PAVmed Successfully Completes Clinical Safety Study Procedures for CarpX™ 510(k) Re-submission
All 20 patients underwent successful CarpX procedures while passing primary effectiveness endpoint, with all follow-up patients to date passing primary safety endpoint
NEW YORK, Aug. 15, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced that all 20 patients of its first-in-human (FIH) 510(k) clinical safety study underwent successful CarpX procedures. The study is being conducted to support PAVmed’s planned 510(k) re-submission to the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its CarpX minimally invasive carpal tunnel release device.
“We are excited to have achieved this critical milestone,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Our success with this study brings us one step closer to fulfilling our mission to transform how carpal tunnel syndrome is treated for millions of people worldwide, representing a billion-dollar market opportunity in the U.S. alone.”
“CarpX performed flawlessly as a precision cutting device in these 20 consecutive patients. Using CarpX, surgeons were able to replicate the outstanding results of our pre-clinical testing and achieve the same anatomic results as traditional open surgery – complete and precise cutting of the transverse carpal ligament – using a minimally invasive approach.”
Brian J. deGuzman, M.D., PAVmed’s Chief Medical Officer, who trained the surgeons and was present in the operating room during all of the procedures, noted other positive observations from the study, which included:
- The final set of procedures were completed in 15-20 minutes “skin-to-skin”, suggesting after only a short learning curve the CarpX procedure can be performed in the same or less time as traditional carpal tunnel release.
- As they gained experience with the CarpX procedure during the study, the surgeons were able to use progressively smaller incisions. The final set of procedures were performed through the smallest keyhole incisions that would pass the introducer sheath, approximately 5-10 mm each, with no incision crossing the base of the palm, the problematic area for healing, recovery and persistent pain after traditional surgery.
- CarpX’s balloon appeared to create more space within the carpal tunnel at completion of the procedure compared to traditional surgery. This unique feature of CarpX has the potential to enhance both short and long-term outcomes.
- CarpX required less power and lower balloon pressures to cut the scarred ligament in live human patients than it had previously demonstrated in cadavers, an unexpected positive finding which should further enhance the procedure.
- Most importantly, initial patient feedback has been positive, including one patient who noted his recovery was much faster than a friend who had a “mini-open” carpal tunnel release and insisted the procedure on his other hand be performed with CarpX.
The procedures were performed at St. George’s Hospital in Christchurch, New Zealand, with patients completing preoperative testing in accordance with the study protocol developed in collaboration with the FDA. All 20 patients underwent successful minimally invasive carpal tunnel release using the CarpX device and passed the protocol’s primary effectiveness endpoint – intraoperative confirmation of complete division of the transverse carpal ligament by endoscopic visualization of its cut edges across its entire width. There were no device-related adverse events.
As per the protocol, patients are undergoing post-operative clinical follow-up at two weeks and 90 days. All of the patients who have completed their follow-up have passed the study’s specified primary safety endpoint and, based on clinical observations, it is expected that all of the remaining patients will as well. PAVmed will resubmit the CarpX 510(k) application incorporating the clinical safety and effectiveness data from the study once 90-day follow-up is completed in all 20 patients.
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 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.
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. 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.
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.
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Chief Commercial Officer
Released August 15, 2019