Neuraxis(NRXS)
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Neuraxis(NRXS) - 2024 Q3 - Quarterly Report
2024-11-12 13:05
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 September 30, 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) | --- | --- | ...
NeurAxis Announces New CPT® Category I Code for Percutaneous Electrical Nerve Field Stimulation
GlobeNewswire News Room· 2024-10-22 13:00
CARMEL, Ind., Oct. 22, 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, announced that the American Medical Association (AMA) has established a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures effective January 1, 2026. NeurAxis’ PENFS technology ...
Zacks Initiates Coverage of NeurAxis With Neutral Recommendation
ZACKS· 2024-09-25 15:50
Zacks Investment Research has recently initiated coverage of NeurAxis, Inc. (NRXS) , assigning a "Neutral" recommendation to the company's shares. This assessment comes amid a mixed outlook for the company, which has been making notable strides in the neuromodulation therapies space despite industry challenges. NRXS, headquartered in Carmel, IN, specializes in developing neuromodulation therapies to address chronic conditions, particularly in pediatric populations. NeurAxis' flagship product, the IB-Stim, i ...
NeurAxis to Participate in the Lytham Partners Fall 2024 Investor Conference on October 1, 2024
GlobeNewswire News Room· 2024-09-19 13:00
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 ...
NeurAxis Announces Geisinger Health Plan Medical Policy Coverage for PENFS, Effective September 15 2024
GlobeNewswire News Room· 2024-08-27 13:00
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 ...
NeurAxis Announces BCBS of Vermont Medical Policy Coverage for PENFS, effective October 1st 2024
GlobeNewswire News Room· 2024-08-13 13:00
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 ...
Neuraxis(NRXS) - 2024 Q2 - Earnings Call Transcript
2024-08-11 09:44
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]
Neuraxis(NRXS) - 2024 Q2 - Quarterly Report
2024-08-09 12:10
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 June 30, 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) | --- | --- | --- | ...
Neuraxis(NRXS) - 2024 Q2 - Quarterly Results
2024-08-09 12:05
Exhibit 99.1 NeurAxis Reports Second Quarter 2024 Financial Results Conference call will be held today, Friday, August 9 at 9:00 am ET Carmel, Ind., August 9, 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 cover ...
NeurAxis Reports Second Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-08-09 12:00
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 ...