Medical Segment Revenue Grows 231% Year-Over-Year
Enters Strategic Distribution Agreement to Expand CompuFlo® Access Across VA and Department of Defense Health Systems
Reaffirms 2026 Outlook for Double-Digit Revenue Growth, Including Significant Growth in CompuFlo® Sales
ROSELAND, N.J., Aug. 14, 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 six months ended June 30, 2026.
“Our second quarter results reflect continued execution on the strategy we laid out at the start of the year,” said Eric Hines, Chief Executive Officer of Milestone Scientific. “Total revenue grew 22% year-over-year to $2.8 million, and for the six months ended June 30, 2026, total revenue grew 10% to $5.0 million. Our base business performed well, contributing $2.4 million in the quarter, further supported by approximately $500,000 in upside from international orders. Importantly, our medical business continued to build momentum, with CompuFlo® revenue growing 230% compared to the second quarter of last year, reflecting continued physician adoption and progress on reimbursement, including additional claims submitted across multiple Medicare Administrative Contractor jurisdictions and our first successful paid workers' compensation claim. We currently have Medicare reimbursement of approximately $325 per procedure for CompuFlo® under CPT® 0777T ((real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure) through Novitas and First Coast, covering three regions and 13 states. We are pursuing the remaining MACs while launching direct sales alongside three distribution partners in covered markets.“We also received meaningful third-party validation of CompuFlo this quarter with the publication of a peer-reviewed University of Texas Medical Branch study in Operative Neurosurgery that associated CompuFlo-guided epidural access during spinal cord stimulator implantation with a 91% reduction in the odds of composite complications,.This compelling evidence reinforces CompuFlo’s differentiated value proposition and supports growing physician acceptance and expanding utilization across critical spinal and epidural procedures including spinal cord stimulator implantation, obstetric epidurals, thoracic and cervical epidurals, neuromodulation therapies and surgical epidural anesthesia. CompuFlo has now been evaluated or utilized across more than 40 universities, academic medical centers and teaching hospitals worldwide.
“Subsequent to quarter end, we took a significant step in expanding our addressable market for CompuFlo, entering into a strategic distribution agreement with Red One Medical, an established federal healthcare distributor, to market and support the CompuFlo Epidural System across the U.S. Department of Veterans Affairs, Department of Defense, Defense Health Agency, Indian Health Service and other federal healthcare organizations, which together serve more than 18 million enrolled veterans and military beneficiaries. On the dental side, we signed a new national distribution partner to expand our sales network and complement our e-commerce business, and continued to build out our international footprint, including a recent registration approval in Uzbekistan, with additional registrations targeted in Japan, Mexico, Turkey and India in coming quarters.
“We also launched the first phase of our artificial intelligence strategy this quarter, with the pilot debut of Milo™, our AI-enabled digital engagement platform, at the American Society of Pain and Neuroscience (ASPN) 2026 conference in Miami Beach. Milo is designed to answer product questions, provide educational information, support lead qualification and connect healthcare professionals with our sales, clinical and customer support teams. In addition, we strengthened our Board of Directors, with Benedetta I. Casamento transitioning from Chair to Executive Chair and the appointments of two new independent directors, Greg Shilling and Kelly Ann Ulto, adding healthcare technology, finance and governance expertise.
“We remain focused on disciplined execution, directing incremental investment toward the areas of the business, particularly medical, where we believe there is the greatest long-term opportunity. At the same time, we are maintaining the cost discipline that has meaningfully narrowed our losses over the past year and continue to target cash flow breakeven in early 2027.”
Financial Results for the Three Months Ended June 30, 2026
For the three months ended June 30, 2026, total revenue was $2.8 million, compared to approximately $2.3 million for the same period in 2025, representing an increase of approximately $518,000, or 22.3%.. The increase in total net sales was driven by growth in dental product sales and continued early-stage adoption and commercialization of the Company’s medical products.
Gross profit for the three months ended June 30, 2026 was $1.9 million, compared to $1.6 million in the prior year period. Gross margin was 67.2% for the three months ended June 30, 2026 compared with 69.6% for the same period in 2025. The decrease in gross margin was primarily due to product and customer mix and increased product costs, including tariffs imposed on certain imported products and components. These cost pressures were partially offset by the higher level of sales during the current period.
Operating expenses decreased by approximately $0.1 million, or 4.2%, to approximately $3.0 million for the three months ended June 30, 2026, compared with approximately $3.1 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower quality and regulatory expenses, consulting and professional service fees, research and development expenses, rent and occupancy costs, and other segment items. These decreases were partially offset by increases in stock-based compensation, warehousing expense, royalty expense, marketing expense, salaries and employee benefits, and travel expense. increased promotional activities, trade shows, advertising, product launches, or customer-acquisition initiatives.
Net loss was $1.1 million or ($0.01) per share, compared to a net loss of $1.5 million, or ($0.02) per share, in the prior year period.
Financial Results for the Six Months Ended June 30, 2026
For the six months ended June 30, 2026 and 2025, total revenue was $5.0 million and $4.6 million, respectively, an increase of $447,000, or 9.8%, driven by continued growth in international dental sales and higher recurring revenue from the Company’s medical segment.
Gross profit for the six months ended June 30, 2026 was $3.5 million, or 69.4% of revenue, compared to $3.3 million, or 71.7% of revenue, for the same period in 2025. Gross margin decreased by approximately 2.2 percentage points, primarily due to product and customer mix and increased product costs, including tariffs imposed on certain imported products and components. These cost pressures were partially offset by the higher level of sales and increased contribution from the Medical segment during the current-year period.
Operating expenses decreased by approximately $1.4 million, or 20.5%, to approximately $5.4 million for the six months ended June 30, 2026, compared with approximately $6.7 million for the six months ended June 30, 2025. The decrease was primarily attributable to lower consulting and professional service fees, research and development expenses, and quality and regulatory expenses, partially offset by increases in salaries and employee benefits, stock-based compensation expense, warehousing expense, royalty expense, and travel expense. Net loss for the six months ended June 30, 2026 was $1.9 million, or $(0.02) per share, compared to a net loss of $3.5 million, or $(0.04) per share, for the comparable period in 2025. As of June 30, 2026, the Company had cash and cash equivalents of $2.1 million, working capital of $3.7 million and $466,000 in convertible debt outstanding.
2026 Outlook
Management reaffirms its outlook for the year ending December 31, 2026, with expected revenue of $9.8 million to $10.2 million, representing double-digit growth driven by continued expanding commercial adoption across both the dental and medical segments. CompuFlo revenue is expected to grow at a faster rate than the overall business for the remainder of the year. Combined with the structural cost reductions implemented in 2025, this revenue growth is expected to result in improved operating leverage and a meaningful reduction in cash burn compared with to the prior year.
The Company notes that second quarter 2026 revenue benefited from two large international orders that are not expected to recur in the third quarter of 2026, and that the third quarter is typically a seasonally slower period. Management expects medical segment initiatives, including the Company's expanding federal, Medicare and commercial payer channels, supported by the recently secured Medicare reimbursement across three MAC regions and the planned investment in direct sales in those areas, to contribute more meaningfully in the second half of 2026, with additional detail to be provided alongside third quarter results in November 2026.
Conference Call
Milestone will host a conference call at 8:30 AM Eastern Time today, Friday, August 14, 2026, to discuss the company’s financial results for the second quarter ended June 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 +1 973-528-0011 for international callers and by entering the access code: 252290. A live webcast and replay are available here: https://www.webcaster5.com/Webcast/Page/2306/54387.
An audio replay of the call will be available through August 28, 2026, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 54387.
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
[email protected]
Brett Maas
(646) 536-7331
[email protected]
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CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) June 30, 2026 December 31, 2025 ASSETS Current assets: Cash and cash equivalents $2,066,770 $1,112,642 Accounts receivable, net of allowance for credit losses of $10,000, respectively 1,003,063 680,620 Accounts receivable, related party 9,643 25,548 Other Receivables 40,276 - Prepaid expenses and other current assets 633,953 468,792 Inventories 3,086,577 3,781,837 Advances on contracts 1,276,916 1,408,395 Total current assets 8,117,198 7,477,834 Furniture, fixtures and equipment, net 20,127 19,193 Intangibles, net 44,857 79,063 Right of use assets finance lease 48,977 55,811 Right of use assets operating lease 92,489 150,378 Other assets 24,150 24,150 Total assets $8,347,798 $7,806,429 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $1,953,844 $1,430,250 Accounts payable, related party 907,680 1,359,698 Accrued expenses and other payables 956,530 995,206 Accrued expenses, related party 225,018 188,406 Other Current Liabilities 218,146 - Current portion of finance lease liabilities 34,170 27,347 Current portion of operating lease liabilities 101,883 130,355 Total current liabilities 4,397,271 4,131,262 Non-current portion of finance lease liabilities 13,668 27,336 Non-current portion of operating lease liabilities - 35,208 Convertible notes payable, related parties 465,982 800,000 Total liabilities $4,876,921 $4,993,806 Commitments and contingencies Stockholders’ equity Common stock, par value $0.001; authorized 125,000,000 shares; 88,772,518 shares issued and 88,756,989 shares outstanding as of June 30, 2026; 80,486,449 shares issued and 80,453,116 shares outstanding as of December 31, 2025; $88,773 $80,487 Additional paid in capital 139,968,127 137,418,974 Accumulated deficit (135,674,507) (133,775,322)Treasury stock, at cost, 33,333 shares (911,516) (911,516)Total stockholders’ equity $3,470,877 $2,812,623 Total liabilities and stockholders’ equity $8,347,798 $7,806,429
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED) Three Months
Ended Three Months
Ended Six Months
Ended Six Months
Ended June 30, 2026 June 30, 2025 June 30, 2026 June 30, 2025 Product sales, net $2,841,038 $2,323,466 $5,003,071 $4,555,886 Cost of products sold 930,871 705,860 1,528,880 1,290,845 Gross profit $1,910,167 $1,617,606 $3,474,191 $3,265,041 Selling, general and administrative expenses $2,945,532 $3,030,952 $5,318,184 $6,287,680 Research and development expenses 6,609 51,789 6,609 420,909 Depreciation and amortization expense 19,589 19,496 39,043 38,936 Total operating expenses $2,971,730 $3,102,237 $5,363,836 $6,747,525 Loss from operations $(1,061,563) $(1,484,631) $(1,889,645) $(3,482,484)Interest (expense) income, net 2,231 1,521 (9,540) 4,788 Loss before provision for income taxes $(1,059,332) $(1,483,110) $(1,899,185) $(3,477,696)Provision for income taxes - - - - Net loss $(1,059,332) $(1,483,110) $(1,899,185) $(3,477,696) Net loss per share applicable to common stockholders— Basic and Diluted (0.01) (0.02) (0.02) (0.04) Weighted average shares outstanding and to be issued— Basic and diluted 93,126,415 82,049,984 87,386,906 81,903,323