Lucid Diagnostics Selected as Finalist for Medtech Company of the Year 2022 by Medical Device + Diagnostic Industry
December 08 2022 - 8:25AM
Business Wire
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the
“Company”), a commercial-stage, cancer prevention medical
diagnostics company, and majority-owned subsidiary of PAVmed
Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), today announced that the
Company was selected as one of ten finalists for the Medtech
Company of the Year 2022 by Medical Device + Diagnostic Industry
(“MD+DI”), a leading publication serving manufacturers of medical
devices and in vitro diagnostics products, as well as medical
technology professionals, for the past forty years.
“I would like to thank the Medical Device + Diagnostic Industry
editorial board for this honor,” said Lishan Aklog, M.D., Lucid’s
Chairman & Chief Executive Officer. “It is humbling to be
recognized alongside such an impressive group of long-time industry
leaders and newer groundbreaking companies. It is a testament to
the hard work and dedication of our incredibly talented team, our
collective passion for serving patients through technological
innovation, and the extraordinary promise of EsoGuard® as the first
and only commercially available molecular diagnostic tool to
prevent esophageal cancer deaths through early precancer
detection.”
The MD+DI team carefully evaluated medical device and
diagnostics companies that “rose above the ranks” over the past
year and selected as Medtech Company of the Year 2022 Finalists
those who “have made tremendous strides” in 2022. The finalists
include industry leaders such as Abbott Laboratories, Medtronic and
ResMed, as well as newer groundbreaking companies such as
BioIntelliSense and Senseonics. The winner will be announced the
week of December 12, 2022.
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing
esophageal precancer and a highly lethal form of esophageal cancer
(“EAC”). Over 80% of EAC patients die within five years of
diagnosis, making it the second most lethal cancer in the U.S. The
mortality rate is high even in those diagnosed with early stage
EAC. The U.S. incidence of EAC has increased 500% over the past
four decades, while the incidences of other common cancers have
declined or remained flat. In nearly all cases, EAC silently
progresses until it manifests itself with new symptoms of advanced
disease. All EAC is believed to arise from esophageal precancer,
which occurs in approximately 5% to 15% of at-risk GERD patients.
Early esophageal precancer can be monitored for progression to late
esophageal precancer which can be cured with endoscopic esophageal
ablation, reliably halting progression to cancer.
Esophageal precancer screening is already recommended by
clinical practice guidelines in millions of GERD patients with
multiple risk factors, including age over 50 years, male gender,
White race, obesity, smoking history, and a family history of
esophageal precancer or cancer. Unfortunately, fewer than 10% of
those recommended for screening undergo traditional invasive
endoscopic screening. The profound tragedy of an EAC diagnosis is
that likely death could have been prevented if the at-risk GERD
patient had been screened and then undergone surveillance and
curative treatment.
The only missing element for a viable esophageal cancer
prevention program has been the lack of a widespread screening tool
that can detect esophageal precancer. Lucid believes EsoGuard,
performed on samples collected with EsoCheck, is the missing
element – the first and only commercially available test capable of
serving as a widespread screening tool to prevent esophageal cancer
deaths through the early detection of esophageal precancer in
at-risk GERD patients. An updated American College of
Gastroenterology clinical practice guideline and an American
Gastroenterological Association clinical practice update both
endorse nonendoscopic biomarker tests as an acceptable alternative
to costly and invasive endoscopy for esophageal precancer
screening. EsoGuard is the only such test currently available in
the United States.
EsoGuard is a bisulfite-converted NGS DNA assay performed on
surface esophageal cells collected with EsoCheck, which quantifies
methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1
(CCNA1). The assay was evaluated in a 408-patient, multicenter,
case-control study published in Science Translational Medicine and
showed greater than 90% sensitivity and specificity at detecting
esophageal precancer and cancer.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive
swallowable balloon capsule catheter device capable of sampling
surface esophageal cells in, on average, a less than five-minute
office procedure. It consists of a vitamin pill-sized rigid plastic
capsule tethered to a thin silicone catheter from which a soft
silicone balloon with textured ridges emerges to gently swab
surface esophageal cells. When vacuum suction is applied, the
balloon and sampled cells are pulled into the capsule, protecting
them from contamination and dilution by cells outside of the
targeted region during device withdrawal. Lucid believes this
proprietary Collect+Protect™ technology makes EsoCheck the only
noninvasive esophageal cell collection device capable of such
anatomically targeted and protected sampling. The sample is sent by
overnight express mail to Lucid’s CLIA-certified, CAP-accredited
laboratory, LucidDx Labs, for EsoGuard testing.
About Lucid Diagnostics
Lucid Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage,
cancer prevention medical diagnostics company, and subsidiary of
PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of
patients with gastroesophageal disease (GERD), also known as
chronic heartburn, who are at risk of developing esophageal
precancer and cancer. Lucid’s EsoGuard® Esophageal DNA Test,
performed on samples collected in a brief, noninvasive office
procedure with its EsoCheck® Esophageal Cell Collection Device, is
the first and only commercially available diagnostic test capable
of serving as a widespread screening tool to prevent cancer and
cancer deaths through early detection of esophageal precancer in
at-risk GERD patients. EsoGuard is commercialized in the U.S. as a
Laboratory Developed Test (LDT). EsoCheck is commercialized in the
U.S. as a 510(k)-cleared esophageal cell collection device.
EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device
designation and is the subject of multiple ongoing clinical trials.
Lucid is building nationwide direct sales and marketing teams
targeting primary care physicians, specialists, and institutions,
as well as a network of Lucid Test Centers, where at-risk GERD
patients can undergo the EsoCheck procedure for EsoGuard testing.
For more information, 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.
Forward-looking statements are any statements that are not
historical facts. Such forward-looking statements, which are based
upon the current beliefs and expectations of Lucid’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 Lucid’s common stock; general
economic and market conditions; the uncertainties inherent in
research and development, including the cost and time required to
advance Lucid’s products to regulatory submission; whether
regulatory authorities will be satisfied with the design of and
results from Lucid’s clinical and preclinical studies; whether and
when Lucid’s products are cleared by regulatory authorities; market
acceptance of Lucid’s products once cleared and commercialized;
Lucid’s ability to raise additional funding as needed; and other
competitive developments. In addition, Lucid has been monitoring
the COVID-19 pandemic and the pandemic’s impact on Lucid’s
businesses. Lucid expects the significance of the COVID-19
pandemic, including the extent of its effect on its financial and
operational results, to be dictated by, among other things, the
success of efforts to contain the pandemic and the impact of such
efforts on Lucid’s businesses. These factors are difficult or
impossible to predict accurately and many of them are beyond
Lucid’s control. In addition, new risks and uncertainties may arise
from time to time and are difficult to predict. For a further list
and description of these and other important risks and
uncertainties that may affect Lucid’s future operations, see Part
I, Item 1A, “Risk Factors,” in Lucid’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 Lucid after its most recent
Annual Report. Lucid 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221208005505/en/
Investors and Media Adrian K.
Miller PAVmed Inc. AKM@PAVmed.com
PAVmed (NASDAQ:PAVMZ)
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