Milestone Scientific Announces Favorable Medicare Pricing for its CompuFlo® Epidural System within First JMAC Region Covering Florida

ROSELAND, N.J., July 10, 2024 (GLOBE NEWSWIRE) — Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced at the Sixth Annual American Society of Pain & Neuroscience Conference in Miami Beach that First Coast Service Options Inc. (FCSO), a Jurisdictional Medicare Administrative Contractor (“JMAC”), has granted favorable Medicare Part B physician price assignment across Florida for use of 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). Additionally, the Company reports that it is making progress on its reimbursement strategy in additional JMAC regions.

This favorable Medicare reimbursement is a significant milestone in the Company’s strategy to advance broad coverage and appropriate payment for the CompuFlo technology when determined to be medically necessary and clinically appropriate for the Medicare beneficiary. This decision by FCSO marks an important step forward in making the CompuFlo® Epidural System more accessible to patients who can benefit from this advanced technology.

An estimated 1.6 million epidural (ESI) steroid injection procedures are performed in Florida, which represents 18% of the total ESI procedures for the treatment of chronic back pain in the USA. Additionally, Medicare represents 40% of the clinical practice volume, representing an initial addressable market of $125 million among Florida Medicare patients alone.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “Based on FCSO’s price assignment for the Category III CPT code CPT 0777T, Medicare payment in Florida is a significant reimbursement achievement, and one of the most important events in the history of our Company. Accordingly, we are actively pursuing reimbursement in other Medicare jurisdictions across the country. As previously reported, we took a very methodical and strategic approach to reimbursement, working closely with clinicians to document medical necessity. As illustrated by our engagement with this Medicare jurisdiction, Milestone has been educating the payers on the clinical utility and economic value of the CompuFlo technology, thus enabling the JMACs to understand coverage parameters and address appropriate pricing. We could not be more pleased with the positive outcome by FCSO. We believe this is a significant validation of the safety benefits of our technology. While there is more work to be done in order to introduce our technology across Florida, we have overcome what we believe has been a major gating factor to broad adoption. I am extremely proud of our entire team that worked tirelessly to achieve this milestone and we look forward to providing further updates on our nationwide reimbursement initiatives, as well as our disciplined commercial rollout strategy for Florida in the near future.”

The FDA cleared CompuFlo® Epidural System, known for its ability to reduce the morbidity, pain and discomfort associated with traditional epidural procedures, uses the Company’s patented Dynamic Pressure Sensing® technology. This real-time feedback technology ensures accurate placement of the epidural needle, enhancing patient safety and comfort.

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

• Increased Accessibility: Medicare reimbursement will make this advanced technology more accessible to a broader patient population, ensuring that 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 committed to expanding its reimbursement strategy among additional JMAC regions, which would broaden the settings in which the CompuFlo® Epidural System can be more broadly adopted. This comprehensive approach aims to establish the CompuFlo® technology as a standard of care in epidural procedures.

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.

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