PAVmed Announces First Human CarpX™ Procedures
May 20 2019 - 09:30AM
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today announced that the first group of nine patients with
carpal tunnel syndrome underwent successful CarpX procedures as
part of the first-in-human (FIH) clinical safety study PAVmed is
conducting in support of its planned U.S. Food and Drug
Administration (FDA) 510(k) re-submission.
“Simply stated, CarpX works. In fact, it works
extremely well,” Lishan Aklog, M.D., PAVmed’s Chairman and Chief
Executive Officer declared. “This initial human experience leaves
little doubt in my mind that our CarpX device will transform how
carpal tunnel syndrome is treated in millions of people worldwide,
addressing a billion dollar market opportunity in the U.S. alone.
CarpX proved to be a precision cutting device, consistent with its
design and the results of extensive pre-clinical testing.”
The procedures were performed at St. George’s
Hospital in Christchurch, New Zealand by veteran plastic,
reconstructive and hand surgeons Terrence A. Creagh MBChB,
MRCS(Eng), FRACS(Plast) and Howard W. Klein M.D. FRACS, FRCSC,
FACS. Nine patients with a clinical diagnosis of carpal tunnel
syndrome were enrolled in PAVmed’s FIH clinical safety study and
underwent preoperative testing, including electrodiagnostic
testing, according to the study protocol developed in collaboration
with the FDA. The patients then underwent successful minimally
invasive carpal tunnel release using the CarpX device. Complete
division of the transverse carpal ligament, the protocol’s
effectiveness endpoint, was confirmed by endoscopic visualization
of the cut edges of the ligament across its entire width. There
were no device-related adverse events. As per the protocol,
patients will undergo post-operative clinical follow-up at two
weeks and 90 days, with repeat electrodiagnostic testing during the
90-day follow-up to document the protocol’s safety endpoint.
“I would like to thank Terrence Creagh and
Howard Klein for their extraordinary efforts in helping us reach
this major milestone,” said Brian J. deGuzman, M.D., PAVmed’s Chief
Medical Officer who led the PAVmed team in New Zealand, trained the
surgeons on the CarpX procedure in cadavers and was present in the
operating room during all of the procedures. “The surgeons were
able to replicate the outstanding results of our pre-clinical
testing in actual patients with carpal tunnel syndrome. These first
CarpX procedures achieved the same anatomic result as traditional
open surgery, namely complete division of the transverse carpal
ligament, using the device’s minimally invasive approach.
Endoscopic visualization showed that the cuts were precise and
clean, without charring, in every case, consistent with our
preclinical experience.”
“We learned a tremendous amount from these
initial human cases,” Dr. deGuzman added. “The CarpX procedure was
technically straightforward with a short learning curve. Procedure
times fell rapidly with each successive case and should be similar
to or possibly shorter than traditional surgery. We were also
impressed with how much space the CarpX device’s balloon created
within the carpal tunnel at completion of the procedure compared to
traditional surgery. This unique feature has the potential to
enhance the procedure’s short and long-term outcomes. Finally,
certain procedural steps were successfully enhanced to address
anatomic and tissue property differences between normal cadavers
and living patients with carpal tunnel syndrome. In particular, the
CarpX device required less power and lower balloon pressures to cut
the ligament in human patients than it had in cadavers, an
unexpected positive finding which should further enhance the
procedure.”
Another group of patients are scheduled to
undergo CarpX procedures in the coming weeks. Once these procedures
and 90-day follow-up are completed, PAVmed will resubmit the CarpX
510(k) application incorporating the clinical safety and
effectiveness data from the study.
About CarpX
CarpX is a minimally invasive device developed
to treat carpal tunnel syndrome while reducing recovery times.
CarpX is designed to closely mimic the anatomic results of invasive
carpal tunnel surgery, but do so 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 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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