PAVmed Receives FDA 510(k) Clearance for its CarpX™ Minimally Invasive Carpal Tunnel Device
April 21 2020 - 09:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced it has received 510(k) marketing clearance
from the U.S. Food and Drug Administration (FDA) for its CarpX™
minimally invasive carpal tunnel device.
The FDA determined that CarpX is “substantially
equivalent to legally marketed predicates” and that PAVmed may
market CarpX for “the minimally invasive isolation and
incision/division of ligaments, tendons, or fascia such as the
transverse carpal ligament for treatment of carpal tunnel
syndrome.” The FDA reached this determination after reviewing
detailed data from the Company’s successful CarpX clinical safety
study performed in New Zealand.
“We are very excited to introduce CarpX as the
first 510(k)-cleared minimally invasive device to utilize common
catheter, balloon and wire techniques to facilitate carpal tunnel
release,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief
Executive Officer. “We believe CarpX will revolutionize the
treatment of carpal tunnel syndrome, a widely prevalent condition
that exacts a significant clinical and economic burden on society,
by dramatically reducing recovery times compared to traditional
open surgery – an estimated billion-dollar U.S. market opportunity.
We look forward to offering CarpX’s benefits to patients and their
physicians following its upcoming commercial launch. We have
identified an outstanding national sales manager candidate with
over twenty-two years of experience calling on orthopedic and hand
surgeons to lead this effort, working closely with our clinical,
manufacturing and commercial teams.”
“This very important milestone could not have
been reached without the tenacious hard work, singular expertise,
and relentless perseverance of our entire team, including our
world-class regulatory consultants at Hogan Lovells, LLP and
product development and manufacturing partners at Sage Product
Development, Inc.,” Dr. Aklog added. “We also owe a debt of
gratitude to the team at the FDA for completing their work
expeditiously, despite the strain on resources from the current
pandemic.”
“Observations from our clinical safety study
strongly support CarpX’s clinical and commercial potential,” said
Brian J. deGuzman, M.D., PAVmed’s Chief Medical Officer, who
trained the surgeons and was present in the operating room for all
procedures. “CarpX performed flawlessly as a precision cutting
device, consistently and cleanly cutting the ligament without
evidence of thermal spread beyond the target tissue cut line.
Procedure times fell after a short learning curve, indicating the
CarpX procedure can be performed in the same or less time as
traditional open carpal tunnel release, using 5-10 mm keyhole
incisions and with no incision crossing the base of the palm, the
problematic area for healing, recovery and persistent pain after
traditional surgery. CarpX’s balloon also appeared to create more
space within the carpal tunnel at completion of the procedure which
has the potential to enhance both short and long-term
outcomes.”
As previously announced, all twenty patients in
the Company’s successful CarpX clinical safety study in New Zealand
underwent successful CarpX minimally invasive carpal tunnel release
and met the pre-specified effectiveness endpoint – clinical device
technical success defined as the endoscopic confirmation of
complete division of the transverse carpal ligament. Two-week and
90-day post-operative follow-up rates were 100% and 95%,
respectively. All patients who completed follow-up also met the
study’s pre-specified primary safety endpoint – device safety
defined as no serious device-related adverse events. Results of
additional pre-specified outcome assessments were excellent and
similar to, or better than, expected results following traditional
open carpal tunnel release.
About CarpX
CarpX is a patented single-use disposable
minimally invasive device designed to treat carpal tunnel syndrome
while reducing recovery times. 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 designed to be inserted
under the scarred ligament in a minimally invasive fashion, 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.
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 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 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 Disposable
Intravenous Infusion Set), and Emerging Innovations (non-invasive
laser-based glucose monitoring, NextCath™ self-anchoring catheters,
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. 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
- CarpX™ Minimally Invasive Carpal Tunnel Device
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