FDA confirms receipt of CarpX 510(k) resubmission for review
NEW YORK, July 25, 2018 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today provided its most recent update on its business.
“Since our last business update less than one month ago, we have experienced a strong surge of investor interest in PAVmed and our products,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “We remain strongly committed to transparency and robust investor communications, and in that spirit, I want to provide a detailed business update on CarpX™, EsoCheck™, other products in our pipeline and general corporate matters.
CarpX Update
“CarpX, our most important lead product, is a groundbreaking minimally invasive device to treat carpal tunnel syndrome which we believe will dramatically reduce recovery times compared to traditional open surgery and target an estimated immediately addressable domestic market opportunity of over $1 billion,” said Dr. Aklog.
“Yesterday we received written confirmation that the U.S. Food and Drug Administration (FDA) received our CarpX 510(k) resubmission. We believe that the extensive data incorporated into this resubmission now provides a robust and complete response to the FDA’s requests, strengthening our application and the near-term prospects for 510(k) clearance of this device,” Dr. Aklog added. “The resubmission includes excellent results from an animal study, which documented that the device’s bipolar electrode design results in minimal spread of thermal energy – less than one-millimeter thermal injury by pathologic analysis and no increase in tissue temperatures except directly over the cutting electrodes. The resubmission also included additional physician usability testing. Each hand surgeon successfully performed the CarpX procedure multiple times in cadavers. We expect to receive the FDA’s response to our resubmission by the end of the summer.
“Our preparations for the U.S. commercial launch of CarpX are accelerating in anticipation of FDA clearance. This week, Shaun O’Neil officially started as our new Chief Commercial Officer and is having an immediate impact. His primary focus is on all aspects of the domestic commercialization of CarpX, including sales & marketing, clinician engagement and professional education. Shaun is already working closely with the founder and former CEO of a successful upper extremity orthopedic company, whom we recently retained as a consultant. This industry veteran built a hybrid sales channel at his former company which targeted the same call points as CarpX. We look forward to leveraging his experience and network in an effort to replicate this commercial success for CarpX in an accelerated fashion. We remain on target for European CE Mark submission late this year and a first-in-human clinical series in New Zealand this fall. Discussions with entities in Asia, Europe and South America seeking to commercially partner with us on CarpX in their regions remain ongoing and active.
EsoCheck Update
“Our newest lead product, EsoCheck™, is a revolutionary office-based alternative to endoscopy which our subsidiary, Lucid Diagnostics Inc., recently licensed from Case Western Reserve University,” Dr. Aklog said. “We believe EsoCheck has the potential to save many lives through the early detection of Barrett’s Esophagus, a pre-cursor to esophageal cancer, which occurs in patients with chronic heart burn or acid reflux, also known as GERD, or Gastroesophageal Reflux Disease. We estimate an immediately addressable domestic market opportunity for EsoCheck of at least $2 billion based on tens of millions of U.S. patients with GERD who are candidates for Barrett’s Esophagus screening. We believe EsoCheck screening to prevent esophageal cancer has the potential to replicate the widespread adoption and impact that routine Pap screening has had in preventing cervical cancer.
“We continue to target the first quarter of 2019 for the U.S. launch of the first commercial EsoCheck product which combines a non-invasive, cell-sampling device and a highly accurate DNA biomarker test. We have begun building devices for verification and validation testing with FDA 510(k) submission targeted for the end of this year. We are also working closely with the reference laboratory performing the DNA biomarker test to complete the CLIA certification and clinical validation testing steps required to achieve EsoCheck’s designation as a commercial Laboratory Developed Test (LDT), a process which is on target for a first quarter 2019 launch. The ongoing multicenter National Institutes of Health-funded clinical study, which seeks to establish the definitive clinical evidence for widespread EsoCheck screening of Barrett’s Esophagus, has expanded to eight enrolling centers. Lucid is working closely with the investigators to provide all necessary support to accelerate enrollment and ensure that the data is of the highest quality for future regulatory submission.
Other Products
“With regard to our other lead products, PortIO™, our implantable intraosseous vascular access device, continues to progress along its FDA de novo regulatory pathway,” he added. “This summer we look forward to initiating its GLP animal study and preparing an IDE application for a small clinical study. Preparations are underway to begin an animal study this summer to assess resorption rates of DisappEAR™, our resorbable, antimicrobial pediatric ear tube, which we are now able to consistently machine from solid silk rods. Finally, we recently elevated NextFlo, our fixed-rate infusion set based on a proprietary variable flow-resistor, to lead product status. We believe this exciting technology will permit hospitals to return to gravity-driven infusions and eliminate expensive and troublesome electronic pumps for most of the over 1 million hospital infusions performed in the U.S. each day. Since our last update we have definitively established proof of concept and are proceeding with design work to ensure a cost-effective device with the potential to drive down health care costs.
Other Corporate Matters
“As we begin to lay the foundation for our transition from development-stage to commercial-stage company, I am happy to report that PAVmed is as strong as ever,” Dr. Aklog noted. “Two successful financings this year have left us with a strong balance sheet, providing us with the resources to strengthen our management and consulting teams and advance our expanding pipeline of innovative products at full throttle. Most importantly, it has extended our cash runway well past critical value-inflection milestones, namely the expected commercial launches of CarpX and EsoCheck. We have solidified our capital markets position by regaining compliance with Nasdaq’s shareholder equity, minimum market capitalization and minimum share price continued-listing requirements. We are exploring opportunities to restructure or pay off debt and finally, consistent with our ethos, we remain vigilant for additional opportunities to enhance shareholder value whether through M&A activity or licensing of groundbreaking technologies like EsoCheck.”
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 three lead products provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (EsoCheck), infusions (PortIO and NextFlo and pediatric ear infections (DisappEAR). The company is also developing innovative products in other areas while seeking to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For further information, please visit www.pavmed.com.
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.