Milestone Scientific Highlights Building a Scalable Growth Platform for CompuFlo® Medical Business

Milestone is seeking repeat procedure use and disposable revenue as it expands beyond its current reimbursed markets.

Rhea-AI Summary

Milestone Scientific (MLSS) outlined physician activity, reimbursement access and commercial coverage for its CompuFlo medical business.

Medical segment revenue has grown, and the Advisor Program collected over 180 epidural procedure feedback submissions through September 2026. Healthcare providers have access to Medicare payment of approximately $325 per CompuFlo-guided procedure under Category III code 0777T in the Novitas and First Coast jurisdictions. The commercial organization includes three dedicated medical sales professionals, approximately 15 sales consultants and three distribution partners.

In a peer-reviewed 79-patient study, CompuFlo-guided epidural access was associated with approximately a 91% reduction in the adjusted odds of composite complications compared with conventional loss-of-resistance techniques. Milestone is expanding activity in Palmetto, pursuing additional payer access and developing markets in Italy, Chile and Qatar.

6 points · 0 major

PositiveiHow this balance works

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointMedical segment revenue has grown.
• Moderate pointMedicare payment of approximately $325 per procedure is accessible to providers in the Novitas and First Coast jurisdictions.
• Minor pointOver 180 epidural procedure feedback submissions came through the Advisor Program through September 2026.
• Minor pointApproximately a 91% reduction in adjusted odds of composite complications was associated with CompuFlo-guided access in a 79-patient study.
• Minor pointCommercial coverage now includes three dedicated medical sales professionals, approximately 15 sales consultants and three distribution partners.
• Minor pointInternational market development is advancing in Italy, Chile and Qatar.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Additional Medicare and commercial payer access remains under pursuit beyond the stated reimbursed jurisdictions.
• Minor point. Forward-looking: it has not happened yet and may not happen.Category I code status remains a longer-term opportunity; the current reimbursement code is Category III.

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-4.85% vs previous close $0.39 last price 4.5x rel. volume Open Argus

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Market Reaction – MLSS

$0.39 – $0.42 Day Range

$35.41M Market Cap

On Sep 29, the day this news came out, the latest delayed price for MLSS is 4.85% below the previous close. Our momentum scanner has recorded 2 alerts for this stock so far that day. The latest delayed price is $0.39. Relative volume is very high at 4.5x the average.

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Market Context

The Sep 16 CompuFlo advisor announcement covered a 22-location practice, an earlier physician-networ...

Analysis

The Sep 16 CompuFlo advisor announcement covered a 22-location practice, an earlier physician-network development connected to this update’s Advisor Program expansion and its report of over 180 procedure-feedback submissions.

Key Figures

Procedure feedback submissions: Over 180 submissions Earlier procedure evaluation: 145 procedures Reported ease of use: 99.3% +4 more

Procedure feedback submissions

Over 180 submissions

Advisor Program through September 2026

Earlier procedure evaluation

145 procedures

Across seven U.S. states

Reported ease of use

99.3%

Respondents in the earlier evaluation

Medicare payment

Approximately $325 per procedure

CPT Category III code 0777T in Novitas and First Coast jurisdictions

Study participants

79 patients

University of Texas Medical Branch study

Adjusted odds reduction

Approximately 91%

Composite complications versus conventional loss-of-resistance techniques

Target study participants

Approximately 50 participants

University of Minnesota study evaluating CathCheck against epidurography

Historical Context

2 past events · Latest: Sep 16

2 events

1. Sep 16

   Advisor partnership

   24h Move

   -0.1%

   Named a CompuFlo advisor and development partner tied to a 22-location interventional pain practice.

2. Aug 14

   Quarterly results

   24h Move

   -10.5%

   Reported medical-segment revenue growth alongside a narrower net loss and lower gross margin.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cpt category iii, adjusted odds, loss-of-resistance, epidurography

4 terms

cpt category iii regulatory

"under CPT® Category III code 0777T in the Novitas and First Coast jurisdictions"

CPT Category III codes are temporary billing labels used to identify and track new or experimental medical procedures, services, or technologies while evidence about their safety, usefulness, and cost is being collected. For investors, these codes matter because they help measure real-world adoption and outcomes—similar to a temporary product barcode that lets payers and hospitals gather data before deciding on permanent coverage and reimbursement, which can influence revenue prospects for healthcare companies.

adjusted odds technical

"approximately a 91% reduction in the adjusted odds of composite complications"

Adjusted odds (often reported as an adjusted odds ratio) is a statistical measure from a model that estimates how much more or less likely an outcome is for one group compared with another after accounting for other factors that could influence the result. Think of it as comparing two players’ chances while holding constant differences like age or prior health, so the comparison isolates the effect of the factor of interest. Investors use it to judge whether reported links—such as between a treatment and an outcome—remain after controlling for confounding variables.

loss-of-resistance medical

"compared with conventional loss-of-resistance techniques"

A loss-of-resistance is a medical technique used to identify the epidural space during procedures such as epidural anesthesia: a clinician advances a needle while applying pressure to a syringe and feels a sudden drop in resistance when the needle passes into the hollow space around the spinal cord, similar to a finger slipping from a tight to a loose spot. It matters to investors because reports about this technique appear in clinical trial protocols, device descriptions, safety incidents, or regulatory filings, where proper use or malfunction can affect trial results, product approvals, liability, and commercial prospects.

epidurography medical

"CathCheck® against epidurography for confirmation of epidural catheter placement"

Epidurography is a medical imaging procedure that maps the epidural space around the spinal cord by injecting a contrast dye and taking X‑ray or fluoroscopic images. Think of it as putting a colored marker into a building’s corridors to reveal blockages, leaks or anatomical changes. It matters to investors because companies that make imaging equipment, contrast agents or spinal treatment devices may report clinical results, regulatory clearances or sales tied to the use and demand for this diagnostic technique.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CompuFlo Builds Momentum as Physician Adoption, Reimbursement Access, Commercial Coverage and Clinical Evidence Expand

ROSELAND, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE American: MLSS), a medical technology company specializing in advanced computerized injection and drug-delivery technologies, today highlighted continued progress in building a structured and scalable growth platform for its CompuFlo® medical business.

“We are building CompuFlo into a scalable medical business, and the early results are demonstrating the potential of that strategy,” said Eric Hines, Chief Executive Officer of Milestone Scientific. “Our growth in medical segment revenue reflects increasing market activity, while the expansion of our Advisor Program, reimbursement access, commercial organization and clinical footprint is creating the infrastructure to support much broader adoption. We are focused on converting physician experience into repeat utilization, expanding our presence in reimbursed markets and building the recurring disposable revenue model that can support sustained growth.”

Milestone has implemented a coordinated strategy centered on physician adoption, reimbursement, dedicated commercial execution, clinical support, market development and evidence generation. Together, these initiatives are designed to increase utilization, drive recurring disposable revenue and establish a repeatable model for geographic expansion.

Advisor Program Expanding Physician Experience and Adoption

A central element of the Company’s strategy is the CompuFlo Advisor Program, designed to accelerate hands-on physician experience, encourage repeat utilization, generate real-world reimbursement experience and identify physician champions who can support broader adoption.

Through September 2026, the Advisor Program generated over 180 epidural procedure feedback submissions across Medicare, commercial and other payer categories. This builds on an earlier evaluation involving 145 epidural procedures across seven U.S. states, where 99.3% of respondents reported CompuFlo was easy to use and all participating physicians indicated they would recommend the technology to colleagues.

The Company believes this growing base of physician experience can provide an important foundation for developing reference accounts, physician advocates and repeat utilization as commercial coverage expands.

Reimbursement Creates a Framework for Commercial Expansion

Milestone has also established an important reimbursement foundation for CompuFlo-guided procedures.

Healthcare providers currently have access to Medicare payment of approximately $325 per procedure under CPT® Category III code 0777T in the Novitas and First Coast jurisdictions. The Company is concentrating its commercial resources within these reimbursed markets while expanding activity within Palmetto and pursuing additional Medicare and commercial payer opportunities. Milestone has partnered with Avania Medical LLC for reimbursement and market-access support to help providers navigate reimbursement and support broader adoption.

The Company’s strategy is to establish utilization in markets where reimbursement is available, develop reference accounts and physician champions, and use those experiences to support expansion into additional jurisdictions.

Expanded Commercial Infrastructure Extends Market Coverage

Milestone has significantly expanded its commercial infrastructure to extend coverage. The organization now includes three dedicated medical sales professionals, approximately 15 sales consultants, three distribution partners, clinical and reimbursement support, physician advisors and key opinion leaders, with additional resources being added to expand coverage across other MAC jurisdictions.

This broader field organization is designed to reach key care settings including interventional pain practices, multisite physician groups, ambulatory surgery centers, hospitals and academic medical centers. The Company is pursuing a focused commercial model intended to combine direct sales resources, distribution partners, physician education, reimbursement support and clinical expertise.

“We are building commercial infrastructure around utilization rather than simply device placement,” said Mr. Hines. “The objective is to support physicians through the adoption process, help establish successful reference accounts and create the infrastructure needed to replicate that success across additional markets.”

Clinical Evidence Supporting Broader Utilization

Clinical validation continues in parallel with commercial expansion. CompuFlo has been evaluated or utilized at more than 40 universities, academic medical centers and teaching hospitals worldwide.

A recent 79-patient peer-reviewed University of Texas Medical Branch study associated CompuFlo-guided epidural access during spinal cord stimulator implantation with approximately a 91% reduction in the adjusted odds of composite complications compared with conventional loss-of-resistance techniques.

Additional research is underway, including a University of Minnesota study evaluating CathCheck® against epidurography for confirmation of epidural catheter placement, targeting approximately 50 participants. The Company believes continued clinical research can support broader utilization across pain management, neuromodulation, obstetric and other epidural procedures.

Physician Education and Market Development

The Company is also increasing physician awareness and market recognition through participation in leading pain and neuromodulation meetings, including NANS, ASPN, FSIPP, ISPN and other regional and international conferences, together with webinars, physician education and direct engagement with key opinion leaders.

These activities are intended to complement the Company’s commercial and clinical initiatives by increasing physician familiarity with CompuFlo and creating additional opportunities for hands-on evaluation and adoption.

International Market Development Expands Growth Opportunities

Internationally, Milestone is advancing market-development activities in Italy, Chile and Qatar, while evaluating additional opportunities across Europe, Latin America, the Middle East and Asia. The Company is pursuing international expansion through local distributors, physician champions, clinical education and targeted conference participation.

Milestone intends to apply the same general commercialization framework internationally: identify appropriate reimbursement and market-access pathways, establish physician experience and reference accounts, support clinical education and develop local commercial capabilities.

Positioned to Scale Utilization and Recurring Revenue

Mr. Hines concluded, “We have moved beyond establishing the building blocks of the CompuFlo medical business and are now focused on scaling the platform we have built. Physician adoption is expanding, reimbursement pathways are developing, our commercial organization is materially broader, and a growing body of clinical experience and evidence is supporting the technology.

“Our objective is to increase utilization, convert physician experience into recurring procedure volume and disposable revenue, expand our presence in reimbursed U.S. markets, and replicate that model across additional U.S. and international markets. As we continue to build the clinical and utilization evidence around CompuFlo, we are also working toward the longer-term opportunity to support a future transition of CPT 0777T from Category III to Category I.

“We believe the opportunity ahead is not simply to place more devices, but to establish CompuFlo as a repeat-use technology embedded in everyday clinical practice. The infrastructure we are putting in place today is designed to support that objective and create a scalable medical business with increasing recurring revenue potential.”

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. 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. This release also contains forward-looking statements regarding the development, capabilities, adoption, timing and expected benefits of Milo and Milestone's broader artificial intelligence strategy, and the anticipated impact of the Company's distribution agreement with Red One Medical, which does not guarantee contract awards, product evaluations, purchase orders or adoption by any federal agency or healthcare facility.

Contact:

HAYDEN IR:

James Carbonara
(646)-755-7412
james@haydenir.com

Brett Maas
(646) 536-7331
brett@haydenir.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Where is Medicare payment available for Milestone Scientific's CompuFlo-guided procedures?

Healthcare providers have access to Medicare payment of approximately $325 per procedure under Category III code 0777T in the Novitas and First Coast jurisdictions.

What did the 79-patient study find about CompuFlo-guided epidural access?

The peer-reviewed study associated CompuFlo-guided epidural access during spinal cord stimulator implantation with approximately a 91% reduction in the adjusted odds of composite complications compared with conventional loss-of-resistance techniques.

What is the University of Minnesota studying in relation to Milestone Scientific's CompuFlo business?

The University of Minnesota is studying CathCheck against epidurography for confirmation of epidural catheter placement. The study is underway and targets approximately 50 participants.