PAVmed Reports Excellent DisappEAR™ Animal Study Results
April 24 2019 - 9:30AM
Resorbable pediatric ear tube expected to benefit
up to one million U.S. children per year
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced that its DisappEAR™ resorbable pediatric
ear tube achieved a major developmental milestone with the
successful completion of a 90-day study in an established animal
model to support a planned U.S. Food and Drug Administration (FDA)
510(k) submission later this year.
“The results of our recently completed 90-day
DisappEAR animal study are exciting for two significant reasons,”
said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive
Officer. “First, the resorbable ear tubes, machined from blocks of
a proprietary silk technology, performed very well from a
functional and anatomic point of view, retaining their position and
remaining patent for the duration of the study. Perhaps more
impressively, the tubes demonstrated unexpected surfactant
properties which appear to provide several unique benefits over
traditional plastic tubes, including enhanced flow of fluid in and
out of the tube and potential intrinsic antimicrobial
properties.”
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, performed the study. He implanted
eighteen DisappEAR ear tubes, one in the tympanic membrane (ear
drum) of each ear of nine chinchillas and evaluated them
endoscopically at regular intervals over three months. Ear drops
delivered under direct vision demonstrated rapid wicking through
the tube channel in contrast to plastic tubes where surface tension
causes the drop of fluid to sit on the tube orifice and not pass
through the channel. At the completion of the study, the ear tubes
were explanted and found to be patent without structural
degradation and the tympanic membranes showed good healing. The
unexpected finding was that there were no cases of otorrhea – a
difficult to manage condition where pus and fluid drains out of the
middle ear and into the ear canal. When traditional plastic ear
tubes are used in clinical practice, as well as in this animal
model, otorrhea typically occurs in at least 25-30% of recipients,
despite administration of antibiotic ear drops.
“The surprising absence of otorrhea in this
study suggests that these silk ear tubes may possess unique and
unexpected surface properties which enhance drainage of fluid from
the middle ear compared to plastic ear tubes,” said Dr. Hartnick.
“If these results are reflected in longer term follow-up and in
human cases, this would represent a major breakthrough in the
treatment of millions of children with chronic ear infections and
fluid buildup.”
About DisappEAR
PAVmed licensed the technology underlying its
DisappEAR resorbable ear tube from 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 tubes are manufactured from a
proprietary aqueous silk technology which is designed to slowly be
reabsorbed over the intended course of treatment.
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 ventilate and 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 believes that DisappEAR has the potential to revolutionize
the care of children with complex or recurrent otitis media by
eliminating the need for a second procedure as well as the seven to
10-day post-operative ear drop regimen, which is challenging for
parents to administer. It also expects fewer complications,
including ear tubes remaining in the ear canals for years after
becoming dislodged and causing pain, bleeding or obstructing a
clear view of the ear drum to identify occult middle ear infection.
Based on premium pricing and cost savings from replacing
post-procedure antibiotic drops, we estimate an annual domestic
market opportunity for this device of $200-$300 million.
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct medical device company employing a unique business
model designed to advance innovative products 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 pipeline strategy with a view to
enhancing and accelerating value creation. PAVmed’s diversified
pipeline of products address unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its five lead technologies
provide groundbreaking approaches to carpal tunnel syndrome
(CarpX™), precancerous conditions of the esophagus
(EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear
infections (DisappEAR™) and medical infusions (NextFlo™). The
company is also developing innovative products in other areas, such
as catheters and tissue ablation, while seeking to further expand
its pipeline through engagements with clinician innovators and
leading academic medical centers. For more information, please
visit www.pavmed.com, follow us on Twitter, connect with us on
LinkedIn, and watch our videos on YouTube.
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 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 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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