PAVmed Sets Q4 2016 Timeline for FDA Submission of Its First Product

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.
About PAVmed
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.
Forward-Looking Statements
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.