PAVmed Inc. (Nasdaq: PAVM, PAVMZ)
(the “Company” or “PAVmed”), a highly differentiated, multiproduct
medical device company, today provided an update on its business.
“I am gratified by the increasing level of
engagement of our shareholders and the broader investment community
since our last business update in August,” said Lishan Aklog, M.D.,
PAVmed’s Chairman and Chief Executive Officer. “In September we
hired a full-time Director of Investor Relations to ensure that we
live up to our commitment to robust and transparent investor
communications. The strong interest in the status of our most
important lead products, CarpX™ and EsoCheck™, makes this is an
opportune time to provide comprehensive updates on our pipeline and
general corporate matters.”
CarpX Update
CarpX, PAVmed’s most important lead product, is
a minimally invasive device designed to treat carpal tunnel
syndrome. The Company believes CarpX will dramatically reduce
recovery times compared to traditional open surgery and target an
estimated immediately addressable domestic market opportunity of
over $1 billion. PAVmed has been working closely with the U.S. Food
and Drug Administration (FDA) during this past year to secure U.S.
regulatory clearance of CarpX through the FDA’s 510(k) pathway,
which is based on demonstrating substantial equivalence to a
previously cleared predicate device.
“As we publicly disclosed in an 8-K SEC filing
and quarterly conference call, on August 22, 2018 we were notified
by the lead FDA branch reviewing the CarpX 510(k) submission that
it had not reached a consensus with the consulting branch within
the review period allotted under the FDA’s rules and regulations,”
Dr. Aklog explained. “Accordingly, the lead branch recommended that
we take the appropriate steps to extend the review process through
resubmission of the 510(k) application, following an in-person
pre-submission meeting. Securing a date for a pre-submission
meeting requires submission of a complete pre-submission
package.
“Soon after receiving the FDA’s response, we
formally engaged the founding partner of one of nation’s leading
FDA law firms to help us ensure that we enter the pre-submission
meeting in the strongest possible position and with the highest
probability of securing near-term clearance.
“Our FDA counsel’s most critical recommendation
was that our pre-submission package include an explicit request
that specified senior FDA personnel with oversight over both
branches be present at the meeting. Since these high-level
officers, empowered to make executive decisions on our application,
will be reviewing CarpX for the first time she further recommended
that the pre-submission package carefully codify the large amount
of testing data and other documentation supporting substantial
equivalence, generated during the review of the original
application and multiple written responses, in a manner and
structure more easily digestible to these senior FDA personnel.
Although following these recommendations extended the time required
to finalize and submit the pre-submission package, all parties
agree that it has greatly enhanced the likelihood of a positive
outcome.
“Another important recommendation was to
strengthen the team participating in the pre-submission meeting,
which will now include our newly-engaged FDA counsel and two
additional hand surgeons from prestigious academic centers who are
recognized experts in carpal tunnel surgery and strongly support
CarpX’s substantial equivalence arguments.
“The FDA has acknowledged receipt of the
pre-submission package and we are working with them to secure a
meeting date which we will publicly announce once confirmed. We
plan to provide another public update shortly after the meeting
concludes and will then resubmit the 510(k) after completing
additional testing, if any, that the FDA requests. The agency will
have up to 90 cumulative days to review the resubmission once it is
accepted, during which there will be opportunities for interactive
feedback with FDA personnel. I remain strongly convinced that we
have proved that CarpX is substantially equivalent to the predicate
device and we will ultimately succeed in securing marketing
clearance for the benefit of long-suffering carpal tunnel syndrome
patients.
“It is worth noting that we continue to make
significant progress with CarpX on other fronts. During this past
month we attended two major hand surgery meetings – the American
Society for Surgery of the Hand meeting in Boston and the American
Society of Plastic Surgeon in Chicago. We had very positive
engagements with a number of hand surgeons including product
demonstrations and a cadaver training session. We have also
continued our efforts to establish a commercial infrastructure in
anticipation of clearance, including multiple engagements at these
meetings with U.S. distributors interested in partnering on
CarpX.
“We remain on track with several other important
CarpX milestones. Our plans to complete a first-in-human clinical
series in New Zealand later this quarter are going well. Local IRB
approval and initiation of patient recruitment is expected in the
coming weeks. CE Mark submission for European commercialization is
also on target for later this quarter. In anticipation of
successful completion of these milestones, we remain in active
discussions with entities in Asia, Europe and South America seeking
to commercially partner with us on CarpX in their regions.”
EsoCheck Update
EsoCheck, PAVmed’s newest lead product, is a
revolutionary alternative to endoscopy which its majority-owned
subsidiary, Lucid Diagnostics Inc., licensed from Case Western
Reserve University. EsoCheck is a five-minute office-based
procedure performed by non-physician clinical personal, which
combines a non-invasive targeted cell sampling device with a DNA
biomarker test (mVIM + mCCNA1) which has been shown in a published
human study to be highly accurate at detecting Barrett’s Esophagus
(BE), a pre-cursor to esophageal cancer, which occurs in patients
with chronic heart burn or acid reflux (GERD). The Company believes
EsoCheck has the potential to save many lives through the early
detection of BE, which can be carefully monitored and treated with
non-surgical approaches if detected before cancer develops. The
immediately addressable domestic market opportunity for EsoCheck is
estimated to be at least $2 billion based on tens of millions of
U.S. patients with GERD who are candidates for BE screening.
“EsoCheck is progressing on schedule through a
carefully crafted two-phase regulatory and commercialization
strategy which seeks to maximize the long-term commercial
opportunity while providing near-term value-inflection commercial
milestones,” Dr. Aklog explained. “Phase I seeks to launch initial
commercial EsoCheck products in late Q1-2019. The EsoCheck cell
sampling device will be submitted for 510(k) clearance later this
quarter. Given the excellent predicates and low risk profile, we
are optimistic that it will be cleared expeditiously. The EsoCheck
methylated DNA biomarker test is undergoing a battery of tests to
secure CLIA certification which will allow it to be marketed under
a Laboratory Developed Test (LDT) designation without further
regulatory review. In anticipation of these milestones we have
engaged a leading consulting firm with expertise in securing
reimbursement for LDT’s and we have begun applying for EsoCheck
codes through the AMA’s Proprietary Laboratory Analysis (PLA)
process.
“Phase II of our strategy seeks a specific
indication for widespread BE screening through the FDA’s PMA
medical device pathway, based on existing American College of
Gastroenterology (ACG) guidelines, which recommend BE screening of
up 20 million GERD patients. This effort is already well underway –
an ongoing National Institutes of Health funded clinical trial at
eight leading medical centers has enrolled over 100 patients
comparing EsoCheck with endoscopy. We have retained an industry
veteran as a clinical and regulatory consultant and are finalizing
an engagement with a leading regulatory firm whose many ex-FDA
partners include the former director of the FDA’s Office of In
Vitro Diagnostics. We are making excellent progress in finalizing
this Phase II regulatory and commercialization strategy which we
anticipate will culminate in a PMA pre-submission meeting with FDA
in early 2019.
“An important component of both phases of this
strategy is aggressive engagement with gastroenterologists,
including both key opinion leaders and busy practitioners. The
American College of Gastroenterology (ACG) meeting in Philadelphia
provided us with the perfect venue for this. We held a successful
lunch symposium on EsoCheck and demonstrated the EsoCheck device at
a company booth in the industry exhibit hall. We engaged dozens of
gastroenterologists as well as industry members and successfully
completed an EsoCheck market survey. The feedback was strongly
positive and provided excellent data to hone both phases of our
clinical and regulatory strategy.
“The intense interest in cancer prevention
through widespread BE screening at the ACG meeting was further
corroborated in the National Cancer Institute’s 2020 Annual Plan
and Budget Proposal recently submitted to Congress. It not only
will highlight BE screening as an important priority, I am proud to
note that it specifically highlights the EsoCheck technology as one
of the year’s significant advances in cancer prevention.”
Other Products
PAVmed’s other lead product pipeline devices
include PortIO™, an implantable intraosseous vascular access
device; DisappEAR™, a resorbable, antimicrobial pediatric ear tube;
and NextFlo, a fixed-rate infusion set based on a proprietary
variable flow-resistor
“Although CarpX and EsoCheck continue to lead
the way, we remain deeply committed to our strategy of pursuing a
broad portfolio of innovative products which provide additional
opportunities to enhance shareholder value by mitigating risk
through diversification and offering potential sources of
non-dilutive capital,” Dr. Aklog commented. “PortIO continues to
progress along the FDA de novo regulatory pathway, with a
GLP animal study scheduled this month and a planned European CE
Mark submission during early 2019. The design of an ergonomically
improved second-generation device has been completed. We have
secured a major investment bank to advise us on strategic
discussions with potential acquirers which are going well. A
three-month animal study to assess resorption rates of DisappEAR is
also scheduled for this month to support a planned FDA 510(k)
submission in 2019. Finally, we are making steady progress towards
a cost-effective NextFlo design, with a goal of finalizing product
design by year-end and FDA 510(k) submission in 2019.
Other Corporate Matters
“We continue to make efforts to strengthen our
company on multiple fronts,” Dr. Aklog said. “Since our last update
we have continued to expand our consulting teams and hired a
seventh full-time employee, Mike Havrilla, to serve as Director of
Investor Relations to enhance our investor communications across
all platforms, including a new website and social media outlets. We
recently completed an important housekeeping step following several
prior financings and exchanges to assure all investors that
existing and outstanding convertible securities circulating in the
market are exercisable; and that the shares to be issued upon their
exercise are registered and freely tradeable. We are actively
engaged with an investment bank and expect to refinance our senior
secured debt soon, well in advance of its July 2019 maturity.
Finally, we continue to evaluate additional value-creating M&A
or licensing transactions, especially with regard to PortIO.”
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 four 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 more information, please
visit www.pavmed.com, follow us on Twitter, connect with us on
LinkedIn, and watch our videos on YouTube.
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, factors affecting the
timing and effectiveness of the registration statement for our
proposed rights offering; 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.
Contacts:
Investors
Mike Havrilla
Director of Investor Relations
(814) 241-4138
JMH@PAVmed.com
Media
Shaun O’Neil
Chief Commercial Officer
(518) 812-3087
SMO@PAVmed.com
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