U.S. FDA Grants PAVmed Subsidiary, Lucid Diagnostics, Breakthrough Device Designation for its EsoGuard Esophageal DNA Test
February 11 2020 - 9:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced that the Company’s majority owned
subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received
Breakthrough Device designation from the U.S. Food and Drug
Administration (FDA) for its EsoGuard™ Esophageal DNA Test on
esophageal samples collected using its EsoCheck™ Cell Collection
Device in a prevalent well-defined group of patients at elevated
risk for esophageal dysplasia due to chronic gastroesophageal
reflux disease (GERD).
“EsoGuard’s FDA Breakthrough Device designation
represents a major milestone for PAVmed and Lucid,” said Lishan
Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and
Lucid’s Executive Chairman. “This designation validates our belief
that EsoGuard is a groundbreaking technology that has the potential
to have as great an impact on esophageal cancer as widespread Pap
screening has had in preventing deaths from cervical cancer. We
look forward to working closely with the FDA to advance our
EsoGuard in-vitro diagnostic (IVD) clinical development program at
an expedited pace.”
The FDA Breakthrough Device Program was created
to offer patients more timely access to breakthrough technologies
which “provide for more effective treatment or diagnosis of
life-threatening or irreversibly debilitating human disease or
conditions” by expediting their development, assessment and review
through enhanced communications and more efficient and flexible
clinical study design, including more favorable pre/post market
data collection balance. Breakthrough Devices receive priority FDA
review, and a bipartisan bill before Congress (H.R. 5333) seeks to
require Medicare to temporarily cover all Breakthrough Devices for
three years while determining permanent coverage.
”I have dedicated my career to the care of
patients across the disease spectrum from BE, with and without
dysplasia, to lethal esophageal cancer, and have participated in
some of the key developments in this field,” said Nicholas J.
Shaheen MD, MPH, Professor of Medicine and Epidemiology and Chief
of the Division of Gastroenterology and Hepatology at UNC
HealthCare, Director of the American College of Gastroenterology
(ACG) Institute for Clinical Research and Education and lead author
of its guidelines on the Diagnosis and Management of Barrett’s
Esophagus. “I am very excited that the FDA deemed EsoGuard worthy
of Breakthrough Device designation. This recognition significantly
enhances EsoGuard’s potential to prevent deaths from esophageal
cancer through early detection of these conditions.”
“I am very gratified that FDA agreed with us
that EsoGuard satisfies all of its criteria for Breakthrough Device
designation for the proposed indications for use,” said Alberto
Gutierrez, Ph.D., Lucid’s regulatory consultant and former director
of the FDA's Office of In-Vitro Diagnostics (OIVD). “I have
participated in the designation of several IVD Breakthrough Devices
and understand the value this brings to Lucid’s clinical
development program. I look forward to continuing to work with
Lucid and FDA as we take advantage of the enhanced and accelerated
FDA engagement opportunities granted to Breakthrough Devices.”
The EsoGuard Esophageal DNA Test is performed on
esophageal samples that are collected using Lucid’s FDA
510(k)-cleared EsoCheck™ Esophageal Cell Collection Device. These
technologies were highlighted as one of the year’s significant
advances in cancer prevention in the National Cancer Institute’s
2020 Annual Plan and Budget Proposal submitted to Congress. They
are designed to facilitate the diagnosis of Barrett’s Esophagus
(BE), with and without dysplasia – a progression of precursor
conditions that culminate in highly lethal esophageal cancer (EAC)
– as well as EAC itself, in patients with chronic heart burn, also
known as gastroesophageal reflux disease (GERD).
Although the ACG’s professional society practice
guidelines recommend screening in millions of high-risk patients to
detect and treat BE, with or without dysplasia, before it
progresses to EAC, fewer than 10% actually undergo screening using
the traditional invasive approach, upper endoscopy. Most patients
diagnosed with EAC are neither aware of their underlying BE, nor
that they missed the opportunity to undergo treatment which could
have prevented progression to EAC had the BE been diagnosed
earlier.
As a result, over 80% die within five years of
diagnosis. The estimated immediately addressable domestic market
opportunity for EsoGuard is at least $2 billion based on very
modest penetration of the U.S. GERD patients currently recommended
for BE screening according to ACG guidelines.
EsoGuard performs next generation sequencing
(NGS) of bisulfite-converted DNA to detect methylation at 31 sites
on two genes (VIM and CCNA1). EsoGuard has been shown in a
408-patient human study published in Science Translational Medicine
to be highly accurate at detecting BE, with and without dysplasia,
as well as EAC, with greater than 90% sensitivity and
specificity.
EsoGuard, which is already commercially
available as a Laboratory Developed Test (LDT), is the subject of
two Lucid-sponsored international multi-center IVD clinical trials
in support of an FDA PMA. The screening study will enroll GERD
patients without a prior diagnosis of BE or EAC who satisfy ACG BE
screening guidelines. The case control study will enroll patients
with a previous diagnosis of non-dysplastic BE, dysplastic BE (both
low and high-grade) or EAC. In both studies, EsoGuard will be
compared to the gold standard of endoscopy with biopsies. Dr.
Shaheen serves as lead investigator for both studies, which will
begin enrolling patients in the coming weeks at 60 sites in the
U.S. and Europe.
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct 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. PAVmed’s diversified
pipeline of products address unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its five lead technologies
provide groundbreaking approaches to carpal tunnel syndrome
(CarpX™), precancerous conditions of the esophagus
(EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear
infections (DisappEAR™) and medical infusions (NextFlo™). The
company is also developing innovative products in other areas, such
as catheters and tissue ablation, while seeking to further expand
its pipeline through engagements with clinician innovators and
leading academic medical centers. 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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