PAVmed Inc. Announces Second Quarter 2016 Financial Results and Provides Business Update
August 16 2016 - 7:00AM
Business Wire
- Conference Call to be Held August
17th-
PAVmed Inc. (Nasdaq:PAVM) (“PAVmed” or the “Company”), a
highly-differentiated multi-product medical device company, today
announced financial results for the second quarter ended June 30,
2016 and provided a business update.
“We have made solid progress in executing on our milestones and
advancing our growth strategy, during the quarter and recent
weeks,” said Dr. Lishan Aklog, Chairman and Chief Executive Officer
of PAVmed. “Of note, we raised net proceeds of $4.2 million in our
Initial Public Offering completed in April, which provided us with
the funds to accelerate our lead products through the
commercialization pathway. Two products in particular are worth
highlighting. Last month we announced that PortIO™, our implantable
intraosseous vascular access device, entered verification and
validation testing, which is the final phase of pre-submission
testing prior to filing a 510(k) application with the U.S. Food and
Drug Administration (FDA). We expect to file for clearance by the
end of the year, and to begin marketing the product in 2017. In
June, we announced the successful completion of a pre-clinical
human cadaver study, demonstrating that the Company’s completely
percutaneous CarpX™ device reliably and effectively transects the
ligament which causes Carpal Tunnel Syndrome (CTS). We have now
initiated the final design phase for the commercial CarpX device,
and expect to initiate formal verification and validation testing
by the end of the year and to submit our 510(k) application to the
FDA in 2017.”
“We are also pleased with the advancement of our other lead
products including our NextCath™ self-anchoring short-term catheter
platform technology, our Caldus™ disposable tissue ablation
platform technology and NextFlo™, our proprietary highly-accurate
variable flow resistor disposable infusion pump. We expect to
progress towards clearance and commercialization of these products
in 2017,” Dr. Aklog added.
For the three and six months ended June 30, 2016, we incurred
$355,001 and 534,142 of research and development costs,
respectively and $959,734 and $1,477,473 of formation and operating
costs. Cash was $3,022,845 at June 30, 2016.
Full second quarter financial results can be obtained from the
Company’s investor relations website here or directly from the SEC
website here.
Conference Call and Webcast
PAVmed management will hold a conference call and webcast on
Wednesday, August 17th at 4:30 p.m. Eastern time to provide a
business update and discuss near-term milestones and growth
strategy. To access the conference call, U.S.-based listeners
should dial (844) 666-7591 and international listeners should dial
(443) 961-0431. All listeners should provide the following
passcode: 65791790. Individuals interested in listening to the live
conference call via the Internet may do so by logging on to the
Company’s website at www.pavm.com.
Following the conclusion of the conference call, a replay will
be available through August 24, 2016 and can be accessed by dialing
(855) 859-2056 from within the U.S. or (404) 537-3406 from outside
the U.S. All listeners should provide passcode 65791790. The
webcast will be available for 90 days.
About PAVmed
PAVmed Inc. (Nasdaq: PAVM,) is a highly differentiated,
multi-product medical device company employing a unique business
model designed to advance products from concept 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 multi-product pipeline
strategy with a view to enhancing and accelerating value creation.
PAVmed’s diversified pipeline of products address unmet clinical
needs, have attractive regulatory pathways and market opportunities
and encompass a broad spectrum of clinical areas including carpal
tunnel syndrome (CarpX™), medical infusions (NextFlo™ and
NextCath™), interventional radiology (PortIO™ and NextCath), tissue
ablation and cardiovascular intervention (Caldus™). The Company
intends to further expand its pipeline through engagements with
clinician innovators and leading academic medical centers. For
further information, please visit www.pavm.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 the
Company’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 uncertainties inherent in research
and development, including the cost and time required advance our
products to regulatory submission; whether regulatory authorities
will be satisfied with the design of and results from our
pre‐clinical studies; whether and when our products are cleared by
regulatory authorities; market acceptance of our products once
cleared and commercialized; our ability to raise additional funding
and other competitive developments. PAVmed has not yet sought or
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 our control. For a further list and description of these and
other important risks and uncertainties that may affect our future
operations, see Part I, Item IA, “Risk Factors,” in our 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 us after
our most recent Annual Report. We disclaim any intention or
obligation to publicly update or revise any forward-looking
statement to reflect any change in our 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: http://www.businesswire.com/news/home/20160816005453/en/
For PAVmed Inc.InvestorsLHAKim
Sutton Golodetz, 212-838-3777kgolodetz@lhai.comorMediaErich Sandoval,
213-908-6226esandoval@lazarpartners.com
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