PAVmed Provides Update on CarpX™ Clinical Safety Study
NEW YORK, Dec. 13, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today provided an update on its CarpX™ first-in-human (FIH) 510(k) clinical safety study.
This week, senior PAVmed personnel met with the local investigators in New Zealand and completed an on-site review of the study data. Full 90-day follow-up is now 90% complete (18 of 20 patients) and 90-day clinical follow-up is 95% complete (19 of 20 patients) – with one patient completing clinical follow-up but not yet completing electrodiagnostic testing. The research team continues to pursue the two incomplete follow-up patients. The study has, however, already exceeded the minimum 80% follow-up rate requested by the U.S. Food and Drug Administration (FDA) with no device-related adverse events. The team has concluded that the device appears to have met the study’s primary effectiveness and safety endpoints. PAVmed is now proceeding with finalization of the clinical reports, including customary overreads of the diagnostic test results by a U.S. physician. The 510(k) application has been drafted by the Company’s regulatory consultants pending the final reports and is expected to be ready for resubmission in January as anticipated.
“We are extraordinarily grateful to the New Zealand team for their hard work in completing this study,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Having now exceeded the minimum follow-up rate requested by the FDA, we look forward to re-engaging with the agency following resubmission of our 510(k) application next month and completing the regulatory process so we can offer this groundbreaking technology to physicians and their patients.”
CarpX is a minimally invasive, patented 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.
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.
Director of Investor Relations
Chief Commercial Officer
Released December 13, 2019