Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [25] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [25] - Gross margin in Q1 2025 was 84.4%, down from 88.4% in Q4 2024, attributed to a higher growth rate of discounted financial assistance patients [26][27] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company reported significant growth in the IV stim technology, with a 39% growth in Q1 2025 [9] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase, expected to enhance revenue opportunities [15][21] Market Data and Key Metrics Changes - Total covered lives increased from approximately 4 million a year ago to about 51 million today, indicating a substantial expansion in market access [11] - The company is focused on achieving blanket insurance coverage and the implementation of a category one CPT code effective January 1, 2026, which is critical for scaling operations [10][14] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven and profitability by focusing on insurance policy coverage and the category one CPT code [20][24] - The strategy includes leveraging strong published data to drive insurance expansion, leading to sustainable revenues and margins [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth due to the expected publication of guidelines and the implementation of the CPT code [32][34] - The company anticipates that as insurance coverage increases, the percentage of sales through full-price purchase orders will also rise, enhancing revenue potential [19][20] Other Important Information - The company is currently managing a legal settlement from 2019, which will be paid in installments starting January 2026, allowing the company to move forward without the burden of ongoing litigation [42][45] - The company has made strides in expanding its insurance coverage, which is expected to positively impact sales volume in the coming quarters [26] Q&A Session Summary Question: When do you expect the guidelines to be published? - Guidelines are expected to be published by the end of the month, which will lead to increased orders based on policy coverage [32][33] Question: How do you see your operating expenses in the near and medium term? - Operating expenses are expected to increase as investments in sales and marketing are necessary to meet upcoming demand, but as a percentage of sales, they are expected to decrease [35][37] Question: Can you provide more details on the RED technology? - The response to the RED technology has been stronger than expected, and the company is optimistic about its commercial execution despite the slow uptake in revenue [38][40] Question: Can you provide details on the legal settlement? - The legal settlement amounts to $750,000, to be paid in equal monthly installments starting January 2026, which the company views as a positive step to eliminate legal risks [42][45]

Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission file number 001-41775 NEURAXIS, INC. (Exact name of registrant as specified in its charter) | Delaware | 45-50 ...

Core Viewpoint - NeurAxis, Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on neuromodulation therapies for chronic conditions in both children and adults [1][2]. Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies to treat chronic and debilitating conditions [3]. - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [3]. - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions with significant unmet healthcare needs [3]. Event Details - The presentation will take place on April 23, 2025, at 11:00 AM EST during the Planet MicroCap Showcase: VEGAS 2025 [1][2]. - Investors interested in one-on-one meetings with NeurAxis can register for the event, which will be held at the Paris Hotel & Casino in Las Vegas, NV [2].

CARMEL, Ind., April 15, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it will be presenting at the Planet MicroCap Showcase: VEGAS 2025 in partnership with MicroCapClub on Wednesday, April 23, 2025 at 11:00 AM EST. Brian Carico, CEO of NeurAxis will be hosting the presentation and answering questions ...

Core Insights - NeurAxis, Inc. (NRXS) reported a 43% year-over-year revenue growth in Q4 2024, driven by increased unit sales and stronger adoption of its IB-Stim therapy [2][8] - The company achieved a net loss reduction from $5.3 million in Q4 2023 to $1.5 million in Q4 2024, primarily due to the absence of a significant debt extinguishment charge from its 2023 IPO [3][9] - NeurAxis is targeting cash flow breakeven at annual revenues between $10 million and $12 million, with expectations of continued revenue growth into 2025 [7] Revenue Growth and Margin Stability - Q4 2024 revenues reached $761 thousand, up from $531 thousand in the same quarter last year, with full-year revenues increasing by 9.2% to $2.7 million [2] - Gross margin remained stable at 86.4%, with operating loss slightly reduced to $1.5 million from $1.6 million year-over-year [3][4] - The increase in unit sales was attributed to growing insurance reimbursement and the company's financial assistance program, despite lower average selling prices [4][8] Key Business Metrics - NeurAxis treated over 1,000 pediatric patients in the past year, highlighting the potential for accelerated revenue growth as insurance coverage improves [5] - The company expanded its insurance coverage from 4 million to 51 million covered lives, which is expected to enhance market penetration [6] Management Commentary - CEO Brian Carrico noted that the fourth quarter marked a transformational year for NeurAxis, with key milestones including CPT Category I code approval effective January 2026 [6] - CFO Tim Henrichs indicated that revenue growth momentum has continued into Q1 2025, reinforcing the company's financial targets [7] Guidance and Outlook - NeurAxis did not provide formal financial guidance but expressed confidence in achieving accelerated revenue growth through 2025, particularly with the introduction of the Rectal Expulsion Device (RED) [11] - The company anticipates expanded FDA indications, which could potentially double its pediatric addressable market [11] Other Developments - NeurAxis received FDA 510(k) clearance for RED, a test for diagnosing evacuation disorders, which is expected to accelerate adoption due to existing reimbursement codes [13] - The company also secured FDA clearance to expand the IB-Stim label to a broader age range, significantly increasing market potential [14]

NeurAxis, Inc. (NYSE:NRXS) Q4 2024 Earnings Conference Call March 20, 2025 9:00 AM ET Company Participants Ben Shamsian - Investor Relations Brian Carrico - Chief Executive Officer Tim Henrichs - Chief Financial Officer Operator Good day, and thank you for standing by. Welcome to the NeurAxis' Fourth Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and answer-session. [Operator Instructions] P ...

Core Viewpoint - NeurAxis, Inc. reported strong financial performance in Q4 2024, highlighting significant growth in revenue and operational achievements, positioning the company for continued expansion in the neuromodulation therapy market [3][4][7]. Financial Highlights - Revenues in Q4 2024 increased by 43% to $761 thousand compared to $531 thousand in Q4 2023 [7][8]. - For the fiscal year 2024, total revenue was $2.7 million, a 9% increase from $2.5 million in fiscal year 2023 [9]. - The gross margin for Q4 2024 remained steady at 86.4%, while the fiscal year 2024 gross margin was 86.5%, down from 87.7% in fiscal year 2023 [10][11]. Operational Highlights - The company expanded insurance coverage to approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [4][7]. - NeurAxis received a new CPT Category I code for PENFS procedures effective January 1, 2026, and FDA clearance for its RED device [7][8]. - Over the past year, more than 1,000 pediatric patients were treated, representing just over 0.1% of the 600,000 children in the U.S. suffering from debilitating IBS [4]. Management Commentary - The CEO emphasized the company's strong performance and growth prospects, driven by expanded insurance coverage and disciplined cost management [3]. - The company is optimistic about upcoming academic society guidelines that are expected to enhance insurance policy coverage for treatments [5]. Expenses and Losses - Selling, general, and administrative expenses in Q4 2024 were $2.1 million, a 2% increase from $2.0 million in Q4 2023 [12]. - The operating loss for Q4 2024 was $1.5 million, an improvement of 10% compared to $1.6 million in Q4 2023 [14]. - The net loss for the full year 2024 was $8.2 million, a decrease of 44% compared to $14.6 million in 2023 [16].

Regulatory Compliance - The FDA's 510(k) premarket notification process can be resource-intensive, expensive, and lengthy, impacting the time to market for new medical devices [106]. - Class II medical devices are required to submit a premarket notification under Section 510(k) to request permission for commercial distribution [109]. - The FDA's performance goal for reviewing a 510(k) submission is 90 days, but clearance often takes longer due to additional information requests [121]. - The FDA may require clinical data for 510(k) submissions, which can significantly prolong the review process [121]. - The company may face significant regulatory fines or penalties if modifications to devices require new 510(k) clearance or PMA approval [124]. - Recent FDA proposals could increase requirements for clinical data and extend review periods for the 510(k) clearance process [125]. - The FDA has introduced a "safety and performance based" premarket review pathway for certain well-understood device types, potentially simplifying the clearance process [126]. - The PMA approval process for Class III devices requires extensive data from preclinical studies and human clinical trials, with a standard application fee of $365,657 for fiscal year 2021 [127]. - FDA review of a PMA application generally takes between one and three years, but can extend significantly longer due to various factors [131]. - If the FDA's evaluation is favorable, it may issue an approval letter or an approvable letter, which may include conditions for final approval [129]. - Manufacturers must comply with ongoing regulatory requirements even after receiving FDA approval, including modifications that could affect safety or effectiveness [132]. - The FDA has broad regulatory compliance and enforcement powers, which can result in sanctions such as recalls, fines, or production shutdowns for non-compliance [136]. - In the EU, medical devices must meet essential requirements and undergo a conformity assessment procedure, typically involving a Notified Body [139]. - The EU Medical Devices Regulation, effective May 25, 2017, aims to establish a uniform regulatory framework across EU member states [145]. - Manufacturers must report incidents that may lead to serious health risks and take corrective actions, including recalls or modifications [142]. - Compliance with the EU medical device vigilance system is mandatory, requiring manufacturers to report incidents and take necessary corrective actions [142]. - The Medical Devices Regulation transition period was extended until May 26, 2021, with devices placed on the market before this date allowed until May 26, 2025 [146]. - The EU-UK Trade and Cooperation Agreement does not specifically address medical devices, and the UK will implement its own regulatory regime post-Brexit, with UKCA marking becoming mandatory after June 30, 2023 [148]. Financial and Reimbursement Issues - The company plans to provide only two years of audited financial statements and unaudited condensed financial statements for interim periods in its prospectus [105]. - The company’s products are not separately reimbursed by third-party payors in the U.S., and reimbursement policies vary significantly among payors [156]. - Third-party payors are increasingly auditing prices for medical products, which may impact demand for the company's products [157]. - The Affordable Care Act has significantly changed healthcare financing and delivery, affecting medical device manufacturers [163]. Legal and Data Protection - The U.S. federal Anti-Kickback Statute prohibits remuneration to induce purchases of goods or services reimbursable under federal healthcare programs, with broad interpretations of "remuneration" [150]. - The federal False Claims Act prohibits presenting false claims for payment to the federal government, with violations potentially leading to civil actions and penalties [151]. - The GDPR imposes strict requirements for processing personal data, with potential fines for noncompliance reaching up to €20 million or 4% of annual global revenues [168]. - The invalidation of the Privacy Shield in July 2020 has created uncertainty regarding data transfer mechanisms between the EU and the U.S. [169]. Manufacturing and Operations - The Company entered into a Manufacturing Services Agreement with GMI Corporation for the manufacture and supply of the IB-STIM device, with an initial term of 24 months [173]. - GMI's facility is 69,000 square feet, with approximately 1,000 square feet dedicated to producing the IB-STIM device, located in Indiana [175]. - GMI has a quality management system that is ISO 13485:2016 certified, FDA registered, and ITAR registered [177]. - As of December 31, 2024, the Company had 21 full-time employees [178]. - GMI has sufficient kit production capacity for all projected needs, supported by a new environmentally controlled build room established in 2022 [176].

CARMEL, Ind., March 12, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, will report summarized financial results for its fourth quarter and fiscal year 2024, for the period ended December 31, 2024, on Thursday, March 20, 2025, before market open. The Company has scheduled a conference call for the same day, Thursday, March ...