Full Press Release Details
and Former Chairman & CEO of Exact Sciences Stanley Lapidus Joins PAVmed Subsidiary Lucid Diagnostics as Strategic Advisor
YORK, June 15, 2020 (GLOBE NEWSWIRE) - PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"),
a highly differentiated, multiproduct medical device company, today announced that medical diagnostics pioneer Stanley Lapidus,
founder and former Chairman and CEO of Exact Sciences (Nasdaq: EXAS), has joined its majority owned subsidiary, Lucid Diagnostics
Inc. ("Lucid"), as a Strategic Advisor to assist with its commercial, regulatory, clinical trial and capital markets
am thrilled to welcome Stan Lapidus as a Lucid Strategic Advisor and look forward to tapping into his vast wealth of knowledge,
experience and wisdom as we advance EsoGuard and EsoCheck commercialization," said Lishan Aklog, M.D., PAVmed's Chairman
and Chief Executive Officer and Lucid's Executive Chairman. "Stan is a medical diagnostics industry titan and one
of its most accomplished innovators in the early detection of cancer and its precursors, including cervical and colon cancer.
Since its inception, Lucid's stated goal has been for its early detection technologies to have as great an impact on preventing
esophageal cancer as widespread Pap testing has had in preventing cervical cancer. We are fortunate that one of the most impactful
persons in preventing deaths from cervical cancer will be helping us achieve this mission."
have spent most of my professional career in a quest to save lives through the early detection of cancer and its precursors,"
said Mr. Lapidus. "Lucid Diagnostics' EsoGuard and EsoCheck technologies have the potential to be game changers in
the diagnosis of conditions along the spectrum from Barrett's Esophagus to esophageal cancer, which is a growing scourge.
The ability to noninvasively screen at-risk patients for these conditions has substantial clinical and commercial potential. The
Lucid team is poised to reach key inflection points and I look forward to working with them as they accelerate commercialization,
embark on important IVD clinical trials and explore capital market strategies."
Lapidus brings more than three decades of experience founding and leading breakthrough diagnostic companies. He founded and served
as President of Cytyc Inc., whose ThinPrep Pap test technology which he invented, revolutionized early detection
of cervical cancer. Cytyc was acquired by Hologic Inc. in 2007 for $6.2 billion. Mr. Lapidus also founded and served as President
& CEO and later as Chairman of Exact Sciences, whose Cologuard stool DNA test has revolutionized early detection
of colorectal cancer. Exact Sciences became the fastest growing company in the history of the diagnostics industry and now is
a leading provider of cancer screening and diagnostic tests, with a market cap over $12 billion. Mr. Lapidus also founded and
led medical diagnostic companies Helicos BioSciences Inc. and SynapDx Inc. He currently serves on the Board of Directors of Binx
Health Inc., Glympse Bio Inc., PathAI Inc, Fractyl Laboratories Inc. and T2 Biosystems Inc. He also serves as a Co-Founding Pillar
of Pillar VC, Managing Director of his own incubator LapidDx Research, has served as an Instructor at the Massachusetts Institute
of Technology and is Fellow of the American Institute of Medical and Biological Engineering.
Diagnostics Inc. is a highly differentiated, medical device innovator with products designed to diagnose and treat conditions
of the esophagus. Lucid's EsoGuard Esophageal DNA Test and EsoCheck Collection Device are designed to facilitate the diagnosis
of Barrett's Esophagus (BE) and related precursors to highly lethal esophageal adenocarcinoma (EAC) in patients with chronic
heart burn, also known as gastroesophageal reflux disease (GERD).
is commercially available in the United States as a Laboratory Developed Test (LDT) and is the first DNA test designed to facilitate
the diagnosis of Barrett's Esophagus (BE) and related precursors to highly lethal esophageal adenocarcinoma (EAC). EsoGuard
is performed on cells sampled from the lower esophagus in a five-minute noninvasive office-based procedure. Next-generation sequencing
(NGS) of DNA extracted from these cells is used to determine the epigenetic methylation status of 31 sites on two genes (VIM and
CCNA1). A positive or negative result is determined based on algorithmic assessment of the percentage of DNA molecules for which
a proportion of methylated sites on either gene exceeds a certain threshold. A positive result has been correlated, with greater
than 90% sensitivity and specificity, with the presence of non-dysplastic BE, dysplastic BE or EAC, in a clinical study of 408
patients published in Science Translational Medicine.
EsoCheck Collection Device is an FDA 510(k)-cleared non-invasive cell collection device designed to sample cells from the esophagus
in a five-minute office-based procedure, without the need for endoscopy - the only such device capable of doing so in an
anatomically targeted fashion without sample dilution or contamination (EsoCheck animation). Patients swallow a vitamin pill-sized
capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs surface cells
from the target area and protects them as the device is removed. The sampled cells can then be subjected to any commercially available
diagnostic test, including EsoGuard. EsoCheck is also being evaluated to assist in monitoring BE disease progression and in the
diagnosis and management of Eosinophilic Esophagitis (EoE), a rapidly emerging allergy-mediated inflammatory condition of the
esophagus similar to, and often associated with, inflammatory bowel disease (IBD).
Inc. is a highly differentiated, multiproduct commercial stage medical device company employing a unique business model designed
to advance innovative products to commercialization rapidly and with 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 Infusion Platform Technology),
and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support).
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.
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 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
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