PAVmed Adds EsoCure™ Esophageal Ablation Device with Patented Caldus™ Technology to Commercial Product Pipeline
February 18 2020 - 9:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a
highly differentiated, multiproduct medical device company, today
announced it has added the EsoCure™ Esophageal Ablation Device with
Caldus™ Technology to its commercial product pipeline.
EsoCure’s disposable single-use thermal balloon
ablation catheter is designed to advance through the working
channel of a standard endoscope and allow the clinician to treat
dysplastic Barrett’s Esophagus (BE) before it can progress to
highly lethal esophageal cancer (EAC) and to do so without the need
for complex and expensive capital equipment. It complements Lucid
Diagnostics’ (“Lucid”) portfolio of EsoGuard™ and EsoCheck™
products, which are designed to detect nondysplastic and dysplastic
BE, as well as EAC itself.
EsoCure incorporates PAVmed’s patented Caldus™
Technology (“Caldus”) which allows direct thermal tissue ablation
using disposable single-use ablation devices. Devices which
incorporate Caldus use a proprietary heating and infusion system
built into the device handle to continuously circulate heated fluid
through a proprietary multi-lumen balloon catheter, while
maintaining constant balloon volume, pressure and tissue contact.
The balloon ablates and destroys the cells of the targeted region
by directly heating them above their cytotoxic threshold for a
specified period of time. EsoCure consists of a device handle with
a fluid cartridge, heating, infusion and control mechanisms; a
multi-lumen catheter which passes through the working channel of
the endoscope; and, a proprietary distal balloon which directly
delivers thermal ablation energy to the esophagus.
“I am excited to add EsoCure to PAVmed’s
expanding commercial product pipeline,” said Lishan Aklog, M.D.,
PAVmed’s Chairman and Chief Executive Officer. “EsoCure is a major
addition to our product portfolio, with a substantial market
opportunity and strong synergies to Lucid’s EsoGuard™ and EsoCheck™
products. Once commercialized, PAVmed and Lucid will be able to
offer the only comprehensive panel of products capable of detecting
and treating conditions across the spectrum of conditions from
Barrett’s Esophagus to esophageal cancer. With our progress to date
we expect to complete development and FDA 510(k) submission of
EsoCure by early 2021, if not earlier.
Caldus, one of PAVmed’s original technologies
invented by its co-founders, Lishan Aklog, M.D. and Brian J.
deGuzman, M.D., is protected by two recent U.S. patents, entitled
“Continuous Flow Balloon Catheter Systems and Methods of Use” – one
granted (US 10,213,245) and one allowed, pending grant (US
16/254,717) – as well as multiple pending patent applications. Soon
after Lucid acquired the commercial rights to EsoGuard™ and
EsoCheck, PAVmed’s Emerging Innovations division began working to
apply its patented Caldus technology to disposable single-use
esophageal ablation devices. This led to the development of EsoCure
which, thanks to a recent technological breakthrough, is now
capable of delivering temperatures greater than traditional RF
ablation devices – an important clinical threshold with significant
commercial implications.
“PAVmed’s EsoCure technology has the potential
to make ablation of dysplastic BE safer, more efficient and
cost-effective than current technologies by allowing ablation under
direct vision, eliminating multiple endoscope changes, shortening
ablation times, enhancing circumferential coverage and eliminating
the need for capital equipment,” said Amitabh Chak, M.D. Professor
of Medicine at Case Western Reserve University and Director of the
Advanced Technology & Innovation Center of Excellence at UH
Cleveland Medical Center’s Division of Gastroenterology.
“Simplifying the ablation procedure will be increasingly important
as our efforts to enhance BE screening increases the number of
dysplastic BE patients requiring ablation. I am looking forward to
having the opportunity to offer EsoCure’s benefits to my BE
patients.”
The American College of Gastroenterology
recommends endoscopic ablation as the preferred treatment modality
for both low- and high-grade dysplastic BE. Procedures have
increased steadily since the commercial introduction of BE ablation
devices in the early 2000’s. Commercially available devices for
endoscopic BE ablation use radiofrequency (RF) or cryoablation and
rely on complex and expensive consoles and/or gas tanks to perform
the ablation. Capital equipment costs can range from $30,000 to
over $100,000. These devices often require multiple introductions
and removals of the endoscope, sizing catheter and ablation
balloons, which is labor-intensive, time consuming and
uncomfortable to the patient.
In contrast, EsoCure is a disposable single-use
device designed to be delivered through the working port of the
endoscope which does not have to be manipulated once it is
positioned above the affected region of the distal esophagus. The
balloon is positioned and inflated in the distal esophagus under
endoscopic vision, confirming good circumferential esophageal
contact and complete coverage of all visible BE tissue. The
underlying Caldus technology circulates heated fluid from a fluid
cartridge in the device handle, through the catheter, to the
balloon and the back up to the cartridge. This allows EsoCure to
maintain a very high balloon temperature while keeping balloon
volume, pressure and tissue contact constant. The very high balloon
temperatures permit very low ablation times which should enhance
procedural safety and efficiency. Eliminating endoscope changes and
the need for complex, expensive capital equipment should make
EsoCure significantly more efficient and cost-effective than
existing BE ablation devices.
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
product pipeline addresses 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. 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. 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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