Advocated stronger transparency and
predictability, and inclusion of diagnostics, in federal proposals
to improve equitable access to innovative lifesaving
technologies
Highlighted EsoGuard's life-saving potential,
and unprecedented early detection results of a recently posted
NCI-supported EsoGuard study
NEW
YORK, July 19, 2023 /PRNewswire/ -- PAVmed
Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed"), a diversified
commercial-stage medical technology company, operating in the
medical device, diagnostics, and digital health sectors, and its
majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq:
LUCD) ("Lucid Diagnostics" or "Lucid"), a commercial-stage cancer
prevention diagnostics company, announced that PAVmed and Lucid's
Chairman and Chief Executive Officer, Lishan Aklog, M.D, testified yesterday at the
U.S. House of Representatives Energy and Commerce Committee,
Subcommittee on Health, hearing entitled "Innovation Saves
Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs,
Medical Devices, and Technology".
Dr. Aklog, who serves on the Executive Committee of the Board of
Directors of AdvaMed, the world's largest medical technology
association, and as the inaugural chair of its committee focused on
health equity, vigorously advocated for stronger transparency and
predictability, and the inclusion of diagnostics, in two related
federal proposals to improve equitable access to innovative
technologies such as Lucid's EsoGuard® Esophageal DNA
Test ("EsoGuard)—the Ensuring Patient Access to Critical
Breakthrough Products Act of 2023 (H.R. 1691) and the proposed
Center for Medicare and Medicaid Services ("CMS") Transitional
Coverage for Emerging Technologies (TCET) pathway.
Dr Aklog testified, "Although medical technology innovation has
saved millions of lives, the arduous process of translating
innovation into life-saving products lacks transparency and
predictability…America remains the world's engine for medical
technology innovation. Most of this innovation, fueled by our
entrepreneurial spirit, occurs in small companies…Government,
including Congress, must keep pace and adjust…This Committee's work
on H.R.1691 and TCET can help establish a transparent and
predictable path to transitional Medicare coverage to ensure
equitable access to life-saving technologies." During questioning,
he vigorously argued that there is no justification for TCET to
exclude molecular diagnostic testing which lies "…at the leading
edge of innovation." Multiple Committee Members concurred.
Dr. Aklog used the opportunity to inform the Committee of the
devastating impact of highly lethal esophageal cancer and
EsoGuard's potential to save lives by detecting esophageal
precancer, before it progresses to cancer, consistent with the
goals of the Administration's Cancer Moonshot. He highlighted two
recent studies, including a multi-center National Cancer
Institute-supported study recently posted as a preprint, which
demonstrated unprecedented early cancer detection results—with
EsoGuard detecting 100 percent of esophageal cancers and over 80
percent of precancers.
EsoGuard's life-saving potential was brought into human focus
through the powerful story of an elderly man who requested an
EsoGuard test after reading a #CheckYourFoodTube educational poster
in his doctor's office. EsoGuard successfully detected a very late
stage esophageal precancer, for which he successfully underwent
curative ablation treatment to prevent progression to cancer.
A copy of Dr. Aklog' s prepared written testimony and link to a
video of the full hearing can be found on the PAVmed and Lucid
websites in the Investor Relations section, under "Events".
About PAVmed and its Subsidiaries
PAVmed Inc. is a diversified commercial-stage medical technology
company operating in the medical device, diagnostics, and digital
health sectors. Its majority-owned subsidiary, Veris Health Inc.,
is a digital health company focused on enhanced personalized cancer
care through remote patient monitoring using implantable biologic
sensors with wireless communication along with a custom suite of
connected external devices. Veris is concurrently developing an
implantable physiological monitor, designed to be implanted
alongside a chemotherapy port, which will interface with the Veris
Cancer Care Platform. Its other majority-owned
subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a
commercial-stage cancer prevention medical diagnostics company that
markets the EsoGuard® Esophageal DNA Test and
EsoCheck® Esophageal Cell Collection Device—the
first and only commercial tools for widespread early detection of
esophageal precancer to prevent esophageal cancer deaths.
For more and for more information about PAVmed, please
visit pavmed.com.
For more information about Veris Health, please
visit verishealth.com.
For more information about Lucid Diagnostics, please
visit luciddx.com.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risks and uncertainties. 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 PAVmed's and 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, PAVmed's
inability to regain, or subsequently maintain, compliance with
Nasdaq's listing standards; volatility in the price of PAVmed's and
Lucid's common stock; PAVmed's Series Z warrants; general economic
and market conditions; the uncertainties inherent in research and
development, including the cost and time required to advance
PAVmed's and Lucid's products to regulatory submission; whether
regulatory authorities will be satisfied with the design of and
results from PAVmed's and Lucid's clinical and preclinical studies;
whether and when PAVmed's and Lucid's products are cleared by
regulatory authorities; market acceptance of PAVmed's and Lucid's
products once cleared and commercialized; PAVmed's and Lucid's
ability to raise additional funding as needed; and other
competitive developments. 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 PAVmed's and Lucid's future
operations, see Part I, Item 1A, "Risk Factors," in PAVmed's and
Lucid'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 or Lucid after its most recent Annual Report.
PAVmed and Lucid disclaim 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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SOURCE PAVmed Inc.