1Q26 Financial Highlights
Revenues increased 80% year over year to $1.6M, reflecting the AMA Category I CPT® code assignment for Percutaneous Electrical Nerve Field Stimulation (PENFS) effective January 1, 2026, substantially increasing payor coverage.
Expanded gross margin by 200 basis points and improved operating loss by 24% year over year as more IB-Stim® devices were sold at full price due to the recently secured Category I CPT® Code.
Cash balance was $7.1 million as of March 31, 2026. Subsequently, the Company successfully completed an additional $2.1 million through its at-the-market equity offering and warrant exercises in April and May of 2026.
Recent Operational Highlights
Category I CPT® code assignment to report Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures is now effective, completing a successful commercial milestone for the Company's proprietary technology, IB-Stim®.
Awarded a Veterans Affairs Federal Supply Schedule (FSS) contract, officially designating NeurAxis as a federal contractor, demonstrating a clear commercial pathway into the Veterans Affairs health system, which serves ~7 million patients annually.
Awarded the first-ever FDA clearance for the treatment of abdominal pain in functional dyspepsia (FD), with associated nausea symptoms, in patients 8 years of age and older, expanding the total addressable market for IB-Stim.
Secured key important academic society guidelines recommendation for treatment of functional abdominal pain (FAP) in irritable bowel syndrome (IBS) in pediatrics. NeurAxis's PENFS technology is the only FDA-cleared or approved treatment recommended in the pediatrics guidelines, enabling momentum for large-scale insurance coverage for IB-Stim.
Received expanded FDA clearance for the age and treatment time per patient for IB-Stim in the 2nd half of 2025:
The age range expanded from 8-21 years to 8 years and older.
The new recommended treatment per patient increased from 3 devices to 4 devices, one device per week, for 4 consecutive weeks.
Management Commentary
Brian Carrico, Chief Executive Officer of NeurAxis, commented, "The first quarter marked a transformational period for NeurAxis, representing our first full quarter operating with the Category I CPT® code for PENFS in effect. This provided our clearest view to date into the key drivers of adoption, and where we will focus our resources. We delivered a strong 80% year-over-year revenue growth alongside healthy gross margins, driven by expanding insurance coverage that is enabling more devices to be sold at full price.
"Our value proposition continues to resonate with payers, patients, and physicians. IB-Stim addresses a significant unmet need in disorders of the gut-brain interaction. Our products favorable safety profile serves as a beneficial alternative to off-label drug use, including medications with FDA black-box warnings. Expanded clinical evidence, accepted published guidelines, the Category I CPT code, and growing payer adoption together provide a strong foundation for continued coverage expansion."
First Quarter 2026 Financial Results
Revenues in the first quarter of 2026 of $1.6 million were up 80% compared to $896 thousand in the first quarter of 2025. Unit deliveries increased 35% year over year due to the Category I CPT® code for PENFS becoming effective January 1, 2026, and corresponding increased payor coverage.
Gross margin in the first quarter of 2026 increased to 86.4% from 84.4% in the first quarter of 2025. The increase in gross margin was due to a mix shift in unit deliveries from patients utilizing the Company's discounted financial assistance program to full reimbursement payors on account of the Category I CPT® code.
Operating expenses in the first quarter of 2026 of $3.1 million increased 3% compared to $3.0 million in the first quarter of 2025 due to higher selling expenses driven by the Company's revenue growth, partially offset by the absence of a one-time, non-recurring legal settlement incurred in the first quarter of 2025.
Operating loss and net loss in the first quarter of 2026 decreased 24% and 23%, respectively, compared to the first quarter of 2025 due to higher ...
