PAVmed Files 510(k) FDA Submission for PortIO™ Intraosseous Infusion System
First product regulatory submission marks major corporate milestone
NEW YORK--(BUSINESS WIRE)-- 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.
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Pictured: The PortIO Device (Photo: Business Wire)
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.”
The PortIO Intraosseous Infusion System consists of an implantable vascular access device and insertion kit. Instead of a catheter located in a vein, it has a short extension from the device, which a physician inserts into a bone, leaving the device to reside completely beneath the skin. This allows direct access to the bone marrow, which is a well-established route for the delivery of medications, fluids and other substances. PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or significant dissection and will not require confirmation of the position of the tip by x-ray or other means. Once in place, the device can be accessed by the nurse through the skin using the same techniques as existing implantable ports.
PAVmed Inc. (Nasdaq: PAVM, PAVMW) is a highly differentiated, multi-product medical device company employing a unique business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding multi-product pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs, have attractive regulatory pathways and market opportunities and encompass a broad spectrum of clinical areas including carpal tunnel syndrome (CarpX™), medical infusions (NextFlo™ and NextCath™), interventional radiology (PortIO™ and NextCath), tissue ablation and cardiovascular intervention (Caldus™) and pediatric ear infections (DisappEAR™). The Company intends to further expand its pipeline through ongoing internal innovations as well as engagements with clinician innovators and leading academic medical centers. For further information, please visit www.pavmed.com
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, the uncertainties inherent in research and development, including the cost and time required advance our products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from our pre‐clinical studies; whether and when our products are cleared by regulatory authorities; market acceptance of our products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market any of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item IA, “Risk Factors,” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by us after our most recent Annual Report. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
Source: PAVmed Inc.
Released December 19, 2016