PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or
“PAVmed”), a highly differentiated, multiproduct medical device
company, today provided a business update following its recently
closed, oversubscribed rights offering.
“During our recently completed rights offering we had the
pleasure of meeting with many existing investors as well as new
investors who were learning about PAVmed for the first time,” said
Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer.
“A common theme during these interactions and subsequent inquiries
from investors has been a strong interest in more frequent updates
from the Company as we progress towards important milestones. We
have always had a strong commitment to transparency and robust
investor communications, and in that spirit we believe this is an
opportune time to provide a detailed business update on our
finances, capital markets status and key products in our
pipeline.”
Financial and Corporate Update
On June 12, 2018 PAVmed completed an oversubscribed rights
offering whereby stockholders exercised and the Company accepted
equity subscription rights resulting in the issuance of the maximum
9 million units, with each unit consisting of one share of common
stock (Nasdaq: PAVM) and one Series Z Warrant (Nasdaq: PAVMZ) at a
subscription price of $1.15 per unit. This resulted in gross and
net proceeds of $10.35 million and $9.44 million, respectively.
“We were very gratified by the vote of confidence in PAVmed
shown by our shareholders through their strong participation in
this rights offering, including several large long-term
shareholders who have been with us since the founding of the
company,” said Dr. Aklog. “The proceeds of the offering coupled
with the $3.6 million in cash and equivalents we reported as of
March 31, 2018 extends our cash runway significantly and through
the expected commercial launch of two of our lead products. We do
not anticipate needing to raise additional capital until well after
achieving these value-infection milestones.”
The Company also believes the receipt of the proceeds from the
rights offering will increase the Company’s stockholders’ equity in
a sufficient amount to allow the Company to regain compliance with
Nasdaq’s continued-listing requirements pursuant to Listing Rule
5550(b)(1). PAVmed has initiated discussions with Nasdaq and will
promptly provide the requested documentation and file the necessary
public report to regain compliance.
Product Update
“CarpX™, our groundbreaking minimally invasive device to treat
carpal tunnel syndrome and our most important lead product, is
steadily moving through the U.S. Food and Drug Administration’s
(FDA) 510(k) process,” said Dr. Aklog. “Several weeks ago, we filed
a resubmission with the FDA including excellent results from an
animal study the agency had requested, which documented that the
device’s bipolar electrode design results in minimal spread of
thermal energy, as we had expected. The pathologic specimens showed
that the thermal injury was limited to less than one millimeter and
thermal sensors showed no increase in tissue temperatures except
directly over the cutting electrodes. We expect that there will be
some delay in the review of our resubmission and, upon the advice
of our regulatory consultant, we have elected to use that time to
submit physician usability and design verification testing on the
most current version of the device, which incorporates several
performance-enhancing improvements. This development pushes the
regulatory timeline back by about six weeks, with FDA review of the
resubmission beginning in mid-to-late July and an expected FDA
response in the late summer. We believe this strategy strengthens
our submission and the prospects for clearance.
“In anticipation of receiving FDA clearance, we are accelerating
preparations for the U.S. commercial launch of CarpX, which we
estimate has an immediately addressable market opportunity of over
$1 billion. We are recruiting a Chief Commercial Officer to oversee
these activities and have held increasingly active discussions with
several potential distribution partners. Our CarpX activities
outside the United States have also progressed. We are on target
for European CE Mark submission late in this year’s third quarter.
We have pushed our anticipated first-in-man clinical series in New
Zealand to the early fall to take advantage of the recently
completed improvements in device, and are in active discussions
with entities in Asia, Europe and South America seeking to
commercially partner with us on CarpX in their regions.
“Our newest lead product, EsoCheck, is off to a strong start six
weeks after our subsidiary Lucid Diagnostics Inc. completed a
definitive licensing agreement with Case Western Reserve University
to develop and commercialize this revolutionary technology. We
believe EsoCheck will save many lives through the early detection
of pre-cancerous conditions of the esophagus and has an immediately
addressable market opportunity of at least $2 billion. Since the
launch of Lucid, I have had many conversations with clinicians as
well as potential strategic partners and the excitement and
anticipation for EsoCheck, its clinical and commercial potential
has been palpable.
“Lucid has completed all necessary transition work and has begun
to aggressively pursue EsoCheck commercialization by seeking FDA
510(k) clearance of the cell sampling device and a Laboratory
Developed Test (LDT) designation of the DNA biomarker test. The
work required for regulatory submission of the device has begun and
we are working closely with the reference laboratory performing the
DNA biomarker test on the CLIA certification and lab validation
testing required to achieve LDT designation. We are targeting the
first quarter of 2019 for the launch of the first commercial
product in the U.S. The ongoing multicenter National Institutes of
Health (NIH)-funded clinical study of EsoCheck is also going well,
with enrollment at six leading centers and several new centers
coming online soon. As the clinical evidence from this study will
be important in seeking a specific indication for widespread
screening of Barrett’s Esophagus, Lucid is working closely with the
investigators to provide support to accelerate enrollment and
assure that the data is of the highest quality.
“With regard to our other lead products, PortIO™, our
implantable intraosseous vascular access device is progressing
along the FDA’s de novo pathway based on detailed guidance from the
agency,” he added. “The next milestone is initiation of a GLP
animal study this summer and preparation of an IDE application in
anticipation of a formal request for a small clinical study.
Consistent with our strategy for PortIO, we are actively pursuing
potential acquirers or clinical trial partners prior to the IDE
study. DisappEAR™, our resorbable, antimicrobial pediatric ear
tube, reached an important developmental milestone with the
successful machining of ear tubes from commercially-sourced silk
monoblocks. The next step is to assess resorption rates in a small
animal study.
“Lastly, we decided to use some of the proceeds from the rights
offering to accelerate the development of NextFlo, our fixed-rate
infusion set based on a proprietary, variable-flow resistor that we
believe will permit hospitals to return to gravity-driven infusions
and eliminate expensive and troublesome infusions pumps for most
inpatient infusions. After some additional development work, we
foresee NextFlo moving into the regulatory and commercial path as
our fifth lead product,” he concluded.
About PAVmed
PAVmed Inc. is a highly differentiated, multiproduct medical
device company employing a unique business model designed to
advance innovative products to commercialization much more rapidly
and with significantly 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. PAVmed’s diversified pipeline of
products address unmet clinical needs encompassing a broad spectrum
of clinical areas with attractive regulatory pathways and market
opportunities. Its three lead products provide groundbreaking
approaches to carpal tunnel syndrome (CarpX™), precancerous
conditions of the esophagus (EsoCheck), vascular access (PortIO™)
and pediatric ear infections (DisappEAR™). The company is also
developing innovative products in other areas, such as medical
infusions and tissue ablation, while seeking to further expand its
pipeline through engagements with clinician innovators and leading
academic medical centers. For further information, please visit
www.pavmed.com.
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 any of its products. 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 statements.
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InvestorsLHA Investor RelationsKim
Sutton Golodetz, 212-838-3777kgolodetz@lhai.comorMediaPAVmed Inc.212-949-4319info@pavmed.com
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