone having an estimated 25 to 45 million people affected by IBS. The North American IBS treatment market was valued at USD 1.3 billion in 2023 and is predicted to grow at a CAGR of 8.1% (North America).

Neuromodulation Market

Neuraxis's IB-Stim utilizes neuromodulation technology, making the broader neuromodulation market relevant.

• The global neuromodulation market was valued at approximately USD 6.81 billion in 2025 and is projected to reach USD 10.68 billion by 2030, with a CAGR of 9.4% (global).
• Another report states the global neuromodulation market size at USD 9.07 billion in 2025, anticipated to hit USD 10.18 billion by 2026, and projected to surpass around USD 25.51 billion by 2034, growing at a CAGR of 12.17% (global).
• North America leads the neuromodulation market. The U.S. neuromodulation market size was USD 2.60 billion in 2024 and is projected to be worth around USD 8.36 billion by 2034, growing at a CAGR of 12.37% (U.S.).

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Neuraxis (symbol: NRXS) anticipates several key drivers to fuel its revenue growth over the next 2-3 years:

1. Expansion of Insurance Coverage: Neuraxis has significantly expanded its insurance coverage for its IB-Stim therapy, increasing the number of covered lives from approximately 4 million to 51 million within the past year. This expansion is expected to drive broader reimbursement at full commercial rates and contribute to higher revenue per device.
2. Implementation of Category I CPT Code: A new Category I permanent CPT (Current Procedural Terminology) billing code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures, which includes IB-Stim, is scheduled to become effective on January 1, 2026. This is anticipated to streamline billing processes, facilitate broader reimbursement, and boost overall revenue.
3. FDA Label Expansion for IB-Stim: The company has received FDA clearance to expand the IB-Stim label. This includes extending the approved age range for treatment from 11-18 years to 8-21 years and increasing the allowance to up to four devices per patient, effectively nearly doubling the addressable market for the device.
4. Commercialization of the Rectal Expulsion Device (RED): Neuraxis obtained FDA clearance for its Rectal Expulsion Device (RED) and initiated its commercialization in the first quarter of 2025. This new product is designed to simplify anorectal function testing and is expected to generate meaningful revenues starting in the second quarter of 2025.
5. Inclusion in Clinical Practice Guidelines: Neuraxis's proprietary PENFS technology has been included in the clinical practice guidelines from leading academic societies, such as the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). This endorsement is expected to further expand access and drive broader insurance policy coverage.

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Share Issuance

• In May 2025, NeurAxis completed a registered direct offering of 1,538,461 shares of common stock at $3.25 per share, generating approximately $5.0 million in gross proceeds.
• The company secured an additional $5 million in August 2025 through an equity-only financing round, which included participation from existing and new institutional investors.
• As of October 23, 2025, NeurAxis increased its At-The-Market (ATM) program capacity to $6,270,000 for potential future equity raises, although no shares had been sold under this program from August 29, 2025, through October 23, 2025.

Inbound Investments

• NeurAxis generated approximately $5.0 million in gross proceeds from a registered direct offering of common stock that closed in May 2025.
• The company secured $5 million in August 2025 through an equity-only financing round with both existing and new institutional investors.
• Over $1 million was obtained from warrant exercises during the week of May 22, 2025.

Capital Expenditures

• Capital expenditures for June 2025 were $7,288.
• In the first quarter of 2025, research and development costs increased due to the completion of the Rectal Expulsion Device (RED) development and the initiation of a new medical research project.
• The company's Property, Plant & Equipment was reported as $0.37 million for fiscal year 2024 and $0.16 million for fiscal year 2023.