Neuraxis, INC
Neuraxis, INC is a U.S.-based medical device company focused on neuromodulation therapies for pediatric and adult patients. Its product portfolio includes the IB-Stim device for functional abdominal pain associated with IBS in children and the RED device for identifying chronic constipation due to pelvic floor dyssynergia in adults.
Fiscal year 2025 · change from previous year
Development 2022–2025
Business
Share of revenuePENFS neuromodulation therapy used for children and adolescents with functional abdominal pain associated with IBS.
Office-based diagnostic device used to identify chronic constipation due to pelvic floor dyssynergia in adults.
Development-stage uses and future indications for the company's neuromodulation platform.
Customers
The company sells primarily to healthcare companies, especially hospitals and clinics that purchase devices on a purchase-order basis. Its end users are patients treated for functional abdominal pain, IBS-related symptoms, and constipation-related disorders, with reimbursement coverage playing a central role in adoption. The business also serves lower-income patients through discounting and financial assistance programs when insurance coverage is unavailable.
Primary buyers of IB-Stim devices for treating pediatric functional abdominal pain and related conditions.
Purchasers that place purchase orders and integrate the devices into clinical workflows.
Not direct buyers, but critical to adoption because coverage determines patient access and volume.
Users of RED for point-of-care identification of pelvic floor dyssynergia in constipation patients.
Patients receiving discounted devices when insurance coverage is unavailable.
Strategy
The company’s strategy is to expand insurance coverage for IB-Stim, which it describes as the main driver of customer adoption and revenue. It is also pursuing FDA clearance for additional indications and expanding adoption of RED, while continuing product development and commercialization efforts.
Coverage determines patient access and is the main driver of device adoption and revenue.
Additional indications can expand the addressable market and increase device usage per patient.
RED adds a second commercial product and broadens the company beyond a single indication.
Geography
2025Neuraxis is headquartered in the United States and appears to operate primarily in the U.S. healthcare market. Its commercial exposure is tied to domestic reimbursement, FDA clearance, and adoption by U.S. hospitals, clinics, and insurers rather than to a broad international footprint.
Risks
The business depends on reimbursement adoption, regulatory clearance, and successful commercialization of a narrow product set, so delays in any of these areas can materially affect growth. It also faces going-concern, internal control, and execution risks typical of early-stage medical device companies that rely on external financing and continued clinical/regulatory progress.
The company has required external capital to fund operations and commercialization efforts.
Exposure: Corporate liquidity
Commercial adoption is tied to insurer coverage, so slow payer acceptance can limit patient access and sales volume.
Exposure: IB-Stim
Future growth depends on FDA clearance for additional indications and product uses.
Exposure: Pipeline indications
Revenue is concentrated in a small number of devices and indications, increasing sensitivity to adoption changes.
Exposure: IB-Stim and RED
Reported material weaknesses and prior restatement increase the risk of financial reporting errors.
Exposure: Financial reporting
Accounting
Judgemental itemsSales are made on purchase orders with standard terms, so cut-off and contract completeness matter for period revenue.
Impact: Net sales timing
Discounts for lower-income or uninsured patients reduce realized selling prices and affect gross margin.
Impact: Net sales and gross margin
Expired inventory charges can arise from product shelf-life and regulatory clearance timing.
Impact: Cost of goods sold
Changes in warrant valuation can create non-operating gains or losses unrelated to core operations.
Impact: Other income/expense
Prior material weaknesses and a restatement increase the likelihood of future accounting adjustments.
Impact: Financial statement reliability
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Last updated: 24/09/2026