EsophaCap device recalled due to recent
publication of serious device failures
Lucid Diagnostics' EsoCheck®
unaffected by recall and remains the gold standard for
non-endoscopic cell
collection
NEW
YORK, May 9, 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"), announced that the legacy
EsophaCap sponge-on-a-string (SOS) esophageal cell collection
device, which it briefly supplied to third-party institutions for
their own research studies, has been subjected to a Class II FDA
recall due to two serious device failures reported in a recent
publication of one of these studies. EsophaCap is not a commercial
Lucid product.
"Approximately 16,000 Americans tragically die each year from
highly-lethal esophageal cancer. Professional society guidelines
now recommend non-endoscopic biomarker testing to detect early
esophageal precancer and prevent cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief
Executive Officer. "Brillo pad-like sponge-on-a-string (SOS)
devices, first introduced in the early 1990s, indiscriminately
scrape cells from the stomach, esophagus and mouth, limiting their
efficacy. In addition, troubling reports of serious device failures
have plagued SOS devices for many years, leading to multiple Class
II FDA recalls similar to this one. All SOS devices, including
repackaged and/or rebranded versions, have fundamentally the same
design and limitations as those that have been previously subjected
to FDA recalls."
Dr. Aklog added, "In stark contrast, Lucid's
EsoCheck® Esophageal Cell Collection Device, with its
patent-protected Collect+Protect™ technology, is a modern
groundbreaking technology. EsoCheck allows for precise, targeted
collection of cells for esophageal precancer testing using the
EsoGuard® Esophageal DNA Test, resulting in
unprecedented early precancer detection. EsoCheck's gentle approach
to noninvasive cell collection is a dramatic and elegant
improvement over decades-old SOS technology. It has proved
particularly critical in detecting early short segment precancer
(SSBE), which accounts for at least 70% of cases in the at-risk
target population and is responsible for at least half of all
future cancers. Unlike most SOS devices, EsoCheck has never caused
any serious adverse events nor been associated with reportable
device failures in over 10,000 procedures."
The technology underlying the EsophaCap SOS was first
FDA-cleared in 1993 and then again in 2020 (K203450). Lucid
acquired the technology for research purposes in 2021 and supplied
it to two academic institutions for their ongoing research studies
until early 2022. In a recently-published research article of one
of these studies, two patients suffered from serious device
failures, specifically SOS detachments, one of whom required
invasive endoscopic retrieval. These detachments were similar to
previously-reported detachments of the Cytosponge Cell Collection
Device, an SOS manufactured by Medtronic, which led to two Class II
FDA recalls, including a June 2023
open global recall, which remains in effect. In this most-recent
recall, Medtronic reported to FDA that patients "may be at
increased risk of the sponge detaching from the string during
removal of the device from the patient, which could lead to device
fragments in patient, obstruction, airway obstruction, secondary
intervention, secondary intervention (with the primary procedure),
supraglottic airway obstruction, and aspiration." In an
accompanying Urgent Field Safety Notice sent to customers in the
United Kingdom, Medtronic reported
"nine (9) customer complaints where the sponge detached from the
string during the removal of the device from the patient. All nine
(9) patients underwent an unplanned urgent secondary intervention
(upper endoscopy) where the detached sponge was retrieved from the
stomach or esophagus" between December
2022 and May 2023.
As the manufacturer of record, Lucid proactively informed the
FDA of the reported device failures and concluded that a Class II
recall of the EsophaCap SOS was necessary and was made effective as
of April 25, 2024. Notice Letters
were sent to the two research institutions which had been supplied
with devices.
About Lucid Diagnostics
Lucid Diagnostics Inc. 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 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 - the
first and only commercially available tools designed with the goal
of preventing cancer and cancer deaths through widespread, early
detection of esophageal precancer in at-risk patients.
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