MILESTONE SCIENTIFIC INC.
For the period ended Mar 31, 2026. Filed May 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 13, 2026
MLSS$0.30+1.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022276
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001493152-26-022701
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 75 previous paragraphs and 44 current paragraphs.
11 unchanged; 7 reworded; 25 added; 53 removed; 4 previous and 1 current paragraphs rearranged.
Tables are not compared: 15 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (25)
Current report
The Company’s proprietary Dynamic Pressure Sensing Technology® (DPS) platform is a computer-controlled system designed to improve the precision, efficiency, and patient comfort of injections by regulating flow rate and monitoring pressure at the needle tip in real time.
Current report
The Company operates in two reportable segments:
Current report
The Company continues to focus on expanding adoption of its DPS technology platform, advancing commercialization of its Medical segment, and maintaining disciplined cost management while supporting targeted growth initiatives.
Current report
Total product sales for the three months ended March 31, 2026 were approximately $2.2 million, compared to approximately $2.2 million for the same period in 2025, representing a decrease of approximately $70,000, or 3%.
Current report
Dental product revenue was approximately $2.05 million, representing a decrease of approximately $127,000, or 6%, compared to the prior period. The change in Dental revenue primarily reflects lower international distributor demand during the quarter. The Company believes this was influenced by ongoing geopolitical conditions, including the Russia–Ukraine conflict and recent instability in the Middle East, which impacted purchasing patterns in certain markets.
Current report
Revenue from China was not recognized during the current period, compared to approximately $110,000 in the prior period. The Company has received a purchase order in April 2026, indicating renewed activity in that market.
Current report
Medical revenue increased to approximately $108,000, compared to approximately $51,000 in the prior period, representing growth of approximately 110%, reflecting continued early-stage adoption of the Company’s medical products.
Current report
Overall, the Company maintained a relatively stable revenue base, with modest variability primarily attributable to external market conditions.
Current report
Gross profits for 2026 and 2025 were as follows:
Current report
Gross margin was approximately 72.3%, compared to approximately 73.8% in the prior period.
Current report
The decrease in gross profit was primarily attributable to lower Dental segment sales. The slight decline in gross margin reflects a combination of factors, including product mix and lower sales volume, as well as cost pressures, including tariffs on certain imported components. These factors were partially offset by improved contribution from the Medical segment.
Current report
Selling, general and administrative expenses decreased by approximately $884,000 or 27.2%, to $2.37 million for the current period compared to $3.26 million in the prior period. Thedecrease was primarily attributable to a significant reduction in professional fees, lower research and development spending, and reduced marketing-related expenditures.
Current report
Professional fees declined by approximately $893,000, or 69.5%, primarily due to lower legal, consulting, and other outside service costs incurred during the current period compared to the prior year. In addition, marketing expenses decreased by approximately 34.3%, reflecting reduced promotional and advertising activities, while royalty expense decreased by 15.0%.
Current report
Partially offsetting these decreases were increases in certain operating expense categories, including salaries and compensation, warehousing, and quality control and regulatory expenses. Salaries and compensation increased by approximately 3.8%, reflecting ongoing personnel-related costs to support operations. Warehousing expenses increased by 6.1%, while QC and regulatory expenses increased by 12.6%, primarily due to higher operational and compliance-related activities.
Current report
Research and development expense decreased by approximately $369,000, as no R&D expenses were incurred during thecurrent period compared to the prior period.
Current report
The Company continues to evaluate its research and development priorities and may make targeted investments in future periods to support product enhancements, new applications, and long-term growth initiatives.
Current report
Loss from operations improved to approximately $828,000 for the three months ended March 31, 2026, compared to approximately $2.0 million in the prior period, representing an improvement of approximately $1.2 million, or 58%.
Current report
The improvement was primarily attributable to reduced operating expenses, partially offset by lower gross profit.
Current report
Net cash provided by operating activities was approximately $87,000 for the three months ended March 31, 2026, compared to net cash used in operating activities of approximately $1.0 million in the prior period. This improvement was primarily driven by reduced net loss and favorable changes in working capital.
Current report
Net cash used in investing and financing activities was minimal in both periods.
Current report
Consideration of the Company’s ability to continue as a going concern.
Current report
The Company has incurred recurring operating losses and has an accumulated deficit. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
Current report
On April 20, 2026, the Company completed a private placement of 7,962,963 units at a purchase price of $0.27 per unit, generating gross proceeds of approximately $2.15 million, consisting of $1.80 million in cash and a reduction of $351,000 in outstanding principal of the Company’s outstanding convertible notes, the holders of which applied such principal amounts toward the purchase of units in the offering in lieu of cash (the “Private Placement”)
Current report
The Company’s ability to continue as a going concern is dependent upon its ability to generate sufficient revenue, manage operating expenses, and obtain additional financing, if necessary.
Current report
The Company believes that its current cash resources, together with expected collections and financing proceeds, will be sufficient to support near-term operations. However, there can be no assurance that additional financing will be available on acceptable terms, or at all.
Removed paragraphs (53)
Previous report
Our proprietary Dynamic Pressure Sensing (DPS®) Technology System enables controlled flow and real-time pressure monitoring at the needle tip, facilitating safer and more consistent drug delivery and fluid aspiration. This platform supports multiple medical and dental applications, including accurate epidural space identification in regional anesthesia procedures.
Previous report
In dentistry, our Wand® device—marketed as CompuDent® and STA Single Tooth Anesthesia System®—is a single-use disposable handpiece suitable for all local anesthetic procedures. The dental systems are marketed in the United States, Canada, and more than 40 other countries. In medicine, our CompuFlo® Epidural Computer Controlled Anesthesia System has received FDA 510(k) clearance for use in the lumbar, thoracic, and cervical thoracic junction regions of the spine, as well as CE Mark approval for commercialization across most European countries.
Previous report
The recent issuance of a chronology-specific CPT code by the American Medical Association represents a significant advancement, expanding reimbursement potential for epidural procedures using the CompuFlo® system and supporting broader adoption in anesthesia and pain management practices across the United States. Milestone Scientific and its subsidiaries hold over 317 U.S. and international patents, with additional applications pending. These patents encompass innovations in computer-controlled drug delivery, dynamic pressure sensing, automated flow regulation, tissue identification, and anesthetic injection devices.
Previous report
Milestone Scientific remains focused on advancing efforts to achieve the following three primary objectives:
Previous report
Our dental devices have been used to administer more than 95 million injections worldwide. Each of our devices is designed with a corresponding single-use disposable handpiece, providing a recurring revenue stream following the initial device sale. Currently, we continue to sell disposable handpieces unique to our legacy products—The Wand® and CompuDent®—to customers who have not yet upgraded to our current dental product, the STA Single Tooth Anesthesia System®.
Previous report
The Single Tooth Anesthesia System (Dental)
Previous report
Since its introduction in early 2007, the STA Single Tooth Anesthesia System® and earlier computer-controlled local anesthetic delivery (C-CLAD) devices have been used to deliver more than 95 million safe, effective, and comfortable injections. The instrument has been favorably evaluated in numerous peer-reviewed clinical studies and publications. There is a growing consensus among users that the STA System is a valuable and beneficial instrument that is positively transforming dental practice worldwide.
Previous report
Medical Market Product
Previous report
In June 2017, Milestone Scientific received FDA clearance to market the CompuFlo® Epidural Computer Controlled Anesthesia System in the United States for epidural injections.
Previous report
In May 2022, the Company received a chronology-specific CPT code for its technology from the American Medical Association, marking an important milestone. Effective January 1, 2023, this temporary tracking code enables clinicians to submit reimbursement claims to healthcare insurers for epidural sterile injections in the lumbar, thoracic, and cervical thoracic junction regions of the spine. This CPT code significantly expands the reimbursement potential for epidural procedures in pain management utilizing the CompuFlo® Epidural System, supporting broader clinical adoption.
Previous report
Consolidated revenue for the three months ended September 30, 2025, was approximately $2.4 million, compared to $2.5 million for the same period in 2024, representing a decrease of approximately $154,000, or 6%. The decline in total revenue was primarily attributable to lower international and e-commerce dental sales, partially offset by new contributions from the Company’s re-entry into the China market and modest growth in institutional sales.
Previous report
Revenue from Dental Service Organizations (DSOs), government agencies, and dental schools increased slightly to approximately $83,000 for the three months ended September 30, 2025, compared to $81,000 in the prior-year period, reflecting steady institutional demand.
Previous report
E-commerce dental revenue totaled approximately $1.0 million for the three months ended September 30, 2025, compared to $1.1 million for the same period in 2024, a decrease of approximately $105,000, or 9%. The decline was primarily driven by reduced order volume from certain online distributors and the timing of promotional campaigns during the quarter.
Previous report
International dental revenue decreased to approximately $1.0 million in the third quarter of 2025, compared to $1.2 million in the third quarter of 2024, a reduction of approximately $242,000, or 20%. The decrease was largely the result of slower distributor purchasing activity in certain European markets, partially offset by resumed sales in China.
Previous report
Sales in China for the three months ended September 30, 2025, were approximately $200,000, compared to no sales in the same period of 2024. The increase reflects the Company’s successful efforts to reestablish operations and distribution channels in the region following prior-year market disruptions.
Previous report
Revenue from the medical segment totaled approximately $41,000 for the three months ended September 30, 2025, compared to $47,000 in the same period of 2024, a decrease of approximately $6,000, or 13%. The decline was primarily related to the timing of equipment sales and ongoing efforts to expand awareness and adoption of the Company’s CompuFlo® Epidural and CathCheck® Systems within the U.S. pain management market.
Previous report
Gross Profit for 2025 and 2024 were as follows:
Previous report
Consolidated gross profit for the three months ended September 30, 2025, was approximately $1.6 million, compared to $1.8 million for the same period in 2024, representing a decrease of approximately $195,000, or 11%. The decline in gross profit was primarily attributable to lower revenue levels during the quarter, particularly within international and e-commerce dental sales, as well as a slight shift in the sales mix toward lower-margin products and markets. Gross margin remained strong overall, reflecting the Company’s continued focus on cost management and operational efficiency.
Previous report
Consolidated selling, general, and administrative (SG&A) expenses for the three months ended September 30, 2025, were approximately $2.7 million, compared to $3.1 million for the same period in 2024, representing a decrease of approximately $325,000, or 10%. The reduction primarily reflects management’s continued focus on cost containment and operational efficiency.
Previous report
Employee salaries and benefits decreased by approximately $147,000 for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to workforce realignment and headcount optimization. In addition, the Company achieved further savings of approximately $178,000 through reductions in marketing, consulting, professional service fees, insurance, royalties, regulatory, travel, and other general administrative expenses.
Previous report
These cost reduction measures are part of management’s ongoing initiatives to streamline operations, align expenses with current revenue levels, and support the Company’s transition toward sustainable profitability
Previous report
Consolidated research and development (R&D) expenses for the three months ended September 30, 2025, were approximately $16,000, compared to approximately $232,000 for the same period in 2024, representing a decrease of approximately $216,000, or 93%. The decrease reflects management’s strategic decision to delay development activities related to the next-generation STA Single Tooth Anesthesia System® instrument.
Previous report
This temporary reduction in R&D spending allows the Company to focus financial resources on the commercial expansion of existing products and the continued global rollout of its CompuFlo® and CathCheck® Systems, while maintaining flexibility to resume development activities at a later date based on market conditions and strategic priorities.
Previous report
The loss from operations for the three months ended September 30, 2025, was approximately $1.1 million, compared to $1.5 million for the same period in 2024, representing an improvement of approximately $335,000, or 22%. The reduction in operating loss was primarily attributable to lower selling, general, and administrative (SG&A) expenses and reduced research and development (R&D) expenditures during the quarter.
Previous report
Management’s ongoing cost-control initiatives, combined with the Company’s focus on operational efficiency and disciplined spending, contributed to the improvement in quarterly operating performance despite a modest decline in consolidated revenue.
Previous report
Nine months ended September 30, 2025 compared to nine months ended September 30, 2024
Previous report
Consolidated revenue for the nine months ended September 30, 2025, was approximately $6.9 million, compared to $6.6 million for the same period in 2024, representing an increase of approximately $300,000, or 5%. The year-over-year improvement was primarily driven by higher international and medical sales, partially offset by declines in e-commerce and institutional dental revenue.
Previous report
Revenue from Dental Service Organizations (DSOs), government agencies, and dental schools totaled approximately $277,000 for the nine months ended September 30, 2025, compared to $316,000 in the prior-year period, reflecting a decrease of approximately $39,000, or 12%.
Previous report
E-commerce dental revenue decreased to approximately $3.3 million for the nine months ended September 30, 2025, from $3.5 million for the same period in 2024, a decline of approximately $239,000, or 7%. The reduction was primarily attributable to lower order volumes and timing differences in recurring purchases from certain online distributors.
Previous report
International revenue for the nine months ended September 30, 2025, was approximately $2.9 million compared to $2.7 million for the same period in 2024, an increase of approximately $211,000, or 8%.
Previous report
Sales in China for the nine months ended September 30, 2025, were approximately $310,000, compared to no sales in the same period of 2024. The increase reflects the Company’s successful efforts to reestablish operations and distribution channels in the region following prior-year market disruptions.
Previous report
Medical revenue also increased, totaling approximately $125,000 for the nine months ended September 30, 2025, compared to $74,000 in the prior-year period, representing an increase of approximately $51,000, or 69%. The increase primarily reflects ongoing progress in expanding the clinical use and adoption of the CompuFlo® Epidural and CathCheck® Systems within the pain management and anesthesia markets.
Previous report
Gross Profit for 2025 and 2024 were as follows:
Previous report
Consolidated gross profit for the nine months ended September 30, 2025, and 2024 was approximately $4.9 million for each period, reflecting no material change year over year. Stable gross profit performance was primarily the result of consistent product margins, favorable manufacturing cost management, and a balanced sales mix between domestic and international markets.
Previous report
Despite modest fluctuations in regional and product-level revenue, the Company maintained gross margin stability through ongoing operational efficiencies, disciplined pricing strategies, and continued supply chain optimization.
Previous report
Consolidated selling, general, and administrative (SG&A) expenses for the nine months ended September 30, 2025, and 2024 were approximately $9.0 million in both periods, reflecting a slight net increase of approximately $58,000 year over year. The modest change primarily resulted from higher consulting, professional, and regulatory expenses totaling approximately $611,000, which were largely offset by reductions in employee salaries and benefits, marketing, warehousing, and travel expenses amounting to approximately $552,000.
Previous report
The overall stability in SG&A spending demonstrates management’s ongoing focus on expense control, operational efficiency, and resource optimization, while continuing to support the Company’s commercial initiatives and regulatory compliance activities
Previous report
Consolidated research and development (R&D) expenses for the nine months ended September 30, 2025, were approximately $437,000, compared to $641,000 for the same period in 2024, representing a decrease of approximately $204,000, or 32%. The decrease primarily reflects the Company’s decision to delay development activities related to the next-generation STA Single Tooth Anesthesia System®.
Previous report
This strategic decision allows the Company to conserve resources and prioritize commercialization efforts for its existing product portfolio, including the continued expansion of the CompuFlo® Epidural and CathCheck® Systems, while maintaining the flexibility to resume product development as market conditions and business priorities warrant.
Previous report
The loss from operations for the nine months ended September 30, 2025, was approximately $4.6 million, compared to $4.7 million for the same period in 2024, representing an improvement of approximately $98,000, or 2%. The modest improvement primarily reflects lower research and development (R&D) expenses during the period, partially offset by slightly higher consulting, professional, and regulatory costs within selling, general, and administrative (SG&A) expenses.
Showing the first 40 of 53 passages. Open the source sections for the rest.
Reworded paragraphs (7)
Previous wording
s Discussion and Analysis of Financial Condition and Results of Operations
Current wording
ITEM 2. Management**’s Discussion and Analysis of Financial Condition and Results of Operations
Previous wording
The following discussions of the financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements contained in this report and in connection with management’s discussion and analysis and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission, or SEC on April 15, 2025. Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of Section 21E of the Exchange Act, which involve risks and uncertainties. The actual results may differ materially from those anticipated in these forward-looking statements.
Current wording
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q, as well as our Annual Report on Form 10-K for the year ended December 31, 2025.
Previous wording
Milestone Scientific is a biomedical technology company that patents, designs, develops, and commercializes innovative diagnostic and therapeutic injection technologies for medical and dental applications. Since our inception, we have pioneered proprietary computer-controlled injection systems that are proven, reliable, and well established in clinical use. Our common stock has been listed on the NYSE American since June 1, 2015, under the symbol “MLSS.” The Company’s mission is to redefine the global standard of care for injection techniques by improving precision, efficiency, and patient comfort while reducing the anxiety associated with traditional injections.
Current wording
Milestone Scientific Inc. is a biomedical technology company that designs, develops, patents, and commercializes innovative diagnostic and therapeutic injection technologies for medical and dental applications. The Company’s common stock trades on the NYSE American under the symbol “MLSS.”
Previous wording
The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category Certain reclassifications have been made to the 2025 unaudited condensed consolidated financial statements to conform to the 2024 unaudited condensed consolidated financial statement presentation. These reclassifications had no effect on net loss or cash flows as previously reported.:
Current wording
The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment, product category:
Previous wording
The following table sets forth the consolidated results of operations for the three and nine months ended September 30, 2025 and 2024, respectively. The trends suggested by this table may not be indicative of future operating results:
Current wording
The following table sets forth the consolidated results of operations for the three months ended March 31, 2026 and 2025, respectively. The trends suggested by this table may not be indicative of future operating results:
Previous wording
The following table summarizes our sources and uses of cash for the nine months ended:
Current wording
The following table summarizes our sources and uses of cash for the three months ended:
Previous wording
Since its inception, the Company has incurred aggregate losses of approximately $132.7 million. Operating losses were approximately $1.1 million and $4.6 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, Milestone Scientific had cash and cash equivalents of approximately $1.3 million and working capital of approximately $3.1 million. Net cash flows used in operating activities were approximately $2.7 million and $1.4 million for the nine months ended September 30, 2025, and 2024, respectively. Based on the Company’s available cash resources, recurring operating losses, accumulated deficit, and the need for additional capital to finance ongoing operations. Management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of one year from the date these unaudited condensed financial statements are issued.
Current wording
As of March 31, 2026, the Company had cash and cash equivalents of approximately $1.2 million and working capital of approximately $2.5 million.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
This discussion contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those anticipated in these forward-looking statements.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Net sales for 2025 and 2024 were as follows:
Previous report — wording carried elsewhere
Selling, general and administrative expenses for 2025 and 2024 were as follows:
Previous report — wording carried elsewhere
Research and Development for 2025 and 2024 were as follows:
Previous report — wording carried elsewhere
Profit (Loss) from Operations for 2025 and 2024 were as follows: