PAVmed Subsidiary Lucid Diagnostics Receives CE Mark Certification for its EsoCheck® Esophageal Cell Collection Device
May 26 2021 - 8:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), a
highly differentiated, multi-product, commercial-stage medical
device company, and its major subsidiary Lucid Diagnostics Inc.
(“Lucid”), today announced that Lucid’s EsoCheck® Esophageal Cell
Collection Device with Collect+Protect™ technology (“EsoCheck”) has
received CE Mark certification.
EU-based Notified Body TÜV Rhineland LGA
Products GMBH issued a CE Certificate, effective May 24, 2021,
declaring that EsoCheck conforms to the essential requirements of
Medical Device Directive 93/42/EEC. With CE Mark secured, EsoCheck
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.
EsoCheck is an FDA-cleared swallowable balloon
capsule catheter, which allows a clinician to sample surface cells
from the esophagus in a less than 5-minute non-invasive office
procedure, the only such device capable of doing so in an
anatomically targeted fashion, without sample dilution or
contamination (EsoCheck animation). EsoCheck, paired with Lucid’s
EsoGuard® Esophageal DNA Test (“EsoGuard”), are the first and only
commercially available diagnostic technologies capable of serving
as a widespread screening tool to prevent deaths through the early
detection of esophageal precancer and cancer in at-risk chronic
heartburn patients. As a “General IVD” under Europe’s In-Vitro
Diagnostic Medical Devices Directive 98/79/EC, EsoGuard only
requires self-certification, which Lucid and its authorized
representative expect to complete in the very near future.
“Chronic heartburn is as ubiquitous, and
esophageal cancer as deadly, in Europe as it is in the U.S. so this
certification represents yet another important milestone in our
mission to prevent deaths through the early detection of esophageal
precancer and cancer,” said Lishan Aklog, M.D., PAVmed’s Chairman
and Chief Executive Officer, and Lucid’s Executive Chairman. “Lucid
has already developed strong relationships with European key
opinion leaders in esophageal disease who are participating in our
pivotal clinical trials. We look forward to leveraging these
relationships 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. 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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