Milestone Scientific Provides Major Commercial Growth Update as CompuFlo® Expands Across 30 Million+ Annual Global Epidural Procedures

The commercial strategy focuses on converting physician interest into active accounts and repeat disposable purchases.

Rhea-AI Summary

Milestone Scientific (MLSS) reported medical segment revenue growth of more than 200% year over year as it expanded CompuFlo commercialization. The revenue comparison covers the second quarter of 2026. Its U.S. pipeline exceeds 500 commercial leads, with prospective healthcare-network opportunities at varying stages. Red One Medical provides access to federal healthcare customers, while distribution relationships support expansion in Italy, Qatar and Chile.

The company illustrated $33 million in potential annual disposable revenue at 2% penetration of the estimated U.S. epidural procedure market, assuming approximately 220,000 annual procedures and a $150 selling price per procedure. This is not a revenue projection and assumes clinical eligibility, physician adoption and disposable purchasing. Approximately $325 per qualifying CPT 0777T procedure has been reported in Novitas and First Coast jurisdictions.

10 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 increased 200%+ year over year in the second quarter of 2026.
• Moderate pointU.S. commercial pipeline includes more than 500 leads for physician and institutional outreach.
• Moderate pointRed One Medical provides access to VA, Department of Defense, Defense Health Agency and other federal customers.
• Minor pointCommercial resources include five dedicated medical sales professionals, approximately 15 sales consultants and three distribution partners.
• Minor pointMedicare payment pathways include approximately $325 per qualifying CPT 0777T procedure in Novitas and First Coast jurisdictions.

5 minor points

• Minor pointInternational distribution relationships cover Italy, Qatar and Chile, supporting the company's expansion efforts.
• Minor pointA 79-patient study associated CompuFlo-guided access during spinal cord stimulator implantation with approximately 91% lower adjusted odds of composite complications versus conventional loss-of-resistance techniques.
• Minor pointThe technology platform has approximately 305 issued patents, including approximately 121 CompuFlo-related patents, and regulatory approvals in 30 countries.
• Minor point. Forward-looking: it has not happened yet and may not happen.The company plans to advance clinical and utilization evidence to pursue CPT Category I status.
• Minor point. Forward-looking: it has not happened yet and may not happen.Milestone intends to explore additional Dynamic Pressure Sensing applications beyond the current epidural market.

Negative

• Moderate pointHealthcare-network engagements remain prospective opportunities at varying stages, rather than completed institutional adoption.
• Minor point. Forward-looking: it has not happened yet and may not happen.The illustrative $33 million annual disposable revenue opportunity assumes clinical eligibility, physician adoption and disposable purchasing; it is not a projection.

Argus Oct 29 session 2 alerts

-0.54% close to close 2.6x rel. volume Open Argus

Details

News Market Reaction – MLSS

-8.8% Trough Tracked

$29.90M Mkt Cap at Peak Alert

On Oct 29, the day this news came out, MLSS closed 0.54% below the previous close. Argus tracked a trough of -8.8% from its starting point during tracking. Our momentum scanner recorded 2 alerts for this stock that day. Relative volume reached 2.6x the daily average during tracking.

Data tracked by StockTitan Argus for the Oct 29 session.

Key Figures

Potential annual disposable revenue: $33 million U.S. market penetration assumption: 2% Assumed selling price: $150 per procedure +5 more

Potential annual disposable revenue

$33 million

Illustrative scenario at 2% penetration of the estimated U.S. procedure market; not a revenue projection

U.S. market penetration assumption

2%

Illustrative estimate of the U.S. epidural procedure market

Assumed selling price

$150 per procedure

Assumption used in the illustrative disposable-revenue scenario

Medical segment revenue growth

200%+ year-over-year

Second quarter of 2026

U.S. commercial leads

500+

Physician and institutional pipeline

Study sample size

79 patients

University of Texas Medical Branch study of CompuFlo-guided epidural access

Adjusted odds of composite complications

Approximately 91% lower

CompuFlo-guided access compared with conventional loss-of-resistance techniques

Annual global epidural procedures

30 million+

Estimated global procedure market

Historical Context

1 past event · Latest: Sep 29

1 event

1. Sep 29

   Commercial update

   24h Move

   +0.0%

   Earlier update reported over 180 feedback submissions; this update reports over 200 across approximately 15 sites.

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

Key Terms

cpt category i, loss-of-resistance, adjusted odds

3 terms

cpt category i regulatory

"pursue CPT Category I status"

CPT Category I are the standard five-digit Current Procedural Terminology codes, maintained by the American Medical Association, used to report established medical procedures and services for clinical documentation and billing. A procedure qualifies for a Category I code when it is widely performed, has an accepted clinical practice, and—when regulatory clearance or approval is relevant—meets any applicable FDA requirements; Category I codes carry set descriptors and are used by payers and providers to identify services for reimbursement and claims processing. They are distinct from other CPT groupings (for example, Category III temporary codes for emerging or investigational procedures) and do not indicate a payment rate by themselves but provide the standardized code that payers use to determine coverage and payment.

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.

adjusted odds technical

"approximately 91% lower 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.

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

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Company Reports 500+ U.S. Leads, Expanding Healthcare Network Relationships, Federal Market Access, International Distribution and 300+ Issued and Pending Patents Worldwide

Just 2% Penetration of Estimated U.S. Epidural Procedure Market Represents $33 Million in Potential Annual Disposable Revenue

Medical Segment Revenue Increased 200%+ in Q2 2026 as Company Advances Commercial Expansion and Recurring Revenue Strategy

ROSELAND, N.J., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE American: MLSS), a medical technology company specializing in advanced computerized injection and drug-delivery technologies, today provided a comprehensive commercial update highlighting significant progress in expanding its CompuFlo^® Epidural System across U.S. and international markets.

Milestone believes its proprietary Dynamic Pressure Sensing^® technology addresses a substantial opportunity within an estimated 30 million-plus annual epidural procedures globally, including more than 11 million in the United States.

At just 2% penetration of the estimated U.S. procedure market, approximately 220,000 annual procedures would represent $33 million in potential annual disposable revenue, assuming a $150 selling price per procedure. This illustrative opportunity excludes equipment sales, international markets and potential future medical applications. It is not a revenue projection and assumes clinical eligibility, physician adoption and disposable purchasing.

With an expanded commercial organization, growing physician pipeline, established reimbursement pathways, international distribution and a substantial global patent portfolio, Milestone believes it is positioned to pursue a significantly larger share of this market.

Commercial Expansion and Recent Highlights

• 200%+ Medical Revenue Growth: Medical segment revenue increased 200%+ year-over-year in the second quarter of 2026, demonstrating early commercial momentum.
• 500+ U.S. Commercial Leads: Expanding physician and institutional pipeline generated through targeted sales, digital marketing, medical conferences, physician referrals and clinical outreach.
• Digital Marketing Momentum: Since launching its social media marketing in April 2026, CompuFlo^® social media content has generated more than 217,000 views and approximately 1,600 link clicks through October 27, 2026, expanding awareness among potential customers and supporting physician outreach and lead generation.
• Major Healthcare Network Opportunities: Milestone’s development relationship with Pain and Spine Specialists, led by Dr. Sudhir Rao, spans 22 locations across four states. Additional commercial engagement includes Rothman Orthopaedics, Main Line Health and Memorial Health, representing prospective institutional opportunities at varying stages.
• Growing Physician Adoption: The CompuFlo Advisor Program has generated more than 200 procedure-feedback submissions across approximately 15 sites, supporting clinical experience, physician advocacy and reimbursement development.
• Established Medicare Payment Pathways: Approximately $325 per qualifying CPT^® 0777T procedure has been reported in Novitas and First Coast jurisdictions, with Avania Medical LLC supporting broader reimbursement and market-access initiatives.
• Expanded U.S. Commercial Organization: Five dedicated medical sales professionals, approximately 15 sales consultants, three distribution partners, and additional clinical, reimbursement and physician-advisor resources support market penetration.
• Federal Healthcare Expansion: Strategic distribution partner Red One Medical provides access to VA, Department of Defense, Defense Health Agency and other federal healthcare customers, supporting potential nationwide institutional adoption.
• Growing International Footprint: Clinical education initiatives in Italy reached more than 40 physicians from over 10 hospitals, while relationships with Movi S.p.A. in Italy, Avalon Medical in Qatar and Luxxustone Spa in Chile support broader international expansion.
• Extensive Global Intellectual Property: Approximately 305 issued patents, including approximately 121 CompuFlo-related patents, together with regulatory approvals in 30 countries, support the Company's technology platform and potential future applications.
• Expanding Clinical Evidence: CompuFlo has been evaluated or utilized at more than 40 universities, academic medical centers and teaching hospitals worldwide, with additional clinical research and academic collaborations underway.

Large Market Opportunity and Recurring Revenue Potential

Milestone believes CompuFlo's commercial opportunity is supported by the scale of the global epidural market and its recurring-use business model.

Each additional active physician and procedure creates potential demand for the Company's proprietary disposable products, providing an opportunity to build predictable purchasing patterns as clinical adoption expands.

The Company's commercial strategy focuses on converting physician interest into active accounts through demonstrations, training, initial procedures, reimbursement support and repeat purchasing.

Milestone believes larger multisite physician practices and healthcare systems provide particularly attractive opportunities, as initial successful adoption may enable expansion across additional physicians and affiliated locations.

Building the Foundation for Broader Market Penetration

Milestone is executing a targeted geographic strategy, initially concentrating commercial resources in Medicare jurisdictions with established payment pathways and expanding into additional regions as physician utilization and reimbursement experience develop.

The Company is increasing its visibility through leading pain and neuromodulation conferences, including ASPN, FSIPP and ISPN, together with physician webinars, hands-on education and engagement with key opinion leaders.

Clinical validation remains a central component of this strategy. A recent 79-patient peer-reviewed University of Texas Medical Branch study associated CompuFlo-guided epidural access during spinal cord stimulator implantation with approximately 91% lower adjusted odds of composite complications compared with conventional loss-of-resistance techniques.

Additional research, including a University of Minnesota evaluation of CathCheck^®, is intended to support broader clinical understanding and utilization across appropriate epidural applications.

Milestone also intends to leverage its broad intellectual-property portfolio to explore additional applications of Dynamic Pressure Sensing^® technology beyond the current epidural market.

Management Commentary

Eric Hines, Chief Executive Officer of Milestone Scientific, commented:

“We believe Milestone is entering an important new phase of commercial growth. We are addressing a large global market with patented technology, growing clinical validation, established reimbursement pathways and a significantly expanded commercial organization.

“The scale of the opportunity is compelling. Just 2% penetration of the estimated U.S. procedure market represents approximately $33 million in potential annual disposable revenue at our illustrative selling-price assumption, before considering international expansion, equipment sales or additional medical applications.

“Our commercial strategy is now focused on converting our growing pipeline of more than 500 U.S. opportunities into active accounts, increasing procedure volumes and expanding successful adoption across larger healthcare networks.

“With growing physician utilization, federal market access, expanding international distribution and a substantial global patent portfolio, we believe the Company has established a stronger foundation for long-term growth.

“Our goal is to scale recurring disposable revenue, replicate successful commercialization across additional markets and continue advancing the clinical and utilization evidence necessary to pursue CPT Category I status, supporting broader adoption of CompuFlo.”

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:

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FAQ

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

How much did Milestone Scientific's medical segment revenue grow in Q2 2026?

Milestone Scientific's medical segment revenue increased 200%+ year over year in the second quarter of 2026.

What did the CompuFlo study show about complications during spinal cord stimulator implantation?

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

How is Milestone Scientific prioritizing CompuFlo's geographic expansion?

Milestone is initially concentrating commercial resources in Medicare jurisdictions with established payment pathways. Its strategy calls for expansion into additional regions as physician utilization and reimbursement experience develop.

What participation has Milestone Scientific reported in the CompuFlo Advisor Program?

The CompuFlo Advisor Program has generated more than 200 procedure-feedback submissions across approximately 15 sites, supporting clinical experience, physician advocacy and reimbursement development.