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 ...

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. Compli ...

Financial Data and Key Metrics - Q1 2024 revenue was $647,000, down 19.7% YoY from $805,000 in Q1 2023, primarily due to fewer shipments from certain customers managing through the insurance reimbursement process [35] - Gross profit for Q1 2024 was $572,000, with a gross margin of 88.4%, slightly up from 88.1% in Q1 2023 [36] - Net loss in Q1 2024 was $2.1 million, a 2.4% improvement from $2.2 million in Q1 2023, driven by the absence of debt-related costs and higher general and administrative expenses [37] - Operating loss for Q1 2024 was $1.8 million, compared to $896,000 in Q1 2023, due to lower sales volume, increased payroll, and higher public company costs [29] Business Line Data and Key Metrics - 888 IB-Stim devices were shipped in Q1 2024, treating 222 children, with 49% of sales through purchase orders (insurance-covered) and 51% through patient financial assistance programs [1] - The GPS program assisted 231 patients in Q1 2024, a 40% YoY increase, with prior authorization services launched in May 2023 serving 191 patients through Q1 2024 [2] - To date, approximately 2,900 children have been treated with IB-Stim, with a penetration rate of 0.14% in 2023 and less than 0.25% of the total addressable market in Q1 2024 [6] Market Data and Key Metrics - Covered lives for IB-Stim reached 22.5 million, a 400% YoY increase, with expectations to expand significantly by the end of 2024 [4][5] - The first state Medicaid office has written policy for PENFS, and a Blue Cross Blue Shield licensee in Florida with 6 million covered lives was approved, contributing to the 22.5 million total [8] - The company has achieved 7% of national covered lives, with policies recently taking effect, and expects a revenue ramp as more policies become effective [20] Company Strategy and Industry Competition - The company's top priority is increasing insurance coverage for PENFS, leveraging strong peer-reviewed publications and support from academic societies like NASPGHAN and the American Academy of Pediatrics [3][7] - The commercialization of RED (Rectal Expulsion Device) is on track for FDA submission in late Q2 2024, with potential market entry by the end of 2024, offering a significant opportunity in the adult market [20][21] - The company is focused on obtaining a permanent Category 1 CPT billing code for IB-Stim, which is critical for streamlining billing processes and increasing access to care [13] Management Commentary on Operating Environment and Future Outlook - Management expects revenue growth to accelerate in the latter half of 2024 and into 2025, driven by expanded insurance coverage and the commercialization of RED [17][22] - The company is optimistic about achieving profitability by 2025, supported by strong gross margins and increasing sales volume [26] - The biggest challenge is the speed of gaining national insurance policy coverage, with a 90-120 day lag between policy coverage and hospital purchasing [18][20] Other Important Information - The company secured $6.1 million in financial commitments through convertible notes, with $1.5 million funded in Q1 2024, strengthening its liquidity position [27][38] - A national multi-site registry of 292 patients showed sustained benefits of PENFS up to 12 months post-treatment, supporting its move toward becoming a standard of care [8] - The company launched its Centers of Excellence program, with the first center at Children's Hospital of Orange County, which has treated 700 patients with IB-Stim [14][15] Summary of Q&A Session Question: Capital allocation plans for 2024 and 2025 - The company plans to allocate capital to areas with positive PENFS policy coverage, educate families and physicians, leverage data for more policy coverage, and invest in RED technology [48] Question: Path to profitability - The company believes it has enough patient demand to achieve profitability, with the key challenge being the speed of gaining national insurance coverage [49][50] Question: Challenges in gaining written policy coverage - The primary challenge is the speed of getting policy coverage in place, as the data is already published and the company is awaiting payer announcements [52] Question: Plans to increase visibility among the investment community - The company is conducting weekly investor meetings, outsourcing investor relations, and participating in monthly conferences to drive interest in the stock [53] Question: Concerns about Q1 revenue decline - The company is not concerned about the Q1 revenue decline, attributing it to short-term insurance issues and expecting revenue growth as policy coverage expands [54]

CARMEL, Ind., May 21, 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 Spring 2024 Investor Conference, taking place virtually on Thursday, May 30, 2024. Company Webcast The webcasted presentation will take place ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission file number 001-41775 NEURAXIS, INC. (Exact name of registrant as specified in its charter) (812) 689-0791 (Re ...

Following today's filing of a Form 12b-25 with the SEC, the Company expects to file its Form 10-Q on Monday, May 20, 2024. Conference Call Details Date and Time: Wednesday, May 22, 2024, at 9:00am ET Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company's website at https://edge.media- server.com/mmc/p/jbecdhzi or https://ir.neuraxis.com/. For participants listening through the webcast, questions ca ...

Notified Body certificates of conformity are valid for a fixed duration (which shall not exceed five years). Throughout the term of the certificate, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements. In particular, there will be a new audit by the Notified Body before it will renew the relevant certificate(s). The advertising and promotion of medical devices is subject to some general principles set forth by EU directives. Accord ...