Milestone Scientific , 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.