LIVINGSTON, NJ--(Marketwired - April 19, 2017) - Milestone Scientific Inc. (NYSE: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced that it has been granted a Medical Device Marketing Authorization (MDMA) by the Saudi Food and Drug Authority (SFDA), allowing Milestone Scientific to market and sell its epidural instrument and disposable kit in Saudi Arabia.
This marketing clearance follows the recent Authorized Representative (AR) license approval by the SFDA in late 2016, which was an important step to allowing Milestone's distributor, Aleltiqa International Operations Co. to import and commercialize the epidural instrument in Saudi Arabia.
Milestone's Dynamic Pressure Sensing® (DPS) capability in the CompuFlo® Epidural instrument provides feedback that allows anesthesiologists to correctly identify the epidural space, which has the potential to significantly reduce complications and malpractice compared to conventional techniques. CompuFlo® Epidural provides drug delivery accuracy, reduces patient discomfort and prevents needle deflection.
Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, "We are pleased that we have received regulatory marketing clearance for our Compuflo Epidural Computer Controlled Anesthesia System and disposable kit in Saudi Arabia. Not only is Saudi Arabia an important gateway to the Middle East, but also represents a sizable market for our technology with more than 600,000 live births per year. The CompuFlo® Epidural instrument provides new clinical tools to enhance both the safety and reduce pain associated with epidural procedures."
About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technology. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.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, 2016. 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.