PAVmed Subsidiary Lucid Diagnostics Completes European CE Mark Certification of its EsoGuard Esophageal DNA Test
10 Juni 2021 - 03:30PM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), a
highly differentiated, multi-product, commercial-stage medical
device company, today announced that its major subsidiary, Lucid
Diagnostics Inc. (“Lucid”), has completed European IVDD CE Mark
certification of its EsoGuard® Esophageal DNA Test (“EsoGuard”).
Lucid and its EU authorized representative
completed the EC declaration of conformity procedure, including the
associated technical documentation, ensuring and declaring that
EsoGuard meets the essential requirements of Europe’s In-Vitro
Diagnostic Medical Devices Directive 98/79/EC (“IVDD”). EsoGuard
may now be marketed in CE Mark European countries, which include
the European Economic Area (the EU, Norway, Iceland, and
Lichtenstein), Switzerland, and, until July 1, 2023, the United
Kingdom.
EsoGuard is a molecular diagnostic test,
performed on surface esophageal cells collected with Lucid’s
EsoCheck® Cell Collection Device in a brief non-invasive office
procedure. It is the first and only commercially available
diagnostic test capable of serving as a widespread screening tool
to prevent esophageal cancer deaths through early detection of
esophageal precancer and cancer in at-risk chronic heartburn
patients. It has been shown to be highly accurate at detecting
these conditions in a 408-patient human study published in Science
Translational Medicine.
“We believe Europe will be an important market
for EsoGuard and EsoCheck, where chronic heartburn is as
ubiquitous, and esophageal cancer as deadly, as it is in the U.S.,”
said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive
Officer, and Lucid’s Executive Chairman. “We look forward to
leveraging the strong relationships we have already built with
European key opinion leaders in esophageal disease who are
participating in our pivotal clinical trials, and proceeding with a
commercial launch in select European countries in the near
future.”
About PAVmed and
Lucid
PAVmed Inc. is a highly differentiated,
multi-product, commercial-stage medical technology company with a
diversified product pipeline addressing unmet clinical needs
encompassing a broad spectrum of clinical areas with attractive
regulatory pathways and market opportunities. Its major subsidiary,
Lucid Diagnostics Inc., markets the first and only commercial tools
for widespread early detection of esophageal precancer and cancer –
the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell
Collection Device. Its GI Health division also includes the
complementary EsoCure™ Esophageal Ablation Device with Caldus™
Technology. Its Minimally Invasive Interventions markets its CarpX®
Minimally Invasive Device for Carpal Tunnel Syndrome. Another major
subsidiary, Veris Health, is a digital health company developing
the first intelligent implantable vascular access port with
biologic sensors and wireless communication to improve personalized
cancer care through remote patient monitoring. Other divisions
include Infusion Therapy (PortIO™ Implantable Intraosseous Vascular
Access Device and NextFlo™ Intravenous Infusion Set), and Emerging
Innovations (non-invasive laser-based glucose monitoring, pediatric
ear tubes, and mechanical circulatory support). For more
information, please visit www.pavmed.com, follow us on
Twitter, connect with us on LinkedIn, and watch our videos on
YouTube. For more information on our majority owned subsidiary,
Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid
on Twitter, and connect with Lucid on LinkedIn. For detailed
information on EsoGuard, please visit www.EsoGuard.com and follow
us on Twitter, Facebook and Instagram.
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 many of its products. The Company
has been monitoring the COVID-19 pandemic and its impact on our
business. The Company expects the significance of the COVID-19
pandemic, including the extent of its effect on the Company’s
financial and operational results, to be dictated by, among other
things, the success of efforts to contain it and the impact of
actions taken in response. 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
Report 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
Jim Heins / Katie GallagherLaVoieHealthScience(646) 491-7042 /
(617) 792-3937PAVmed@lavoiehealthscience.com
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