Press Releases May 7, 2026 08:30 AM

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

Milestone Scientific expands national adoption and commercial infrastructure for its CompuFlo® drug delivery system.

By Ajmal Hussain MLSS

Milestone Scientific (NYSE: MLSS) announced progress on expanding its CompuFlo® medical business, including growth of an Advisor Program driving physician utilization, regional expansion into Medicare and commercial payer jurisdictions, and partnerships with academic institutions for clinical validation. The company is building out its sales presence targeting pain clinics, ambulatory surgery centers, and hospitals, with an emphasis on recurring revenue through disposables. Milestone is also focusing on payer engagement and advancing reimbursement pathways, with ongoing efforts aimed at achieving Category I CPT® code designation for the technology.

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

Key Points

  • Launch and expansion of the CompuFlo® Advisor Program across multiple Medicare Administrative Contractor regions and commercial payers to increase clinical use.
  • Growing national sales network targeting pain management clinics and ASCs to drive device placement and procedural adoption.
  • Collaborations with leading universities for clinical validation and training to support broader physician acceptance and data generation.

ROSELAND, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments, today provided an update on the expansion of its CompuFlo® medical business, highlighting increasing physician utilization, expanding clinical engagement, and continued development of its commercial and reimbursement infrastructure.

Advisor Program Driving Utilization and Real-World Data Generation

Since launching the CompuFlo® Advisor Program in February 2026, the Company has onboarded physician advisors and initiated procedural use across key Medicare Administrative Contractor (MAC) jurisdictions, including Novitas, First Coast Service Options, and Palmetto, as well as select commercial payers.

The program is currently active in NJ, FL, PA, NY, TN, TX, and GA, with expansion into additional MAC regions underway, including Noridian and NGS.

• Active epidural procedures being performed using CompuFlo®
• Initial cases submitted across Medicare and commercial payers
• Continued onboarding of physician advisors

Milestone is executing a structured roadmap to expand clinical utilization, support real-world data generation, and enhance payer engagement, with a scalable recurring revenue model driven by disposables.

Building the Foundation for Long-Term Growth and Reimbursement Pathway

Milestone continues to expand its national sales footprint through a growing network of sales consultant partners across NJ, NY, PA, FL, TX, WA, CA, OR, and CO, targeting pain clinics, ASCs, and hospitals. In parallel, digital and social media initiatives are increasing inbound interest from medical professionals, supporting advisor recruitment and conversion into direct purchasing accounts, driving both device placement and procedural utilization.

The Company is also collaborating with leading academic institutions, including the University of Texas, University of Kansas, and University of Minnesota, to support clinical validation and training, contributing to broader clinical acceptance as additional data is generated.

These efforts are aligned with Milestone’s focus on advancing the key elements required for long-term commercialization, including expanding physician utilization, increasing geographic coverage across MAC jurisdictions, driving recurring revenue through disposable utilization, and strengthening clinical and commercial infrastructure.

CompuFlo® is currently associated with CPT® Category III code 0777T. Progression to Category I designation is determined by the American Medical Association and typically requires sustained clinical utilization, peer-reviewed evidence, and broad physician adoption. Milestone’s ongoing initiatives—including physician utilization programs, clinical studies, and payer engagement—are intended to support these factors over time; however, there can be no assurance that Category I designation will be achieved.

“The progress we are making reflects the early stages of building a durable clinical and commercial adoption engine,” said Eric Hines, CEO of Milestone Scientific. “We are focused on expanding physician utilization, generating clinical evidence, and engaging with payers—foundational elements for long-term growth. We expect adoption and broader commercialization to build over time as utilization expands and additional clinical experience is accumulated.”

About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) 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, 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. Coding and payment decisions are determined solely by providers and payers based on applicable laws and policies. Any potential Category I designation is determined solely by the American Medical Association and is not guaranteed. Providers remain responsible for compliance with all applicable billing, coding, and regulatory requirements. Forward-looking case submission expectations, reimbursement targets, and revenue estimates referenced herein are based on current program enrollment, advisor commitments, and historical payer activity, and are subject to change based on clinical scheduling, payer processing timelines, regulatory developments, and other factors. There can be no assurance that Category I designation, targeted reimbursement levels, or projected revenue levels will be achieved.

Contact:

HAYDEN IR:
James Carbonara
(646)-755-7412
[email protected]

Brett Maas
(646) 536-7331
[email protected]


Risks

  • Uncertainty whether CompuFlo® will achieve Category I CPT® code designation, which requires sustained clinical adoption and evidence.
  • Potential delays or failures in reimbursement approval processes impacting revenue realization.
  • Competitive pressures and regulatory risks within the medical device and healthcare sectors that may affect Milestone's growth prospects.

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