Full Press Release Details
PAVmed Partners with Leading Academic Institutions
to Develop Revolutionary Ear Device
Agreement provides PAVmed with license
to develop and commercialize antibiotic-eluting resorbable ear tube devices expected to benefit up to one million children per
New York, NY, (November 4, 2016) - PAVmed Inc.
(Nasdaq: PAVM, PAVMW), a highly differentiated, multi-product medical device company, today announced that it has signed a definitive
licensing agreement with a group of leading academic institutions, including Tufts University and two Harvard Medical School teaching
hospitals - Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital. The agreement provides PAVmed with an
exclusive worldwide license to develop and commercialize antibiotic-eluting resorbable ear tubes based on a proprietary aqueous
silk technology conceived and developed at these institutions.
Lishan Aklog, M.D., Chairman and CEO of PAVmed, said, "We
are thrilled to partner with these world-renowned institutions to develop and commercialize this revolutionary technology. Academic
medical centers and individual clinician innovators have often struggled to advance their medical device innovations to commercialization.
One of PAVmed's central goals has been to provide innovators with a rapid, capital-efficient and streamlined pathway to commercialization,
free from traditional structural and capital constraints. We anticipate this agreement will serve as a model for future engagements
with medical device innovators worldwide."
PAVmed also announced that one of the visionaries behind this
technology, Christopher J. Hartnick, M.D., Professor of Otolaryngology at Harvard Medical School and Chief of Pediatric Otolaryngology
at Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital, has joined its Medical Advisory Board and will work
closely with the PAVmed team on its development. Dr. Hartnick also serves as Vice Chair of Safety and Quality, and of Clinical
Research in the Department of Otolaryngology at Harvard Medical School and as Director of its Pediatric Airway, Voice and Swallowing
Each year, up to 1 million children with persistent ear infections
(otitis media) or middle ear fluid collections (effusions) undergo placement of metal, plastic or latex bilateral ear tubes to
ventilate and drain the middle ear. This is the most common pediatric surgical procedure in the U.S.
Dr. Hartnick said, "I believe that the antibiotic-eluting
resorbable ear tube technology will revolutionize the care of children with complex or recurrent otitis media. I see many clinical
benefits, including eliminating the post-operative ear drop regimen, which is a major challenge for parents, and reducing the need
for a second operation to remove retained tubes. I also expect fewer complications such as ear tubes remaining in the ear canals
for years after becoming dislodged and either causing pain or bleeding, which may lead to a separate procedure to remove the tubes,
or obstructing a clear view of the ear drum to identify occult middle ear infection."
The agreement provides PAVmed with a worldwide license to develop
and commercialize the aqueous silk-based resorbable ear tube technology for the life of the underlying patents. PAVmed has committed
to a timeline with certain milestones on the path to commercialization. Once commercialized, the institutions will receive royalties
based on revenue and a portion of certain additional proceeds from the sale or sublicensing of the technology to a third party.
Financial terms were not disclosed.
PAVmed Inc. (Nasdaq: PAVM, PAVMW) 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.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 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, factors affecting the timing and effectiveness of the registration statement; general economic and
market conditions; 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