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]

Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].

[PART I](index=4&type=section&id=PART%20I) [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) NeurAxis, Inc.'s unaudited condensed financial statements for Q1 2025 are presented, detailing balance sheets, operations, equity, cash flows, and notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity decreased from December 31, 2024, to March 31, 2025, due to reduced cash and increased accumulated deficit | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :--------------------------- | :------------------ | | Cash and cash equivalents | $2,005,370 | $3,696,870 | | Total current assets | $2,541,026 | $4,266,183 | | Total Assets | $3,029,809 | $4,757,572 | | Total current liabilities | $2,101,203 | $2,433,325 | | Total liabilities | $2,771,330 | $2,689,824 | | Total stockholders' equity | $258,479 | $2,067,748 | | Accumulated deficit | $(59,078,296) | $(56,799,612) | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) Q1 2025 net sales and gross profit increased, but operating and net losses rose due to higher general and administrative, and R&D expenses | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------ | :-------------------------------- | :-------------------------------- | | Net Sales | $895,655 | $646,635 | | Cost of Goods Sold | $139,475 | $75,081 | | Gross Profit | $756,180 | $571,554 | | Selling Expenses | $133,954 | $80,030 | | Research and Development | $60,556 | $5,570 | | General and Administrative | $2,856,768 | $2,318,074 | | Operating Loss | $(2,295,098) | $(1,832,120) | | Total other income (expense), net | $16,414 | $(288,531) | | Net loss | $(2,278,684) | $(2,120,651) | | Preferred stock dividends | $(213,543) | — | | Net loss available to common stockholders | $(2,492,227) | $(2,120,651) | | Basic and diluted loss per share | $(0.33) | $(0.32) | [Condensed Statements of Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity significantly decreased from **$2,067,748** to **$258,479** in Q1 2025, due to net loss and restricted stock awards | Metric | Balances at January 1, 2025 | Balances at March 31, 2025 | | :----------------------------------- | :-------------------------- | :------------------------- | | Convertible Series B Preferred Stock | $4,281 | $4,281 | | Common Stock | $6,990 | $7,216 | | Additional Paid In Capital | $58,856,089 | $59,325,278 | | Accumulated Deficit | $(56,799,612) | $(59,078,296) | | Total Stockholder's Equity | $2,067,748 | $258,479 | - Issuance of restricted stock awards contributed **$356,922** to additional paid-in capital during the three months ended March 31, 2025[11](index=11&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash and cash equivalents decreased in Q1 2025, driven by increased cash used in operations and significantly reduced cash from financing activities | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(1,603,655) | $(1,332,160) | | Net cash used in investing activities | $(18,000) | $(14,722) | | Net cash (used in) provided by financing activities | $(69,845) | $1,350,074 | | Net (Decrease) Increase in Cash and Cash Equivalents | $(1,691,500) | $3,192 | | Cash and Cash Equivalents at End of Period | $2,005,370 | $81,752 | - The decrease in financing activities cash flow is primarily due to the absence of convertible note issuances in 2025 that occurred in 2024[140](index=140&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) These notes provide essential context for the condensed financial statements, detailing operations, accounting policies, related party transactions, debt, equity, commitments, and litigation [1. Basis of Presentation, Organization and Other Matters](index=9&type=section&id=1.%20Basis%20of%20Presentation,%20Organization%20and%20Other%20Matters) NeurAxis, Inc. specializes in medical neuromodulation devices, with four FDA-cleared products, and financial statements prepared under U.S. GAAP for interim reporting - NeurAxis, Inc. develops, produces, and sells medical neuromodulation devices[14](index=14&type=chunk) - Key FDA-cleared products include IB-STIM (for functional abdominal pain in ages 8-21), Rectal Expulsion Device (RED) (for adult chronic constipation), and NSS-2 Bridge (licensed to Masimo Corporation for opioid withdrawal symptoms)[14](index=14&type=chunk)[16](index=16&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines critical accounting policies and estimates, including revenue recognition, fair value measurements, stock-based compensation, and the company's going concern assessment - Management makes estimates for revenue recognition, allowance for credit losses, stock-based compensation, income tax provisions, inventory reserves, and impairment of assets[20](index=20&type=chunk) - The allowance for credit losses on accounts receivable remained at **$5,000** as of March 31, 2025, with no credit losses recorded in Q1 2025, compared to **$13,634** in Q1 2024[21](index=21&type=chunk) - Inventories are valued at the lower of cost or net realizable value using the weighted average method, with reserves totaling **$4,454** as of March 31, 2025, and December 31, 2024[22](index=22&type=chunk) - The company's Level 3 financial instruments include warrant liabilities, valued using model-based techniques with unobservable inputs[27](index=27&type=chunk) - Basic and diluted loss per share was **$(0.33)** for Q1 2025, compared to **$(0.32)** for Q1 2024, with common stock equivalents excluded due to anti-dilutive effect[30](index=30&type=chunk) - Stock-based compensation expense for RSUs was **$105,811** in Q1 2025, down from **$227,000** in Q1 2024, with unrecognized expense for unvested awards totaling **$1,654,312** as of March 31, 2025[87](index=87&type=chunk) - Revenue is recognized when customers obtain control of promised goods, typically at the point of receipt, with estimated returns of **$6,587** as of March 31, 2025[35](index=35&type=chunk)[39](index=39&type=chunk)[41](index=41&type=chunk) - Management has identified substantial doubt about the Company's ability to continue as a going concern due to accumulated losses and negative cash flows, with future profitability dependent on securing widespread insurance coverage and additional funding[46](index=46&type=chunk)[50](index=50&type=chunk) [3. Related Party Transactions](index=16&type=section&id=3.%20Related%20Party%20Transactions) Related party transactions include demand notes receivable from shareholders, a royalty-free license, IB-STIM sales to a board member, and accounting services from a former CFO's firm | Related Party Transaction | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Shareholder Notes Receivable (Net) | $0 | $0 | | License Costs | $1,317 | $0 | | IB-STIM Sales to Director | $1,957 | $0 | | Accounting/Tax Services | $21,871

Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the first quarter of 2025 on May 12, 2025, before market open, followed by a conference call to discuss the results [1]. Financial Results Announcement - The financial results will cover the period ended March 31, 2025 [1]. - A conference call is scheduled for May 12, 2025, at 9:00 a.m. Eastern Time to review the results [1]. Conference Call Details - Interested parties can access the conference call via a live webcast available on the Company's Investor Relations website [2]. - Participants can submit questions through the webcast portal or via email [2]. - Call-in participants must register to receive dial-in information and a unique PIN [3]. Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4]. - 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 [4]. - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4].

Core Viewpoint - NeurAxis, Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on neuromodulation therapies for chronic conditions in both children and adults [1][2]. Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies to treat chronic and debilitating conditions [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 8-21 [3]. - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions with significant unmet healthcare needs [3]. Event Details - The presentation will take place on April 23, 2025, at 11:00 AM EST during the Planet MicroCap Showcase: VEGAS 2025 [1][2]. - Investors interested in one-on-one meetings with NeurAxis can register for the event, which will be held at the Paris Hotel & Casino in Las Vegas, NV [2].

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 8-21 [3] Upcoming Presentation - NeurAxis will present at the Planet MicroCap Showcase: VEGAS 2025 on April 23, 2025, at 11:00 AM EST, with CEO Brian Carico hosting the presentation [1] - The presentation will be accessible via a webcast, and 1x1 investor meetings can be scheduled during the conference at the Paris Hotel & Casino in Las Vegas, NV [2] Clinical Trials and Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions that have significant unmet healthcare needs [3]

Core Insights - NeurAxis, Inc. (NRXS) reported a 43% year-over-year revenue growth in Q4 2024, driven by increased unit sales and stronger adoption of its IB-Stim therapy [2][8] - The company achieved a net loss reduction from $5.3 million in Q4 2023 to $1.5 million in Q4 2024, primarily due to the absence of a significant debt extinguishment charge from its 2023 IPO [3][9] - NeurAxis is targeting cash flow breakeven at annual revenues between $10 million and $12 million, with expectations of continued revenue growth into 2025 [7] Revenue Growth and Margin Stability - Q4 2024 revenues reached $761 thousand, up from $531 thousand in the same quarter last year, with full-year revenues increasing by 9.2% to $2.7 million [2] - Gross margin remained stable at 86.4%, with operating loss slightly reduced to $1.5 million from $1.6 million year-over-year [3][4] - The increase in unit sales was attributed to growing insurance reimbursement and the company's financial assistance program, despite lower average selling prices [4][8] Key Business Metrics - NeurAxis treated over 1,000 pediatric patients in the past year, highlighting the potential for accelerated revenue growth as insurance coverage improves [5] - The company expanded its insurance coverage from 4 million to 51 million covered lives, which is expected to enhance market penetration [6] Management Commentary - CEO Brian Carrico noted that the fourth quarter marked a transformational year for NeurAxis, with key milestones including CPT Category I code approval effective January 2026 [6] - CFO Tim Henrichs indicated that revenue growth momentum has continued into Q1 2025, reinforcing the company's financial targets [7] Guidance and Outlook - NeurAxis did not provide formal financial guidance but expressed confidence in achieving accelerated revenue growth through 2025, particularly with the introduction of the Rectal Expulsion Device (RED) [11] - The company anticipates expanded FDA indications, which could potentially double its pediatric addressable market [11] Other Developments - NeurAxis received FDA 510(k) clearance for RED, a test for diagnosing evacuation disorders, which is expected to accelerate adoption due to existing reimbursement codes [13] - The company also secured FDA clearance to expand the IB-Stim label to a broader age range, significantly increasing market potential [14]

Financial Data and Key Metrics Changes - Revenues in Q4 2024 were $761,000, up 43% compared to $531,000 in Q4 2023 [35] - Revenue for fiscal year 2024 was $2.7 million, an increase of 9% compared to $2.5 million in fiscal year 2023 [36] - Gross margin in Q4 2024 was 86.4%, consistent with Q4 2023 [37] - Net loss for Q4 2024 was $1.5 million, a decrease of 73% compared to $5.3 million in Q4 2023 [42] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 and 43% in Q4 for IB-Stim revenue [11] - Unit sales increased approximately 45% in Q4 2024 due to growth from patients with undiscounted insurance reimbursement [35] - The number of treated cases increased to over 1,000 in the last 12 months, representing just over 0.1% of the 600,000 children in the U.S. suffering from IBS [24] Market Data and Key Metrics Changes - Covered lives increased from 4 million on January 1 of the previous year to approximately 51 million today [13] - The expansion of the IB-Stim age indication from 11-18 years to 8-21 years significantly increases the market opportunity [21] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the implementation of a Category 1 CPT code [28] - The commercialization of the RED device is expected to drive significant revenues in the coming quarters [30] - The company aims to transition patients from inadequate or no insurance coverage to full reimbursement, which will enhance future revenues and gross margins [59] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the continued growth in covered lives and the commercialization of RED [33] - The company anticipates that the Category 1 CPT code will streamline prior authorizations and enhance revenue generation [52] - Management believes that strong peer-reviewed publications and key society support will lead to successful insurance coverage [27] Other Important Information - The company held no long-term debt as of December 31, 2024, with cash on hand of $3.7 million [43] - Operating loss in Q4 2024 was $1.5 million, an improvement of 10% compared to the previous year [41] Q&A Session Summary Question: Significance of receiving the Category 1 code and the 510(k) extensions - The Category 1 code is crucial as it allows physicians to receive RVUs for procedures, which is essential for their compensation [50] - The 510(k) extension increases the total addressable market by approximately 75% [54] Question: Variability of gross margins and future expectations - Gross margins are currently in the mid to high 80s, with expectations to increase as more patients transition to insurance coverage [56][59] Question: Early learnings from the RED commercial mode - Feedback from physicians has been positive, with higher than expected usage [64] Question: Revenue needed to achieve breakeven - Breakeven revenues are expected to be in the $10 million to $12 million range based on current cash burn [66] Question: Product manufacturing and tariff exposure - 95% of technology is sourced and manufactured in the U.S., with minimal exposure to tariffs [68] Question: Development timeline for a second-generation IB-Stim device - The second-generation device is expected to be available in 2026, featuring a more modern design [70] Question: Response after a course of IB-Stim treatment - Approximately 70% of patients report significant long-term relief after treatment [76]

Core Viewpoint - NeurAxis, Inc. reported strong financial performance in Q4 2024, highlighting significant growth in revenue and operational achievements, positioning the company for continued expansion in the neuromodulation therapy market [3][4][7]. Financial Highlights - Revenues in Q4 2024 increased by 43% to $761 thousand compared to $531 thousand in Q4 2023 [7][8]. - For the fiscal year 2024, total revenue was $2.7 million, a 9% increase from $2.5 million in fiscal year 2023 [9]. - The gross margin for Q4 2024 remained steady at 86.4%, while the fiscal year 2024 gross margin was 86.5%, down from 87.7% in fiscal year 2023 [10][11]. Operational Highlights - The company expanded insurance coverage to approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [4][7]. - NeurAxis received a new CPT Category I code for PENFS procedures effective January 1, 2026, and FDA clearance for its RED device [7][8]. - Over the past year, more than 1,000 pediatric patients were treated, representing just over 0.1% of the 600,000 children in the U.S. suffering from debilitating IBS [4]. Management Commentary - The CEO emphasized the company's strong performance and growth prospects, driven by expanded insurance coverage and disciplined cost management [3]. - The company is optimistic about upcoming academic society guidelines that are expected to enhance insurance policy coverage for treatments [5]. Expenses and Losses - Selling, general, and administrative expenses in Q4 2024 were $2.1 million, a 2% increase from $2.0 million in Q4 2023 [12]. - The operating loss for Q4 2024 was $1.5 million, an improvement of 10% compared to $1.6 million in Q4 2023 [14]. - The net loss for the full year 2024 was $8.2 million, a decrease of 44% compared to $14.6 million in 2023 [16].

Regulatory Compliance - The FDA's 510(k) premarket notification process can be resource-intensive, expensive, and lengthy, impacting the time to market for new medical devices [106]. - Class II medical devices are required to submit a premarket notification under Section 510(k) to request permission for commercial distribution [109]. - The FDA's performance goal for reviewing a 510(k) submission is 90 days, but clearance often takes longer due to additional information requests [121]. - The FDA may require clinical data for 510(k) submissions, which can significantly prolong the review process [121]. - The company may face significant regulatory fines or penalties if modifications to devices require new 510(k) clearance or PMA approval [124]. - Recent FDA proposals could increase requirements for clinical data and extend review periods for the 510(k) clearance process [125]. - The FDA has introduced a "safety and performance based" premarket review pathway for certain well-understood device types, potentially simplifying the clearance process [126]. - The PMA approval process for Class III devices requires extensive data from preclinical studies and human clinical trials, with a standard application fee of $365,657 for fiscal year 2021 [127]. - FDA review of a PMA application generally takes between one and three years, but can extend significantly longer due to various factors [131]. - If the FDA's evaluation is favorable, it may issue an approval letter or an approvable letter, which may include conditions for final approval [129]. - Manufacturers must comply with ongoing regulatory requirements even after receiving FDA approval, including modifications that could affect safety or effectiveness [132]. - The FDA has broad regulatory compliance and enforcement powers, which can result in sanctions such as recalls, fines, or production shutdowns for non-compliance [136]. - In the EU, medical devices must meet essential requirements and undergo a conformity assessment procedure, typically involving a Notified Body [139]. - The EU Medical Devices Regulation, effective May 25, 2017, aims to establish a uniform regulatory framework across EU member states [145]. - Manufacturers must report incidents that may lead to serious health risks and take corrective actions, including recalls or modifications [142]. - Compliance with the EU medical device vigilance system is mandatory, requiring manufacturers to report incidents and take necessary corrective actions [142]. - The Medical Devices Regulation transition period was extended until May 26, 2021, with devices placed on the market before this date allowed until May 26, 2025 [146]. - The EU-UK Trade and Cooperation Agreement does not specifically address medical devices, and the UK will implement its own regulatory regime post-Brexit, with UKCA marking becoming mandatory after June 30, 2023 [148]. Financial and Reimbursement Issues - The company plans to provide only two years of audited financial statements and unaudited condensed financial statements for interim periods in its prospectus [105]. - The company’s products are not separately reimbursed by third-party payors in the U.S., and reimbursement policies vary significantly among payors [156]. - Third-party payors are increasingly auditing prices for medical products, which may impact demand for the company's products [157]. - The Affordable Care Act has significantly changed healthcare financing and delivery, affecting medical device manufacturers [163]. Legal and Data Protection - The U.S. federal Anti-Kickback Statute prohibits remuneration to induce purchases of goods or services reimbursable under federal healthcare programs, with broad interpretations of "remuneration" [150]. - The federal False Claims Act prohibits presenting false claims for payment to the federal government, with violations potentially leading to civil actions and penalties [151]. - The GDPR imposes strict requirements for processing personal data, with potential fines for noncompliance reaching up to €20 million or 4% of annual global revenues [168]. - The invalidation of the Privacy Shield in July 2020 has created uncertainty regarding data transfer mechanisms between the EU and the U.S. [169]. Manufacturing and Operations - The Company entered into a Manufacturing Services Agreement with GMI Corporation for the manufacture and supply of the IB-STIM device, with an initial term of 24 months [173]. - GMI's facility is 69,000 square feet, with approximately 1,000 square feet dedicated to producing the IB-STIM device, located in Indiana [175]. - GMI has a quality management system that is ISO 13485:2016 certified, FDA registered, and ITAR registered [177]. - As of December 31, 2024, the Company had 21 full-time employees [178]. - GMI has sufficient kit production capacity for all projected needs, supported by a new environmentally controlled build room established in 2022 [176].