PAVmed Inc. (Nasdaq: PAVM,PAVMW), a highly differentiated, multi-product medical device company, today announced that it has filed a 510(k) premarket notification submission with the U.S. Food and Drug Administration (FDA) for its first product, the PortIO™ Intraosseous Infusion System.
Lishan Aklog, M.D., Chairman and CEO of PAVmed, said “We are excited to have achieved this important corporate milestone, the submission of our first product for regulatory clearance, on schedule and under budget. Our growth strategy is built on a capital and time efficient business model which enables us to pursue an expanding multi-product pipeline. PortIO is the first FDA submission from our pipeline and we look forward to additional regulatory submissions and product commercializations in 2017 and beyond.”
PAVmed’s Chief Medical Officer, Brian J. deGuzman M.D., explained “PortIO was designed to eliminate many of the shortcomings of existing implantable vascular access devices and intraosseous infusion systems. We expect PortIO to provide physicians with a rapid and efficient system to establish an intraosseous route for delivery of medications, fluids and other substances. We look forward to receiving FDA clearance and beginning commercialization of this exciting product in 2017.”
Timothy P. Murphy, M.D., a member of PAVmed’s medical advisory board, Professor and Director of the Vascular Disease Research Center at the Brown University’s Warren Alpert Medical School and the former President of the Society of Interventional Radiology, stated “We eagerly anticipate PortIO’s regulatory clearance and introduction into clinical practice. We expect PortIO to have significant advantages relative to traditional ports and intraosseous devices, which gives it the potential to be game-changing with respect to improved outcomes and reduced costs.”