Milestone Scientific Announces Medicare Price Assignment for the CompuFlo® Epidural System in Texas, Pennsylvania, New Jersey, Maryland, Colorado, Oklahoma, Louisiana, Arkansas, Mississippi, New Mexico, District of Columbia, and Delaware

Rhea-AI Summary

Milestone Scientific (NYSE: MLSS) has secured Medicare price assignment for its CompuFlo® Epidural System in 12 states through Novitas Solutions. This covers Medicare regions Jurisdiction L and H, following a recent approval in Florida. The decision applies to the AMA's Category III CPT® code CPT0777T for real-time pressure-sensing epidural guidance systems.

This expansion represents a significant market opportunity, with an estimated 3.0 million epidural steroid injection procedures performed annually in these jurisdictions, accounting for about one-third of total U.S. procedures. The initial addressable market among Medicare patients in these regions is approximately $250 million. The CompuFlo® system uses Dynamic Pressure Sensing® technology to enhance patient safety and outcomes in epidural procedures.

Positive

• Medicare price assignment secured for CompuFlo® Epidural System in 12 additional states
• Expands addressable market to approximately one-third of total U.S. epidural steroid injection procedures
• Initial addressable market among Medicare patients in these regions estimated at $250 million
• Medicare reimbursement expected to increase accessibility and support healthcare providers

Negative

• None.

ROSELAND, N.J., July 23, 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 Novitas Solutions, Inc. (Novitas), a Jurisdictional Medicare Administrative Contractor (JMAC), has granted a Medicare Part B Physician payment rate for the Company’s 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).

This new price assignment applies to two Medicare regions: Jurisdiction L (JL) and Jurisdiction H (JH). JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.

The pricing assignment by Novitas represents a significant step forward in Milestone Scientific’s strategy to ensure broad coverage and appropriate payment for the CompuFlo® technology when deemed medically necessary and clinically appropriate for Medicare beneficiaries. This decision follows the recently announced Medicare Jurisdiction N (JN) pricing assignment in Florida by First Coast Service Options Inc. (FCSO), marking another milestone in the Company's ongoing efforts to expand access to this advanced technology.

Arjan Haverhals, CEO and President of Milestone Scientific, commented, “Securing Medicare price assignment for the CompuFlo® Epidural System in these additional states is a testament to the clinical value and safety of our technology. This approval by Novitas significantly expands our addressable market and enhances our ability to provide patients with safer, more comfortable epidural procedures. We remain committed to pursuing reimbursement in other Medicare jurisdictions across the country and are confident in our strategic approach to gain nationwide coverage. We also look forward to leveraging this momentum into new international markets.”

An estimated 3.0 million epidural steroid injection (ESI) procedures are performed each year in these three jurisdictions (JL, JH, JN), which represent approximately one-third of the total ESI procedures for the treatment of chronic back pain in the United States. Additionally, it is believed Medicare accounts for up to 40% of the clinical practice volume, representing an initial addressable market of approximately $250 million among Medicare patients in these three jurisdictions.

The CompuFlo® Epidural System uses Milestone Scientific’s patented Dynamic Pressure Sensing® technology, which provides real-time feedback to ensure accurate needle placement during epidural procedures. This technology is designed to reduce the morbidity, pain, and discomfort associated with traditional epidural techniques, enhancing patient safety and outcomes.

Medicare reimbursement for the CompuFlo® Epidural System is expected to provide several key benefits:

• Increased Accessibility: Medicare reimbursement will make this advanced technology more accessible to a broader patient population, ensuring more Medicare beneficiaries can benefit from safer and more comfortable epidural procedures.
• Enhanced Patient Outcomes: By ensuring accurate needle placement, the CompuFlo® technology reduces the risk of complications, leading to better patient outcomes and higher satisfaction.
• Support for Healthcare Providers: The availability of reimbursement will support healthcare providers by allowing them to offer advanced pain management solutions without financial barriers, improving the overall quality of care.
  

Milestone Scientific is dedicated to expanding its reimbursement strategy across additional JMAC regions, with the goal of establishing the CompuFlo® technology as a standard of care in epidural procedures nationwide.

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 and efficient, as well as increase overall patient comfort and safety. The Company’s proprietary DPS Dynamic Pressure Sensing Technology^® provides a platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions involving subcutaneous drug delivery of 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 recent Medicare pricing decision for Milestone Scientific's CompuFlo® Epidural System (MLSS)?

Novitas Solutions has granted Medicare Part B Physician payment rate for Milestone Scientific's CompuFlo® Epidural System in 12 states, covering Medicare regions Jurisdiction L and H.

How many epidural steroid injection procedures are estimated to be performed annually in the newly approved Medicare jurisdictions for MLSS?

An estimated 3.0 million epidural steroid injection procedures are performed annually in the newly approved Medicare jurisdictions for Milestone Scientific's CompuFlo® Epidural System.

What is the estimated initial addressable market for Milestone Scientific (MLSS) among Medicare patients in the newly approved jurisdictions?

The initial addressable market for Milestone Scientific's CompuFlo® Epidural System among Medicare patients in the newly approved jurisdictions is approximately $250 million.

What technology does Milestone Scientific's CompuFlo® Epidural System (MLSS) use?

Milestone Scientific's CompuFlo® Epidural System uses patented Dynamic Pressure Sensing® technology, which provides real-time feedback to ensure accurate needle placement during epidural procedures.