Milestone Scientific Announces Commercial Rollout of CompuFlo® Epidural System at iHeal Pain Center Following Medicare Price Assignment

Rhea-AI Summary

Milestone Scientific Inc. (NYSE: MLSS) announced the commercial rollout of its CompuFlo® Epidural System at iHeal Pain Center following successful epidural steroid injection (ESI) procedures. This marks the launch of Milestone's next phase of commercial activities after achieving a granted Medicare Part B Physician payment rate for the system under CPT code CPT0777T.

The company also reported a robust pipeline of clinics in trials across multiple states through its partnership with Axial Biologics. The Medicare Price Assignment was granted across several Jurisdictional Medicare Administrative Contractors (JMAC) regions, including key states like Florida, Texas, and Pennsylvania.

Arjan Haverhals, CEO of Milestone Scientific, expressed satisfaction with the Axial Biologics partnership and the positive feedback from clinicians. The company is actively providing demos and performing procedures at numerous clinics, aiming to convert them into long-term users of the CompuFlo® technology.

Positive

• Successful adoption of CompuFlo® Epidural System at iHeal Pain Center
• Granted Medicare Part B Physician payment rate for CompuFlo® Epidural System
• Strategic partnership with Axial Biologics to accelerate adoption
• Robust pipeline of clinics in trials across multiple states
• Positive feedback from clinicians on the CompuFlo® system

Negative

• None.

Insights

Medical Research Analyst

The commercial rollout of Milestone Scientific's CompuFlo® Epidural System at iHeal Pain Center marks a significant milestone in the company's growth strategy. This adoption follows successful epidural steroid injection (ESI) procedures, demonstrating the system's clinical efficacy and potential for wider acceptance.

The recent Medicare Part B Physician payment rate granted for the CompuFlo® Epidural System under the CPT code CPT0777T is a important development. This pricing assignment across multiple Jurisdictional Medicare Administrative Contractors (JMAC) regions, including key states, significantly enhances the system's market potential and accessibility.

The strategic partnership with Axial Biologics appears to be accelerating adoption, with multiple customer pilots underway in states like New Jersey, Texas and Florida. This expansion strategy, combined with positive clinician feedback, suggests a promising outlook for increased market penetration.

However, investors should note that while initial adoption is encouraging, the long-term success will depend on consistent positive outcomes, continued clinician acceptance and the company's ability to scale its operations effectively.

Financial Analyst

The commercial rollout of the CompuFlo® Epidural System and the Medicare price assignment are positive developments for Milestone Scientific's financial outlook. The Medicare coverage across multiple regions significantly expands the potential market and could drive revenue growth.

With a market cap of $68,013,188, MLSS is a small-cap company and these developments could have a substantial impact on its financial performance. The partnership with Axial Biologics and the robust pipeline of clinics in trials suggest potential for accelerated revenue growth in the near term.

However, investors should consider that the company's ability to capitalize on these opportunities will depend on factors such as:

• Speed of adoption in new clinics
• Ability to manage production and distribution costs
• Potential competition in the market

While the news is positive, the company's small size makes it potentially volatile. Investors should monitor upcoming financial reports to assess the tangible impact of these developments on revenue and profitability.

Reports Robust Pipeline of Clinics in Trials Across Multiple States through Partnership with Axial Biologics

ROSELAND, N.J., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced that iHeal Pain Center has adopted the CompuFlo® Epidural System following successful epidural steroid injection (ESI) procedures by Dr. Desai, DO. Dr. Desai has performed six cervical and two lumbar ESI procedures using the CompuFlo® Epidural System, leading to its integration within the clinic.

This milestone marks the launch of the next phase of Milestone Scientific's commercial activities, following the recent achievement of a granted Medicare Part B Physician payment rate with First Coast Service Options Inc. (FCSO) and Novitas Solutions, Inc. for the CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure). The favorable Medicare Price Assignment was granted across multiple Jurisdictional Medicare Administrative Contractors (JMAC) regions, including key states such as Florida, Texas, Pennsylvania, New Jersey, Maryland, Colorado, Oklahoma, Louisiana, Arkansas, Mississippi, New Mexico, District of Columbia, and Delaware.

In addition to the Medicare pricing, Milestone Scientific recently announced a strategic partnership with Axial Biologics aimed at accelerating the adoption of the CompuFlo® Epidural System. The iHeal Pain Center represents the first clinic added through this partnership, with multiple customer pilots underway in key states such as New Jersey, Texas, and Florida.

“We are extremely pleased with our partnership with Axial Biologics, which has already led to the successful integration of the CompuFlo® Epidural System at iHeal Pain Center,” stated Arjan Haverhals, CEO of Milestone Scientific. “The feedback we’ve received from clinicians has been positive, particularly following the recent Medicare price assignment. The clinical benefits of the CompuFlo® system are clear—it provides real-time feedback, increasing precision for providers while reducing complications and enhancing patient safety. We are working tirelessly, providing demos and performing procedures at numerous clinics. This robust pipeline gives us confidence in our ability to convert these clinics into long-term users of the technology.”

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, 2022. 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: mlss@crescendo-ir.com
Tel: 212-671-1020

FAQ

What is the CompuFlo® Epidural System by Milestone Scientific (NYSE: MLSS)?

The CompuFlo® Epidural System is a computerized drug delivery instrument developed by Milestone Scientific that provides painless and precise injections for epidural procedures, offering real-time feedback to increase precision and enhance patient safety.

Has Milestone Scientific (NYSE: MLSS) received Medicare coverage for the CompuFlo® Epidural System?

Yes, Milestone Scientific has received a granted Medicare Part B Physician payment rate for the CompuFlo® Epidural System under the CPT code CPT0777T across multiple Jurisdictional Medicare Administrative Contractors (JMAC) regions.

Which pain center has adopted Milestone Scientific's (NYSE: MLSS) CompuFlo® Epidural System?

iHeal Pain Center has adopted the CompuFlo® Epidural System following successful epidural steroid injection (ESI) procedures performed by Dr. Desai, DO.

What partnership has Milestone Scientific (NYSE: MLSS) formed to accelerate adoption of the CompuFlo® Epidural System?

Milestone Scientific has formed a strategic partnership with Axial Biologics aimed at accelerating the adoption of the CompuFlo® Epidural System across multiple states.