Investor Relations

Press Releases

PAVmed Provides Business Update

NEW YORK, Oct. 17, 2018 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today provided an update on its business.

“I am gratified by the increasing level of engagement of our shareholders and the broader investment community since our last business update in August,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “In September we hired a full-time Director of Investor Relations to ensure that we live up to our commitment to robust and transparent investor communications. The strong interest in the status of our most important lead products, CarpX™ and EsoCheck™, makes this is an opportune time to provide comprehensive updates on our pipeline and general corporate matters.”

CarpX Update

CarpX, PAVmed’s most important lead product, is a minimally invasive device designed to treat carpal tunnel syndrome. The Company believes CarpX will dramatically reduce recovery times compared to traditional open surgery and target an estimated immediately addressable domestic market opportunity of over $1 billion. PAVmed has been working closely with the U.S. Food and Drug Administration (FDA) during this past year to secure U.S. regulatory clearance of CarpX through the FDA’s 510(k) pathway, which is based on demonstrating substantial equivalence to a previously cleared predicate device.

“As we publicly disclosed in an 8-K SEC filing and quarterly conference call, on August 22, 2018 we were notified by the lead FDA branch reviewing the CarpX 510(k) submission that it had not reached a consensus with the consulting branch within the review period allotted under the FDA’s rules and regulations,” Dr. Aklog explained. “Accordingly, the lead branch recommended that we take the appropriate steps to extend the review process through resubmission of the 510(k) application, following an in-person pre-submission meeting. Securing a date for a pre-submission meeting requires submission of a complete pre-submission package.

“Soon after receiving the FDA’s response, we formally engaged the founding partner of one of nation’s leading FDA law firms to help us ensure that we enter the pre-submission meeting in the strongest possible position and with the highest probability of securing near-term clearance.

“Our FDA counsel’s most critical recommendation was that our pre-submission package include an explicit request that specified senior FDA personnel with oversight over both branches be present at the meeting. Since these high-level officers, empowered to make executive decisions on our application, will be reviewing CarpX for the first time she further recommended that the pre-submission package carefully codify the large amount of testing data and other documentation supporting substantial equivalence, generated during the review of the original application and multiple written responses, in a manner and structure more easily digestible to these senior FDA personnel. Although following these recommendations extended the time required to finalize and submit the pre-submission package, all parties agree that it has greatly enhanced the likelihood of a positive outcome.

“Another important recommendation was to strengthen the team participating in the pre-submission meeting, which will now include our newly-engaged FDA counsel and two additional hand surgeons from prestigious academic centers who are recognized experts in carpal tunnel surgery and strongly support CarpX’s substantial equivalence arguments.

“The FDA has acknowledged receipt of the pre-submission package and we are working with them to secure a meeting date which we will publicly announce once confirmed. We plan to provide another public update shortly after the meeting concludes and will then resubmit the 510(k) after completing additional testing, if any, that the FDA requests. The agency will have up to 90 cumulative days to review the resubmission once it is accepted, during which there will be opportunities for interactive feedback with FDA personnel. I remain strongly convinced that we have proved that CarpX is substantially equivalent to the predicate device and we will ultimately succeed in securing marketing clearance for the benefit of long-suffering carpal tunnel syndrome patients.

“It is worth noting that we continue to make significant progress with CarpX on other fronts. During this past month we attended two major hand surgery meetings – the American Society for Surgery of the Hand meeting in Boston and the American Society of Plastic Surgeon in Chicago. We had very positive engagements with a number of hand surgeons including product demonstrations and a cadaver training session. We have also continued our efforts to establish a commercial infrastructure in anticipation of clearance, including multiple engagements at these meetings with U.S. distributors interested in partnering on CarpX.

“We remain on track with several other important CarpX milestones. Our plans to complete a first-in-human clinical series in New Zealand later this quarter are going well. Local IRB approval and initiation of patient recruitment is expected in the coming weeks. CE Mark submission for European commercialization is also on target for later this quarter. In anticipation of successful completion of these milestones, we remain in active discussions with entities in Asia, Europe and South America seeking to commercially partner with us on CarpX in their regions.”

EsoCheck Update

EsoCheck, PAVmed’s newest lead product, is a revolutionary alternative to endoscopy which its majority-owned subsidiary, Lucid Diagnostics Inc., licensed from Case Western Reserve University. EsoCheck is a five-minute office-based procedure performed by non-physician clinical personal, which combines a non-invasive targeted cell sampling device with a DNA biomarker test (mVIM + mCCNA1) which has been shown in a published human study to be highly accurate at detecting Barrett’s Esophagus (BE), a pre-cursor to esophageal cancer, which occurs in patients with chronic heart burn or acid reflux (GERD). The Company believes EsoCheck has the potential to save many lives through the early detection of BE, which can be carefully monitored and treated with non-surgical approaches if detected before cancer develops. The immediately addressable domestic market opportunity for EsoCheck is estimated to be at least $2 billion based on tens of millions of U.S. patients with GERD who are candidates for BE screening.

“EsoCheck is progressing on schedule through a carefully crafted two-phase regulatory and commercialization strategy which seeks to maximize the long-term commercial opportunity while providing near-term value-inflection commercial milestones,” Dr. Aklog explained. “Phase I seeks to launch initial commercial EsoCheck products in late Q1-2019. The EsoCheck cell sampling device will be submitted for 510(k) clearance later this quarter. Given the excellent predicates and low risk profile, we are optimistic that it will be cleared expeditiously. The EsoCheck methylated DNA biomarker test is undergoing a battery of tests to secure CLIA certification which will allow it to be marketed under a Laboratory Developed Test (LDT) designation without further regulatory review. In anticipation of these milestones we have engaged a leading consulting firm with expertise in securing reimbursement for LDT’s and we have begun applying for EsoCheck codes through the AMA’s Proprietary Laboratory Analysis (PLA) process.

“Phase II of our strategy seeks a specific indication for widespread BE screening through the FDA’s PMA medical device pathway, based on existing American College of Gastroenterology (ACG) guidelines, which recommend BE screening of up 20 million GERD patients. This effort is already well underway – an ongoing National Institutes of Health funded clinical trial at eight leading medical centers has enrolled over 100 patients comparing EsoCheck with endoscopy. We have retained an industry veteran as a clinical and regulatory consultant and are finalizing an engagement with a leading regulatory firm whose many ex-FDA partners include the former director of the FDA’s Office of In Vitro Diagnostics. We are making excellent progress in finalizing this Phase II regulatory and commercialization strategy which we anticipate will culminate in a PMA pre-submission meeting with FDA in early 2019.

“An important component of both phases of this strategy is aggressive engagement with gastroenterologists, including both key opinion leaders and busy practitioners. The American College of Gastroenterology (ACG) meeting in Philadelphia provided us with the perfect venue for this. We held a successful lunch symposium on EsoCheck and demonstrated the EsoCheck device at a company booth in the industry exhibit hall. We engaged dozens of gastroenterologists as well as industry members and successfully completed an EsoCheck market survey. The feedback was strongly positive and provided excellent data to hone both phases of our clinical and regulatory strategy.

“The intense interest in cancer prevention through widespread BE screening at the ACG meeting was further corroborated in the National Cancer Institute’s 2020 Annual Plan and Budget Proposal recently submitted to Congress. It not only will highlight BE screening as an important priority, I am proud to note that it specifically highlights the EsoCheck technology as one of the year’s significant advances in cancer prevention.”

Other Products

PAVmed’s other lead product pipeline devices include PortIO™, an implantable intraosseous vascular access device; DisappEAR™, a resorbable, antimicrobial pediatric ear tube; and NextFlo, a fixed-rate infusion set based on a proprietary variable flow-resistor

“Although CarpX and EsoCheck continue to lead the way, we remain deeply committed to our strategy of pursuing a broad portfolio of innovative products which provide additional opportunities to enhance shareholder value by mitigating risk through diversification and offering potential sources of non-dilutive capital,” Dr. Aklog commented. “PortIO continues to progress along the FDA de novo regulatory pathway, with a GLP animal study scheduled this month and a planned European CE Mark submission during early 2019. The design of an ergonomically improved second-generation device has been completed. We have secured a major investment bank to advise us on strategic discussions with potential acquirers which are going well. A three-month animal study to assess resorption rates of DisappEAR is also scheduled for this month to support a planned FDA 510(k) submission in 2019. Finally, we are making steady progress towards a cost-effective NextFlo design, with a goal of finalizing product design by year-end and FDA 510(k) submission in 2019.

Other Corporate Matters

“We continue to make efforts to strengthen our company on multiple fronts,” Dr. Aklog said. “Since our last update we have continued to expand our consulting teams and hired a seventh full-time employee, Mike Havrilla, to serve as Director of Investor Relations to enhance our investor communications across all platforms, including a new website and social media outlets. We recently completed an important housekeeping step following several prior financings and exchanges to assure all investors that existing and outstanding convertible securities circulating in the market are exercisable; and that the shares to be issued upon their exercise are registered and freely tradeable. We are actively engaged with an investment bank and expect to refinance our senior secured debt soon, well in advance of its July 2019 maturity. Finally, we continue to evaluate additional value-creating M&A or licensing transactions, especially with regard to PortIO.”

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 four lead products provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (EsoCheck™), vascular access (PortIO™) and pediatric ear infections (DisappEAR™). The company is also developing innovative products in other areas, such as medical infusions 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, 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, factors affecting the timing and effectiveness of the registration statement for our proposed rights offering; 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.



Mike Havrilla
Director of Investor Relations
(814) 241-4138

Shaun O’Neil
Chief Commercial Officer
(518) 812-3087



Source: PAVmed Inc.

Released October 17, 2018