PAVmed Subsidiary Lucid Diagnostics Partners with Fred Hutchinson Cancer Research Center to Evaluate Barrett’s Esophagus (B...
February 20 2020 - 9:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced that its majority owned subsidiary, Lucid
Diagnostics Inc. (“Lucid”), has entered into a sponsored research
agreement with the Fred Hutchinson Cancer Research Center (“Fred
Hutchinson”) at the University of Washington in Seattle, WA to
evaluate Barrett’s Esophagus (BE) progression biomarkers in
patients using Lucid’s EsoCheck™ Esophageal Cell Collection Device
with Collect+Protect™ Technology.
The agreement covers a research program entitled
“Biomarkers for the Detection of Cancer” led by principal
investigator William M. Grady, M.D. AGAF. Dr. Grady is the Rodger
Haggitt Professor of Medicine in the Gastroenterology Division of
the University of Washington School of Medicine and a Full Member
of the Clinical Research Division at Fred Hutchinson. He also
serves as the Medical Director of the GI Cancer Prevention Program
at the Seattle Cancer Care Alliance.
Pursuant to the agreement, Fred Hutchinson has
granted Lucid the exclusive option, exercisable at its sole
discretion, to license Fred Hutchinson’s candidate BE progression
biomarkers during an option period extending twelve months past the
completion of a phase II study demonstrating their accuracy. The
license would be assignable and exclusive within any field or
fields of use in which Lucid reasonably determines it could develop
a product that incorporates or utilizes the biomarkers. The license
would provide that Lucid would pay to Fred Hutchinson royalties on
net sales of products incorporating the BE progression biomarkers
at rates not to exceed amounts specified in the agreement.
The research program will include human clinical
studies to explore the candidate BE progression biomarkers, which
have shown promise in differentiating nondysplastic BE from
dysplastic BE and esophageal adenocarcinoma (EAC), on esophageal
samples obtained using EsoCheck. Lucid seeks to determine whether a
panel of these biomarkers, in conjunction with EsoCheck, can serve
as a non-invasive, office-based diagnostic test to monitor patients
with nondysplastic BE for evidence of progression to dysplastic BE
or EAC. This early detection would permit curative ablation of
dysplastic BE before progression to deadly EAC, using esophageal
ablation devices such as PAVmed’s recently announced EsoCure
Esophageal Ablation Device targeted for commercialization in
2021.
“We look forward to working with Dr. Grady and
his team at the Fred Hutchinson Cancer Research Center to explore
this new EsoCheck application to monitor BE disease progression
using Dr. Grady’s promising BE progression biomarkers,” said Lishan
Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and
Lucid’s Executive Chairman. “I am very pleased that Lucid has also
secured the exclusive option to license these biomarkers for
commercialization. Several research centers and companies are also
pursuing BE progression markers to enhance the surveillance of BE
patients and prevent EAC. However, since EsoCheck is the only
esophageal cell collection device capable of performing targeted
and protected sampling of these esophageal cells, I believe that
for any of these candidate BE progression markers to be clinically
and commercially viable, they will have to be used on cells
collected with EsoCheck.”
“I am excited to partner with Lucid on this
important research project,” said Dr. Grady. “I solicited Lucid
because EsoCheck is the only device capable of collecting distal
esophageal cells in an anatomically targeted fashion without
dilution and contamination from more proximal cells of the
esophagus and oropharynx. Anatomically targeted sampling is
absolutely necessary for any BE progression biomarker assay to
accurately and non-invasively detect disease progression from
nondysplastic BE to dysplastic BE and esophageal cancer. Our
biomarkers have shown great progress in preliminary work and if
they prove accurate in this study, EsoCheck could play an important
complementary role to endoscopy in BE monitoring.”
PAVmed and Lucid are seeking to offer the only
comprehensive and complementary panel of products capable of
detecting and treating conditions across the spectrum of conditions
from BE to EAC.
Lucid’s EsoGuard Esophageal DNA Test and
EsoCheck are designed to facilitate the diagnosis of nondysplastic
and dysplastic BE – precursors of highly lethal EAC – as well as
EAC itself, in patients with chronic heart burn or gastroesophageal
reflux disease (GERD). Lucid recently launched EsoGuard as a
commercial Laboratory Developed Test (LDT). EsoGuard, which
recently received FDA Breakthrough Device Designation, is also the
subject of two Lucid-sponsored international multi-center IVD
clinical trials, ESOGUARD-BE-1 and 2, in support of an FDA PMA
application to establish EsoGuard as an FDA-registered IVD to
detect BE in samples collected with EsoCheck in high-risk GERD
patients recommended for BE screening by the American College of
Gastroenterology.
PAVmed’s recently announced EsoCure™ Esophageal
Ablation Device with Caldus™ Technology is a disposable single-use
thermal balloon ablation catheter designed to advance through the
working channel of a standard endoscope. Once cleared and
commercialized, EsoCure would allow clinicians to treat dysplastic
BE before it can progress to highly lethal EAC and to do so without
the need for complex and expensive capital equipment. PAVmed
expects to complete development and FDA 510(k) submission of
EsoCure by early 2021.
The patent portfolio underlying PAVmed’s current
license agreement with Case Western Reserve University includes
promising candidate BE progression biomarkers in addition to
EsoGuard and EsoCheck. A new test designed to detect progression of
nondysplastic BE to dysplastic BE using the Fred Hutchinson
biomarkers alone or in combination with other biomarkers would
effectively complete Lucid-PAVmed’s comprehensive and complementary
panel of BE-EAC products by providing clinicians with:
- EsoGuard on samples collected with EsoCheck – a non-invasive
diagnostic test designed to detect BE in high-risk GERD patients
without a prior diagnosis of BE;
- New BE progression biomarker test on samples collected with
EsoCheck – a non-invasive diagnostic test designed to detect
progression of non-dysplastic BE to dysplastic BE and EAC in BE
patients as part of a surveillance program with or without periodic
endoscopy; and
- EsoCure - a therapeutic ablation device to treat these
dysplastic BE patients prior to further progression to deadly
EAC.
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct commercial stage medical device company employing a
unique business model designed to advance innovative products to
commercialization much more rapidly and with significantly less
capital than the typical medical device company. This proprietary
model enables PAVmed to pursue an expanding pipeline strategy with
a view to enhancing and accelerating value creation while seeking
to further expand its pipeline through relationships with its
network of clinician innovators at leading academic centers.
PAVmed’s diversified product pipeline addresses unmet clinical
needs encompassing a broad spectrum of clinical areas with
attractive regulatory pathways and market opportunities. Its four
operating divisions include GI Health (EsoGuard™ Esophageal DNA
Test, EsoCheck™ Esophageal Cell Collection Device, and EsoCure™
Esophageal Ablation Device with Caldus™ Technology), Minimally
Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal
Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus
Vascular Access Device and NextFlo™ Highly Accurate Disposable
Intravenous Infusion Set), and Emerging Innovations (non-invasive
laser-based glucose monitoring, NextCath™ self-anchoring
cathethers, 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.
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. 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 Reports 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.
Contacts:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
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