Reports expansion of CompuFlo® Epidural System across additional pain management clinics and ambulatory surgery centers following Medicare price assignment in multiple U.S. states

ROSELAND, N.J., April  15, 2025  (GLOBE NEWSWIRE) --  Milestone Scientific Inc. (NYSE: 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 year ended December 31, 2024.

Neal Goldman, Chairman and Interim Chief Executive Officer of Milestone Scientific, stated, “While 2024 was a year of transition for Milestone Scientific, we laid the foundation for a strong rebound in 2025. We focused intently on streamlining operations and aligning our cost structure to support sustainable growth. The initial performance in Q1 2025 has been highly encouraging, and we are optimistic about continued traction in both the dental and medical segments.”

“On the medical side, we made substantial progress in establishing the reimbursement infrastructure to drive adoption of our CompuFlo® Epidural System. In 2024, First Coast Service Options (FCSO) and Novitas Solutions, two Jurisdictional Medicare Administrative Contractors (JMACs), assigned favorable Medicare Part B physician payment rates for our technology under CPT code 0777T. These assignments now cover providers in Florida, New Jersey, Texas, Pennsylvania, Maryland, Delaware, Washington D.C., Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Arkansas. These Medicare pricing decisions have significantly expanded our addressable market and positioned us to scale adoption. Importantly, we are actively pursuing reimbursement approvals with additional JMACs to further our national expansion and make the CompuFlo system more widely accessible across the U.S.”

“Additionally, we were awarded a contract for the Federal Supply Schedule (FSS), enabling federal medical facilities to purchase CompuFlo. We are currently working with key stakeholders to drive adoption of the CompuFlo® Epidural System and improve patient outcomes within the U.S. Department of Veterans Affairs (VA), Department of Defense (DoD), Indian Health Service (IHS), and other federal healthcare systems.”

“Beyond our federal initiatives, we are seeing strong commercial traction in the private sector, highlighted by new rollouts during Q1 2025 at Advanced Spine and Pain Management, Pain Doctors Medical LLC, and InfiniSurg, LLC. These recent adoptions demonstrate growing clinical confidence in the CompuFlo system and broader market acceptance of our technology across pain management clinics and ambulatory surgery centers. Our strategic partnership with Axial Biologics has also continued to enhance our distribution footprint in key U.S. markets.”

“In the dental segment, our STA Single Tooth Anesthesia System remains the global leader in computer-controlled local anesthetic delivery, with over 95 million injections administered to date. In 2024, we further leveraged this leadership through the expansion of our direct-to-consumer e-commerce platform, which is already delivering improved margins and increased customer engagement.”

Mr. Goldman concluded, “We believe we are in the early stages of unlocking the true commercial potential of our core technology. The clinical response has been exceptionally positive, and we are well-positioned to capitalize on the growth opportunities ahead. Q1 2025 results thus far reinforce our confidence, and we are highly encouraged by the outlook for the balance of the year on both the dental and medical fronts.”

Financial Results for the Year Ended December 31, 2024

For the years ended December 31, 2024 and 2023, revenue was approximately $8.6 million and $9.8 million, respectively, a decrease of approximately $1.2 million. The Company launched an e-commerce platform to sell and ship the STA Single Tooth Anesthesia System® (STA) and handpieces directly to dental offices and groups within the U.S. U.S. E-commerce revenue was approximately $5.1 million in 2024, compared to $4.8 million in 2023.

The Company recorded no revenue from Henry Schein in 2024, compared to approximately $179,000 in 2023. Revenue from other U.S. distributors was approximately $9,000 in 2024, down from $485,000 in 2023. The Company terminated all non-exclusive distributor agreements in the U.S. in September 2023.

International revenue was approximately $3.4 million in 2024, a decline of $756,000 from 2023, primarily due to underperformance in certain markets and shipping delays.

Gross profit for 2024 was $6.4 million, compared to $6.8 million in 2023. The decrease reflects lower international sales, partially offset by higher margins from e-commerce. In 2023, the Company also recorded a $258,000 inventory write-off for expired/obsolete medical inventory.

Operating loss for 2024 was $6.8 million, an improvement from $7.1 million in 2023. The improvement was driven by higher-margin e-commerce sales and reduced SG&A. Net loss was approximately $4.7 million, or $(0.06) per share, compared to a net loss of $6.9 million, or $(0.10) per share, in 2023.

As of December 31, 2024, the Company had cash of $3.3 million, working capital of approximately $5.5 million, and no debt.

About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS), 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, 2024. 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:  
Crescendo Communications, LLC
Email: [email protected]
Tel: 212-671-1020

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MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS   December 31, 
2024  December 31, 
2023 ASSETS Current assets: Cash and cash equivalents $3,258,058  $2,977,713 Marketable securities  -   2,976,573 Accounts receivable, net of allowance for credit losses of $10,000, respectively  475,376   312,664 Prepaid expenses and other current assets  564,645   517,785 Inventories  3,713,215   2,638,186 Advances on contracts  1,275,260   1,371,548 Total current assets  9,286,554   10,794,469 Furniture, fixtures and equipment, net  12,921   10,024 Intangibles, net  148,404   178,636 Right of use assets finance lease  67,201   8,998 Right of use assets operating lease  257,842   355,235 Other assets  24,150   24,150 Total assets $9,797,072  $11,371,512   LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $1,021,393  $689,604 Accounts payable, related party  493,313   410,512 Accrued expenses and other payables  1,796,319   1,511,717 Accrued expenses, related party  304,293   137,189 Accrued liabilities noncontrolling interest  -   214,000 Current portion of finance lease liabilities  12,530   10,264 Current portion of operating lease liabilities  116,279   103,427 Total current liabilities  3,744,127   3,076,713 Non-current portion of finance lease liabilities  54,672   434 Non-current portion of operating lease liabilities  165,573   281,853 Total liabilities $3,964,372  $3,359,000  Commitments and contingencies  Stockholders’ equity Common stock, par value $0.001; authorized 100,000,000 shares; 78,047,798 shares issued and 78,014,465 shares outstanding as of December 31, 2024; 75,881,840 shares issued and 75,848,507 shares outstanding as of December 31, 2023;  78,048   75,881 Additional paid in capital  134,719,274   132,187,656 Accumulated deficit  (128,053,106)  (123,339,509)Treasury stock, at cost, 33,333 shares  (911,516)  (911,516)Total Milestone Scientific, Inc. stockholders' equity  5,832,700   8,012,512  Total liabilities and stockholders’ equity $9,797,072  $11,371,512

MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR YEARS ENDED DECEMBER 31,   2024  2023  Product sales, net $8,629,928  $9,827,444 Cost of products sold  2,195,340   3,034,832 Gross profit  6,434,588   6,792,612  Selling, general and administrative expenses  12,295,330   13,135,796 Research and development expenses  858,767   701,378 Depreciation and amortization expense  37,448   61,912 Total operating expenses  13,191,545   13,899,086  Loss from operations  (6,756,957)  (7,106,474)Interest income  60,265   125,527 Gain on sale of net operating losses  1,983,095   - Loss before provision for income taxes  (4,713,597)  (6,980,947) Net loss  (4,713,597)  (6,980,947)Net loss attributable to noncontrolling interests  -   (51,843)Net loss attributable to Milestone Scientific Inc. $(4,713,597) $(6,929,104) Net loss per share applicable to common stockholders— Basic and Diluted  (0.06)  (0.10) Weighted average shares outstanding and to be issued— Basic and diluted  79,791,188   72,775,781