Full Press Release Details
Announces FDA 510(k) Re-submission for its
Minimally Invasive Carpal Tunnel Device
data from successful clinical safety study in which all patients met pre-specified safety and effectiveness endpoints
YORK, March 9, 2020 (GLOBE NEWSWIRE) - PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"),
a highly differentiated, multiproduct medical device company, today announced the U.S. Food and Drug Administration (FDA) has
acknowledged receipt of a 510(k) premarket notification submission for the Company's CarpX minimally invasive carpal
tunnel device. This re-submission incorporates data from the Company's successful first-in-human CarpX clinical safety
study, in which all patients met the study's pre-specified safety and effectiveness endpoints.
look forward to completing the U.S. regulatory process for CarpX so we can begin offering this groundbreaking technology for alleviating
carpal tunnel syndrome to physicians and their patients," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive
Officer. "We believe the data in this 510(k) re-submission demonstrate the safety and effectiveness of CarpX as well as
its substantial equivalence to the predicate device. As expected, our clinical safety study found CarpX to be a precision cutting
device, consistent with its design and the results of extensive pre-clinical testing, meeting both pre-specified safety and effectiveness
endpoints, with no device-related adverse events. Based on these results, we believe CarpX has the potential to transform carpal
tunnel syndrome treatment by dramatically reducing recovery times compared to traditional open surgery, an estimated billion-dollar
U.S. market opportunity."
is seeking FDA 510(k) clearance to market CarpX for minimally invasive carpal tunnel release. Extensive pre-clinical testing,
performed under close FDA consultation, demonstrated that CarpX was safe, effective and substantially equivalent to
the selected predicate. This testing specifically documented a very precise thermal profile, with negligible
thermal energy spread beyond the target tissue cut line, as recommended by the FDA.
FDA subsequently recommended a clinical safety study to support 510(k) re-submission. The Company consulted closely
with the FDA during development of the study protocol, which it then utilized in its recently completed CarpX
first-in-human clinical safety study. Twenty carpal tunnel syndrome patients in New Zealand underwent successful CarpX
minimally invasive carpal tunnel release. All patients met the study's pre-specified effectiveness
endpoint - clinical device technical success defined as the ability of CarpX to perform complete division of the transverse
carpal ligament (TCL) as assessed by post-procedural endoscopic inspection of the TCL after treatment. Two-week and 90-day
post-operative follow-up rates were 100% and 95%, respectively, exceeding the target 80% rate recommended by the FDA. The
only loss to follow-up was a patient who was documented to be "back to normal" with resolution of symptoms at six
weeks, but opted not to return to the study site because he was traveling a significant distance away and was overall very
satisfied with the procedure's outcome.
patients who completed follow-up met the study's pre-specified primary safety endpoint - device safety defined as
no serious adverse event probably or definitely related to the device resulting in significant morbidity through 90-day follow-up.
Patients underwent additional pre-specified outcome assessments at baseline and during post-operative follow-up, using well-established,
standardized and validated measures to assess patient satisfaction, as well as changes in symptoms, motor and sensory function
and neurophysiological parameters following carpal tunnel release. These outcome assessments included the Global Satisfaction
Questionnaire, QuickDASH and Boston Carpal Tunnel Syndrome (BCTQ) Questionnaires, Ten Test and Semmes-Weinstein Monofilament
sensory tests, Grip and Pinch Strength motor function tests, as well as nerve conduction and electromyographic studies. The
excellent results of these pre-specified outcome assessments following CarpX minimally invasive carpal tunnel release were similar
to, or better than, expected results following traditional open surgery.
observations from the study strongly support CarpX's clinical and commercial potential. Surgeons were able to achieve the
same anatomic result as traditional open surgery using a minimally invasive approach. Endoscopic visualization showed that CarpX
cut the ligament cleanly and precisely, without evidence of thermal spread beyond the target tissue cut line. Procedure
times fell after a short learning curve, indicating that CarpX minimally invasive carpal tunnel release can
be performed in the same or less time as traditional open surgery. The final set of procedures were performed through 5-10
mm keyhole incisions, with no incision crossing the base of the palm, an area known to be problematic for healing, resulting
in delayed recovery and persistent pain after traditional open surgery. The surgeons also observed that the CarpX
balloon appeared to create more space within the carpal tunnel than traditional carpal tunnel release, which could favorably
impact long-term outcomes.
is a patented single-use disposable minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery
times. PAVmed believes CarpX will dramatically reduce recovery times compared to traditional open surgery while targeting an estimated
$1 billion immediately addressable domestic market opportunity. 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.
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.
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.
of Investor Relations