Milestone Scientific Receives Regulatory Approval to Market CompuFlo® Epidural System in Brazil

Rhea-AI Summary

Milestone Scientific has received approval from Brazil's National Health Surveillance Agency (ANVISA) to market its CompuFlo® Epidural System in Brazil. This system uses patented Dynamic Pressure Sensing® technology for accurate, safe, and comfortable epidural needle placement, applicable to lumbar, thoracic, and cervical-thoracic areas. Brazil, being the 9th largest economy, has over 21 million people with chronic back pain and performs an estimated 4-5 million epidural procedures annually. The company has established key relationships with medical institutions and commercial entities in Brazil, expecting to expand the addressable market and improve patient safety and provider experience. This approval follows prior FDA approval in the U.S. and marks a significant step in Milestone's global expansion.

Positive

• Regulatory approval from ANVISA to market CompuFlo® Epidural System in Brazil.
• Potential market expansion in Brazil due to 4-5 million annual epidural procedures.
• Key relationships established with leading medical institutions and commercial entities in Brazil.
• Potential for increased market share in Latin and South America due to comprehensive regulatory framework.

Negative

• None.

Brazil is the 9th largest economy in the world with more than 21 million people suffering from chronic back pain

An estimated 4-5 million epidural anesthesia procedures are performed annually in Brazil; potential to expand this addressable market due to CompuFlo’s technological advantages

ROSELAND, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, announces that it has received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA) to market and sell its CompuFlo® Epidural System in Brazil. The approval includes the lumbar, thoracic, and cervical-thoracic junction of the spine.

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

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We are thrilled to bring the CompuFlo® Epidural System to Brazil, the 9th largest economy in the world, with a population of more than 200 million people. We have taken the initiative to lay the foundation for our product launch prior to this pivotal regulatory approval and have already established key relationships with leading medical institutions and commercial entities, which we look forward to formalizing in the near future. Based on our extensive prior clinical experience, we are confident that our technology has the potential to improve safety and reduce costs, as well as enhance both the patient and provider experiences across the country."

“In Brazil, there are over 2.8 million births each year, as well as 21 million people suffering from chronic back pain, of which just 60% seek treatment. Moreover, independent market research shows that an estimated 4-5 million epidural anesthesia procedures are currently performed annually. We believe with the right partners we can expand the addressable market of patients seeking treatment due in part to the risk of complications from traditional epidural procedures, as well as our ability to better serve the large rural population that often has limited resources and training in some of these areas.”

“The approval to market and sell in Brazil marks a significant milestone as we continue to expand our global footprint. Brazil also represents an important foothold to introduce our technology across Latin and South America given its comprehensive and well-recognized regulatory framework—building upon our prior FDA approval in the United States,” concluded Haverhals.

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 recent approval did Milestone Scientific receive for the CompuFlo® Epidural System?

Milestone Scientific received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA) to market and sell the CompuFlo® Epidural System in Brazil.

How many epidural procedures are performed annually in Brazil?

An estimated 4-5 million epidural procedures are performed annually in Brazil.

What technology does the CompuFlo® Epidural System utilize?

The CompuFlo® Epidural System uses Dynamic Pressure Sensing® technology for accurate epidural needle placement.

What areas of the spine can the CompuFlo® Epidural System be used for?

The CompuFlo® Epidural System can be used for the lumbar, thoracic, and cervical-thoracic junction of the spine.

What percentage of people with chronic back pain in Brazil seek treatment?

In Brazil, 60% of the 21 million people suffering from chronic back pain seek treatment.

How does Milestone Scientific plan to expand its market in Brazil?

Milestone Scientific plans to expand its market in Brazil by leveraging key relationships with medical institutions and commercial entities and addressing limitations in rural areas with resources and training.

Why is Brazil a significant market for Milestone Scientific's CompuFlo® Epidural System?

Brazil is the 9th largest economy with a large population, significant number of epidural procedures, and a well-recognized regulatory framework, making it a key market for Milestone Scientific.