Core Viewpoint - Milestone Scientific Inc. is experiencing increased adoption of its CompuFlo® Epidural System, driven by favorable Medicare payment rates and a focus on expanding its presence in federal healthcare settings [2][3]. Business Update - The company reported a slight revenue decrease to approximately $2.2 million for the first quarter ended March 31, 2025, compared to the same period in 2024 [3]. - Medical revenue saw a significant increase to approximately $51,000 in Q1 2025 from $7,400 in Q1 2024, indicating growing traction for the CompuFlo technology [3]. - The company is actively engaging with Jurisdictional Medicare Administrative Contractors (JMACs) to expand its reimbursement framework, which is seen as a critical catalyst for adoption [2]. Financial Performance - Gross profit for Q1 2025 was $1.6 million, representing 74% of revenue, slightly down from 75% in Q1 2024 [4]. - The operating loss increased to approximately $(2.0) million in Q1 2025 from $(1.5) million in Q1 2024 [4]. - The net loss for Q1 2025 was approximately $(2.0) million, or $(0.02) per share, compared to a net loss of $(1.4) million, or $(0.02) per share, in Q1 2024 [5]. Strategic Initiatives - The company has secured a contract under the Federal Supply Schedule (FSS) to facilitate access to CompuFlo in federal healthcare settings, including the Department of Veterans Affairs and the Department of Defense [2]. - Milestone Scientific has maintained stable performance in its dental business while exercising financial discipline, including delaying non-essential R&D [2]. - The company secured $800,000 in convertible financing from board members, indicating strong confidence in its growth trajectory [2].

Part I [Item 1. Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Milestone Scientific reported **$9.1 million** total assets, a **$2.0 million** net loss, and **$1.0 million** cash used in operations for Q1 2025, with going concern risk noted [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$9.1 million**, liabilities increased to **$4.6 million**, and stockholders' equity decreased to **$4.5 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,246,387 | $3,258,058 | | Total current assets | $8,624,926 | $9,286,554 | | **Total assets** | **$9,088,016** | **$9,797,072** | | Total current liabilities | $4,443,633 | $3,744,127 | | **Total liabilities** | **$4,625,564** | **$3,964,372** | | **Total stockholders' equity** | **$4,462,452** | **$5,832,700** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 product sales were flat at **$2.2 million**, but increased operating expenses led to a wider net loss of **$2.0 million** compared to **$1.4 million** in Q1 2024 Condensed Consolidated Statements of Operations (Unaudited) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product sales, net | $2,232,420 | $2,248,845 | | Gross profit | $1,647,435 | $1,676,103 | | Total operating expenses | $3,645,288 | $3,141,171 | | Loss from operations | $(1,997,853) | $(1,465,068) | | **Net loss** | **$(1,994,586)** | **$(1,440,529)** | | Net loss per share | $(0.02) | $(0.02) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 saw **$1.0 million** cash used in operations, an improvement from Q1 2024, with minimal investing/financing activities, resulting in cash decreasing to **$2.2 million** Summary of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,008,089) | $(1,218,128) | | Net cash (used in) provided by investing activities | $(1,304) | $2,004,463 | | Net cash (used in) provided by financing activities | $(2,278) | $241,429 | | **Net (decrease) increase in cash** | **$(1,011,671)** | **$1,027,764** | | **Cash and cash equivalents at end of period** | **$2,246,387** | **$4,005,477** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose a going concern warning due to **$130.0 million** accumulated losses, mitigated by cost-cutting and recent financing, with Dental segment profitable and Medical segment losing - The company has incurred total losses of **$130.0 million** since inception and had an operating loss of approximately **$2.0 million** for Q1 2025, raising substantial doubt about its ability to continue as a going concern[20](index=20&type=chunk) - Management's plans to alleviate the going concern doubt include increasing revenues, decreasing professional fees, delaying R&D on the next-generation STA system, and securing **$800,000** in related-party note financing in April 2025[21](index=21&type=chunk) Segment Operating Performance - Q1 2025 vs Q1 2024 | Segment | Product Sales, Net (Q1 2025) | Operating Income (Loss) (Q1 2025) | Product Sales, Net (Q1 2024) | Operating Income (Loss) (Q1 2024) | | :--- | :--- | :--- | :--- | :--- | | Dental | $2,181,170 | $179,354 | $2,241,425 | $625,510 | | Medical | $51,250 | $(421,250) | $7,420 | $(500,857) | | Corporate | - | $(1,755,957) | - | $(1,589,721) | - In April 2025, the company issued **$800,000** in promissory notes to three company directors to provide financing, with notes due in 2028 and convertible into common stock[77](index=77&type=chunk)[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 flat revenues at **$2.2 million**, net loss widening to **$2.0 million** due to increased SG&A and R&D, reiterating going concern risk and mitigation plans [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2025 consolidated revenue was flat at **$2.2 million**, gross profit marginally decreased, while SG&A and R&D expenses significantly rose, leading to a **$2.0 million** operating loss Sales by Segment (Q1 2025 vs Q1 2024) | Segment | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Dental | $2,181,170 | $2,241,425 | $(60,255) | | Medical | $51,250 | $7,420 | $43,830 | | **Total sales, net** | **$2,232,420** | **$2,248,845** | **$(16,425)** | - SG&A expenses increased by approximately **$221,000**, primarily due to a **$368,000** rise in professional fees, warehousing, and travel expenses, partially offset by an **$81,000** decrease in salaries and benefits[100](index=100&type=chunk) - R&D expenses increased by approximately **$275,000**, mainly related to the development of the next-generation STA Single Tooth Anesthesia System, a project since delayed[101](index=101&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is strained, with cash decreasing to **$2.2 million** in Q1 2025, and **$130.0 million** accumulated losses raising going concern doubt, which management plans to mitigate via revenue growth, cost reduction, and recent financing Cash Flow Summary (Q1 2025 vs Q1 2024) | Cash Flow Activity | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,008,089) | $(1,218,128) | | Net cash (used in) provided by investing activities | $(1,304) | $2,004,463 | | Net cash (used in) provided by financing activities | $(2,278) | $241,429 | - The company's ability to continue as a going concern is in substantial doubt due to accumulated losses and negative operating cash flows, with cash at approximately **$2.2 million** and working capital of **$4.2 million** as of March 31, 2025[107](index=107&type=chunk) - Management believes that existing cash, combined with plans to increase revenue, decrease fees, and the **$800,000** in related-party financing from April 2025, will be sufficient to fund operations for the next twelve months[108](index=108&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," Milestone Scientific is not required to provide information regarding quantitative and qualitative disclosures about market risk[110](index=110&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[112](index=112&type=chunk) - No changes were made to the internal control over financial reporting during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, these controls[113](index=113&type=chunk) Part II [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces material risks from changes in U.S. tariff and import/export regulations, particularly due to sourcing from China, and government actions impacting costs and R&D - The company faces risks from potential changes in U.S. trade policies, treaties, and tariffs, which could have a material adverse effect on business as it sources important product elements from China[115](index=115&type=chunk) - Government actions, including tariffs and reductions in research grants, could increase business costs, impede research and development activities with collaborative partners, and make raising capital more challenging[116](index=116&type=chunk) [Other Items](index=26&type=section&id=Other%20Items) This section confirms no unresolved staff comments, cybersecurity incidents, unregistered equity sales, senior security defaults, or other material disclosures for the period - The company reports no unresolved staff comments (Item 1B), no cybersecurity incidents (Item 1C), and states that items concerning unregistered sales of equity securities (Item 2), defaults upon senior securities (Item 3), mine safety disclosures (Item 4), and other information (Item 5) are not applicable[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and Chief Accounting Officer certifications and Inline XBRL financial data files - The exhibits filed with this report include certifications from the Chief Executive Officer and Chief Accounting Officer, along with Inline XBRL instance and taxonomy documents[123](index=123&type=chunk)

Core Insights - Milestone Scientific Inc. is focusing on expanding its CompuFlo® Epidural System in the U.S. following favorable Medicare pricing assignments, which significantly broaden the addressable market for the technology [3][4] - The company reported a decrease in total revenue for 2024, amounting to approximately $8.6 million, down from $9.8 million in 2023, while e-commerce revenue showed growth [4][6] - The company is optimistic about its future growth prospects in both the dental and medical segments, with positive initial performance in Q1 2025 [3][7] Business Update - The company has established reimbursement infrastructure for the CompuFlo® Epidural System, with Medicare Part B payment rates assigned in multiple states, enhancing market access [3] - A contract for the Federal Supply Schedule (FSS) has been awarded, allowing federal medical facilities to purchase the CompuFlo system, targeting adoption within the U.S. Department of Veterans Affairs and other federal healthcare systems [3] - Strong commercial traction is noted in the private sector, with new rollouts at various pain management clinics and ambulatory surgery centers [3] Financial Performance - Revenue for 2024 was approximately $8.6 million, a decrease of about $1.2 million from 2023 [4] - E-commerce revenue reached approximately $5.1 million in 2024, compared to $4.8 million in 2023, indicating growth in this segment [4] - The company recorded an operating loss of $6.8 million in 2024, an improvement from a loss of $7.1 million in 2023, driven by higher-margin e-commerce sales [7] Market Position - The STA Single Tooth Anesthesia System remains a leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date [3] - The company is leveraging its leadership in the dental segment through an expanded direct-to-consumer e-commerce platform, which is enhancing margins and customer engagement [3] - The clinical response to the CompuFlo system has been positive, positioning the company to capitalize on growth opportunities in the medical field [3][7]

Core Insights - Milestone Scientific Inc. is expanding the adoption of its CompuFlo® Epidural System in pain management clinics and ambulatory surgery centers following favorable Medicare pricing assignments in multiple U.S. states [1][2] - The company reported a decrease in total revenue for 2024, amounting to approximately $8.6 million, down from $9.8 million in 2023, while e-commerce revenue showed growth [3][4] - The company is optimistic about its future growth prospects in both the dental and medical segments, with positive initial performance in Q1 2025 [2][6] Business Update - The company has established a reimbursement infrastructure for the CompuFlo® Epidural System, with favorable Medicare Part B payment rates assigned by First Coast Service Options and Novitas Solutions [2] - The Medicare pricing decisions have expanded the addressable market significantly, and the company is pursuing further reimbursement approvals to enhance national expansion [2] - A contract for the Federal Supply Schedule has been awarded, allowing federal medical facilities to purchase the CompuFlo system, targeting adoption within the U.S. Department of Veterans Affairs and other federal healthcare systems [2] Financial Performance - Total revenue for 2024 was approximately $8.6 million, a decrease of about $1.2 million from 2023 [3] - E-commerce revenue reached approximately $5.1 million in 2024, compared to $4.8 million in 2023, indicating growth in this segment [3] - The company recorded an operating loss of $6.8 million in 2024, an improvement from a loss of $7.1 million in 2023, driven by higher-margin e-commerce sales [6] Market Position - The STA Single Tooth Anesthesia System remains a leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date [2] - The company is seeing strong commercial traction in the private sector, with new rollouts at various pain management clinics and ambulatory surgery centers [2] - The strategic partnership with Axial Biologics is enhancing the distribution footprint in key U.S. markets [2]

Part I [Business](index=4&type=section&id=Item%201.%20Business) Milestone Scientific is a biomedical technology company commercializing its proprietary computer-controlled anesthetic delivery platform for dental and medical markets [Overview and Technology](index=4&type=section&id=Overview%20and%20Technology) Milestone Scientific's core is its proprietary DPS Dynamic Pressure Sensing Technology®, a computer-controlled system for subcutaneous drug delivery - The company's core technology is the proprietary DPS Dynamic Pressure Sensing Technology® System, which regulates flow rate and monitors pressure from the needle tip for various subcutaneous drug delivery injections[8](index=8&type=chunk) - The technology provides visual and audible in-tissue pressure feedback, allowing healthcare providers to identify tissue types and prevent injections outside the intended target area, which is crucial for toxic substances like chemotherapeutics[12](index=12&type=chunk) - The system is designed to increase safety and efficacy compared to the 160-year-old hypodermic syringe by controlling pressure and flow rate, thus minimizing pain and tissue damage[14](index=14&type=chunk)[15](index=15&type=chunk) [Products](index=5&type=section&id=Products) The company markets two main product lines based on its core technology: the Wand/STA dental system and the CompuFlo® Epidural System - The Wand/STA dental system has been used to deliver over **95 million injections** and is viewed favorably in numerous clinical studies[18](index=18&type=chunk) - The CompuFlo® Epidural System received expanded 510(k) FDA clearance for use in the thoracic region of the spine, adding to its previous approval for the lumbar region[21](index=21&type=chunk) - A technology-specific CPT code (CPT0777T) became effective on January 1, 2023, allowing clinicians to submit claims for reimbursement when using the CompuFlo Epidural System, which is expected to accelerate its commercial rollout in the U.S[20](index=20&type=chunk) - The company has secured regulatory approval to market and sell the CompuFlo® Epidural System in Brazil and has established favorable Medicare Part B physician price assignments in Florida and other states[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) [Patents, Manufacturing, and Distribution](index=6&type=section&id=Patents%2C%20Manufacturing%2C%20and%20Distribution) Milestone Scientific protects its technology with approximately 317 U.S. and foreign patents and relies on third-party manufacturers and a mix of direct and distributor sales - The company holds approximately **317 U.S. and foreign patents** and **21 registered trademarks** to protect its intellectual property[28](index=28&type=chunk) - Manufacturing is outsourced via informal arrangements, with the Wand/STA System made in the U.S. and dental handpieces manufactured in the People's Republic of China[31](index=31&type=chunk)[32](index=32&type=chunk) - In the U.S., dental products are sold directly to end-users through an online e-commerce portal, while medical products are sold through a small direct sales team and a distributor partnership[36](index=36&type=chunk)[38](index=38&type=chunk) [Competition and Regulation](index=8&type=section&id=Competition%20and%20Regulation) Milestone Scientific competes with other computer-controlled local anesthesia delivery systems and traditional syringes, and its products are subject to extensive FDA regulation - Key competitors in the dental market include C-CLAD systems like Quicksleeper, SleeperOne, Dentapen, and Calajet, in addition to traditional syringes[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - In the medical market for epidural space identification, competitors include the EpiFaith Syringe and the Epidrum[45](index=45&type=chunk) - The company's products are subject to extensive FDA regulation, requiring 510(k) pre-market notification clearance before commercial distribution in the U.S. and adherence to Quality System Regulation (QSR) standards[48](index=48&type=chunk)[49](index=49&type=chunk)[55](index=55&type=chunk) [Risk Factors](index=11&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and regulatory risks, including a history of losses, reliance on third-party manufacturers, and market acceptance challenges [Financial and Capital Risks](index=11&type=section&id=Financial%20and%20Capital%20Risks) Milestone Scientific has a history of significant operating losses and requires additional capital to fund its operations and commercialization efforts - The company has a history of significant operating losses, with losses of **$6.8 million in 2024** and **$7.1 million in 2023**, and these losses are expected to continue[59](index=59&type=chunk) - Future viability is dependent on the ability to raise additional capital, and failure to do so may force delays or elimination of operations; net cash used in operations was approximately **$2.9 million in 2024** and **$5.3 million in 2023**[61](index=61&type=chunk) - The company holds cash deposits exceeding the **$250,000 FDIC insurance limit**, exposing it to risks related to the financial stability of its banking institution[64](index=64&type=chunk) [Sales, Distribution, and Market Risks](index=12&type=section&id=Sales%2C%20Distribution%2C%20and%20Market%20Risks) The company's sales depend on its e-commerce platform and international markets, while the medical business's success hinges on physician acceptance and reimbursement availability - A significant portion of sales is expected to come from the E-Commerce platform launched in January 2023 for its STA systems and handpieces in the United States[66](index=66&type=chunk) - International sales constituted approximately **40% of total sales in 2024**, exposing the company to risks such as currency fluctuations, tariffs, and political instability[67](index=67&type=chunk) - Market acceptance of the CompuFlo Epidural System by physicians is critical for revenue generation and is dependent on perceptions of safety, cost-effectiveness, and the availability of reimbursement[69](index=69&type=chunk)[71](index=71&type=chunk) [Dependence on Third Parties and Manufacturing Risks](index=14&type=section&id=Dependence%20on%20Third%20Parties%20and%20Manufacturing%20Risks) Milestone Scientific relies exclusively on third-party manufacturers, particularly a sole supplier in China, creating significant supply chain and geopolitical risks - The company relies exclusively on third parties for manufacturing, with informal arrangements on a purchase-order basis, lacking price protection or supply commitments[77](index=77&type=chunk)[78](index=78&type=chunk) - The sole manufacturer of dental handpieces is in the People's Republic of China, exposing the business to risks associated with U.S.-China trade policy, tariffs, and regional instability[78](index=78&type=chunk)[83](index=83&type=chunk) - Establishing new manufacturing relationships would be expensive and time-consuming, as it would require recovering or producing new tools and software[81](index=81&type=chunk) [Regulatory and Legal Risks](index=16&type=section&id=Regulatory%20and%20Legal%20Risks) The company is subject to extensive and ongoing regulation by the FDA and international bodies, as well as healthcare fraud and abuse laws, with non-compliance carrying substantial penalties - The company is subject to substantial government regulation, including FDA's Quality System Regulation requirements, and failure to comply could lead to manufacturing shutdowns, recalls, or other penalties[89](index=89&type=chunk)[90](index=90&type=chunk) - Operations are subject to federal and state healthcare fraud and abuse laws, including the Anti-Kickback Statute and False Claims Act, which can result in substantial penalties and exclusion from federal healthcare programs[91](index=91&type=chunk) - Changes in U.S. trade policy, including tariffs on goods from China, could increase supply chain costs and adversely impact operations[103](index=103&type=chunk) [Stock-Related and Intellectual Property Risks](index=19&type=section&id=Stock-Related%20and%20Intellectual%20Property%20Risks) The company faces risks related to stock control by a limited number of stockholders, stock price volatility, and the protection or infringement of intellectual property rights - Principal stockholders Leonard Osser and BP4, Srl, control approximately **20% of the outstanding common stock**, allowing them to exercise substantial control over corporate actions[107](index=107&type=chunk) - Failure to adequately protect patents and other proprietary rights could materially damage business prospects, as intellectual property rights may be challenged, invalidated, or circumvented[117](index=117&type=chunk)[118](index=118&type=chunk) - The company faces risks of third-party claims that its products infringe on other intellectual property rights, which could result in substantial costs, damages, and injunctions against selling its products[121](index=121&type=chunk)[122](index=122&type=chunk)[124](index=124&type=chunk) [Unresolved Staff Comments](index=22&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments - None[129](index=129&type=chunk) [Cybersecurity](index=23&type=section&id=Item%201C.%20Cybersecurity) The company's Board of Directors, through its audit committee, oversees cybersecurity risk management, with no material incidents reported to date - The board of directors, through the audit committee, has overall oversight responsibility for cybersecurity risks, receiving quarterly reports from management[130](index=130&type=chunk) - The company maintains a cybersecurity program that includes risk assessments, employee training, and partnerships with external security service providers for threat detection[131](index=131&type=chunk)[132](index=132&type=chunk) - The company has not identified any cybersecurity incidents or threats that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[134](index=134&type=chunk) [Description of Property](index=23&type=section&id=Item%202.%20Description%20of%20Property) Milestone Scientific's headquarters is located in a leased facility in New Jersey, and the company does not own any real property - The company's principal executive office is a leased facility in Roseland, New Jersey, with a seven-year lease term that commenced in 2021[135](index=135&type=chunk) - The company does not own any real property and has no policy to invest in real estate[136](index=136&type=chunk) [Legal Proceedings](index=23&type=section&id=Item%203.%20Legal%20Proceedings) The company reports that it is not involved in any material litigation - Milestone Scientific is not involved in any material litigation[137](index=137&type=chunk) [Mine Safety Disclosure](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Not applicable[138](index=138&type=chunk) Part II [Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities](index=24&type=section&id=Item%205.%20Market%20for%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Small%20Business%20Issuer%20Purchases%20of%20Equity%20Securities) Milestone Scientific's common stock is listed on NYSE American, with approximately 97 stockholders, and the company does not anticipate paying dividends Quarterly Stock Price (MLSS) | Period | 2024 High | 2024 Low | 2023 High | 2023 Low | | :--- | :--- | :--- | :--- | :--- | | **First Quarter** | $0.78 | $0.52 | $1.00 | $0.46 | | **Second Quarter** | $0.85 | $0.54 | $1.22 | $0.72 | | **Third Quarter** | $1.10 | $0.58 | $1.35 | $0.81 | | **Fourth Quarter** | $1.05 | $0.60 | $1.00 | $0.56 | - As of March 27, 2024, the company had approximately **97 stockholders of record** and an estimated **3,488 beneficial owners**[141](index=141&type=chunk) - The company has not paid and does not expect to pay any dividends in the foreseeable future[142](index=142&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20or%20Plan%20of%20Operations) Revenue decreased to **$8.6 million** in 2024, but net loss improved to **$4.7 million** due to NOL sale and lower expenses, with management confident in future funding [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Consolidated revenue fell by **$1.2 million** to **$8.6 million** in 2024, primarily due to lower international dental sales, while net loss improved to **$4.7 million** Consolidated Results of Operations (2024 vs. 2023) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Product sales, net** | $8,629,928 | $9,827,444 | | **Gross profit** | $6,434,588 | $6,792,612 | | **Total operating expenses** | $13,191,545 | $13,899,086 | | **Loss from operations** | $(6,756,957) | $(7,106,474) | | **Gain on sale of net operating losses** | $1,983,095 | - | | **Net loss** | $(4,713,597) | $(6,980,947) | Net Sales by Segment (2024 vs. 2023) | Segment | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | **Dental** | $8,527,108 | $9,761,444 | $(1,234,336) | | **Medical** | $102,820 | $66,000 | $36,820 | | **Total sales, net** | **$8,629,928** | **$9,827,444** | **$(1,197,516)** | - The decrease in revenue was primarily due to a **$756,000 drop in international revenue** and a **$270,000 decrease in revenue from China**; U.S. E-commerce revenue grew from **$4.8 million to $5.1 million**[171](index=171&type=chunk)[172](index=172&type=chunk) - Selling, general and administrative (SG&A) expenses decreased by approximately **$840,000**, driven by lower employee salaries, benefits, and marketing expenses[174](index=174&type=chunk) - Research and development expenses increased by approximately **$157,000** due to the development of the next-generation STA system, a project which has since been delayed[176](index=176&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Net cash used in operating activities decreased significantly to **$2.9 million** in 2024, and management believes existing cash and financing will fund operations for the next twelve months Summary of Cash Flows (2024 vs. 2023) | Cash Flow Activity | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | $(2,919,875) | $(5,326,129) | $2,406,254 | | **Net cash provided by (used in) investing activities** | $2,966,449 | $(2,972,172) | $5,938,621 | | **Net cash provided by financing activities** | $233,771 | $2,560,735 | $(2,326,964) | - The decrease in cash used for operations was primarily driven by the receipt of approximately **$2.0 million** from the sale of New Jersey net operating losses (NOLs)[179](index=179&type=chunk) - Management's plans to increase revenues, decrease fees, and delay R&D, combined with existing cash and an **$800,000 related party note financing** in April 2025, are expected to fund operations for the next twelve months[167](index=167&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2024 - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[188](index=188&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[189](index=189&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=33&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20Promoters%20and%20Control%20Persons%20and%20Corporate%20Governance%3B%20Compliance%20with%20Section%2016%20%28a%29%20of%20the%20Exchange%20Act) The company's leadership includes Neal Goldman as Interim CEO, with an independent board and established governance committees, and a code of ethics - Neal Goldman serves as Interim Chief Executive Officer and Chairman of the Board, while Leonard Osser is the Vice Chairman; Arjan Haverhals, the former CEO, remains a director[193](index=193&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - The Board has three independent directors: Michael McGeehan, Benedetta Casamento, and Dr. Didier Demesmin[216](index=216&type=chunk) - The Board has standing Audit, Compensation, and Nominating and Corporate Governance committees, each composed of independent directors; Benedetta Casamento is designated as the audit committee financial expert[208](index=208&type=chunk)[209](index=209&type=chunk)[211](index=211&type=chunk)[210](index=210&type=chunk) [Executive Compensation](index=38&type=section&id=Item%2011.%20Executive%20Compensation) The company's compensation program includes base salary, bonuses, and equity awards, with detailed pay for Named Executive Officers and significant agreements for key personnel Summary Compensation Table (2023-2024) | Name and Principal Position | Year | Salary | Bonuses | Other Compensation | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | **Jan Adriaan (Arjan) Haverhals** | 2024 | $350,000 | $478,000 | $53,422 | $881,422 | | Chief Executive Officer | 2023 | $350,000 | $281,853 | $48,412 | $680,265 | | **Peter Milligan** | 2023 | $70,000 | $100,000 | - | $170,000 | - Leonard Osser has employment and consulting agreements providing for total annual compensation of **$400,000** (**$200,000 cash**, **$200,000 in shares**) for **9.5 years** from May 19, 2021[228](index=228&type=chunk)[229](index=229&type=chunk) - Arjan Haverhals, who retired as CEO on December 31, 2024, entered into a consulting agreement for an annual fee of **$350,000**, effective January 1, 2025[231](index=231&type=chunk) Director Compensation for Fiscal Year 2024 | Name | Stock Awards | Total | | :--- | :--- | :--- | | Neal Goldman | $120,000 | $120,000 | | Benedetta Casamento | $120,000 | $120,000 | | Leonard Osser | $100,000 | $100,000 | | Dr. Didier Demesmin | $100,000 | $100,000 | | Michael McGeehan | $110,000 | $110,000 | | Gian Domenico Trombetta | $100,000 | $100,000 | [Security Ownership of Certain Beneficial Owners and Management](index=42&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Directors and executive officers collectively own **12.00%** of common stock, with BP4 S.R.L. as the largest beneficial owner, and shares available under the 2021 Stock Option Plan Security Ownership of Major Holders (as of March 15, 2025) | Name of Beneficial Owner | Beneficially Owned Shares | Percentage | | :--- | :--- | :--- | | **Leonard Osser** | 5,198,813 | 6.73% | | **All directors & executive officers as group (6 persons)** | 9,264,282 | 12.00% | | **BP4 S.R.L** | 9,672,192 | 12.52% | Equity Compensation Plan Information (as of Dec 31, 2024) | Plan | Securities to be issued upon exercise | Weighted avg. exercise price | Securities remaining for future issuance | | :--- | :--- | :--- | :--- | | **2021 Stock Option Plan** | 3,051,985 | $2.12 | 7,579,778 | [Certain Relationships and Related Transactions](index=43&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company engages in several related party transactions, including purchases from United Systems, royalty and consulting fees, and recent promissory notes issued to directors - The company purchased approximately **$1.7 million** in handpieces from its principal supplier, United Systems, in 2024[243](index=243&type=chunk) - The Director of Clinical Affairs earned approximately **$442,000 in royalty fees** and **$156,000 in consulting fees** during 2024[246](index=246&type=chunk) - In April 2025, the company received **$800,000 in financing** through promissory notes issued to directors Neal Goldman, Benedetta Casamento, and Dr. Didier Demesmin; the notes are due in 2028 and are convertible into common stock[252](index=252&type=chunk) [Principal Accountant Fees and Services](index=45&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Marcum LLP serves as the principal accountant, with all services pre-approved by the Audit Committee, and fees detailed for fiscal years 2024 and 2023 Accountant Fees (Marcum LLP) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | **Audit Fees** | $220,000 | $295,200 | | **Tax Fees** | $33,000 | $42,000 | | **Audit Related Fees** | $0 | $0 | | **All Other Fees** | $0 | $0 | Part IV [Exhibits and Financial Statement Schedules](index=46&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the annual report and serves as an index to the financial statements - This section provides a list of all exhibits filed with the annual report, incorporating by reference documents from previous filings where applicable[259](index=259&type=chunk) Financial Statements and Supplementary Data [Report of Independent Registered Public Accounting Firm](index=50&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Marcum LLP issued a fair opinion on the financial statements, highlighting a critical audit matter regarding the company's going concern ability - The auditor's opinion is that the financial statements are presented fairly in all material respects[270](index=270&type=chunk) - A critical audit matter was identified concerning the company's ability to continue as a going concern due to operating losses and negative cash flows; the audit included evaluating the reasonableness of management's plans to mitigate this risk[276](index=276&type=chunk)[277](index=277&type=chunk) [Consolidated Financial Statements](index=52&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position, performance, and cash flows, showing a net loss of **$4.7 million** on **$8.6 million** revenue in 2024 Consolidated Balance Sheet Data (as of Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Total Current Assets** | $9,286,554 | $10,794,469 | | **Total Assets** | $9,797,072 | $11,371,512 | | **Total Current Liabilities** | $3,744,127 | $3,076,713 | | **Total Liabilities** | $3,964,372 | $3,359,000 | | **Total Stockholders' Equity** | $5,832,700 | $8,012,512 | Consolidated Statement of Operations Data (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Product sales, net** | $8,629,928 | $9,827,444 | | **Gross profit** | $6,434,588 | $6,792,612 | | **Loss from operations** | $(6,756,957) | $(7,106,474) | | **Net loss** | $(4,713,597) | $(6,980,947) | | **Net loss per share (Basic & Diluted)** | $(0.06) | $(0.10) | [Notes to Consolidated Financial Statements](index=56&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed disclosures on going concern, accounting policies, segment data, related party transactions, and commitments, supplementing the financial statements [Note B: Going Concern and Liquidity](index=56&type=section&id=NOTE%20B--GOING%20CONCERN%20AND%20LIQUIDITY) The company's history of losses and negative cash flow raises substantial doubt about its going concern ability, but management's plans and recent financing are expected to alleviate this - The company has incurred losses of **$6.8 million in 2024** and **$7.1 million in 2023**, with an accumulated deficit of **$128.1 million**, raising substantial doubt about its ability to continue as a going concern[289](index=289&type=chunk) - Management's plan to alleviate this doubt includes increasing revenues, decreasing professional fees, delaying R&D, and securing an **$800,000 related party note financing** in April 2025[290](index=290&type=chunk) [Note K: Segment and Geographic Data](index=67&type=section&id=NOTE%20K%20%E2%80%94%20SEGMENT%20AND%20GEOGRAPHIC%20DATA) The company operates in Dental and Medical segments, with Dental generating **$8.5 million** in sales and U.S. sales totaling **$5.2 million** in 2024 Segment Performance (2024) | Segment | Product Sales, Net | Operating Income (Loss) | | :--- | :--- | :--- | | **Dental** | $8,527,108 | $1,576,042 | | **Medical** | $102,820 | $(2,057,750) | | **Corporate** | - | $(6,275,249) | | **Total** | **$8,629,928** | **$(6,756,957)** | Sales by Geography (2024) | Region | Grand Total Sales | | :--- | :--- | | **Domestic: US** | $5,200,849 | | **International: Rest of World** | $3,429,079 | | **International: China** | $0 | | **Total Product Sales** | **$8,629,928** | [Note P: Subsequent Event](index=73&type=section&id=NOTE%20P%20%E2%80%94SUBSEQUENT%20EVENT) Subsequent to year-end, the company issued **$800,000** in convertible promissory notes to three of its directors - On April 9, 2025, the company secured **$800,000 in financing** by issuing convertible promissory notes to three directors[388](index=388&type=chunk) - The notes are due in 2028, bear interest, and are convertible into common stock at a price no less than **$0.50 per share**[388](index=388&type=chunk)

Core Insights - Milestone Scientific Inc. has announced the integration of its CompuFlo® Epidural System at InfiniSurg, LLC, a New Jersey-based ambulatory surgery center, enhancing its clinical practice with advanced technology [1][3][4] Company Overview - Milestone Scientific Inc. (NYSE: MLSS) specializes in developing computerized drug delivery instruments aimed at providing painless and precise injections, focusing on improving patient comfort and safety [5] - The company’s proprietary Dynamic Pressure Sensing Technology® is designed to enhance the precision of injections and reduce complications associated with traditional methods [5] Technology and Innovation - The CompuFlo® Epidural System utilizes objective pressure sensing technology to provide real-time feedback, which may enhance procedural confidence and reduce complications during epidural placements [3][4] - The system aims to establish a new standard of care for epidural procedures by improving procedural efficiency and patient safety through visual and audible feedback mechanisms [4] Leadership and Expertise - Dr. Roman Kosiborod, a highly experienced anesthesiologist and pain management physician, will utilize the CompuFlo® Epidural System at InfiniSurg, bringing over two decades of expertise in interventional pain management [2][3] - InfiniSurg is recognized for its patient-centric approach and commitment to innovation in outpatient surgical care, aligning with Milestone's mission to leverage advanced technologies for better patient outcomes [3]

Core Insights - Milestone Scientific Inc. has successfully integrated its CompuFlo® Epidural System into Pain Doctors Medical LLC, enhancing patient safety and procedural efficiency following a positive clinical evaluation by Dr. Ilana Etelzon [1][3] Company Overview - Milestone Scientific Inc. (MLSS) specializes in developing computerized drug delivery instruments aimed at providing painless and precise injections [5] - The company’s proprietary Dynamic Pressure Sensing Technology® is utilized in the CompuFlo® Epidural System to ensure real-time verification of epidural needle placement, thereby improving safety and reducing complications [2][5] Product Implementation - The CompuFlo® Epidural System has been adopted at Pain Doctors Medical LLC, which is a specialized interventional pain management center, following a successful evaluation by Dr. Etelzon [1][3] - The system's ability to confirm needle placement with real-time feedback enhances procedural accuracy and provides reassurance to both physicians and patients [3] Market Expansion - The recent assignment of Medicare pricing for the CompuFlo® Epidural System is expected to increase accessibility across interventional pain management and rehabilitation centers [3] - The company aims to expand its reach within interventional pain management centers, with a focus on further adoption of the CompuFlo® technology [4] Leadership Commentary - Neal Goldman, Chairman and Interim CEO of Milestone Scientific, emphasized the importance of expanding the company's presence in interventional pain management and highlighted Dr. Etelzon's positive experience as a validation of the system's clinical benefits [4]

Core Insights - Milestone Scientific Inc. has launched the commercial rollout of its CompuFlo® Epidural System at Advanced Spine and Pain Management, following a successful pilot program that validated its clinical benefits [1][4] - The CompuFlo® Epidural System utilizes patented Dynamic Pressure Sensing Technology® to provide real-time feedback for accurate needle placement, significantly enhancing patient safety and procedural efficiency [3][5] - The adoption of the CompuFlo® Epidural System is increasing, particularly after the recent Medicare price assignment, indicating its clinical and economic advantages [2][4] Company Overview - Milestone Scientific Inc. is a technology-focused medical research and development company that specializes in innovative injection technologies for medical and dental applications [5] - The company's computer-controlled systems aim to make injections more precise and efficient while improving patient comfort and safety [5] Industry Context - Advanced Spine and Pain Management operates within the SurgiCore network, which consists of 12 centers in the New York/New Jersey metropolitan area, presenting opportunities for further expansion [2] - The integration of the CompuFlo® Epidural System into clinical workflows is expected to enhance care delivery in pain management clinics across the nation [4]

ROSELAND, N.J., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced that its CEO Arjan Haverhals and Chairman Neal Goldman will be presenting at The Benchmark Company’s 13th Annual Discovery One-on-One Investor Conference to be held Wednesday, December 11th, 2024 at the New York Athletic Club in New York City. The conference offers emerging growth and dynamic publ ...

Reports 57% increase in international dental sales for the third quarter of 2024 Advances commercial rollout of CompuFlo® Epidural System across additional pain management clinics following Medicare price assignment in multiple U.S. states ROSELAND, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today reported financial results for the third quarter ended September 30, ...