CARMEL, Ind., Nov. 11, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE:NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the third quarter period ended September 30, 2025.

3Q25 Financial highlights

Revenues increased 22% year over year to $811 thousand in 3Q25 compared to $667 thousand in 3Q24.
Operating loss in 3Q25 increased 27% year over year compared to 3Q24 due to increased sales and marketing efforts.
Cash balance was $4.4 million as of September 30, 2025. Subsequently, the Company secured an additional $2.8 million through an at-the-market equity offering and warrant exercises in October 2025.

Recent Operational Highlights

Awarded first ever FDA clearance for the treatment of pain in Functional Dyspepsia (FD) with associated nausea symptoms in the adult patient population
Secured key academic society guidelines recommendation for treatment of Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS). NeurAxis's Percutaneous Electrical Nerve Field Stimulation (PENFS) technology is the only FDA-cleared or approved treatment that is recommended in the pediatrics guidelines, enabling momentum for large-scale insurance coverage for IB-Stim.
Awarded first ever FDA Clearance for the treatment of pediatric FAP/FD and associated nausea symptoms, significantly expanding IB-Stim's total addressable market.
Expanded total covered lives to approximately 55 million.
Assignment of a new Current Procedural Terminology (CPT) Category I code for PENFS procedures. This code is effective for utilization on January 1, 2026 and includes RVUs and financials for reimbursement.
Received new FDA clearance for the expansion of IB-Stim label:
- to allow for a larger patient population beyond 11-18 years of age to 8-21 years.
- to increase devices per patient to 4 devices.
Received 510(k) clearance from the FDA for its Rectal Expulsion Device (RED) product. RED's innovative design simplifies anorectal function testing in adult patients with chronic constipation and can be used without interrupting clinical workflow.

Management Commentary

Brian Carrico, Chief Executive Officer of NeurAxis, commented: "We remain highly optimistic as we lay the foundation for what we expect will be a major scaling phase in 2026. The years of work to secure the CPT Category I code and expanded insurance coverage, ensuring greater access to IB-Stim, will come to fruition in less than 60 days. With the Category I code effective January 1, 2026, and our proprietary PENFS technology now included in leading clinical practice guidelines, we believe NeurAxis is well positioned for substantial revenue growth and margin expansion. In addition, the recent FDA clearance expanding IB-Stim's indication to include functional dyspepsia and nausea in patients 8 years and older significantly broadens our market opportunity, supported by strong operational momentum with second-quarter revenue up 22% and units sold rising 38% year-over-year."

Third Quarter 2025 Financial Results

Revenues in the third quarter of 2025 were $811 thousand, up 22% compared to $667 thousand in the third quarter of 2024. Unit deliveries increased approximately 38% year over year due to growth from patients in the Company's financial assistance program that offers discounts for patients without insurance coverage.

Gross margin in the third quarter of 2025 declined to 83.3% from 85.4% in the third quarter of 2024. Despite the increase in sales volume, the decrease in gross margin was due to higher discounting based on lower income levels of patients participating in the Company's financial assistance programs, stronger unit growth from lower margin financial assistance programs compared to full reimbursement programs and expired RED inventory charges. As the Company continues to treat all patients regardless of their financial position, increasing demand from financial assistance patients is expected to translate into higher gross margins upon insurance coverage.

Operating expenses of $2.8 million and an operating loss of $2.1 million in the third quarter of 2025 increased 25% and 27%, respectively, compared to the third quarter of 2024 due to higher selling and marketing costs from sales commissions and targeted advertising spend as the Company approaches the January 1, 2026 CPT Category I code effective date for the IB-Stim indication.

Net loss attributable to shareholders in the third quarter of 2025 was $2.1 million compared to $1.8 million in the third quarter of 2024. Higher sales volume was offset by increased sales and marketing expenses.

Cash on hand as of September 30, 2025, was $4.4 million. In October 2025, the Company improved its liquidity position by raising $2.8 million through an at-the-market common stock offering and the exercises of warrants.

Conference Call Details

Date and Time: Tuesday, November 11, 2025, at 9:00am ET

Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company's website at https://ir.neuraxis.com/ or https://edge.media-server.com/mmc/p/uat4r9m5. For participants listening through the webcast, questions can be sent in through the portal using the "Ask a Question" link or by emailing questions to NRXS@lythampartners.com.

Call-in Information: Interested parties can also access the live conference call by initially registering at the following Call In Link. Upon completion of the registration link, call-in participants will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details.

Replay: A webcast replay will be available in the Investor Relations section of the Company's website at https://ir.neuraxis.com/ or https://edge.media-server.com/mmc/p/uat4r9m5.

About NeurAxis, Inc.

NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive the adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA-cleared for Functional Abdominal Pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia and associated Nausea Symptoms in adolescents ages 8 and over. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com.

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 U.S. and global economy, the trading price and volatility of the Company's stock, public health issues or other events, the Company's compliance with applicable laws, the results of the Company's clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis's public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

For contraindications, precaution, 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

NeurAxis, Inc.

info@neuraxis.com

Investor Relations

Lytham Partners

Ben Shamsian

646-829-9701

shamsian@lythampartners.com


NeurAxis, Inc. Condensed Statements of Operations

	(Unaudited)						(Unaudited)
	Three Months Ended Sep 30,						Nine Months Ended Sep 30,
		2025			2024			2025			2024

Net sales	$	811,414		$	666,625		$	2,601,155		$	1,924,760
Cost of goods sold		135,487			97,050			421,265			256,949
Gross profit		675,927			569,575			2,179,890			1,667,811
Selling expenses		762,548			338,523			1,694,354			1,012,920
Research and development		130,850			126,247			347,433			295,188
General and administrative		1,882,614			1,756,078			6,251,143			6,049,928
Operating loss		(2,100,085	)		(1,651,273	)		(6,113,040	)		(5,690,225	)
Other (expense) income:
Financing charges		(30,240	)		-			(30,240	)		(230,824	)
Interest expense, net		(29,661	)		(64,676	)		(45,333	)		(171,934	)
Change in fair value of warrant liability		(1,740	)		(6,726	)		(28	)		(8,434	)
Amortization of debt discount and issuance costs		-			(40,888	)		-			(126,387	)
Other income		38,930			17,072			96,743			20,032
Other expense		-			(8,743	)		-			(585,824	)
Total other (expense) income, net		(22,711	)		(103,961	)		21,142			(1,103,371	)
Net loss	$	(2,122,796	)	$	(1,755,234	)	$	(6,091,898	)	$	(6,793,596	)

NeurAxis Reports Strong Third Quarter 2025 Financial Results Driven by a 22% Growth in Revenues