Chronic heartburn patients in Phoenix, Denver,
Salt Lake City, and Las Vegas can now request video telemedicine
physician evaluation and referral for rapid, office-based EsoGuard
testing to detect esophageal precancer before it progresses to
deadly cancer
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”) a
commercial-stage, cancer prevention medical diagnostics company,
and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM,
PAVMZ) (“PAVmed”), today announced it has launched its EsoGuard
Telemedicine Program in partnership with UpScriptHealth, a leading,
nationwide, direct-to-consumer telemedicine company.
Chronic heartburn patients in four metropolitan areas—Phoenix,
Denver, Salt Lake City, and Las Vegas—can now access a
Lucid-branded web-based telemedicine platform to request video
evaluation of their condition by an independent
UpScriptHealth-managed telemedicine physician. If clinically
indicated, the patient will be referred to a local Lucid Test
Center or other clinical facility offering rapid, office-based
testing to detect esophageal precancer using Lucid’s EsoGuard® DNA
Esophageal Test (“EsoGuard”). A direct-to-consumer marketing
campaign utilizing radio, television, billboards and digital media,
will be launched, tested and refined in the Phoenix market before
proceeding to other Lucid Test Center cities.
“Many, if not most, chronic heartburn sufferers treat their
symptoms without physician supervision using widely available,
heavily advertised, over-the-counter heartburn medications—entirely
unaware they may be at risk for esophageal precancer and cancer,”
said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive
Officer. “An important pillar of our growth strategy is to educate
consumers on the link between chronic heartburn and esophageal
cancer, and the availability of a rapid, office-based test to
detect esophageal precancer before it progresses to cancer.”
“The launch of Lucid’s EsoGuard Telemedicine Program is a very
important milestone which completes the foundation for our
multi-channel EsoGuard commercialization strategy directly
targeting primary care physicians (PCPs), gastroenterologists and
now consumers. We believe, based on the experience of other
successful early cancer detection companies, that telemedicine
programs with direct-to-consumer engagement can have broad reach,
accelerate commercialization, and drive long-term growth. We are
fortunate to have an ideal partner in UpScriptHealth, a pioneer in
online healthcare prescribing with a nationwide network of
telemedicine physicians, as we look to expand the EsoGuard
Telemedicine Program and Lucid Test Center network regionally and
nationally.”
Lucid Test Centers currently operate in leased medical office
suites located in three locations in Phoenix and one each in
Denver, Salt Lake City and Las Vegas. Lucid plans to add upcoming
test centers in the Pacific Northwest and then steadily expand
nationwide. Each test center is staffed with Lucid-employed
clinical personnel who use Lucid’s EsoCheck® Cell Collection Device
(“EsoCheck”) to collect esophageal cells which are sent for
EsoGuard testing. Lucid estimates that a single nurse practitioner
can perform up to twenty EsoCheck procedures per day and expects
each center to cover its personnel and medical office leases costs
with only a few tests per week.
Since their launch, the test centers have been seeing patients
referred for EsoGuard testing by their PCPs. Now, patients who
respond to direct-to-consumer engagements can request video
telemedicine evaluation through the EsoGuard Telemedicine Program
by contacting 1-888-FOODTUBE or registering at
www.EsoGuardConsultation.com. If clinically indicated, the
telemedicine physician will refer the patient to a Lucid Test
Center or other clinical facility for EsoGuard testing. The
EsoGuard test result will be reported to this physician who will
refer the patient for gastroenterology evaluation if indicated.
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 and EsoCheck are the missing element and
constitute 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.
EsoGuard is a bisulfite-converted next-generation sequencing
(NGS) DNA assay performed on surface esophageal cells collected
with EsoCheck. It 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. EsoGuard
is commercially available in the U.S. as a Laboratory Developed
Test (LDT) performed at a CLIA/CAP-certified laboratory.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive
swallowable balloon capsule catheter device capable of sampling
surface esophageal cells in 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 third-party CLIA-certified
laboratory partner 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 two large, actively enrolling,
international multicenter clinical trials to support FDA PMA
approval. Lucid is building a network of Lucid Test Centers where
at-risk GERD patients can undergo the EsoCheck procedure for
EsoGuard testing.
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
Lucid’s Registration Statement No. 333-259721 filed with the
Securities and Exchange Commission. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211201005355/en/
Investors Lisa DeScenza
LaVoieHealthScience (617) 351-0243
ldescenza@lavoiehealthscience.com
Media Kristi Bruno
LaVoieHealthScience (617) 865-3940
PAVmed@lavoiehealthscience.com
PAVmed (NASDAQ:PAVMZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
PAVmed (NASDAQ:PAVMZ)
Historical Stock Chart
From Apr 2023 to Apr 2024