Total national coverage footprint for PENFS increases to roughly 100 million covered livesCARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage sp ...

CARMEL, Ind., Dec. 01, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced that it has been awarded a Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, effective December 1, 2025. The first product listed on the FSS is the IB-Stim®, a drug-free treatment for functional abdominal pain in patients 8 years and ...

Core Insights - NeurAxis, Inc. (NRXS) shares have declined 8.6% since the Q3 2025 earnings report, underperforming the S&P 500 Index's 1.7% decline during the same period [1] - The stock has experienced a significant drop of 36.4% over the past month, contrasting with a slight growth of 0.1% in the S&P 500 [1] Financial Performance - Q3 2025 revenues reached $0.8 million, a 21.7% increase from $0.7 million in the same quarter last year, marking the fifth consecutive quarter of double-digit growth [2] - Unit deliveries increased by 38% year over year, driven by the financial assistance program that provides discounted devices to uninsured patients [2] - Operating loss widened to $2.1 million from $1.7 million a year earlier, primarily due to a 125.3% year-over-year increase in selling expenses outpacing revenue growth [2] Margins and Losses - Gross margin decreased to 83.3% from 85.4%, attributed to increased discounting and expired inventory charges related to the Rectal Expulsion Device (RED) [3] - Net loss for the quarter was $2.1 million, compared to $1.8 million in the prior-year quarter [3] Liquidity and Cash Flow - NeurAxis ended the quarter with $4.4 million in cash and improved its liquidity by raising an additional $2.8 million through an equity offering and warrant exercises in October 2025 [4] - Free cash flow burn remained stable at approximately $1.5 million for the quarter, with increased inventory purchases in anticipation of demand once reimbursement improves [4] Management Insights - Management believes Q3 2025 set the stage for a significant scaling phase expected to begin in 2026, with a new CPT Category I code effective January 1, 2026, anticipated to streamline billing and reduce administrative hurdles [6] - Executives highlighted efforts to enhance payer engagement, supported by new clinical practice guidelines and outreach to large insurers, aiming for broader national medical policy coverage [6] Revenue Drivers and Expenses - Revenue growth was primarily driven by increased patient volume, particularly from the financial assistance program, and the soft launch of the RED product line [7] - Operating expenses rose significantly due to higher commissions from increased sales activity, targeted advertising, and preparatory spending ahead of the new CPT code launch [7] R&D and Administrative Costs - Research and development expenses increased by 3.6% year over year as NeurAxis continued to invest in clinical programs related to expanded FDA indications [8] - General and administrative costs rose by 7.2% year over year due to a new long-term incentive plan and system-related expenditures [8] Future Guidance - While no formal numerical guidance was provided, management expressed confidence in continued revenue growth for Q4 2025, supported by strong provider momentum [9] - The outlook for 2026 includes expectations for improved reimbursement clarity and broader patient access, although policy changes are anticipated to occur gradually [9][10] Regulatory and Market Developments - NeurAxis achieved several regulatory milestones, including FDA clearances for expanded indications of IB-Stim and the RED device for anorectal function testing [11] - The company secured academic society guideline recommendations for its technology, expanded total covered lives to approximately 55 million, and received a new Category I CPT code effective January 1, 2026, enhancing long-term reimbursement prospects [12]

Core Insights - NeurAxis, Inc. announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, increasing access to approximately 566,000 covered lives in Michigan, bringing total national coverage to about 55 million lives [1][3] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic conditions in both children and adults, with its proprietary IB-Stim technology FDA-cleared for treating functional abdominal pain associated with IBS and functional dyspepsia in patients aged 8 and older [2][4] - The IB-Stim device is non-invasive and stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and brain, addressing a significant unmet medical need as no FDA-approved drug therapies exist for pediatric patients with abdominal pain-related disorders [2][4] Market Strategy - The company is actively working to expand insurance coverage for IB-Stim, with discussions ongoing with several major insurers as they approach policy review cycles over the next eight months [3] - A Category I CPT code will take effect on January 1, 2026, which is expected to facilitate reimbursement and enhance revenue growth and margin expansion for NeurAxis [3] Clinical Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs, further solidifying its position in the market [4]

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $811,000, up 22% compared to $677,000 in Q3 2024, marking the fifth consecutive quarter of double-digit growth [19][17] - Gross margin in Q3 2025 was 83.3%, down from 85.4% in Q3 2024, attributed to higher discounting and stronger unit growth in lower-margin programs [20][21] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [25] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth in Q3 2025, driven by a 38% increase in unit deliveries, primarily from the financial assistance program [19][20] - The RED device is seeing good physician interest, but its adoption is slower due to changes in practice flow and habits [14][48] Market Data and Key Metrics Changes - The company now has approximately 55 million covered lives, indicating positive payer momentum [7] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [10][11] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, with a strong emphasis on pediatric coverage [5][6] - The strategy includes mobilizing a coalition for payer engagement and prioritizing children's hospitals for treatment [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, expecting continued revenue growth [6][9] - The company is preparing for a significant transition in 2026 with the new CPT code, which is anticipated to enhance revenue predictability [33][35] Other Important Information - The company raised an additional $2.8 million in October 2025 through an equity offering, improving its liquidity position [26][50] - The company is committed to treating all patients regardless of income level or insurance coverage, which is reflected in its financial assistance program [20] Q&A Session Summary Question: How is the company tracking success and incentivizing the team for expected volume inflection? - The company has a strong sales force with a commission structure that incentivizes prioritization of accounts with good insurance coverage [31][32] Question: Any updates on engagement with payers for national coverage? - Management believes payers are aware of the new CPT code and are responsive, with a comprehensive approach being taken for engagement [38][39] Question: Can you quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers specifically, with expectations for continued higher marketing costs into 2026 [40][41]

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $811,000, up 22% compared to $677,000 in Q3 2024, marking the fifth consecutive quarter of double-digit growth [20][18] - Gross margin in Q3 2025 was 83.3%, down from 85.4% in Q3 2024, attributed to higher discounting and stronger unit growth in lower-margin programs [21][22] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [27] - Cash on hand as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [28][52] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth driven by a 38% increase in unit deliveries, primarily from the financial assistance program [20][19] - The RED device is seeing good physician interest, but adoption is slower due to changes in practice flow and habits [15][50] Market Data and Key Metrics Changes - Approximately 55 million covered lives are now associated with the company's products, indicating positive payer momentum [8] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [11][12] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, particularly in pediatric populations [4][5] - A multi-channel approach is being employed to engage payers, including support from academic societies and leading children's hospitals [6][8] - The strategy includes prioritizing children's hospitals based on utilization potential and launching comprehensive education and outreach programs [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, emphasizing the importance of insurance coverage and physician compensation for adoption [7][10] - The company anticipates continued revenue growth in the coming quarters, driven by the new CPT code and expanded market opportunities [10][19] Other Important Information - The company is preparing for a significant transition in 2026 with the new CPT code, which is expected to enhance reimbursement and reduce barriers to access [11][12] - The RED device's future revenue ramp is uncertain, pending further clarity on CPT code reimbursement [50] Q&A Session Summary Question: How is the company tracking success and incentivizing the team ahead of expected volume inflection? - The company has a strong sales force that is highly incentivized and focused on areas with good insurance policy coverage [32][33] Question: Can the company provide insights on volume inflection from the Category 1 CPT code alone? - The company has begun forecasting and expects better adoption rates in areas with insurance coverage [37] Question: Any updates on engagement with payers and national coverage? - Payers are responsive and aware of the new Category 1 code, which adds credibility to the company's position [40][41] Question: Can the company quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers, and R&D costs are expected to increase with market expansion [43][45]

Core Insights - NeurAxis, Inc. reported a 22% increase in revenues for Q3 2025, reaching $811 thousand compared to $667 thousand in Q3 2024, driven by a 38% rise in unit deliveries [4][6] - The company is optimistic about significant revenue growth and margin expansion in 2026, supported by the upcoming CPT Category I code effective January 1, 2026, and recent FDA clearances [3][5] Financial Highlights - Revenues for Q3 2025 were $811 thousand, a 22% increase from $667 thousand in Q3 2024 [4][6] - Gross margin decreased to 83.3% from 85.4% year-over-year due to higher discounting and lower-margin sales from financial assistance programs [5][6] - Operating loss increased by 27% year-over-year to $2.1 million in Q3 2025, attributed to higher sales and marketing expenses [6][7] - Cash balance as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [6][8] Operational Highlights - The FDA granted clearance for IB-Stim to treat functional dyspepsia and nausea in patients aged 8 years and older, expanding the market opportunity [3][6] - The company secured a new CPT Category I code for PENFS procedures, effective January 1, 2026, which includes reimbursement financials [6][8] - Total covered lives increased to approximately 55 million, enhancing the potential patient base for NeurAxis's therapies [6][8] Management Commentary - The CEO expressed optimism about the company's positioning for substantial growth in 2026, emphasizing the importance of the CPT code and FDA clearances [3][5] - The company aims to treat all patients regardless of financial status, anticipating that increased demand from financial assistance patients will lead to higher gross margins once insurance coverage is established [5][6]

Financial Performance - Net sales for Q3 2025 reached $811,414, an increase of 21.7% compared to $666,625 in Q3 2024[9] - Gross profit for the nine months ended September 30, 2025, was $2,179,890, up 30.7% from $1,667,811 in the same period of 2024[9] - Operating loss for Q3 2025 was $(2,100,085), compared to $(1,651,273) in Q3 2024, reflecting an increase in selling expenses[9] - Net loss available to common stockholders for Q3 2025 was $(2,321,503), compared to $(1,800,054) in Q3 2024[9] - Basic and diluted loss per share for Q3 2025 was $(0.24), slightly improved from $(0.25) in Q3 2024[9] - The company reported a net loss of $(6,091,898) for the nine months ended September 30, 2025, down from $(6,793,596) in the same period of 2024[9] - For the nine months ended September 30, 2025, NeurAxis reported a net loss of $6,091,898, a decrease of 10.3% compared to a net loss of $6,793,596 for the same period in 2024[12] - As of September 30, 2025, the Company reported a net loss of $2,122,796 for the three months ended, compared to a net loss of $1,755,234 for the same period in 2024, indicating an increase in losses of approximately 20.9%[36] Equity and Cash Position - Total stockholders' equity as of September 30, 2025, was $2,284,941, compared to a deficit of $(1,793,932) as of September 30, 2024[11] - Cash and cash equivalents at the end of the period increased to $4,377,109 from $260,885 at the end of September 2024, representing a significant growth[12] - The Company had stockholders' equity of $2,284,941 and cash of $4,377,109 as of September 30, 2025, indicating a strong liquidity position despite ongoing losses[53] - The company had cash of $4,377,109 and a working capital surplus of $1,840,599 as of September 30, 2025[53] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, totaled $347,433, a 17.7% increase from $295,188 in the prior year[9] - Selling expenses for the nine months ended September 30, 2025, amounted to $414,134, a significant increase from $154,299 in the same period of 2024[25] - Selling expenses for Q3 2025 were $292,678, a significant increase from $34,468 in Q3 2024, representing a growth of 748%[25] - The company recorded expired and other inventory charges of $24,339 for the nine months ended September 30, 2025, compared to $2,030 for the same period in 2024, indicating a significant increase in inventory-related expenses[24] Inventory and Reserves - Inventory reserves totaled $28,793 as of September 30, 2025, compared to $4,454 at the end of 2024, indicating increased inventory management efforts[24] - The estimated returns reserve totaled $8,714 as of September 30, 2025, up from $5,000 as of December 31, 2024[48] Financing Activities - The company generated $5,204,211 in net cash from financing activities, compared to $4,550,198 in the same period of 2024, indicating a 14.4% increase[12] - NeurAxis raised $4,999,999 from the issuance of common shares during the nine months ended September 30, 2025, contributing to its cash flow from financing activities[12] - Common stock issued from agreements in Q3 2025 included 39,471 shares, contributing $112,493 to additional paid-in capital[11] Legal and Regulatory Matters - The Company recorded a tentative settlement of $750,000 related to ongoing litigation, with payments starting in January 2026[114] - The Company has no pending or threatened legal proceedings that could materially affect its operations[124] Future Outlook - The company plans to continue expanding its market presence and investing in new product development to drive future growth[9] - Future capital requirements will depend on various factors, including the ability to secure purchase orders and the adoption of insurance coverage by commercial insurance carriers, which is a top priority for the Company[54] - The Company has incurred losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[56] Stock and Shares - The weighted average shares of common stock outstanding for basic and diluted EPS were 9,878,020 for the three months ended September 30, 2025, compared to 7,172,229 for the same period in 2024, reflecting a 37.7% increase in shares outstanding[37] - The Company had 9,886,294 shares of common stock issued and outstanding as of September 30, 2025, an increase from 6,990,227 shares as of December 31, 2024[81] - During the nine months ended September 30, 2025, the Company issued 1,538,461 shares of common stock for gross proceeds of $4,999,999 at a price of $3.25 per share[84] Research and Development - Research and development expenses are primarily focused on clinical studies and new product development, with costs expensed as incurred[26] - The Company has developed four FDA cleared products, including the IB-STIM and the Rectal Expulsion Device (RED), with ongoing efforts to expand their indications[15] Lease and Asset Management - The Company recognized operating lease expense of $24,193 for the three months ended September 30, 2025, compared to $27,891 for the same period in 2024[79] - As of September 30, 2025, the Company reported operating lease right-of-use assets of $277,219 and operating lease liabilities of $219,933, with a total present value of lease payments amounting to $282,767[80] - The total present value of operating lease payments as of September 30, 2025, was $282,767, with total lease payments amounting to $363,523[80]

Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the third quarter of 2025 on November 11, 2025, before market open, followed by a conference call to discuss the results [1] Group 1: Financial Results Announcement - The financial results for the third quarter of 2025 will be reported on November 11, 2025, for the period ending September 30, 2025 [1] - A conference call is scheduled for the same day at 9:00 a.m. Eastern Time to review the financial results [1] Group 2: Conference Call Details - Interested parties can access the conference call via a live webcast available on the Company's Investor Relations website [2] - Participants can submit questions through the webcast portal or via email [2] Group 3: Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The Company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4] - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Click Holdings Limited (CLIK) is up 81% at $11.17 [3] - Avidity Biosciences, Inc. (RNA) is up 43% at $70.72 [3] - Dyne Therapeutics, Inc. (DYN) is up 37% at $23.58 [3] - Zenas BioPharma, Inc. (ZBIO) is up 21% at $29.00 [3] - ProPetro Holding Corp. (PUMP) is up 18% at $7.47 [3] - PepGen Inc. (PEPG) is up 17% at $5.35 [3] - Unusual Machines, Inc. (UMAC) is up 15% at $14.85 [3] - Semler Scientific, Inc. (SMLR) is up 14% at $27.32 [3] - ETHZilla Corporation (ETHZ) is up 13% at $20.51 [3] - Relmada Therapeutics, Inc. (RLMD) is up 13% at $2.38 [3] Premarket Losers - Smart Logistics Global Limited (SLGB) is down 37% at $3.21 [4] - MaxsMaking Inc. (MAMK) is down 22% at $4.08 [4] - Prenetics Global Limited (PRE) is down 14% at $14.40 [4] - United States Antimony Corporation (UAMY) is down 14% at $10.22 [4] - NeurAxis, Inc. (NRXS) is down 12% at $3.01 [4] - Obook Holdings Inc. (OWLS) is down 9% at $11.39 [4] - Qualigen Therapeutics, Inc. (QLGN) is down 9% at $3.30 [4] - Critical Metals Corp. (CRML) is down 8% at $13.70 [4] - Neuphoria Therapeutics Inc. (NEUP) is down 8% at $5.73 [4] - Beam Therapeutics Inc. (BEAM) is down 7% at $25.86 [4]