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].

NeurAxis (NRXS) Q1 2025 Earnings Call May 12, 2025 09:00 AM ET Company Participants Ben Shamsian - VP Investor RelationsBrian Carrico - CEO & PresidentTimothy Henrichs - Chief Financial Officer Operator Good day, and thank you for standing by. Welcome to the Neuraxis First Quarter twenty twenty five Results and Update Call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need ...

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]