PAVmed Subsidiary Lucid Diagnostics Receives FDA 510(k) Clearance for EsoCheck™
June 24 2019 - 10:46AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multi-product medical device
company, today announced that its majority owned subsidiary, Lucid
Diagnostics Inc. (“Lucid”), has received 510(k) marketing clearance
for its EsoCheck Cell Collection Device™ (“EsoCheck”) from the U.S.
Food and Drug Administration (FDA).
“I have spent my career seeking to improve the
care of patients with gastroesophageal reflux disease and Barrett’s
Esophagus and to prevent deaths from esophageal cancer. I have
actively participated in the development of key advances in this
field and am particularly excited that EsoCheck is now available as
an FDA-cleared tool in our armamentarium. EsoCheck’s unique ability
to sample cells from a targeted area of the esophagus has the
potential to save lives through the early detection of esophageal
abnormalities,” said Nicholas J. Shaheen MD, MPH, Professor of
Medicine and Epidemiology and Chief of the Division of
Gastroenterology and Hepatology at the University of North Carolina
School of Medicine, Director of American College of
Gastroenterology (ACG) Institute for Clinical Research and
Education.
EsoCheck is a non-invasive cell collection
device that is designed to sample cells from a targeted region of
the esophagus in a five-minute office-based procedure, without the
need for endoscopy. The patient swallows a vitamin pill-sized
capsule containing a small inflatable balloon attached to a thin
catheter. As the catheter is withdrawn, it swabs the target area
for a sample of cells and protects that sample from contamination
as the device is removed. The sampled cells can then be subjected
to any commercially available diagnostic test. FDA determined that
EsoCheck is substantially equivalent to legally marketed predicate
devices for its indications for use, namely “the collection and
retrieval of surface cells of the esophagus in the general
population of adults, 22 years of age or older”.
“I am excited to report this major milestone for
PAVmed and Lucid,” said Lishan Aklog, MD, PAVmed’s Chairman and CEO
and Lucid’s Executive Chairman. “We are proud to have received FDA
clearance for EsoCheck just over one year from the day we founded
Lucid and licensed this groundbreaking technology from Case Western
Reserve University. We look forward to offering EsoCheck to
physicians and patients this summer and believe EsoCheck presents
many advantages over existing sponge-on-a-string esophageal cell
collection devices. These devices have a capsule which must be
digested in the stomach before it can be used to sample cells,
while EsoCheck can begin sampling immediately upon insertion. More
importantly, EsoCheck’s Collect+Protect™ technology allows it to
perform a targeted sample of the lower esophagus, while spherical
sponge-on-a-string devices sample cells from the entire esophagus,
throat and mouth which dilutes and contaminates the lower
esophageal cells.”
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct medical device company employing a unique business
model designed to advance innovative products 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 pipeline strategy with a view to
enhancing and accelerating value creation. PAVmed’s diversified
pipeline of products address unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its five lead technologies
provide groundbreaking approaches to carpal tunnel syndrome
(CarpX™), precancerous conditions of the esophagus
(EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear
infections (DisappEAR™) and medical infusions (NextFlo™). The
company is also developing innovative products in other areas, such
as catheters and tissue ablation, while seeking to further expand
its pipeline through engagements with clinician innovators and
leading academic medical centers. For more information, please
visit www.pavmed.com, follow us on Twitter, connect with us on
LinkedIn, and watch our videos on YouTube.
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 PAVmed’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, volatility in the
price of PAVmed’s common stock, Series W Warrants and Series Z
Warrants; general economic and market conditions; the uncertainties
inherent in research and development, including the cost and time
required advance PAVmed’s products to regulatory submission;
whether regulatory authorities will be satisfied with the design of
and results from PAVmed’s preclinical studies; whether and when
PAVmed’s products are cleared by regulatory authorities; market
acceptance of PAVmed’s 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 PAVmed’s control.
For a further list and description of these and other important
risks and uncertainties that may affect PAVmed’s future operations,
see Part I, Item IA, “Risk Factors,” in PAVmed’s 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 PAVmed
after its most recent Annual Report. PAVmed disclaims any intention
or obligation to publicly update or revise any forward-looking
statement to reflect any change in its 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.
Contacts:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
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