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].

Financial Performance - Net sales for the three months ended September 30, 2024, were $666,625, a 39.6% increase from $477,460 in the same period of 2023[6] - Gross profit for the nine months ended September 30, 2024, was $1,667,811, compared to $1,697,590 for the same period in 2023, reflecting a slight decrease of 1.8%[6] - The operating loss for the three months ended September 30, 2024, was $(1,651,273), an improvement from $(3,022,339) in the same period of 2023[6] - The net loss for the nine months ended September 30, 2024, was $(6,793,596), compared to $(13,034,385) for the same period in 2023, indicating a reduction of 47.8%[6] - The company reported a basic and diluted loss per share of $(0.25) for the three months ended September 30, 2024, compared to $(2.38) for the same period in 2023[6] - Net loss for September 2024 was $6,793,596, a decrease from $13,034,385 in September 2023, representing a 48.1% improvement[21] - The Company reported a net loss of $1,755,234 for the three months ended September 30, 2024, compared to a net loss of $8,625,363 for the same period in 2023[46] - Net loss decreased by $6,870,129, or 79.7%, from $8,625,363 for the three months ended September 30, 2023, to $1,755,234 for the three months ended September 30, 2024[176] Cash Flow and Liquidity - Cash used by operating activities was $4,340,097 in September 2024, compared to $4,064,419 in September 2023, indicating a 6.8% increase[21] - The company reported net cash provided by financing activities of $4,550,198 in September 2024, slightly down from $4,627,710 in September 2023, a decrease of 1.7%[21] - Cash on hand decreased from $761,249 as of September 30, 2023, to $260,885 as of September 30, 2024[178] - The company recognized a right of use asset valued at $284,339 during the period[21] - The company incurred $30,756 in cash paid for interest during the period[21] Research and Development - Research and development expenses for the three months ended September 30, 2024, were $72,422, up 61.2% from $44,950 in the same period of 2023[6] - Research and development expenses increased by $27,472, or 61.1%, from $44,950 for the three months ended September 30, 2023, to $72,422 for the three months ended September 30, 2024[170] Stockholder Equity and Liabilities - Total liabilities and stockholders' deficit increased to $1,143,269 as of September 30, 2024, from $509,498 at the end of 2023[6] - The accumulated deficit as of September 30, 2023, was $(46,965,813), reflecting ongoing financial challenges[7] - The total stockholders' deficit as of September 30, 2023, was $(1,061,087), indicating a deterioration in financial position[7] - As of September 30, 2024, the Company had a stockholders' deficit of $1,793,932 and a working capital deficit of $2,032,284[60] - The total liabilities as of September 30, 2024, were $55,351,706, reflecting ongoing financial obligations[20] Capital Management - The company completed an IPO on August 9, 2023, raising gross proceeds of $6,592,002 from the sale of 1,098,667 shares at $6.00 per share[25] - The company entered into a $5,000,000 investment agreement with a life sciences fund, replacing a $3,200,000 reduction in committed funding from an existing investor[154] - The company issued common stock from agreements totaling 798,929 shares, reflecting an increase in capital[15] - The company issued 1,260,504 shares of Series B Convertible Preferred Stock for an aggregate purchase price of $3,000,000, with payments commencing on January 10, 2024[73] Operating Expenses - Selling expenses increased by $31,220, or 48.6%, from $64,210 for the three months ended September 30, 2023, to $95,430 for the same period in 2024[169] - General and administrative expenses decreased by $1,270,356, or 38.2%, from $3,323,352 for the three months ended September 30, 2023, to $2,052,996 for the three months ended September 30, 2024[171] - Other expense decreased by $5,499,063, or 98.1%, from $5,603,024 for the three months ended September 30, 2023, to $103,961 for the three months ended September 30, 2024[174] Future Outlook - Management believes that increased sales and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term[63] - The company expects to incur significant expenses and operating losses as it seeks FDA clearance for additional indications of the IB-Stim device[156] - The company anticipates gross profit to increase in the foreseeable future as net sales grow through broader insurer acceptance of the IB-Stim device[161] Shareholder Agreements and Compensation - The total base salaries for nine key employees under employment agreements are $1,920,000 per year, with additional special incentive payments totaling $1,100,000[140] - The company has recorded a backpay amount of $417,390, which was paid in 2023, as part of the special incentive payments[140] - The company anticipates that the special options bonuses of $14,821,830 will be recorded when paid, contingent upon a successful initial public offering[143]

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 ...

CARMEL, Ind., Aug. 13, 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 Blue Cross Blue Shield (BCBS) of Vermont Medical Members, effective 10/1/2024. This medical policy will bring our national total coverage for PENFS ...

Financial Data and Key Metrics - Q2 2024 revenue was $612,000, a 5% decline year-over-year, but an improvement compared to the 20% and 13% declines in Q1 2024 and Q4 2023, respectively [21] - Gross profit for Q2 2024 was $538,000, with a gross margin of 88%, slightly down from 89.5% in Q2 2023 due to growth in the financial assistance program [23] - Operating loss in Q2 2024 was $2.2 million, up from $1.1 million in Q2 2023, driven by lower sales volume, increased payroll, public company costs, and non-recurring expenses [24] - Net loss for Q2 2024 was $2.9 million, compared to $2.2 million in Q2 2023, primarily due to higher general and administrative costs and non-cash settlements [25] - Cash on hand as of June 30, 2024, was $1.8 million, up from $51,000 in June 2023, supported by $4.9 million in financing during the first half of 2024 [25][26] Business Line Data and Key Metrics - IB-Stim revenue trajectory improved significantly from Q1 to Q2 2024, with year-over-year revenue declining by 5% and unit sales increasing by 16% [12] - The company has treated over 850 cases in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [12] - RED (Rectal Expulsion Device) submitted an FDA 510(k) in early August 2024, with commercialization expected in late 2024 [10][18] Market Data and Key Metrics - Written insurance policy coverage for IB-Stim is expected to increase covered lives from $22.5 million to $35.1 million once the policy becomes public [8] - Approximately 15 payers are in the review process, and the company expects to exceed $50 million covered lives by the end of 2024 [9] - The company has secured written confirmation from one of the nation's largest not-for-profit health plans, covering 12.6 million members, with policy expected to take effect around October 1, 2024 [8] Company Strategy and Industry Competition - The company's strategy focuses on leveraging strong peer-reviewed publications and academic society support to drive insurance coverage and revenue growth [14] - The submission for a Category 1 CPT code for IB-Stim and the FDA label expansion to include patients aged 8 to 21 are key initiatives to increase market access [9] - RED is expected to become a significant revenue driver, with a Category 1 CPT billing code already in place, enabling immediate reimbursement upon commercialization [18] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about revenue growth in the second half of 2024 and into 2025, driven by increased insurance coverage and the commercialization of RED [20] - The company expects to reach profitability in Q1 2025, supported by strong gross margins and the anticipated ramp-up in IB-Stim and RED revenues [20][31] - The systematic review by NASPGHAN, showing the highest grade certainty level for IB-Stim, is expected to expedite insurance policy coverage and revenue growth [6][9] Other Important Information - The company has closed necessary financing with reputable healthcare funds, ensuring liquidity to reach profitability [11] - The internal prior authorization team, launched in 2023, has been successful in increasing access to care for pediatric patients [16] - The company has submitted an application for a Category 1 CPT code for IB-Stim, which is expected to streamline billing and reimbursement processes [16] Q&A Session Summary Question: Operating expenses and breakeven timeline - Operating expenses averaged $2.5 million per quarter, with $625,000 in non-recurring costs in Q2 2024. The company expects to reach profitability by Q1 2025 [31][32] - Cash burn is estimated at $400,000 to $500,000 per month, with $1.8 million cash on hand and $4.2 million in upcoming financing, providing a 12-month runway [33][34] Question: Feedback from doctors and patients using IB-Stim - Pediatric gastroenterologists have expressed strong support for IB-Stim, citing its efficacy and evidence base. Patient feedback has been overwhelmingly positive, with many families reporting life-changing results [35][36] Question: Timeline and revenue potential for RED - RED is expected to launch in late 2024, with a Category 1 CPT billing code already in place. Revenue predictions are not yet shared, but the product is anticipated to be a significant revenue driver [37] Question: Relationships with investors and potential future financing - The company has strong relationships with healthcare-focused investors and is cautiously optimistic about not needing additional financing before reaching profitability [34][35]

Carmel, Ind., Aug. 09, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the second quarter period ended June 30, 2024. Recent Operational Highlights Expanded total covered lives to approximately 22.5 million covered lives compared to 4.5 million covered lives as of May 1, 2023. Recent medical policy cov ...

CARMEL, Ind., June 07, 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 a submission to the FDA for expansion of its IB-Stim label. The new submission is significant as it would allow access to a larger patient population beyond 11-18 years of age and allow for marketing of 4 devices per prescription. Manage ...