Full Press Release Details
Collaborates with Canon on DisappEAR Pediatric Ear Tubes
LOI with Canon Virginia, Inc. to develop and implement commercial grade processes to manufacture molded resorbable pediatric ear
tubes from aqueous silk fibroin
YORK, June 3, 2020 (GLOBE NEWSWIRE) - 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.
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."
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.
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."
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.
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 Eidgen ssisches Technishe Hochschule
Z rich. The tubes are manufactured from a proprietary aqueous silk technology which is designed to slowly be reabsorbed over
the intended course of treatment.
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
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
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
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).
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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
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