Milestone Scientific CEO Provides Letter to Shareholders; Provides Positive Reimbursement Update

ROSELAND, N.J., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE:MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provided the following letter to shareholders from the Company’s CEO, Arjan Haverhals, including updates regarding commercialization of the CompuFlo® technology and initial reimbursements of CompuFlo by commercial payors and Medicare:

To our valued shareholders,

While we recognize commercializing a new medical device takes time, we believe we are gaining positive traction and have developed a truly transformative technology that has the potential to become the standard of care, given the patient safety and economic benefits of the CompuFlo® Epidural System. As with any new medical technology, we have had to navigate a number of significant hurdles to position the technology for market adoption. These include the successful completion of clinical studies, FDA regulatory market clearance, and the AMA assignment of a new CompuFlo procedure CPT code for use by providers and payors.

I am proud to report we are making steady progress in advancing commercialization of the CompuFlo technology. Highlights for 2023 include receipt of FDA clearance for expanded use of the CompuFlo technology to now include the thoracic and cervical thoracic junction of the spine, launching a reimbursement plan to educate and support pain management providers in the use of the new CPT code (0777T) for accurate and timely claims submissions, as well as executing a plan to gain real-world feedback from clinicians on their experience using CompuFlo.

Several advisory sites were established across the US that implemented the CompuFlo technology in their practice. These providers deemed the CompuFlo technology clinically appropriate and medically necessary for many of their patients by including the use of CompuFlo in their epidural steroid injection procedures. The medical decision by physicians to use CompuFlo demonstrates the clinical utility and benefit of the technology in patient care.

Since launch, we have been working closely with the advisory sites that have been submitting CompuFlo claims. I am pleased to report they have now submitted claims for over 100 patient procedures and additional cases are continuing as we head into 2024. This is a noteworthy achievement for a company of our size, and the pace continues to accelerate. All claims submitted to date, using CPT 0777T, have been successfully accepted by payor systems for processing.

More importantly, advisory physicians reported 100% success rate for each of their patients using CompuFlo, with zero dural punctures. This is particularly noteworthy, as 50% of these procedures were conducted in the thoracic and thoracic cervical junction of the spine, confirming the importance of the new indication.

In addition to ongoing engagement throughout the year with our advisory sites, Milestone conducted a follow-up survey to gain feedback regarding the ‘real world’ use of the technology. All provider sites participated in the survey and their results further validated the clinical safety, predictability, utility and efficacy of the use of CompuFlo.

For a new medical device, the process of submission, including the handling of denials and appeals can be a lengthy process for the physicians and their practice. Early adopters using the CompuFlo® knowingly embarked on this pathway, and I cannot express how grateful we are for the considerable time and effort they have expended to support and advance our technology.

Given that we started our reimbursement project execution in the beginning of the second quarter of 2023, and being respectful of the time that is required for going through this process, which can take up to 6-9 months, we are now able to share the data provided from the preliminary analysis. A review and analysis of claims data shared by providers indicated that roughly one-third of claims have already received positive payor reimbursement. More than half of these payments were paid by commercial payors, followed by Medicare. The remaining two-thirds of the claims submitted are still pending adjudication.

Overall, I could not be more pleased with the commercialization progress we have made, including the positive clinical feedback we have received from the physicians and medical institutions. In fact, as recently reported, University of Texas Medical Branch (UTMB) Health Clear Lake Campus Hospital, recently expanded the use of the CompuFlo® beyond the labor and delivery department to now include our technology for epidural needle placement and verification within the epidural space in spinal cord stimulator implantation procedures. This follows a successful evaluation process, reporting 100% success and a favorable review by the value assessment committee.

In summary, I would like to extend my sincere gratitude to all of our shareholders that have stood by as we pushed through these monumental hurdles. We have not reached the end of the road yet, but the achievement of our vision is in sight. Moving into 2024, Milestone is focused on increasing the number of CompuFlo providers in the US to further advance clinical utilization of the CompuFlo technology. In addition, we remain committed to accelerating patient access to this technology through ongoing education and engagement with payors to attain consistent coverage and reimbursement for this clinically valuable procedure. We look forward to a number of exciting developments in the months and years ahead and plan to keep investors fully apprised of our progress.

Regards,

Arjan Haverhals

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. Since inception, Milestone Scientific has engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets.

Milestone Scientific has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, our DPS Dynamic Pressure Sensing Technology® System, to meet the needs of various subcutaneous drug delivery injections and fluid aspiration – enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished with the 160-year-old manual syringe. The company’s proprietary DPS Dynamic Pressure Sensing technology is a technology platform that advances the development of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical injections. It has specific medical applications for epidural space identification in regional anesthesia procedures. To learn more, view the or visit .

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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