Lucid Diagnostics Commences Production of EsoCheck Devices with High-Volume Manufacturer
09 November 2022 - 2:25PM
Business Wire
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”, the
“Company”), a commercial-stage, cancer prevention medical
diagnostics company, and majority-owned subsidiary of PAVmed
Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), today announced the
commencement of production of its EsoCheck® Esophageal Cell
Collection Devices (“EsoCheck”) at Coastline International, Inc.
(“Coastline”), a high-volume manufacturer headquartered in San
Diego, CA with plants in Mexico. The Company has worked closely
with Coastline over the past year to transfer the EsoCheck
manufacturing lines from its prior low-volume manufacturer and to
complete all the necessary validations to commence high-volume
production at Coastline’s facility.
“The successful transition of EsoCheck production to a
high-volume manufacturer reflects our deep commitment to drive
efficiencies throughout the entire commercialization cycle,” said
Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer.
“This transition will reduce the per-unit manufacturing cost of
EsoCheck devices by approximately 60% and provide scalable
manufacturing capacity to accommodate accelerating growth in
EsoGuard® Esophageal DNA Test testing volume. Following this
transition, EsoCheck manufacturing capacity is now approximately
20,000 units per year. The system has been designed to allow
capacity to be scaled to over one million units per year by adding
additional manufacturing lines as demand dictates.”
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 and
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.
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Investors and Media Adrian K.
Miller PAVmed Inc. AKM@PAVmed.com
PAVmed (NASDAQ:PAVMZ)
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