PAVmed Inc. (Nasdaq: PAVM, PAVMZ)
(the “Company” or “PAVmed”), a highly differentiated,
multi-product, commercial-stage medical technology company, today
announced the launch of a new subsidiary, digital health company
Veris Health Inc. (“Veris”), which acquired Oncodisc Inc.
(“Oncodisc”), a digital health company with groundbreaking tools to
improve personalized cancer care through remote patient monitoring.
Oncodisc was founded by experienced physician
entrepreneurs, James Mitchell, M.D., who joins Veris as its
full-time Chief Medical Officer, and Andrew Thoreson, M.D., who
will serve as a Veris consultant. Oncodisc’s core technologies
include the first intelligent implantable vascular access port with
biologic sensors and wireless communication, combined with an
oncologist-designed remote digital healthcare platform that
provides patients and physicians with new tools to improve outcomes
and optimize the delivery of cost-effective care through remote
monitoring and data analytics.
“PAVmed is entering the rapidly expanding
digital health sector at an exciting time, characterized by
high-multiple IPO’s and M&A activity driven by dramatically
increased utilization of telemedicine, remote patient monitoring
and artificial intelligence, which collectively seek to establish
new standards for data-driven optimized care,” said Lishan Aklog,
M.D., PAVmed’s Chairman and Chief Executive Officer. “This
acquisition is consistent with our commitment to identify and seize
upon unique and timely opportunities to create value in any sector,
as we did three years ago with Lucid in the diagnostics sector. We
expect Veris to leverage strong synergies with the robust expanded
infrastructure we built to support Lucid during this period.”
“I warmly welcome Drs. Mitchell and Thoreson to
the PAVmed family,” Dr. Aklog added. “They have developed all the
necessary elements to create the premier integrated digital
healthcare platform for millions of cancer patients and their
oncologists, representing an estimated $2 to 3 billion U.S.
addressable market opportunity, based on established reimbursement
codes and an attractive recurring revenue subscription model. The
technology is also applicable to potentially even larger market
opportunities in other conditions such as renal failure and heart
failure. As with many digital health platforms, we have additional
prospects for substantial value-creation through data monetization
and biotherapeutic clinical trial support.”
“Over 80% of U.S. cancer care, including
immunotherapy and chemotherapy, takes place in outpatient clinics,
leaving patients unmonitored while at high risk of complications
and hospitalizations, up to 50% of which can be avoided,” said
James Mitchell, M.D., co-founder and Chief Executive Officer of
Oncodisc, and now Chief Medical Officer of Veris. “Although we have
solid published data demonstrating that remote monitoring of cancer
patients reduces hospital utilization, improves outcomes including
survival, and is well-reimbursed, current consumer-oriented tools
have not succeeded due to limited data points and poor patient
adherence. We are excited to join this impressive team and believe
we have found in PAVmed the ideal partner, with a proven track
record of success, to bring our technologies into the market for
the benefit of patients.”
Oncodisc was founded in 2018 by Mitchell, a
radiation-oncologist, and Thoreson, an interventional radiologist,
who previously co-founded Redsmith, Inc., an interventional
catheter company whose technology was acquired by C.R. Bard Inc.,
now BD Inc. (NYSE: BDX), in 2017. Oncodisc received a National
Science Foundation (“NSF”) Small Business Innovation Research
(“SBIR”) grant award to support its early work and completed both
the MedTech Innovator Accelerator and UCSF Rosenman Institute
Accelerator programs.
Its groundbreaking vascular access port contains
biologic sensors capable of generating continuous data on key
physiologic parameters known to predict adverse outcomes in cancer
patients undergoing treatment. Wireless communication to the
patient’s smartphone and its cloud-based digital healthcare
platform efficiently and effectively delivers actionable real time
data to patients and physicians. The technologies are the subject
of multiple patent applications and one allowed patent awaiting
final issuance. Veris is targeting FDA 510(k) clearance of the
intelligent implantable vascular access port and launch of the
remote digital healthcare platform for H2-2022.
The planned Veris business model seeks to
generate 100% recurring revenue through oncology practice and
hospital-based subscriptions. These entities would purchase seats
on the platform and pay a monthly remote monitoring charge to drive
revenues from remote patient monitoring and device implantation
under existing CPT codes, as well as established CMS Oncology Care
Model (OCM) bonuses and CMS Quality Reporting Program incentives.
Veris also anticipates strong demand for its intelligent
implantable vascular access port and remote monitoring platform
from oncology biotherapeutic companies to support clinical trials
of their novel immunotherapy and chemotherapy agents with
continuous physiologic data and transformative analytics.
Veris inherits a world-class medical advisory
board including oncologists from leading academic centers such as
Harvard’s Dana Farber Cancer Institute, Stanford Medicine,
University of California San Francisco, Cedars-Sinai Medical Center
and Northwell Health.
PAVmed formed Veris Health Inc., a Delaware
Corporation, as a wholly owned subsidiary, which in turn entered
into a Stock Purchase Agreement to acquire 100% of the outstanding
shares of Oncodisc Inc. from Oncodisc Holdings LLC, including all
of Oncodisc’s intellectual property, hardware, and software assets.
In exchange, PAVmed granted Oncodisc Holdings LLC a 19.6% equity
interest in Veris and provided $155,250 in cash to pay off two
Oncodisc convertible notes. No additional cash consideration or
PAVmed stock consideration was provided. A Shareholder Agreement
between the parties provides additional terms and conditions
concerning certain regulatory and commercial milestones,
anti-dilution protection and other customary provisions. PAVmed
will manage Veris through a Management Services Agreement until
such time that the Veris Board of Directors decides to engage a
dedicated management team and will finance its operations through
intercompany advances until Veris decides to raise its own capital.
Mitchell and Thoreson have entered into employment and consulting
agreements, respectively, which include stringent intellectual
property assignment and non-compete provisions.
About PAVmed
and LucidPAVmed Inc. is a highly differentiated,
multi-product, commercial-stage medical technology company with a
diversified product pipeline addressing unmet clinical needs
encompassing a broad spectrum of clinical areas with attractive
regulatory pathways and market opportunities. Its major subsidiary,
Lucid Diagnostics Inc., markets the first and only commercial tools
for widespread early detection of esophageal precancer and cancer –
the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell
Collection Device. Its GI Health division also includes the
complementary EsoCure™ Esophageal Ablation Device with Caldus™
Technology. Its Minimally Invasive Interventions markets its CarpX®
Minimally Invasive Device for Carpal Tunnel Syndrome. Other
divisions include Infusion Therapy (PortIO™ Implantable
Intraosseous Vascular Access Device and NextFlo™ Intravenous
Infusion Set), and Emerging Innovations (non-invasive laser-based
glucose monitoring, pediatric ear tubes, and mechanical circulatory
support). 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. For
detailed information on EsoGuard, please visit www.EsoGuard.com and
follow us on Twitter, Facebook and Instagram.
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. 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
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.
Contacts:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
Jim Heins / Katie GallagherLaVoieHealthScience(646) 491-7042 /
(617) 792-3937PAVmed@lavoiehealthscience.com
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