Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the second quarter of 2025 on August 12, 2025, before market opening, followed by a conference call to discuss the results [1]. Financial Results Announcement - The financial results will cover the period ended June 30, 2025 [1]. - A conference call is scheduled for August 12, 2025, at 9:00 a.m. Eastern Time to review the results [1]. 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]. - Call-in participants must register to receive dial-in information and a unique PIN [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 - NeurAxis, Inc. announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with two health insurers, impacting approximately 700,000 members in Connecticut and Massachusetts, bringing total national coverage to about 53 million [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in adolescents aged 8-21 [2][4] Technology and Market Position - IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear, addressing a significant gap as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders [2] - The technology has been incorporated into treatment guidelines by a leading pediatric academic society, which is expected to enhance policy coverage and reimbursement [3] Future Developments - The activation of a Category I CPT code for PENFS, effective January 1, 2026, is anticipated to improve reimbursement and encourage broader adoption in children's hospitals [3] - NeurAxis is currently conducting additional clinical trials for PENFS across various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - NeurAxis, Inc. has announced that its PENFS technology is now included in clinical practice guidelines for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS), which is a significant milestone for the company [1][6] - The inclusion of IB-Stim in these guidelines is expected to enhance insurance coverage and drive growth, with an estimated addressable market exceeding $3 billion in the U.S. alone [2][3] - The guidelines were developed collaboratively by pediatric gastroenterology societies and emphasize evidence-based recommendations, positioning IB-Stim as a top-tier treatment option [2][6] Company Developments - NeurAxis's CEO highlighted the recognition of IB-Stim as part of the standard care for FAP in IBS, indicating a strong growth strategy and potential for substantial revenue generation [2] - The company has recently received FDA expanded clearances for IB-Stim and is set to implement a new Category I CPT code, further enhancing its market position [2] - The company aims to address the needs of over 600,000 children in the U.S. suffering from FAP, leveraging the new guidelines to expand treatment options [2][3] Market Context - The global market for abdominal pain in IBS presents a multi-billion-dollar opportunity, with IB-Stim being the only FDA-cleared pediatric treatment for FAP in IBS [3] - The guidelines recommend PENFS among other therapies, which elevates NeurAxis's profile and supports broader adoption of IB-Stim within the healthcare industry [2][6] - The rigorous GRADE approach used in developing the guidelines underscores the efficacy and safety of PENFS, enhancing its credibility as a treatment option [2][6]

Summary of Neuraxis Investor Conference Call Company Overview - Neuraxis is a growth-stage med tech company focused on neuromodulation therapies for chronic gastrointestinal (GI) conditions in pediatrics, with plans to expand into the adult market later in 2025 [3][4] - The company has developed proprietary neuromodulation technology targeting disorders of gut-brain interaction [3] Financial Performance - Neuraxis reported revenue of approximately $2.7 million last year, representing only 0.1% of the total market for their therapies [4] - Gross margins were at 88% last year, with expectations for improvement as insurance coverage increases [5] - Recent revenue growth was reported at 40% in Q3, 43% in Q4, and 39% in Q1, attributed to increased insurance coverage and guideline responses [7] Market Potential - The total addressable market includes approximately 1 million children in the U.S. suffering from functional abdominal pain and functional dyspepsia, with a potential revenue of $5,000 per patient [13][14] - Neuraxis has secured a category one CPT code, effective January 1, 2026, which is expected to enhance reimbursement and revenue growth [25][38] Product Development and Indications - Neuraxis has recently expanded its indications to include functional dyspepsia and nausea symptoms, effectively doubling its addressable market [8][33] - The company is also in the research stage for cyclic vomiting syndrome [14] Competitive Advantage - Neuraxis is the first to market with its technology and has established significant intellectual property (IP) protections, with U.S. patents running through 2039 [24] - The technology offers a non-pharmacological alternative to existing treatments, which often have serious side effects [16][21] Insurance and Reimbursement - The company currently has coverage for 51 million lives and expects this to increase to over 100 million by the end of December [4] - The upcoming publication of academic society guidelines is anticipated to facilitate broader insurance policy coverage [36][37] Capital Structure and Financial Health - Neuraxis recently raised $5 million, enhancing its cash position to $6.8 million, which is expected to sustain operations for over a year at the current burn rate [30][40] - The management team is focused on executing business operations without the need for immediate capital raising [41][42] Conclusion - Neuraxis is positioned for significant growth with a clear path to profitability, driven by expanding market opportunities, strong financial performance, and a robust product pipeline [12][26]

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - 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 [4] - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs [4] Upcoming Events - NeurAxis will participate in the Lytham Partners Spring 2025 Investor Conference, with a webcast presentation scheduled for May 29, 2025, at 9:30 a.m. ET [1][2] - The webcast will be accessible via the conference homepage and will be available for replay after the event [2] - Management will also engage in virtual one-on-one meetings with investors during the conference [3]

Core Viewpoint - NeurAxis, Inc. has successfully closed a registered direct offering, raising approximately $5.0 million to strengthen its balance sheet and support growth initiatives, particularly for its IB-Stim therapy targeting chronic abdominal pain in pediatric patients [1][2]. Group 1: Financial Details - The offering consisted of 1,538,461 shares of common stock priced at $3.25 per share, resulting in gross proceeds of about $5.0 million before expenses [1]. - In addition to the offering, NeurAxis secured over $1 million from warrant exercises, further enhancing its financial position [2]. Group 2: Product and Market Impact - The recent FDA clearance for expanded indications of the IB-Stim treatment for Pediatric Functional Abdominal Pain (FAP) is a significant milestone for the company, addressing a critical need in pediatric care [2]. - The IB-Stim therapy is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, with ongoing clinical trials for various pediatric and adult conditions [5]. Group 3: Future Outlook - The funds raised will be utilized to drive revenue growth for IB-Stim and prepare for the implementation of a CPT Category I code effective January 1, 2026, which is expected to enhance reimbursement and adoption of the therapy [2].

Core Viewpoint - NeurAxis, Inc. has announced a registered direct offering of 1,538,461 shares of its common stock at a price of $3.25 per share, aiming to raise approximately $5.0 million for working capital and general corporate purposes [1][2]. Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [5]. - 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 [5]. - NeurAxis is conducting additional clinical trials of its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology for various pediatric and adult conditions with significant unmet healthcare needs [5]. Offering Details - The offering is expected to close on or about May 22, 2025, pending customary closing conditions [2]. - Craig-Hallum Capital Group is serving as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be around $5.0 million before deducting fees and expenses [2]. Regulatory Information - A shelf registration statement on Form S-3 was filed with the SEC on December 13, 2024, and was declared effective on February 11, 2025 [3]. - The offering will be conducted through a prospectus supplement and accompanying prospectus that are part of the shelf registration statement [3].

Core Insights - NeurAxis, Inc. has received FDA 510(k) clearance for IB-Stim™ to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, marking a significant expansion of its product indications [1][3] - The new indication is expected to nearly double the company's total addressable market, reinforcing its leadership in non-invasive, pediatric-focused neuromodulation therapies [1][6] - The commercial rollout for this expanded indication will begin immediately, leveraging existing reimbursement and provider infrastructure [2][3] Company Overview - NeurAxis, Inc. specializes in neuromodulation therapies aimed at chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim™ technology is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 years [4] - There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of gut-brain interaction, highlighting the unique position of NeurAxis in the market [3][4] Market Strategy - The new indication for IB-Stim™ utilizes the same CPT code and insurance coverage as the existing IBS indication, supporting a seamless and capital-efficient go-to-market strategy [2][3] - The company anticipates significant revenue growth driven by the expanded clinical impact and increased insurance coverage, including a new CPT Category I code effective January 2026 [3]

Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant revenue growth in Q1 2025, with a notable stock performance compared to the S&P 500, despite reporting a net loss that widened year over year [1][3]. Revenue and Earnings Performance - In Q1 2025, NeurAxis reported revenues of $0.9 million, a 38.5% increase from $0.6 million in the same quarter of the previous year [2]. - Unit sales increased by 46% year over year, driven by higher patient volumes with full insurance reimbursement and financial assistance [2]. Profitability Metrics - The company reported a net loss of $2.3 million, compared to a $2.1 million loss in Q1 2024, resulting in a per-share loss of $0.33 versus $0.32 a year ago [3]. - Gross margin decreased to 84.4% from 88.4% due to a higher proportion of discounted sales and increased manufacturing and shipping costs [3]. Operating Expenses - Operating expenses rose by 26.9% to $3.1 million in Q1 2025 from $2.4 million in the same quarter last year [4]. - Excluding a one-time legal settlement, operating expenses remained relatively flat, indicating effective cost controls [4]. Cash Position and Financial Health - As of March 31, 2025, NeurAxis had cash and cash equivalents of $2 million, down from $3.7 million as of December 31, 2024, with no long-term debt reported [5]. - Net cash used in operations for Q1 2025 was $1.6 million, compared to $1.3 million a year ago [5]. Management Insights - CEO Brian Carrico noted that Q1 2025 marked the third consecutive quarter of robust revenue growth, attributing this to improved billing practices and expanding insurance coverage [6]. - CFO Tim Henrichs indicated that while operating expenses may rise in the short term due to sales and marketing efforts, they are expected to decrease as a percentage of sales [7]. Market Dynamics - Revenue growth was supported by the adoption of NeurAxis' proprietary technology, but pricing pressure from financial assistance patients constrained gross margin expansion [8]. - A one-time legal settlement of $750,000 impacted operating and net losses, but without this charge, net loss would have improved by 22% year over year [9]. Future Outlook - Management is optimistic about revenue acceleration in upcoming quarters, driven by the publication of academic guidelines and the implementation of a permanent CPT code for IB-Stim [11]. - FDA clearance is pending for expanding IB-Stim's indication, which could double the addressable market [12]. Regulatory Developments - NeurAxis achieved regulatory milestones, including a broadened FDA label for IB-Stim and 510(k) clearance for its rectal expulsion device [13]. - The company settled a legacy lawsuit for $750,000, payable over 12 months starting January 2026 [14].

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [26] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [26] - 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 [27][28] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [30] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 2024, 43% in Q4 2024, and 39% in Q1 2025 for IV stem technology [9] - 300 patients were treated in Q1 2025, an annualized rate of 1,200 patients, representing only 0.2% of the 600,000 severely affected children in the U.S. [18] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase [16][21] Market Data and Key Metrics Changes - Total covered lives increased from 4 million a year ago to approximately 51 million today [11] - The company expects to see increased orders following the publication of independent guidelines by the academic society [33][34] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the effective date of the category one CPT code on January 1, 2026 [25][20] - The strategy includes leveraging strong published data to drive insurance expansion and sustainable revenues [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding continued revenue growth due to the expected increase in insurance policy coverage and the category one CPT code [21][25] - The company is cautiously optimistic about the timeline for receiving guidelines and subsequent policy coverage from payers [33][35] Other Important Information - The company settled a lawsuit for $750,000, which will be paid in equal monthly installments starting January 2026 [42] - The legal settlement is viewed positively as it mitigates further risks and legal fees [42][43] 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, with orders anticipated to increase based on policy coverage from those guidelines [33][34] 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, but as a percentage of sales, they are expected to decrease [36][37] Question: Can you provide more color on RED and its launch? - The response to the RED soft launch has been stronger than expected, with a significant need for the technology noted [38][40] Question: Can you provide details on the legal settlement? - The legal settlement from 2019 will be paid in installments starting January 2026, and it is seen as a positive step for the company [41][42]