PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced the Company and global manufacturer Canon
Inc.’s United States manufacturing and technology center, Canon
Virginia, Inc. (“Canon Virginia”), have executed a letter of intent
(the “LOI”) to consummate a series of agreements to develop and
utilize Canon Virginia’s commercial grade and scalable aqueous silk
fibroin molding process to manufacture PAVmed’s DisappEAR molded
pediatric ear tubes for commercialization.
“We are very proud to partner with such a
highly-respected leading global manufacturer as Canon to develop
and commercialize our DisappEAR resorbable pediatric ear tubes,”
said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive
Officer. “Canon’s extensive experience and expertise in innovative
and efficient production methods and its vast state-of-the-art
facilities in Newport News, Virginia, make it the ideal partner to
develop this groundbreaking technology for the one million children
who currently undergo ear tube placement each year.”
Under terms outlined in the LOI, PAVmed and
Canon Virginia propose to enter into two sequential agreements
covering a five-phase project culminating in the commercialization
of PAVmed’s DisappEAR molded pediatric ear tubes.
“Canon operates under the philosophy of Kyosei,
which means ‘living and working together for the common good’,”
said Toru Nishizawa, President and Chief Executive Officer of Canon
Virginia, Inc. “We look forward to working together with the PAVmed
team to improve the care of patients by offering our world class
manufacturing and process expertise to the development and
commercialization of silk-based resorbable ear tubes.”
Each year, up to one 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 drain the middle ear. This procedure,
formally known as bilateral tympanostomy, is the most common
pediatric surgical procedure in the United States. Up to 50% of
patients require repeat surgery under general anesthesia to remove
the tubes once they are no longer needed or if they become
dislodged and do not fall out of the ear canal on their own.
PAVmed licensed the technology underlying its
DisappEAR resorbable ear tube from Tufts University on behalf of
itself and other leading academic institutions including, two
Harvard Medical School teaching hospitals – Massachusetts Eye and
Ear Infirmary and Massachusetts General Hospital – as well as,
Massachusetts Institute of Technology and Eidgenössisches Technishe
Hochschule Zürich. The tubes are manufactured from a proprietary
aqueous silk technology which is designed to slowly be reabsorbed
over the intended course of treatment.
PAVmed believes that DisappEAR has the potential
to revolutionize the care of children with complex or recurrent
otitis media by avoiding a second procedure and eliminating the
need for a seven to 10-day post-operative ear drop regimen, which
is challenging for parents to administer. It also expects fewer
complications, including fewer ear tubes remaining in the ear
canals for years after becoming dislodged, a situation which may
lead to pain, bleeding or an obstructed view of the ear drum
required to identify recurrent middle ear infection.
PAVmed has completed extensive animal testing of
DisappEAR ear tubes machined from blocks of this proprietary silk
technology. In a six-month study performed by 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, the DisappEAR
tubes remained widely patent throughout the duration of the study,
retaining their implant position with good healing of the ear drum.
Perhaps more impressively, the tubes showed unexpected surfactant
properties which appear to provide several unique benefits over
traditional plastic tubes, including enhanced drainage of fluid
from the middle ear, potential intrinsic antimicrobial properties
and a surprising absence of otorrhea – a difficult to manage
condition where pus and fluid drains out of the middle ear and into
the ear canal and typically occurs in at least 25-30% of recipients
of traditional plastic tubes, despite administration of antibiotic
ear drops.
Recent advances in molding processes for aqueous
silk fibroin has led PAVmed to transition DisappEAR’s design from
machining blocks of silk to injection molding, a much less costly
and efficient commercial manufacturing process, especially at
scale. PAVmed sought to partner with Canon Virginia because the
Company believed it to be the most technologically capable and
respected manufacturer developing a scalable commercial grade
process to produce aqueous silk fibroin for human clinical
applications.
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct commercial stage medical device company employing a
unique business model designed to advance innovative products to
commercialization rapidly and with 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 while seeking to further expand its
pipeline through relationships with its network of clinician
innovators at leading academic centers. PAVmed’s diversified
product pipeline addresses unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its four operating divisions
include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™
Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation
Device with Caldus™ Technology), Minimally Invasive Interventions
(CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome),
Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access
Device and NextFlo™ Highly Accurate Infusion Platform Technology),
and Emerging Innovations (non-invasive laser-based glucose
monitoring, pediatric ear tubes, and mechanical circulatory
support). For more information, please visit www.pavmed.com,
follow us on Twitter, connect with us on LinkedIn, and watch our
videos on YouTube. For more information on our majority owned
subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com,
follow Lucid on Twitter, and connect with Lucid on LinkedIn.
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, 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 many of its products. The Company
has been monitoring the COVID-19 pandemic and its impact on our
business. The Company expects the significance of the COVID-19
pandemic, including the extent of its effect on the Company’s
financial and operational results, to be dictated by, among other
things, the success of efforts to contain it and the impact of
actions taken in response. 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:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
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