PAVmed Subsidiary Lucid Diagnostics Launches First Lucid Test Centers
10 August 2021 - 3:30PM
Business Wire
Patients undergoing esophageal precancer
testing at centers in Phoenix metro area
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or
“PAVmed”), a highly differentiated, multi-product, commercial-stage
medical technology company, today announced that its majority owned
subsidiary Lucid Diagnostics Inc. (“Lucid”) has begun testing
patients referred by primary care physicians (“PCPs”) at three
Lucid Test Centers in the Phoenix metropolitan area. Patients with
chronic heartburn, also known as gastroesophageal reflux disease
(“GERD”), who are referred to the centers undergo a rapid
non-invasive office procedure, performed by Lucid-employed clinical
personnel, using Lucid’s EsoCheck® Cell Collection Device
(“EsoCheck”) to collect surface esophageal cells for its EsoGuard®
Esophageal Test (“EsoGuard”).
“This launch represents a major milestone for Lucid and our
EsoGuard commercialization efforts,” said Lishan Aklog M.D.,
PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive
Chairman. “An important pillar of our growth strategy is to expand
EsoGuard commercialization across multiple channels by targeting
PCPs and consumers, in addition to the gastroenterologists who have
been our main target to date. We are excited that PCPs in the
Phoenix area can now refer their at-risk GERD patients for a
simple, office-based test to detect esophageal precancer before it
progresses to esophageal cancer.”
“We believe these Lucid Test Centers will play an important role
in expanding EsoGuard referrals as the vast majority of GERD
patients are cared for by PCPs, not gastroenterologists. We also
believe, based on our analysis, that each center can be operated
with very modest fixed costs and attractive margins. After
completing the pilot program in Phoenix, we intend to steadily
expand our Lucid Test Centers to other metropolitan areas, first in
selected Western U.S. states and then nationwide. These test
centers will also support the next phase of this pilot program—an
EsoGuard Telemedicine Program, operated in partnership with
UpScript, our independent third-party telemedicine provider, to
accommodate EsoGuard self-referrals from direct-to-consumer
marketing.”
Millions of patients with GERD are at risk of developing
esophageal precancer and highly lethal esophageal cancer. EsoGuard
is a next-generation sequencing based DNA methylation assay
performed on esophageal cells collected using Lucid’s EsoCheck
device in a less-than five-minute office procedure. Lucid believes
EsoGuard and EsoCheck 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.
The three Lucid Test Centers operate in leased medical office
suites located in Scottsdale, Tempe and Glendale, Arizona and are
staffed by an EsoCheck-trained nurse practitioner and medical
assistant employed by Lucid. Lucid estimates that a single nurse
practitioner will be able to 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.
Lucid has hired its first sales representative specifically tasked
with calling on PCPs and whose efforts, working with regional
business and market development managers, are now driving EsoGuard
referrals to the Phoenix area test centers.
Prior to launching these centers, Lucid established a robust
supporting regulatory and compliance infrastructure, including
engaging highly experienced, dedicated healthcare regulatory and
compliance counsel, adding dozens of new standard operating
procedures to its quality management system, and updating elements
of its contractual agreement with its CLIA-certified laboratory
partner to align with certain regulations. Lucid also established a
new Quality & Compliance Committee of its board of directors to
provide board-level oversight and recruited Dr. Jacque Sokolov, a
highly experienced expert in Board oversight of compliance and
quality for public healthcare companies, to serve on its board and
chair the committee.
About PAVmed and Lucid
PAVmed Inc. is a highly differentiated, multi-product,
commercial-stage medical technology company with a diversified
product pipeline addressing unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its major subsidiary, Lucid
Diagnostics Inc., markets the first and only commercial tools for
widespread early detection of esophageal precancer and cancer – the
EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell
Collection Device. Its GI Health division also includes the
complementary EsoCure™ Esophageal Ablation Device with Caldus™
Technology. Another major subsidiary, Veris Health Inc., is a
digital health company developing the first intelligent implantable
vascular access port with biologic sensors and wireless
communication to improve personalized cancer care through remote
patient monitoring. Its Minimally Invasive Interventions division
markets its CarpX® Minimally Invasive Device for Carpal Tunnel
Syndrome. Other divisions include Infusion Therapy (PortIO™
Implantable Intraosseous Vascular Access Device and NextFlo™
Intravenous Infusion Set), and Emerging Innovations (non-invasive
laser-based glucose monitoring, pediatric ear tubes, and mechanical
circulatory support). For more information, please visit
www.pavmed.com, follow us on Twitter, connect with us on LinkedIn,
and watch our videos on YouTube. For more information on our
majority owned subsidiary, Lucid Diagnostics Inc., 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 that
involve risks and uncertainties. Forward-looking statements are
statements that are not historical facts. Such forward-looking
statements, based upon the current beliefs and expectations of
PAVmed’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 PAVmed’s
common stock, Series W Warrants and Series Z Warrants; general
economic and market conditions; the uncertainties inherent in
research and development, including the cost and time required
advance PAVmed’s products to regulatory submission; whether
regulatory authorities will be satisfied with the design of and
results from PAVmed’s preclinical studies; whether and when
PAVmed’s products are cleared by regulatory authorities; market
acceptance of PAVmed’s products once cleared and commercialized;
our ability to raise additional funding and other competitive
developments. PAVmed has not yet received clearance from the FDA or
other regulatory body to market many of its products. The Company
has been monitoring the COVID-19 pandemic and its impact on our
business. The Company expects the significance of the COVID-19
pandemic, including the extent of its effect on the Company’s
financial and operational results, to be dictated by, among other
things, the success of efforts to contain it and the impact of
actions taken in response. New risks and uncertainties may arise
from time to time and are difficult to predict. All of these
factors are difficult or impossible to predict accurately and many
of them are beyond PAVmed’s control. For a further list and
description of these and other important risks and uncertainties
that may affect PAVmed’s future operations, see Part I, Item IA,
“Risk Factors,” in PAVmed’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 PAVmed after its most recent Annual
Report. PAVmed 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/20210810005613/en/
Investors Mike Havrilla Director of
Investor Relations 814-241-4138 JMH@PAVmed.com
Media Katie Gallagher / Kristi
Bruno LaVoieHealthScience (617) 792-3937 / (617) 865-3940
PAVmed@lavoiehealthscience.com
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