Medical Segment Revenue Grows 136% Year-Over-Year
Expands CompuFlo® Physician Partnerships and Advances Medical Commercialization
Online Demonstrations More Than Double Reflecting Increased Customer Engagement
Reaffirms 2026 Outlook for Double-Digit Revenue Growth, Including Significant Growth in CompuFlo® Sales
Identifies approximately $400,000 in Additional Annual Savings, Supporting Expectation to Approach or Achieve Profitability in Fourth Quarter 2026 and Additional Profitable Quarters in 2027
ROSELAND, N.J., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provided a business update and announced financial results for the three and nine months ended September 30, 2026.
Recent Business Highlights
- Identified cost-reduction initiatives expected to generate approximately $400,000 in additional annual savings, strengthening the Company’s path to potential profitability in Q4 2026 and additional profitable quarters in 2027.
- Expanded CompuFlo® clinical adoption across major healthcare organizations, highlighted by the initiation of clinical use at Rothman Orthopaedics, a nationally recognized orthopedic organization, and the addition of Pain and Spine Specialists, a 22-location Northeastern U.S. pain management network, and its medical director, Dr. Sudhir Rao, to the CompuFlo Advisor Program.
- Built a pipeline of more than 500 U.S. commercial leads, supported by five dedicated medical sales professionals, approximately 15 sales consultants and three distribution partners, with federal market access through Red One Medical.
- Reinforced CompuFlo’s clinical value proposition through a peer-reviewed 79-patient University of Texas Medical Branch study associating CompuFlo-guided epidural access with approximately 91% lower adjusted odds of composite complications compared with conventional loss-of-resistance techniques during spinal cord stimulator implantation.
- Highlighted substantial market potential across an estimated 30 million-plus annual epidural procedures worldwide, including more than 11 million in the U.S. Just 2% U.S. penetration could represent approximately $33 million in annual disposable revenue at $150 per procedure (illustrative only; not a revenue forecast).
- Submitted a provisional patent application for a potential new application of CompuFlo technology in intrathecal pump refills, extending its potential beyond epidural procedures.
- Strengthened international medical commercialization through distributor engagement and market development activities in Italy and Greece to support CompuFlo adoption and recurring sales.
- Pursued global strategic partnerships through go-to-market and licensing discussions with major medical technology organizations to expand international market reach.
- Broadened dental distribution opportunities through engagement with four potential distribution channels collectively serving thousands of dental offices.
- Achieved a debt-free balance sheet by eliminating outstanding director loans through a debt-to-equity conversion, supporting the Company’s focus on financial discipline.
“During the third quarter, we continued to advance our commercial strategy while maintaining disciplined expense management,” said Eric Hines, Chief Executive Officer of Milestone Scientific. “As anticipated, revenue moderated following the second quarter, which benefited from two large international orders. At the same time, we continued to build our commercial pipeline, with completed online demonstrations more than doubling during the first nine months of the year compared with the prior-year period. We believe this reflects growing customer engagement and the continued development of a more scalable sales process that can support future growth across our business. In dental, we are making progress with four potential distribution channels serving thousands of offices.
“In our medical business, we are gaining traction with major healthcare organizations, highlighted by the initiation of clinical use at Rothman Orthopaedics, a nationally recognized orthopedic organization with 34 locations, and the addition of Pain and Spine Specialists, a 22-location pain management network, to our CompuFlo® Advisor Program. These developments represent important milestones in expanding institutional engagement and physician adoption. We continue to strengthen reimbursement access, commercial infrastructure and clinical support to accelerate utilization and recurring disposable revenue with more than 500 U.S. commercial leads, our priority is converting that pipeline into active accounts and increasing procedure volumes. Internationally, we are seeing growing momentum in medical, and we are pursuing go-to-market and licensing initiatives with a few large medical technology organizations.
“Looking ahead, we expect to approach profitability, or be profitable, in the fourth quarter of 2026. Our team has remained focused on identifying cost-saving opportunities across the business, with initiatives expected to generate approximately $400,000 in additional annual savings, further strengthening our path to profitability. For 2027, we expect considerably lower losses than in 2026, and our significantly lower expense base positions us to deliver additional profitable quarters, depending on revenue levels. We believe quarterly revenue of approximately $2.6 million to $2.7 million would bring us near our profitability threshold, beyond which incremental sales can drive meaningful improvements in operating performance. Combined with continued growth in our core dental business and CompuFlo® commercialization, we believe this operating leverage provides a foundation for sustainable growth and long-term shareholder value.”
Financial Results for the Three Months Ended September 30, 2026
For the three months ended September 30, 2026, total revenue was $2.2 million, compared to $2.4 million for the same period in 2025, representing a decrease of $140,000, or 5.9%. As expected, sales declined compared with the prior-year period, primarily reflecting lower dental product sales. The third quarter is typically a seasonally slower period, and the Company anticipated a moderation in revenue following the second quarter, which benefited from two large international orders. The impact of lower dental product sales was partially offset by growth in medical sales, as well as an increase in dental repair income.
Gross profit for the three months ended September 30, 2026 and 2025 was $1.6 million. Gross margin was 72.3% for the three months ended September 30, 2026 compared with 69.5% for the same period in 2025. The increase in gross margin was primarily due to lower product costs relative to sales during the current-year period.
Operating expenses decreased by $424,000, or 15.3%, to $2.4 million for the three months ended September 30, 2026, compared with $2.8 million for the three months ended September 30, 2025. The decrease was primarily attributable to lower salaries and compensation, stock-based compensation, professional fees and contract-related expenses, partially offset by increased marketing, regulatory, warehousing and travel expenses.
Net loss was $748,000, or ($0.01) per share, compared to a net loss of $1.2 million, or ($0.01) per share, in the prior year period.
Financial Results for the Nine Months Ended September 30, 2026
For the nine months ended September 30, 2026 and 2025, total revenue was $7.2 million and $6.9 million, respectively, an increase of $307,000, or 4.4%, driven by continued growth in international dental sales and higher recurring revenue from the Company’s medical segment.
Gross profit for the nine months ended September 30, 2026 and 2025 was $5.1 million and $4.9 million, or 70.3% and 70.9% of revenue, respectively.
Operating expenses decreased by $2.0 million, or 20.9%, to $7.5 million for the nine months ended September 30, 2026, compared with $9.5 million for the nine months ended September 30, 2025. The decrease was primarily attributable to lower professional fees, research and development, salaries and compensation, contract-related expenses, and quality control and regulatory expenses. These decreases were partially offset by higher warehousing and logistics, travel and marketing expenses. Expenses under an existing agreement decreased to approximately $91,000 from approximately $351,000 in the prior-year period, after the Company evaluated and optimized its contractual obligations.
Net loss for the nine months ended September 30, 2026 was $2.5 million, or $(0.03) per share, compared to a net loss of $4.6 million, or $(0.06) per share, for the comparable period in 2025.
As of September 30, 2026, the Company had cash and cash equivalents of $1.3 million, working capital of $3.5 million and $0 debt outstanding.
2026 Outlook
Management reaffirms its full-year 2026 revenue outlook of $9.8 million to $10.2 million, representing double-digit growth driven by continued expansion of commercial adoption across both the dental and medical segments. Revenue from the Company’s CompuFlo® medical business is expected to grow at a faster rate than overall Company revenue as it continues to expand physician engagement, strengthen reimbursement access and build its commercial infrastructure.
Management expects these initiatives, together with continued cost discipline and operating expense management, to support improved operating leverage and a meaningful reduction in cash burn compared with the prior year. The Company remains focused on increasing CompuFlo® adoption and utilization and growing recurring disposable revenue. Management expects the Company to approach or achieve profitability in the fourth quarter of 2026 and expects considerably lower losses in 2027 compared with 2026, with additional profitable quarters depending on revenue levels.
Conference Call
Milestone will host a conference call at 8:30 AM Eastern Time today, Friday, November 13, 2026, to discuss the company’s financial results for the third quarter ended September 30, 2026, as well as the company’s corporate progress and other developments.
The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or 973-528-0011 for international callers and by entering the access code: 612206. A live webcast and replay are available here: https://www.webcaster5.com/Webcast/Page/2306/54665.
An audio replay of the call will be available through November 25, 2026, and can be accessed by dialing 877-481-4010 for U.S. callers or 919-882-2331 for international callers and by entering the access code: 54665.
About Milestone Scientific Inc.
Milestone Scientific Inc. is a technology-focused medical research and development company that patents, designs, and develops innovative injection technologies and instruments for medical and dental applications. Milestone Scientific's computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2025. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Contact:
HAYDEN IR:
James Carbonara
(646)-755-7412
james@haydenir.com
Brett Maas
(646) 536-7331
brett@haydenir.com
-- Tables Follow –
MILESTONE SCIENTIFIC AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,315,401 | $ | 1,112,642 | ||||
| Accounts receivable, net of allowance for credit losses of $10,000, respectively | 1,087,584 | 680,620 | ||||||
| Accounts receivable, related party | 12,834 | 25,548 | ||||||
| Other receivable | 55,664 | - | ||||||
| Prepaid expenses and other current assets | 279,283 | 468,792 | ||||||
| Inventories | 2,735,323 | 3,781,837 | ||||||
| Advances on contracts | 1,279,102 | 1,408,395 | ||||||
| Total current assets | 6,765,191 | 7,477,834 | ||||||
| Furniture, fixtures and equipment, net | 18,795 | 19,193 | ||||||
| Intangibles, net | 27,754 | 79,063 | ||||||
| Right of use assets finance lease | 44,421 | 55,811 | ||||||
| Right of use assets operating lease | 62,433 | 150,378 | ||||||
| Other assets | 24,150 | 24,150 | ||||||
| Total assets | $ | 6,942,744 | $ | 7,806,429 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,250,262 | $ | 1,430,250 | ||||
| Accounts payable, related party | 49,810 | 1,263,651 | ||||||
| Accrued expenses and other payables | 872,925 | 995,206 | ||||||
| Accrued expenses, related party | - | 88,799 | ||||||
| Current portion of finance lease liabilities | 37,587 | 27,347 | ||||||
| Current portion of operating lease liabilities | 68,927 | 130,355 | ||||||
| Total current liabilities | 3,279,511 | 3,935,608 | ||||||
| Non-current portion of finance lease liabilities | 6,834 | 27,336 | ||||||
| Non-current portion of operating lease liabilities | - | 35,208 | ||||||
| Convertible notes payable, related parties | - | 800,000 | ||||||
| Total liabilities | $ | 3,286,345 | $ | 4,798,152 | ||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, par value $0.001; authorized 135,000,000 shares; 90,644,403 shares issued and 90,611,070 shares outstanding as of September 30, 2026; 80,486,449 shares issued and 80,453,116 shares outstanding as of December 31, 2025; | $ | 90,645 | $ | 80,487 | ||||
| Additional paid in capital | 140,524,925 | 137,418,974 | ||||||
| Accumulated deficit | (136,047,655 | ) | (133,579,668 | ) | ||||
| Treasury stock, at cost, 33,333 shares | (911,516 | ) | (911,516 | ) | ||||
| Total stockholders’ equity | 3,656,399 | $ | 3,008,277 | |||||
| Total liabilities and stockholders’ equity | 6,942,744 | $ | 7,806,429 | |||||
MILESTONE SCIENTIFIC AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||||||
| Three Months Ending | Three Months Ending | Nine Months Ending | Nine Months Ending | |||||||||||||
| September 30, 2026 | September 30, 2025 | September 30, 2026 | September 30, 2025 | |||||||||||||
| Product sales, net | $ | 2,219,747 | $ | 2,360,117 | $ | 7,222,818 | $ | 6,916,003 | ||||||||
| Cost of products sold | 614,218 | 719,247 | 2,143,098 | 2,010,092 | ||||||||||||
| Gross profit | 1,605,529 | 1,640,870 | 5,079,720 | 4,905,911 | ||||||||||||
| Selling, general and administrative expenses | 2,321,312 | 2,739,011 | 7,474,552 | 9,026,691 | ||||||||||||
| Research and development expenses | 10,413 | 16,226 | 3,222 | 437,135 | ||||||||||||
| Depreciation and amortization expense | 20,096 | 20,104 | 59,139 | 59,040 | ||||||||||||
| Total operating expenses | 2,351,821 | 2,775,341 | 7,536,913 | 9,522,866 | ||||||||||||
| Loss from operations | (746,292 | ) | (1,134,471 | ) | (2,457,193 | ) | (4,616,955 | ) | ||||||||
| Interest (expense) income, net | (1,253 | ) | (19,488 | ) | (10,792 | ) | (14,700 | ) | ||||||||
| Loss before provision for income taxes | (747,545 | ) | (1,153,959 | ) | (2,467,985 | ) | (4,631,655 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (747,545 | ) | $ | (1,153,959 | ) | $ | (2,467,985 | ) | $ | (4,631,655 | ) | ||||
| Net loss per share applicable to common stockholders— | ||||||||||||||||
| Basic and Diluted | (0.01 | ) | (0.01 | ) | (0.03 | ) | (0.06 | ) | ||||||||
| Weighted average shares outstanding and to be issued— | ||||||||||||||||
| Basic and diluted | 93,913,021 | 82,049,984 | 90,151,697 | 81,903,323 | ||||||||||||
