Financial Performance - Neuraxis, Inc. announced preliminary unaudited estimated revenues for Q4 2024 and the full year ended December 31, 2024[4]. - The financial information provided is preliminary and subject to changes following the completion of the company's normal financial close procedures[5]. - The preliminary financial information does not include all necessary details for a complete understanding of the company's financial condition[5]. Audit and Compliance - The company’s financial statements for the year ended December 31, 2024, are currently undergoing an audit[5]. - The filing does not incorporate the information into any registration statements under the Securities Act[6]. Company Information - Neuraxis, Inc. is classified as an emerging growth company under the Securities Act[3]. - The company is listed on the NYSE American under the trading symbol NRXS[2]. - The report was signed by Brian Carrico, President and CEO of Neuraxis, Inc.[11]. Press Release - The press release regarding the preliminary results was issued on January 8, 2025[4]. - The press release is included as Exhibit 99.1 in the filing[8].

Core Insights - NeurAxis, Inc. reported preliminary, unaudited revenues for Q4 2024 of approximately $800 thousand, marking a 50% increase compared to Q4 2023, and for FY 2024, revenues were approximately $2.7 million, an 11% increase from FY 2023 [1][6] Revenue Growth - The company experienced a significant revenue growth acceleration in Q4 2024, with a 50% increase compared to 40% growth in Q3 2024 [2] - The strong revenue growth in the second half of 2024 was attributed to expanded insurance coverage, which now supports approximately 45 million lives, up from 4 million a year ago [2] Future Outlook - NeurAxis expects continued robust revenue growth in 2025 and beyond, driven by expanding insurance coverage policies and recent FDA 510(k) clearance for IB-Stim, which now includes patients aged 8 to 21 years [3] - The company plans to commercialize its Rectal Expulsion Device (RED) in Q1 2025, following FDA approval [3] Financial Position - As of December 31, 2024, NeurAxis had a cash balance of approximately $3.7 million, positioning the company to achieve near-term growth objectives and reach cash flow breakeven [4][6]

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [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 11-18 [3] - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs [3] Upcoming Events - CEO Brian Carrico will participate in a webcasted company presentation at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 2:30 PM Eastern time [1][2] - The presentation will be accessible via the conference homepage and will also have a replay available [2] - One-on-one investor meetings will be available upon request after the event [2]

Financial Data and Key Metrics Changes - In Q3 2024, the company reported revenues of $667,000, a 40% increase year-over-year compared to $477,000 in Q3 2023 [45] - Unit sales increased approximately 50% year-over-year in Q3 2024 [46] - Gross profit for Q3 2024 was $570,000, up from $410,000 in Q3 2023, with a gross margin of 85.4%, down 50 basis points year-over-year [48] - The operating loss improved to $1.7 million in Q3 2024 from $3 million in Q3 2023 [49] - The net loss for Q3 2024 was $1.8 million, significantly reduced from an $8.6 million net loss in Q3 2023 [51] Business Line Data and Key Metrics Changes - The company achieved a 40% year-over-year revenue growth in Q3, attributed to increased insurance coverage and improved billing practices [11][30] - The number of treated cases increased to about 900 patients in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [28] - The company expects significant revenue growth as more children's hospitals begin to order once insurance policy coverage is established [32] Market Data and Key Metrics Changes - The company expanded its covered lives from 4 million at the beginning of the year to approximately 35 million by Q3 2024 [15][20] - The company anticipates exceeding the projected 50 million covered lives by the end of 2024, contingent on positive decisions from payers [20][81] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and expects to continue revenue growth into 2025, driven by increased insurance coverage and the commercialization of new products [43][36] - The receipt of a Category 1 CPT code is seen as a critical milestone that will facilitate easier billing and reimbursement processes [23][60] - The company is optimistic about the commercialization of the RED device, which is expected to launch in late 2024 and has a similar total addressable market (TAM) to IB-Stim [37][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth trajectory, citing strong demand and enthusiasm from healthcare providers [47] - The company is optimistic about achieving profitability in 2025, supported by the expected publication of academic society guidelines that will enhance insurance coverage [83][85] - Management highlighted the importance of independent academic guidelines for increasing insurance coverage and driving revenue growth [18][84] Other Important Information - The company secured a $5 million investment to strengthen its liquidity position, which is expected to close in mid-November [44][52] - The company has no long-term debt as of September 30, 2024, but has $148,000 in short-term debt related to business insurance premiums [54] Q&A Session Summary Question: Significance of Category 1 code and 510(k) extension - The Category 1 code simplifies billing and reimbursement processes, making it easier for hospitals to adopt the technology [58][60] - The 510(k) extension increases the age range for treatment, allowing more patients to be treated under the new guidelines [63] Question: Impact of age extension on covered lives - While the age extension allows for more patients to be treated, written policy coverage from payers is still necessary to increase covered lives [65][66] Question: Evidence of cure versus treatment - The company does not use the term "cure" but has data showing significant long-term outcomes for patients [72][73] Question: Plans for adult indications - The company is working towards FDA approval for adult indications, aiming for late 2025 [75] Question: Market strategy for new product RED - The company plans to utilize its existing sales force to market the RED device, which has a strong reimbursement framework [79][80] Question: Target of 50 million covered lives and profitability - The company remains optimistic about reaching the target of 50 million covered lives by year-end and achieving cash flow profitability in 2025 [81][83]

Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant stock performance and financial improvement following its third-quarter 2024 earnings report, with a notable increase in revenues and a substantial reduction in net losses compared to the previous year [1][3]. Financial Performance - NeurAxis reported revenues of $0.7 million for Q3 2024, a 39.6% increase from $0.5 million in Q3 2023 [2] - Gross profit rose 38.9% year-over-year to $0.6 million, with a slight decline in gross margin from 85.9% to 85.4% due to increased financial assistance programs [2] - Operating loss improved to $1.7 million in Q3 2024 from $3 million in Q3 2023 [2] Net Loss and Earnings Per Share - The net loss for the quarter was $1.8 million, significantly better than the $8.6 million loss in Q3 2023 [3] - Loss per share decreased to $0.25 in Q3 2024 from $2.38 in Q3 2023, attributed to increased sales and the absence of IPO-related costs [3] Key Business Metrics - Unit sales of the IB-Stim device increased by 50% during the quarter, supported by expanded insurance coverage and patient access [4] - The total covered lives expanded to approximately 35 million, a significant increase from 4.5 million in October 2023, including coverage from major insurers [5] Financial Position - As of September 30, 2024, NeurAxis reported $0.3 million in cash and $147,688 in short-term debt, along with a $5.0 million investment agreement to enhance liquidity [6] Management Commentary - CEO Brian Carrico emphasized strong operational progress, highlighting a 40% year-over-year revenue growth and the expansion of insurance coverage [7] Factors Influencing Results - Revenue growth was driven by increased volume from both new and existing full insurance reimbursement customers and growth in financial assistance programs [8] - The improvement in operating losses was due to the absence of 2023 post-IPO costs and higher sales and gross profit in 2024 [8] Guidance and Outlook - While specific forward-looking financial guidance was not provided, management expressed confidence in ongoing operational momentum, with expectations for further adoption of IB-Stim due to recent FDA approvals and insurance policy expansions [9] Other Developments - NeurAxis achieved FDA clearance to expand IB-Stim's target demographic and increased the allowable devices per patient [10] - The company submitted a rectal expulsion device for FDA approval, with anticipated clearance by the end of 2024 [10]

Core Insights - NeurAxis, Inc. reported a 40% increase in revenues for Q3 2024, reaching $667 thousand compared to $477 thousand in Q3 2023, with an improved operating loss of 45% [2][8]. Financial Highlights - Revenues for Q3 2024 were $667 thousand, a 40% increase from $477 thousand in Q3 2023 [2][6]. - Gross profit rose to $570 thousand, a 39% increase from $410 thousand in Q3 2023, although gross margin slightly declined by 50 basis points [7]. - Operating loss decreased to $1.7 million, down 45% from $3.0 million in Q3 2023 [8]. - Net loss for Q3 2024 was $1.8 million, an 80% reduction from $8.6 million in Q3 2023 [9]. Operational Highlights - The total covered lives expanded to approximately 35 million from 4.5 million as of October 1, 2023 [3]. - Recent medical policy coverages include significant plans from BCBS in Florida and the mid-Atlantic region, covering over 16 million lives combined [3]. - NeurAxis received a new CPT Category I code for PENFS procedures effective January 1, 2026, and FDA clearance to expand IB-Stim's patient age range from 11-18 years to 8-21 years [3][5]. - The company secured a $5.0 million capital investment to replace $3.2 million in committed funding from an existing investor [3][10]. Management Commentary - The CEO expressed excitement over the strong performance in Q3 2024, highlighting a 50% growth in unit sales of the IB-Stim product and the successful expansion of insurance coverage [4][5].

Core Insights - NeurAxis, Inc. announced that the American Medical Association has established a new CPT Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures, effective January 1, 2026, which is a significant milestone for the company [1][2] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18, addressing a gap in available treatments for this demographic [1][3] - NeurAxis is focused on advancing neuromodulation therapies and is conducting additional clinical trials for PENFS in various pediatric and adult conditions with large unmet healthcare needs [3] Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies for chronic and debilitating conditions in both children and adults [3] - The company is dedicated to leveraging evidence-based medicine to promote the adoption of its proprietary IB-Stim therapy within the medical, scientific, and patient communities [3] - There are currently no FDA-approved drug therapies for children suffering from abdominal pain-related disorders of gut-brain interaction, highlighting the importance of NeurAxis's offerings [1]

Core Viewpoint - Zacks Investment Research has initiated coverage of NeurAxis, Inc. (NRXS) with a "Neutral" recommendation, reflecting a mixed outlook for the company despite its advancements in neuromodulation therapies [1] Company Overview - NeurAxis, headquartered in Carmel, IN, focuses on developing neuromodulation therapies for chronic conditions, particularly in pediatric populations. Its flagship product, IB-Stim, is an FDA-cleared device for treating functional abdominal pain related to irritable bowel syndrome in adolescents aged 11-18 years [2] Financial Performance - NeurAxis reported a 16% year-over-year increase in unit sales in Q2 2024 and secured $9.1 million in funding, enhancing its financial position [3] - The company experienced an operating loss of $2.2 million in Q2 2024, nearly doubling from the previous year, with a cash reserve of $1.8 million as of June 30, 2024, and a monthly burn rate of $400,000 to $500,000 [4] Market Expansion - The coverage of NeurAxis' IB-Stim device has expanded from 4.5 million lives in May 2023 to approximately 22.5 million in June 2024, with expectations to exceed 50 million by year-end [3] - The anticipated commercialization of the Rectal Expulsion Device for pelvic floor dysfunction by late 2024 and the planned expansion of IB-Stim's label to a broader age range are expected to significantly enhance market opportunities [5] Growth Drivers - Key factors driving future growth include the rapid expansion of insurance coverage for the IB-Stim device, which is crucial for revenue growth, and the expected acceleration in revenue in the latter half of 2024 and into 2025 [5] Competitive Landscape - NeurAxis' stock has underperformed compared to industry peers and the broader market over the past year, indicating potential risks if the company fails to meet market expectations [7]

CARMEL, Ind., Sept. 19, 2024 (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 participate in a webcasted presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2024 Investor Conference, taking place virtually on Tuesday, October 1, 2024. Company Webcast The webcasted presentation will take plac ...

CARMEL, Ind., Aug. 27, 2024 (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 medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), for Geisinger Health Plan, serving 600,000+ enrollees in central Pennsylvania. This medical policy will bring our national total coverage for PENFS to r ...