Milestone Scientific Receives Regulatory Approval to Market CompuFlo® Epidural System in Brazil
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.
- 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.
- None.
Insights
The regulatory approval of Milestone Scientific's CompuFlo® Epidural System in Brazil is a noteworthy development within the medical technology space. Brazil's market is substantial, with nearly
Dynamic Pressure Sensing® technology, which offers real-time feedback for accurate needle placement, has the potential to significantly reduce procedural risks and improve patient outcomes. Traditionally, epidurals involve a fair amount of guesswork, which can lead to complications. The adoption of this technology could enhance the precision and safety of epidural procedures, potentially reducing healthcare costs associated with procedural complications.
Given the large number of childbirths annually in Brazil, the application of this technology could improve maternal care significantly. By targeting both the chronic pain and maternity segments, Milestone Scientific has a dual opportunity for market penetration.
While the technology's benefits are clear, it will be important to monitor its market adoption and any potential regulatory hurdles in terms of compliance and training within rural healthcare facilities. Overall, this development is highly positive for the company and could lead to increased market share in Latin America.
From a market perspective, Milestone Scientific's entry into Brazil with the CompuFlo® Epidural System represents a substantial growth opportunity. Brazil, as the 9th largest economy globally, provides a robust platform to expand the company's footprint in Latin America. The existing annual volume of
Strategically, Milestone Scientific is well-prepared, having established relationships with key medical institutions and commercial partners even prior to regulatory approval. This proactive approach can smoothen the product's market entry, facilitating faster adoption and revenue generation.
However, investors should keep an eye on the competitive landscape. Although CompuFlo® offers clear technological advantages, market penetration will depend on effective marketing strategies and partnerships to educate both healthcare providers and patients about its benefits over traditional methods.
Additionally, the company's ability to navigate Brazil's healthcare reimbursement system will be critical. Ensuring that the technology is covered by public and private payers will be essential for widespread adoption.
In conclusion, this move is likely to be beneficial for Milestone Scientific's market position, provided they can effectively execute their market entry strategy and demonstrate the system's value proposition to stakeholders.
The regulatory approval serves as a significant milestone for Milestone Scientific, with strong implications for the company's financial performance. Entering the Brazilian market could lead to a considerable increase in revenue given the large number of potential users and procedures. The company's foresight in establishing relationships with medical institutions may result in quicker commercialization and earlier revenue recognition.
It is essential to consider the cost implications of launching a new product in a market like Brazil. While initial marketing and training investments might be substantial, the long-term revenue potential appears promising given the extensive use cases of the CompuFlo® Epidural System.
Moreover, this product approval could serve as a catalyst for further regulatory approvals in other Latin American countries, leveraging Brazil's comprehensive regulatory framework. This would not only diversify revenue streams but also reduce geographic risk.
However, investors should remain cautious about potential operational challenges, such as supply chain logistics, local regulatory compliance and effective implementation of the technology in diverse healthcare settings. The execution of these aspects will be pivotal for translating this regulatory approval into financial success.
Overall, this development signals a positive financial outlook for Milestone Scientific, provided the company can manage its operational and strategic initiatives effectively.
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
“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:
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Email: mlss@crescendo-ir.com
Tel: 212-671-1020
FAQ
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