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]

Financial Data and Key Metrics Changes - Revenues in Q4 2024 were $761,000, up 43% compared to $531,000 in Q4 2023 [35] - Revenue for fiscal year 2024 was $2.7 million, an increase of 9% compared to $2.5 million in fiscal year 2023 [36] - Gross margin in Q4 2024 was 86.4%, consistent with Q4 2023 [37] - Net loss for Q4 2024 was $1.5 million, a decrease of 73% compared to $5.3 million in Q4 2023 [42] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 and 43% in Q4 for IB-Stim revenue [11] - Unit sales increased approximately 45% in Q4 2024 due to growth from patients with undiscounted insurance reimbursement [35] - The number of treated cases increased to over 1,000 in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [24] Market Data and Key Metrics Changes - Covered lives increased from 4 million on January 1 of the previous year to approximately 51 million today [13] - The expansion of the IB-Stim age indication from 11-18 years to 8-21 years significantly increases the market opportunity [21] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the implementation of a Category 1 CPT code [28] - The commercialization of the RED device is expected to drive significant revenues in the coming quarters [30] - The company aims to transition patients from inadequate or no insurance coverage to full reimbursement, which will enhance future revenues and gross margins [59] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the continued growth in covered lives and the commercialization of RED [33] - The company anticipates that the Category 1 CPT code will streamline prior authorizations and enhance revenue generation [52] - Management believes that strong peer-reviewed publications and key society support will lead to successful insurance coverage [27] Other Important Information - The company held no long-term debt as of December 31, 2024, with cash on hand of $3.7 million [43] - Operating loss in Q4 2024 was $1.5 million, an improvement of 10% compared to the previous year [41] Q&A Session Summary Question: Significance of receiving the Category 1 code and the 510(k) extensions - The Category 1 code is crucial as it allows physicians to receive RVUs for procedures, which is essential for their compensation [50] - The 510(k) extension increases the total addressable market by approximately 75% [54] Question: Variability of gross margins and future expectations - Gross margins are currently in the mid to high 80s, with expectations to increase as more patients transition to insurance coverage [56][59] Question: Early learnings from the RED commercial mode - Feedback from physicians has been positive, with higher than expected usage [64] Question: Revenue needed to achieve breakeven - Breakeven revenues are expected to be in the $10 million to $12 million range based on current cash burn [66] Question: Product manufacturing and tariff exposure - 95% of technology is sourced and manufactured in the U.S., with minimal exposure to tariffs [68] Question: Development timeline for a second-generation IB-Stim device - The second-generation device is expected to be available in 2026, featuring a more modern design [70] Question: Response after a course of IB-Stim treatment - Approximately 70% of patients report significant long-term relief after treatment [76]

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].

Core Viewpoint - NeurAxis, Inc. is set to report its financial results for the fourth quarter and fiscal year 2024 on March 20, 2025, and will hold a conference call to discuss these results [1] Group 1: Financial Reporting - The financial results will cover the period ended December 31, 2024 [1] - A conference call is scheduled for March 20, 2025, at 9:00 am ET to review the results [1][2] Group 2: 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 - NeurAxis, Inc. has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with a major insurer covering approximately 5.1 million members across 13 states [1] - The IB-Stim device is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 years [2] - The company has significantly expanded its insurance coverage from 4 million lives to 51 million lives in the past year, indicating strong growth and acceptance of its technology [3] Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [4] - The IB-Stim technology is currently the only FDA-cleared non-surgical option for children suffering from abdominal pain-related disorders of gut-brain interaction, addressing a significant unmet medical need [2][4] - Ongoing clinical trials are exploring the use of PENFS in various pediatric and adult conditions, further expanding the potential applications of the technology [4]

Core Insights - NeurAxis, Inc. has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with Molina Healthcare, expanding its reach to approximately 5.1 million members across 13 states [1][3] - The IB-Stim device is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, addressing a significant gap as there are currently no FDA-approved drug therapies for children with such conditions [2][4] - The company has significantly increased its insurance coverage from 4 million to 51 million lives over the past year, highlighting the growing acceptance and demand for its technology [3] Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies aimed at chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [4] - The IB-Stim therapy is a proprietary technology that utilizes non-surgical methods to deliver electrical impulses to cranial nerve bundles, providing a novel treatment option for patients suffering from abdominal pain-related disorders [2][4] - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions, indicating the company's dedication to expanding its therapeutic applications [4]

Core Insights - NeurAxis, Inc. has highlighted its achievements in 2024 and outlined its vision for 2025, focusing on establishing itself as a leader in the gastroenterology space [1][2] Company Achievements - In 2024, NeurAxis achieved significant milestones with its IB-Stim therapy, which is the first FDA-indicated treatment specifically for pediatric IBS, prescribed to approximately 1,000 patients [3][4] - The company successfully expanded insurance coverage for IB-Stim to approximately 51 million lives, up from 4 million the previous year, driven by robust peer-reviewed data [4] - NeurAxis received FDA 510(k) clearance for an expanded indication of IB-Stim, now including patients aged 8 to 21 years, increasing the addressable market by over 75% [6] Future Plans - The company plans to submit to the FDA for expanded indications in 2025, including adult IBS and pediatric functional dyspepsia [2] - NeurAxis aims to sustain exceptional revenue growth, manage costs carefully, and strengthen its balance sheet to deliver value to shareholders [2][12] Regulatory and Market Developments - The American Medical Association approved a new CPT Category I code for PENFS procedures, effective January 1, 2026, which is expected to enhance patient access to IB-Stim [7][8] - A systematic review presented by NASPGHAN indicated that NeurAxis's technology has the highest GRADE certainty for pediatric IBS, which is anticipated to drive medical policy coverage and accelerate insurance adoption [9][10] Product Launches - In December 2024, NeurAxis obtained FDA clearance for its Rectal Expulsion Device (RED) as a screening tool for chronic constipation, with positive policy coverage from Medicare and most commercial insurers [11]