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) effectiveJanuary 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 ofMarch 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
“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
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
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 gross profit from revenue growth, slightly offset by higher operating expenses.
Cash on hand as of
Conference Call Details
Date and Time:
Toll Free: 1-877-270-2148 (U.S. and
Webcast: https://app.webinar.net/892nzbBzqeJ
Replay: Toll Free: 1-855-669-6958 (U.S. and
Replay access code: 5040620
Webcast: https://app.webinar.net/892nzbBzqeJ
About
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.
For important RED information, including indications, precautions, and contraindications, visit: https://red4constipation.com/information/
Contacts:
Company
info@neuraxis.com
Investor Relations
646-829-9701
shamsian@lythampartners.com
Condensed Statements of Operations | |||||||
| (Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Net sales | $ | 1,607,883 | $ | 895,655 | |||
| Cost of goods sold | 218,366 | 139,475 | |||||
| Gross profit | 1,389,517 | 756,180 | |||||
| Selling expenses | 824,336 | 500,119 | |||||
| Research and development | 99,567 | 117,867 | |||||
| General and administrative | 2,206,293 | 2,433,292 | |||||
| Operating loss | (1,740,679 | ) | (2,295,098 | ) | |||
| Other (expense) income: | |||||||
| Interest expense, net | (26,189 | ) | (2,237 | ) | |||
| Change in fair value of warrant liability | (31,506 | ) | 1,831 | ||||
| Other income | 36,942 | 16,820 | |||||
| Total other (expense) income, net | (20,753 | ) | 16,414 | ||||
| Net loss | $ | (1,761,432 | ) | $ | (2,278,684 | ) | |
Source: