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 year
NEW YORK–(BUSINESS WIRE)–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 Center.
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.
About PAVmed
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.
Contacts
For PAVmed Inc.
Investors
LHA
Kim Sutton Golodetz,
212-838-3777
kgolodetz@lhai.com
or
Media
Rooney
Partners LLC
Kate Barrette, 212-223-0561
Kbarrette@rooneyco.com
