Item 7.01. Regulation FD Disclosure.
On January 17, 2023, PAVmed Inc. (the “Company” or “PAVmed”), together with its
majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), issued a joint
press release providing a strategic business update. A copy of the press release
is attached to this report as Exhibit 99.1 and is incorporated herein by
reference.
The information furnished under Item 7.01, including the exhibit related
thereto, shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, nor shall it be deemed incorporated by
reference in any disclosure document of the Company, except as shall be
expressly set forth by specific reference in such document.
Item 8.01. Other Events.
In the press release, the Company addressed the following strategic updates:
? The Company and Lucid will prioritize near-term Lucid and Veris Health
commercialization efforts.
? The companies 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.
? Specifically, pursuant to this initiative, the Company and Lucid plan to take
the following steps, among others:
Lucid
? 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, Lucid's CLIA-certified commercial clinical
laboratory, 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.
PAVmed
? with respect to the Company's majority-owned subsidiary Veris Health:
? 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 of the Veris Cancer Care
platform, having already eliminated certain technology positions focused on
future data analytics, while retaining personnel directly involved in customer
integration and technical support;
? 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 discussed 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.
Forward-Looking Statements
This Form 8-K 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 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, the risk that PAVmed’s change in
strategy does not generate the expected benefits; volatility in the price of
PAVmed’s common stock; general economic and market conditions; the uncertainties
inherent in research and development, including the cost and time required to
advance PAVmed’s products to regulatory submission; whether regulatory
authorities will be satisfied with the design of and results from PAVmed’s
clinical and preclinical studies; whether and when PAVmed’s products are cleared
by regulatory authorities; market acceptance of PAVmed’s products once cleared
and commercialized; PAVmed’s ability to raise additional funding as needed to
pursue its current business plan; and other competitive developments. In
addition, PAVmed continues to monitor the COVID-19 pandemic and the pandemic’s
impact on PAVmed’s business. These factors are difficult or impossible to
predict accurately and many of them are beyond PAVmed’s 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. 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
Exhibit No. Description
99.1 Press release.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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