First U.S. Patient Undergoes Successful Minimally Invasive Carpal Tunnel Release Using PAVmed’s CarpX® Device
17 February 2021 - 1:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multi-product,
commercial-stage medical technology company, today announced that
the first U.S. patient recently underwent successful carpal tunnel
release using its CarpX® minimally invasive carpal tunnel device.
CarpX relieves the symptoms of Carpal Tunnel
Syndrome (CTS) in a rapid, minimally invasive, office-based
procedure that speeds patients' recovery. CTS is a common
workplace-related condition that causes chronic pain to patients
and, as the top driver of workmen's compensation claims, imposes
high costs on society.
The patient presented with symptoms of carpal
tunnel syndrome to Dr. Edward J. Armbruster of Mercer-Bucks
Orthopaedics, P.C., in greater Philadelphia, who performed
minimally invasive carpal tunnel release using the CarpX device. In
marked contrast to typical recovery times of up to several months
following conventional carpal tunnel release surgery, the patient
returned to work as a truck driver within one week of the
procedure.
“This is a very exciting development and the
most significant advance in minimally invasive carpal tunnel
release since endoscopic techniques were introduced some 30 years
ago” said Dr. Armbruster. “I found that the CarpX balloon creates
significantly more space in the carpal tunnel after the transverse
carpal ligament is divided than traditional techniques, which could
potentially result in superior outcomes for patients. As a busy
hand surgeon, I strongly believe that CarpX will change how future
carpal tunnel surgery will be performed, providing patients with a
less invasive option with significantly shorter recovery times than
existing carpal tunnel release options.”
“We continue to find that CarpX performs as
designed, combining balloon technology to protect critical
structures together with radiofrequency energy to cut the
transverse carpal ligament precisely, offering procedure times
comparable to traditional techniques after a very short learning
curve,” said Dr. Brian deGuzman, PAVmed’s Chief Medical Officer,
who oversees training and proctoring of early CarpX users and was
present as an observer during this procedure.
CarpX has the potential to lower healthcare
costs and increase the numbers of patients treated for CTS by
offering a more attractive option to the large number of patients
who chose to “suffer in silence” to avoid a prolonged recovery from
traditional carpal tunnel surgery.
“We thank Dr. Armbruster for leading the team of
world-class hand surgeons participating in our initial U.S. CarpX
commercial launch,’’ said Lishan Aklog, M.D., PAVmed’s Chairman and
Chief Executive Officer. “We continue to take a steady and
deliberate approach to this initial launch, focusing on training,
proctoring and procedural streamlining, to lay the foundation for
expanded utilization later this year. This initial U.S. commercial
experience along with our clinical trial results in New Zealand
affirm CarpX’s potential to establish a new standard of care in the
treatment of carpal tunnel syndrome by dramatically reducing
recovery times and improving outcomes compared to traditional open
surgery. We believe this represents an estimated billion-dollar
U.S. market opportunity.”
About CarpX
CarpX is a patented U.S. Food and Drug
Administration (FDA) 510(k) cleared single-use disposable minimally
invasive device designed to treat carpal tunnel syndrome while
reducing recovery times (CarpX animation). CarpX is designed to
closely mimic the anatomic results of invasive carpal tunnel
surgery, but much less invasively, using catheters, balloons,
radiofrequency energy and other established tools that have
contributed to percutaneous and minimally invasive revolutions in
the treatment of other conditions. The balloon catheter device is
inserted under the scarred ligament in a minimally invasive
fashion, tensioning it while pushing the nerve and tendons away.
When activated, bipolar radiofrequency electrodes precisely cut the
ligament from the inside out in a matter of seconds. The device
design provides physicians with ongoing feedback to optimize the
safety and completeness of the procedure. Carpal tunnel syndrome
exacts a major clinical and economic burden on society with an
estimated 600,000 patients undergoing carpal tunnel surgery each
year and over one million who suffer in silence because of the long
recovery times associated with traditional invasive carpal tunnel
release.
About PAVmed
PAVmed Inc. is a highly differentiated,
multi-product, 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. For
detailed information on EsoGuard, please visit www.EsoGuard.com and
follow us on Twitter, Facebook and Instagram.
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
Report 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
Katie GallagherLaVoieHealthScience(617)
792-3937PAVmed@lavoiehealthscience.com
- CarpX® Minimally Invasive Carpal Tunnel Device
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