PAVmed and Lucid Diagnostics Provide Strategic Business Update
18 January 2023 - 8:05AM
Business Wire
Strategic resource reallocation, including
workforce reduction and other cost-cutting measures, to prioritize
near-term Lucid and Veris Health commercialization efforts
Conference call to be held today at 4:30PM
EDT
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 subsidiaries Lucid Diagnostics Inc. (Nasdaq: LUCD)
(“Lucid” or “Lucid Diagnostics”), a commercial-stage cancer
prevention diagnostics company, and Veris Health Inc. (“Veris”), a
private digital health company focused on enhanced personalized
cancer care, today provided a strategic business update, outlining
near-term strategic priorities and resource reallocation. The
companies will prioritize near-term Lucid and Veris Health
commercialization efforts. They have implemented a workforce
reduction of approximately 20 percent, product portfolio
streamlining, and other cost-cutting measures which seek to lower
quarterly cash burn by at least 25 percent.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230117006098/en/
“Over the past few quarters, we have engaged in a systematic
effort to maximize our cash runway and protect our long-term
shareholder interests, while executing on our strategic objectives
in what remain challenging market conditions,” said Lishan Aklog,
M.D., PAVmed’s and Lucid’s Chairman and Chief Executive Officer.
“We have decided to further extend this initiative by aggressively
streamlining operations to focus substantially all our resources
and near-term efforts on accelerating the commercialization of
Lucid’s and Veris’ products, resulting in a meaningful reduction in
our workforce and quarterly cash burn. We believe these
groundbreaking commercial products, with their large market
opportunities, are our most valuable assets and focusing on them
provides our shareholders the greatest near and long-term value
creation opportunity. Our leaner, more commercially focused posture
puts us in the best position to realize this opportunity.”
Lucid’s EsoGuard® Esophageal DNA Test (“EsoGuard”) utilizing its
EsoCheck® Cell Collection Device remains the first and only
commercially available diagnostic test recommended by clinical
practice guidelines to prevent esophageal cancer deaths through
early precancer detection. EsoGuard targets a well-established
population of approximately 30 million at-risk patients and an
estimated $60 billion addressable market based on an effective
Medicare payment rate of $1,938, which is consistent with our
per-test gross margins targets. The volume of EsoGuard tests
performed at Lucid’s dedicated CLIA-certified laboratory has grown
steadily in recent quarters. The company began submitting claims to
commercial insurers in late third quarter of 2022 and is starting
to generate claims histories necessary to drive in-network
commercial contract discussions. Out-of-network payments received
to date have respected the Medicare rate.
Pursuant to this initiative, Lucid plans to:
- continue to drive EsoGuard testing volume through ongoing
engagement of sales personnel with primary care physicians,
specialists and institutions, with an increasing focus on closing
larger strategic accounts and new market development
initiatives;
- maintain current team of approximately forty sales
professionals, having completed targeted layoffs and closed prior
vacancies;
- shift sales leadership attention from recruiting and hiring to
ongoing engagement with large institutional and strategic accounts,
while continuing to drive productivity of the current team;
- maintain its team of nurse practitioners and other clinical
personnel to support testing volume growth through existing Lucid
Test Centers (LTC) in eleven states, and its burgeoning satellite
LTC program, whereby Lucid personnel perform EsoCheck cell sampling
procedures at prescribing physicians’ offices;
- continue to invest in LucidDx Labs to assure EsoGuard testing
capacity and drive quality improvements and cost efficiencies;
- complete ongoing clinical utility studies to support in-network
coverage;
- delay completion of the EsoGuard BE-2 study to the second half
of 2023; and
- pause further development of the EsoCure Esophageal Ablation
device.
The Veris Cancer Care Platform, which commercially launched last
month, is a digital cancer care platform with symptom reporting,
telehealth functions, and advanced data analytics, designed to
improve personalized cancer care through remote patient monitoring
(RPM). Veris’ software-as-a-service recurring-revenue business
model allows oncology practices to leverage existing RPM codes,
providing attractive margins to the oncology practice and to Veris.
The company is concurrently developing an implantable physiological
monitor, designed to be implanted alongside a chemotherapy port,
which will interface with the Veris Cancer Care Platform. The
implantable monitor will further enhance the clinical and
commercial value of the platform by providing continuous RPM data
independent of patient compliance. With several million US patients
undergoing cancer treatment each year, the addressable market
opportunity for Veris’ products is substantial. Importantly,
commercial success is not predicated on securing third-party
reimbursement, only on sales and product development execution.
Veris plans to:
- continue to drive commercial adoption of the Veris Cancer Care
Platform utilizing its existing sales personnel, and expand the
commercial team only when commercial traction has been
well-established;
- delay development and regulatory submission of the implantable
physiologic monitor to the second half of 2023; and
- focus its workforce on near-term commercialization, having
already eliminated certain technology positions focused on future
data analytics, while retaining personnel directly involved in
customer integration and technical support.
PAVmed plans to:
- continue research and product development activities in support
of Lucid commercialization, including next generation EsoGuard and
EsoCheck products;
- continue product development activities in support of Veris
commercialization, namely its implantable physiologic monitor, as
above;
- continue its joint early-stage research and development project
with Novosound Ltd. to explore applying its groundbreaking
ultrasound technology to next-generation intravascular ultrasound
imaging;
- continue limited business development activities focused on
high value, near-term accretive opportunities that are synergistic
with existing commercial activity;
- indefinitely pause or halt all other product development
activities including CarpX, PortIO and NextFlo; and
- pursue additional cost-cutting initiatives including not paying
annual cash bonuses.
Conference Call To access the conference call, listeners
should dial 877-407-3982 toll-free in the U.S. or 201-493-6780 and
ask to join the “PAVmed and Lucid Diagnostics Strategic Business
Update Conference Call”. The conference call will be available live
at the investor relations section of PAVmed’s website at
ir.pavmed.com and the investor relations section of Lucid
Diagnostics’ website at ir.luciddx.com. Following the conclusion of
the conference call, a replay will also be available for one week
and can be accessed by dialing 844-512-2921 toll-free in the U.S.
or 412-317-6671, followed by the PIN number 13735527.
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, 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. PAVmed’s other 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.
For more information, please visit www.pavmed.com and
www.luciddx.com and www.verishealth.com.
Forward-Looking Statements This press release includes
forward-looking statements that involve risk 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
Diagnostics’ 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
and Lucid Diagnostics’ common stock; general economic and market
conditions; the uncertainties inherent in research and development,
including the cost and time required to advance PAVmed’s and Lucid
Diagnostics’ products to regulatory submission; whether regulatory
authorities will be satisfied with the design of and results from
PAVmed’s and Lucid Diagnostics’ clinical and preclinical studies;
whether and when PAVmed’s and Lucid Diagnostics’ products are
cleared by regulatory authorities; market acceptance of PAVmed’s
and Lucid Diagnostics’ products once cleared and commercialized;
PAVmed’s and Lucid Diagnostics’ ability to raise additional funding
as needed; and other competitive developments. In addition, PAVmed
and Lucid Diagnostics continue to monitor the COVID-19 pandemic and
the pandemic’s impact on PAVmed’s and Lucid Diagnostics’
businesses. These factors are difficult or impossible to predict
accurately and many of them are beyond PAVmed’s and Lucid
Diagnostics’ control. 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 future operations, see Part
I, Item 1A, “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. For a further list and description of these and
other important risks and uncertainties that may affect Lucid
Diagnostics’ future operations, see Part I, Item 1A, “Risk
Factors,” in Lucid Diagnostics’ 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 Lucid Diagnostics after its most
recent Annual Report. Each of PAVmed and Lucid Diagnostics
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/20230117006098/en/
Investor and Media:
Michael Parks Vice President of Investor Relations PAVmed and
Lucid Diagnostics 484.356.7105 mep@pavmed.com
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