PAVmed Sets Q4 2016 Timeline for FDA Submission of Its First Product
-Commercialization of PortIO™ implantable vascular access device anticipated in 2017-
NEW YORK--(BUSINESS WIRE)-- PAVmed Inc. (Nasdaq:PAVMU), a highly differentiated, multi-product medical device company, announced today that it has set a Q4 2016 timeline for FDA 510(k) submission of its first product, the PortIO™ implantable vascular access device. PortIO has entered verification and validation testing, the final phase of pre-submission testing.
Lishan Aklog, M.D., Chairman and CEO of PAVmed, said “We are excited about our timeline for submitting PortIO to the FDA in 2016 and the prospects for product commercialization in 2017. Since obtaining our IPO funding in April, we have accelerated the pace of advancing the products in our pipeline towards FDA submission and commercialization. Our capital and time efficient business model enables PAVmed to pursue a multi-product pipeline strategy and PortIO will be the first FDA submission from this pipeline. We look forward to following this up with additional product submissions and commercialization 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 which result from the presence of a catheter in the bloodstream. These include clotting, which occurs in up to 30% of patients1, necessitating repeat procedures to clear clots or replace the device. Furthermore, many patients have scarred or otherwise inaccessible veins which can make insertion of existing devices difficult or impossible.”
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 “I believe PortIO holds great promise as an alternative to traditional implantable ports. We eagerly anticipate PortIO’s introduction into clinical practice.” Dr. Murphy added, “In addition to improved resistance to occlusion, infection rates and versatility in patients with poor venous access, we expect PortIO to have additional advantages relative to traditional ports which gives it the potential to be game-changing with respect to improved outcomes and reduced costs.”
PortIO 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. Since it is about one-third the size of a traditional implantable vascular access device, PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or other dissection. In addition, unlike existing devices, PortIO 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 devices.
PAVmed Inc. (Nasdaq:PAVMU) 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™). The Company intends to further expand its pipeline through 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. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including regulatory submission dates; whether regulatory authorities will be satisfied with the design of and results from our pre-clinical studies; whether and when our applications may be approved by regulatory authorities; and other competitive developments.
PAVmed has not yet sought or received clearance from the FDA or other regulatory body to market any of its products including PortIO.
1 Carlo JT, et al. Am J Surg 2004;188:722-727.
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For PAVmed Inc.:
Matthew Ventimiglia, 212-599-1265
Erich Sandoval, 917-497-2867
Source: PAVmed Inc.
Released July 14, 2016