Full Press Release Details
PAVmed Inc. Announces Second Quarter
2016 Financial Results and Provides Business Update
- Conference Call to be Held August
NEW YORK (August 16, 2016) -
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
"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.
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.
Kim Sutton Golodetz, 212-838-3777