Milestone Scientific Reports Financial Results for Third Quarter 2026

(NYSE:MLSS) Milestone Scientific Inc. provided a business update and announced financial results for the three and nine months ended September 30, 2026. The company identified cost-reduction initiatives expected to generate approximately $400,000 in additional annual savings, aiming to strengthen its path to potential profitability in Q4 2026 and additional profitable quarters in 2027. Milestone expanded CompuFlo® clinical adoption, including the initiation of clinical use at Rothman Orthopaedics and the addition of Pain and Spine Specialists, a 22-location Northeastern U.S. pain management network, to the CompuFlo Advisor Program. The company 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. A peer-reviewed 79-patient University of Texas Medical Branch study associated CompuFlo-guided epidural access with approximately 91% lower adjusted odds of composite complications compared with conventional techniques. The company highlighted an estimated 30 million-plus annual epidural procedures worldwide, including more than 11 million in the U.S., and stated that just 2% U.S. penetration could represent approximately $33 million in annual disposable revenue at $150 per procedure (illustrative only; not a revenue forecast). Milestone submitted a provisional patent application for a new application of CompuFlo technology in intrathecal pump refills. International commercialization efforts included distributor engagement and market development activities in Italy and Greece. The company achieved a debt-free balance sheet by eliminating outstanding director loans through a debt-to-equity conversion. 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, a decrease of $140,000 or 5.9%. 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. 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. 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. 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%. 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. Expenses under an existing agreement decreased to approximately $91,000 from approximately $351,000 in the prior-year period. 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. Management reaffirmed its full-year 2026 revenue outlook of $9.8 million to $10.2 million. The company expects CompuFlo® medical business revenue to grow at a faster rate than overall company 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. Quarterly revenue of approximately $2.6 million to $2.7 million would bring the company near its profitability threshold.

Milestone Scientific Highlights Growing Clinical Adoption and Expanding Physician Acceptance of CompuFlo® Across Epidural, Neuromodulation, and Interventional Pain Procedures

Milestone Scientific Inc. announced continued growth in clinical adoption and physician acceptance of its CompuFlo® Epidural System, following new peer-reviewed research from the University of Texas Medical Branch. The study, published in Operative Neurosurgery, showed that CompuFlo-guided epidural access during spinal cord stimulator implantation procedures was associated with significantly lower complication rates compared to conventional techniques. The publication highlights expanding clinical acceptance of CompuFlo technology across a broad range of procedures requiring accurate epidural space identification. CompuFlo provides continuous real-time pressure sensing and audible feedback during needle advancement, improving procedural precision, safety, and physician confidence. The UTMB study found a 91% reduction in the odds of composite complications in SCS procedures with CompuFlo guidance. The technology has been evaluated or utilized across more than 40 universities, academic medical centers, and teaching hospitals worldwide. The announcement also contains forward-looking statements regarding Milestone's business plan, expected revenues, regulatory approvals, and future success.

Milestone Scientific Expands CompuFlo® Medical Business with Advisor Program and Growing National Clinical Adoption

Milestone Scientific Inc. (NYSE: MLSS) provided an update on the expansion of its CompuFlo® medical business, emphasizing increasing physician utilization, expanding clinical engagement, and ongoing development of its commercial and reimbursement infrastructure. The CompuFlo® Advisor Program, launched in February 2026, is active across several Medicare Administrative Contractor (MAC) jurisdictions and commercial payers, with expansion underway. The company is collaborating with academic institutions for clinical validation and is focused on building a scalable recurring revenue model driven by disposables. CompuFlo® is currently associated with CPT® Category III code 0777T, and progression to Category I designation is not guaranteed. The announcement highlights foundational efforts for long-term growth and commercialization.

MILESTONE SCIENTIFIC INC.