Contrasts EsoCheck's powerful cell collection
capabilities to "cruder, decades-old" technologies during comments
on patient access to medical technology innovation
NEW
YORK, Feb. 15, 2024 /PRNewswire/ -- 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 its Chairman and Chief Executive
Officer, Lishan Aklog, M.D.,
highlighted Lucid's EsoCheck® Cell Collection Device
("EsoCheck") during testimony before the U.S. House of
Representatives' Committee on Small Business. Dr. Aklog was
invited by the Congressional committee to testify on the importance
of facilitating and protecting patient access to innovative
life-enhancing and life-saving medical technology products, such as
EsoCheck.
"EsoCheck is a deceptively simple tool which allows precise,
targeted collection of lower esophageal cells for precancer
testing," Dr. Aklog said. "EsoCheck's gentle approach to
noninvasive cell collection is a dramatic and elegant improvement
over cruder, decades-old technology, which involves dragging a
Brillo Pad-like 'sponge-on-a-string', indiscriminately scraping
cells from the stomach, esophagus and mouth." Dr. Aklog further
noted, in separate comments, that "EsoCheck's advanced features are
a major contributor to EsoGuard's unprecedented early precancer
detection results."
EsoCheck and its patented, groundbreaking Collect &
Protect® technology was invented by physician scientists
at Case Western Reserve University,
licensed by Lucid in 2018, and received FDA clearance in 2019.
Manufacturing was transferred to a high-volume, low-cost contract
manufacturer in 2022. EsoCheck is a vitamin pill-sized capsule
containing a soft silicone balloon attached to a thin silicone
catheter. When the balloon is inflated, subtle ridges on its
surface are exposed, which permit gentle swabbing of the cells from
the lower esophagus where esophageal precancer and cancer occur.
When deflated, the balloon retracts into the capsule, protecting
the sample from dilution and contamination by cells outside the
target area during retrieval. Collect &
Protect® technology allows precise, anatomically
targeted collection of esophageal cells in a doctor's office, in
less than two minutes, without the need for anesthesia or sedation.
The efficiency of the cell collection process has allowed EsoCheck
to be used in dozens of high-volume precancer testing events over
the past year, with a single operator able to sample up to fifty
patients in a day. No mechanical failures of the EsoCheck device
have been reported to date. Data on nearly 1,500 patients
undergoing EsoCheck cell collection, presented at Digestive Disease
Week 2023, showed that 98% of patients successfully completed
EsoCheck cell collection, with excellent DNA yields and patient
satisfaction scores. Seminal data from the multi-center National
Cancer Institute's BETRNet consortium, posted as a preprint pending
peer review, demonstrated unprecedented esophageal precancer
(including short-segment) and cancer detection results of Lucid's
EsoGuard® Esophageal DNA Test on samples collected using
EsoCheck.
So-called "sponge-on-a-string" ("SOS") technologies were
introduced in the early 1990's, as an alternative to invasive upper
gastrointestinal endoscopy, with the launch of the
EsophaCap® device (which Lucid acquired in 2022). A
large medical device company briefly marketed the
Cytosponge® device in conjunction with Trefoil Factor 3
(TFF-3), a non-molecular, conventional immunohistochemical test,
before withdrawing it from the U.S. market. Data presented in 2021
from a U.S. study of Cytosponge/TFF-3 showed poor sensitivity,
especially in patients with short segments of esophageal precancer.
Troubling cases of mechanical failure of SOS devices were reported
in this and other studies. All SOS devices, including
repackaged/rebranded versions of Cytosponge, have fundamentally the
same design and operation as the original decades-old technology.
The patient swallows a spherical sponge with a roughened surface
which is encapsulated in a gelatin capsule. After waiting up to ten
minutes for the gelatin to dissolve in the stomach, the SOS is
withdrawn, scraping cells from the stomach, entire esophagus,
throat and mouth along the way. These first-generation devices lack
EsoCheck's ability to anatomically target cell collection at the
approximately two-inch segment of the esophagus near the stomach
where esophageal precancer and cancer arise, and, importantly, lack
EsoCheck's ability to protect these cells from dilution and
contamination by cells outside the target area.
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage medical diagnostics
company focused on cancer prevention, and subsidiary of PAVmed Inc.
(Nasdaq: PAVM). Lucid is focused on the millions of patients with
gastroesophageal reflux 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 for at-risk patients to mitigate the
risks of cancer and cancer deaths through early detection of
esophageal precancer.
For more information, please visit www.luciddx.com and for more
information about its parent company PAVmed, please visit
www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risk and uncertainties. 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 continues to monitor the COVID-19 pandemic and
the pandemic's impact 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 Diagnostics 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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SOURCE Lucid Diagnostics