PAVmed Inc. (PAVM) Q2 2021 Earnings Report, Transcript and Summary

Greetings, and welcome to the PAVmed Inc. Business Update Conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference to your host Mike Havrilla, Director of Investor Relations for PAVmed. Please proceed.

Thanks operator. Good afternoon, everyone. This is Mike Havrilla, PAVmed's Director of Investor Relations. Thanks for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer; and Dennis McGrath, President and Chief Financial Officer. Press release announcing our business updates and financial results is available on PAVmed's website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The business update press release and this conference call, both include forward-looking statements. And these forward-looking statements are subject to known and unknown risks and uncertainties, may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For further list and description of these and other important risks and uncertainties may affect future operations, see Part 1, Item 1A entitled Risk Factors in PAVmed's most recent annual report on Form 10-K filed with the Securities and Exchange Commission and any subsequent updates filed in quarterly reports on Form 10-Q. Except as required by law, PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statements to reflect changes in 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. With that said, I would like to turn the call over to Lishan Aklog. Dr. Aklog?

Thank you, Mike. And good afternoon, everyone. Well, these are very active and exciting times for PAVmed and its subsidiaries. And I look forward to spending the next 45 minutes or so catching you up on important developments over the past quarter in recent weeks, and providing you with some useful insights on the evolution of our strategic thinking, namely, where we are seeking to take this company in the coming quarters and years. First, as always, let me take a moment to thank our long-term shareholders for your unwavering support and commitment to our company. I recently had the opportunity to review another lists of investors and it is really gratifying and frankly remarkable that over five years later, nearly all of our IPO investors remain PAVmed stockholders. Then so many of our long termers have been with us through, they have been up and down victories and challenges. It is satisfying to see how far we have come together and how well positioned we are for what I believe will be an exciting future for us all. I will start with some high level comments on the state of the company, cover some general corporate matters and discuss a few important topics upfront that I know are of keen interest to many of our investors. I'll then hand things over to Dennis who will provide our financial updates, after which I will proceed with usual more systematic comprehensive business update. About nine months ago in the fall of 2020, we decided that the time has come for us to pursue a bigger and bolder future plan for PAVmed and its subsidiaries, to fully realize their long-term potential for success. We decided to accelerate our plans to grow the company on multiple fronts. We decided to expand and expedite our use of our commercialization plans to start laying the groundwork to take Lucid public, to even more aggressively seek out partnership licensing and M&A opportunities. To bring fresh perspectives, experiences, skill sets and diversity to our two Boards. To critically evaluate and assess ways to future proof our relationship with a couple of mission critical partners. And to do this all while strengthening our balance sheet and growing shareholder value. Nine months later, I'm very pleased that this bigger and bolder strategic plan appears to be working out quite well. I will of course discuss many of these successes and some challenges in more detail later. I would however, like to touch on a few of these successes at the corporate level now. We've certainly grown the company as planned. Our full time headcount has more than doubled during this period to almost 50 employees, and we anticipate tripling that number over the next 15 to 18 months. It is especially gratifying that we continue to attract the highest caliber individuals up and down our org chart, many of whom sought us out either as cold calls or emails or following some type of consulting or other third-party engagement. We've also substantially strengthened our balance sheet during this period. We raised approximately $75 million from institutional investors between Christmas and Valentine's Day, including from leading long-term fundamental institutional funds such as Fidelity, Vanguard and Blackstone. And we were able to use a portion of these proceeds to retire all of our outstanding convertible debt. These financings have been supplemented by a meaningful number of our Z warrants being exercised for cash. Dennis will review the numbers in more detail, but I'm happy to say that PAVmed is now debt free, and with a cash runway that extends well into 2023. This estimate of the runway does not take into effect proceeds from the proposed Lucid IPO, which would extend PAVmed's runway even further. Of course, most importantly, our shareholders have benefit from substantial growth and shareholder value during this period, with our stock more than tripling. Finally, during the past quarter, and in recent weeks, our two Boards have seen a flurry of activity with five new Directors including two women between them. Since investors and others often ask us about our new Directors, I thought I would take a couple of minutes to comment on how each new Director has brought fresh perspectives, experiences and skill sets, and have made very meaningful contributions to the company. Let's start with the three new Lucid Directors. Two weeks ago, I was very pleased to welcome Stan Latinas as Vice Chairman of the Lucid Board, after a year of invaluable service to the company as its lead strategic advisor. Those of you who participated in our first quarterly call of 2021, understand how much I respect and admire Stan and the zeal with which he has embraced Lucid's core mission to prevent esophageal cancer deaths through early detection of esophageal pre cancer. He is perhaps more than anyone in the field uniquely positioned to contribute to this mission as the person who introduced groundbreaking early detection programs for two other cancers. Cervical cancer is the founder and President of Cytyc, and colon cancer as the Chairman and CEO of EXACT Sciences. Stan is already fully engaged in this role and leveraging his experience, wisdom and vast rolodex for all aspects of Lucid's business. These include various strategic matters such as potential engagements with large strategies, potential partnership, licensing and M&A opportunities, helping us develop our long-term clinical trial and practice guideline strategy, and frequently engaging with investors, analysts and other stakeholders on behalf of the company. Next, Jacque Sokolov, who joined the Lucid Board in April has already played a very critical role in support of Lucid expansion of its commercial efforts. As many of you know, yesterday, we announced the launch of three Lucid test centers in Phoenix, where we are testing patients referred to Lucid by primary care physicians for EsoGuard testing. What you may not know is that these clinical activities are subject to a byzantine set of federal and state regulations. Jacque, as Chair of our Board new quality and compliance committee, has leveraged his experience in similar roles in large public companies such as Hospira, to make sure that we built a robust quality and compliance infrastructure underpinning these activities. He took over three months of work by numerous members of my team and good number of billable hours by multiple specialist attorneys to put these systems in place, allowing us to proceed with the launch of the centers and their upcoming expansion to other states. Finally, I was pleased to welcome Aster Angagaw to the Lucid Board last week. We have already discussed ways for us to leverage her over two decades of experience as a global industry Executive, and importantly, her long standing roots in the global healthcare sector. Lucid will soon seek to make inroads into large integrated healthcare delivery networks, most of which - most of whom she did extensive business with Sodexo's CEO for Health America, for healthcare in North America. PAVmed's Board also added prominent global executives to its Board during this past quarter. Debbie White, who joined the Board in April and she is based in the UK and has deep industry and professional ties on both sides of the Atlantic. She too has generously opened her rolodex and among other things is connecting us to the Director of Healthcare at one of the largest pharmacy networks and healthcare systems in the UK. She's also working with our other Directors and Management on an important long-term strategic planning initiative the Board is undertaking. Finally, Tim Baxter, a prominent global technology Executive and most recently served as President and CEO of Samsung North America, joined the PAVmed's Board in June, soon after he initiated the dialogue with me acquiring on serving on the Board. He too is heavily focused on the Board's long-term strategic planning initiative. He has also taken a strong interest in the details of our new digital health subsidiary Veris Health. Both the hardware and software elements of a sleet product overlap significantly with his experiences of Samsung, including battery technology, wireless communications, artificial intelligence, digital user interfaces and cloud based digital platforms. He organized and participated in the highly productive meeting with the Chief Medical Officer of Microsoft, which is a market leader in providing IT infrastructure and services for digital health companies to discuss possible collaboration with Veris. As promised, let me now move on to few important topics that I know of are of keen interest to many of our investors. Let's start with the proposed leased in IPO. During our February quarterly call, I publicly announced our intent to take Lucid public as a standalone medical diagnostics company to fulfill its long-term potential, unlock its present value and allow it to access its own growth capital to execute on several major commercial initiatives, we also announced at that time. During our May call, I reaffirmed that intent indicated that we would be pursuing the IPO path and that we had engaged Cantor Fitzgerald to serve as one of the lead banks. I also reaffirms that PAVmed would retain a majority controlling interest in Lucid following any transaction. That said, due to the applicable regulations surrounding IPOs, all I can really do today is strongly reaffirm our previously disclosed plan to take Lucid public through an IPO and think that the process is moving forward and it's going very well. Although I am optimistic that this can be a near term event depends as always how market conditions holding up. As much as I would like to say more we are really at the stage of the process where I can't. We also have some limitations on what we can report with regard to more recent and forward-looking Lucid activities beyond what be in our quarterly financials. The next area of keen interest I would like to discuss upfront includes EsoGuard testing volume claims and payment status and its relationship to revenue recognition. I'm happy to report that we continue to see solid growth in EsoGuard testing by the gastroenterologist who have been the primary target of our EsoGuard commercialization efforts to date. We previously reported 78 EsoGuard tests processed in the first quarter of this year, we are revising that number upwards and 96 EsoGuard tests performed in the first quarter after we review and improving the process by which we distinguish commercial tests from those performed for clinical research and other purposes. We performed more than double the number of EsoGuard tests in the second quarter, 202 tests representing 110% increase sequentially. Given the pre IPO limitations we must now observe, suffice it to say that we continue to have good traction with gastroenterologist and look forward to realizing the complimentary impact. We expect our Lucid test centers will have as we are now targeting and educating primary care physicians and selected locales to begin referring patients to these centers. I'm not going to get a bit in the weeds on the complexities of billing, claim submission and the payment collection world to help you understand where we stand on these areas which of course lag EsoGuard testing volume. The EsoGuard test is performed at a single laboratory as a laboratory developed test or LDC. Our central laboratory partner is Research Dx, located in Irvine, California. Claim submission and billing is performed by Pacific Dx and DBA of Research Dx, which holds the CMS CLIA certificate and state licenses that allow it to perform the EsoGuard test. The laboratory began submitting claims to insurers in Q1. Given the claim cycle times most of these claims remain in process and are still being adjudicated, as this is a new test. Some claims have been fully processed and the laboratory has begun to receive out of network payments from private payers. The final step, of course, is the payment relationship between the billing entity, the laboratory and Lucid and how it will lead to revenue recognition on our part. That Dennis will provide more details on this later, we did not recognize revenue in the second quarter. Again, let me get a bit more in the weeds here. Our relationship with the laboratory and the flow of funds from them to us is governed by a contractual relationship with the laboratory. As I mentioned earlier, prior to launching the Lucid test centers in Phoenix, we had to go to great lengths to establish a robust quality and compliance infrastructure to make sure these activities are strictly compliant with various state and federal regulations, including who would invoice Medicare and how funds would be transferred between the laboratory as the billing entity at Lucid. One outcome from our comprehensive quality and compliance process was that we agreed to modify our contractual relationship with the laboratory and enter into a short term month to month contract whereby the laboratory will pay us a fixed amount that can be adjusted monthly to reflect the activity delivered by Lucid and performed by the laboratory. Of course, these contractual amounts are tempered by actual test collections by the laboratory. That updated contract was executed effective August 1, and will govern payments from Research Dx. We will begin recognizing revenue this quarter under the updated contract. We will report on Lucid's recognize third quarter revenues at our next quarterly call. I mentioned earlier that one element of our expanded strategic plan was to critically evaluate and assess ways to future proof our relationship with a couple of mission critical partners, and Research Dx and its CLIA laboratory certainly one such partner. The quality and compliance exercise and its impact on the complexities of claims, billing, payment processing, and revenue recognition has motivated us to seek to accelerate what was our long-term plan to significantly streamline this process moving forward. The plan is for Lucid to secure its own CLIA certificate and associated licenses. So moving forward, Lucid can directly bill and receive payments from insurers. We are in discussions with Research Dx on how to best effectuate this, and I look forward to updating you as the process advances. So I apologize if much of that was overly technical, but I felt it was important to take you through the details of the process of translating growing the EsoGuard testing volume into recognized revenue is a critical matter of keen interest to all of us. Finally, before handing the reins over to Dennis, I would like to speak up front on one more topic that remains a critical factor for us and all health care companies and something we are carefully monitoring. I am of course referring to the more than tenfold rise in COVID-19 cases in the U.S. and associated strains on the healthcare systems in many parts of the country, as a result of the rapid spread of the highly transmissible Delta variant of the surge COVID-19 virus. The good news is, is that we have not yet seen a meaningful impact on any aspect of our business, and certainly nothing approaching the serious challenges we faced throughout 2020 and during the winter surge that extended into the early part of this year. This is in contrast to many, if not most other healthcare companies, especially those who operate within hospitals, who are seeing Delta related challenges. Our Lucid commercial and clinical activities occur almost exclusively in an outpatient setting and we continue to have mostly unfettered access to physicians in their offices. It also appears that physician practices are better equipped and have learned how to adapt to the pandemic without disrupting their clinical operations. So delta variant is certainly a major test of these systems that they've implemented. But those we interact with seem to be holding up okay. Although we hope that the Delta surge is limited and that cases will start to follow that, as they have in countries like India and the UK, the landscape could shift and impediments to our business could emerge if things continue to worsen into the fall and winter. Just could have a meaningful impact on our ongoing commercial reboot of CarpX, which I'll report on in more detail later. Another area that is always vulnerable to these COVID surges is clinical research, as it may be seen as non-essential as compared to clinical care. Many companies are in fact reporting sharp declines in trial enrollment, and CROs are struggling to maintain staffing. Fortunately, we have not seen an impact on our clinical trial enrollment, although we are closely monitoring the situation. With that I will hand the reins on to Dennis to provide an update on our financials before proceeding with a more comprehensive update on our business.

Thanks Lishan and good afternoon everyone. Let me brief our summary financial results for the second quarter ended June 30 2021, we reported in our press release. It was published earlier this afternoon in our quarterly report on Form 10-Q will be filed with the SEC in the coming days at that time will be available @sec.gov and on our website. So with regard to test performed the revenue recognition, as you already know from our previous quarterly update calls, but as a general rule EsoGuard tests performed so far will be recognized as GAAP revenue when cash is collected by the company. As previously mentioned, this will more and likely be true during this transition period of negotiating third-party private payer reimbursement contracts and related coverage policies. There was no recognized revenue in the quarter as Lishan mentioned. And as only recently the first payments were received by our Medicare and private payer billing agency, and if not been disbursed by them. For compliance purposes, again as Lishan outlined during this reimbursement transition period, we've negotiated a month to month fix payment arrangement with the laboratory, which is processing the EsoGuard assay and is also billing and collecting from the insurance companies. This fixed payment arrangement can be updated monthly to reflect estimated collections. Consequently, it is our expectation that we will begin to recognize GAAP revenue in the third quarter and will be adjusted based upon actual collections received for tests submitted for reimbursement by the laboratory. This obviously can result in timing of revenues recognized versus time they're submitted for third-party reimbursement. As promised in our last corporate update call, EsoGuard tests performed and submitted for payment are now provided in the press release. Obviously, we're in the very early innings here, we'll continue to evolve our reporting metrics as various sales and marketing efforts further influence adoption, particularly with the ramp up of our patient testing centers. Presently, there are now four banking analysts have issued coverage on the company, and others are doing their due diligence. 2021 revenue estimates provided by the analysts clearly are achievable. But quantity and collections are highly dependent upon the evolving reimbursement landscape. As you are likely aware from our last corporate update call the local coverage decision or LCD for CMS related reimbursement is still not yet been published. So with regard to the financial results for the quarter, research and development costs were approximately $4.3 million as compared to $2.1 million for the corresponding period in the prior year with the approximate $700,000 increase principally related to increase in clinical trial costs, outside professional engineering services with respect to CarpX, NetFlo, PortIO, EsoGuard, and our digital health product. General and administrative expenses, not including sales marketing expenses, which are now separately presented as commercial operations were $6.7 million for the second quarter compared with $2.4 million for 2020. The approximate $4.3 million increase is principally related to about $4.5 million increase in related stock-based compensation costs for grants for new hires, new directors and other incentive grants from Board approved equity programs. So again, these are all non-cash charges. Commercial operation expenses were approximately $2 million for the second quarter of 2021, compared to $0.5 million for the corresponding prior year period, with 800,000 event increase principally related to increased headcount in sales and marketing personnel, and 700,000 increase principally related to consulting and professional services with respect to increased commercial activities. PAVmed reported a net loss attributable to common stockholders of $11.5 million or a loss of $0.14 per common share, versus a loss of $5.6 million and $0.13 per share in 2020. A press release provides substantially more detail related to these non-cash charges occurring in the current and prior periods. Also, the press release provides a table, entitled non-GAAP measures, which highlight these amounts along with interest expense and other non-cash charges, namely; depreciation, stock-based compensation and financing related costs to enable better understanding of the company's financial performance. You'll notice from that table that after adjusting the GAAP loss by approximately $5.1 million for non-cash or financing related charges, and other such costs, that company reported non-GAAP adjusted loss for the second quarter 2021 of $6.4 million or $0.08 per common share. PAVmed had cash of $43.2 million as of June 30, and is debt free. During the second quarter, the company received additional net proceeds of approximately $1.4 million from the issuance of common stock in connection with the exercise of Z warrants. So with that, I'll turn it back to Lishan. Lishan?

Thanks, Dennis. So let's now proceed with a systematic update of our business. I'll start with Lucid, which, as usual will take up the bulk of my time, and then proceed with brief updates on CarpX commercialization, the various health launch, and close with the short rapid fire updates on other products in our portfolio. First, some background for those of you who are new or just catching up to the Lucid story. Lucid is a commercial stage medical diagnostics technology company, focused on the millions of patients with gastroesophageal reflux disease or GERD, also known as chronic heartburn, who were at risk of developing the esophageal pre-cancer and cancer, specifically highly lethal esophageal adenocarcinoma or EAC. We believe our lead products the EsoGuard esophageal DNA test performed on samples collected with the EsoCheck esophageal cell collection device constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool, to prevent these esophageal cancer deaths through early detection of esophageal pre-cancer can add risk to our patients. We formed Lucid in May 2018 as a subsidiary of PAVmed to license the technologies underlying EsoGuard and EsoCheck from Case Western Reserve University. Since Lucid's inception, PAVmed has managed Lucid pursuant to a management services agreement and finance its operations through working capital advances. This past June 1, Lucid issued a convertible promissory note to PAVmed and exchange for the cancellation of the $22.4 million in working capital advances and management services fees that have accumulated as of that date. And just over three years since Lucid's inception, we have advanced the technology underlying EsoGuard and EsoCheck from the academic research laboratory to commercial products within a scalable business model. EsoGuard as an NGS DNA methylation assay performed on samples collected with EsoCheck, EsoGuard has shown greater than 90% sensitivity and specificity at detecting esophageal pre-cancer and cancer in a published multicenter case clinical studies. EsoGuard is commercialized in the U.S. as a laboratory developed tests performed at our CLIA certified laboratory partner Research Dx, and was granted final Medicare payment determination of $1,938, effective January 1 of this year. We believe the total addressable market opportunity for these products is approximately $25 billion based on the Medicare payment rate, and a well-defined target population of at least $13 million of the highest risk per patients already recommended for pre-cancer screening. EsoCheck is commercialized in the U.S. as a 510(k) cleared esophageal cell collection device, EsoCheck proprietary collect and protect technology makes it the only non-invasive esophageal cell collection device capable of precise anatomically targeted and protected sampling, which is required to accurately detect early stage esophageal pre-cancer. The EsoCheck procedure can be performed by a nurse or other trained clinician in an office setting in less than five minutes without anesthesia or sedation. As I reaffirmed in my opening remarks, Lucid has disclosed its intent to proceed with an IPO and raise growth capital as a standalone public company to drive a growth strategy focused on expanding commercialization across multiple channels, and expanding the clinical evidence for EsoGuard and EsoCheck to support our ongoing regulatory reimbursement and commercial efforts as well as recommendation of our products and clinical practice guidelines. Bit more of background for those of you that are new to the story on the relationship between GERD esophageal pre-cancer and cancer. This year approximately 20,000 U.S. GERD patients will be diagnosed with esophageal cancer and approximately 16,000 will die from it and over 80% death rate which maintains its position as the second most painful cancer in the U.S. Unlike other common cancers, mortality rates are high even in our stages. As a result of preventing deaths from esophageal cancer, which is Lucid's core mission requires us to detect changes at the pre-cancer stage also known as Barrett's Esophagus, or BE. Esophageal pre-cancer can be monitored in its early stage and cured with endoscopic ablation in its later dysplastic phase, which reliably halts progression to esophageal cancer. In order to take advantage of this opportunity to prevent esophageal cancer deaths, GI clinical practice guidelines recommend screening for patients with long standing or severe GERD and three or more risk factors. The highest risk GERD card which I previously mentioned, that is recommended for screening consists of the estimated $13 million U.S. men over 50 with one additional respect. This group represents the primary target for EsoGuard and EsoCheck. Unfortunately, less than 10% of these at risk GERD patients undergo esophageal pre-cancer screening using traditional upper GI endoscopy. We believe EsoGuard and EsoCheck have the opportunity to correct the tragic shortcomings of the current care paradigm and serve as the first widespread screening tool to prevent cancer deaths through early detection of esophageal pre-cancer in these at risk or patients. Let me now update you on the status of EsoGuard and EsoCheck in certain key areas before doing a deeper dive into EsoGuard commercialization. On the regulatory front, during the past quarter we received CE mark certification for EsoCheck and completed CE mark self-certification for EsoGuard indicating that both may be marketed in CE mark European countries. On the manufacturing side we're in the process of transferring EsoCheck to a high volume manufacturing, Coastline International, Inc. based in San Diego, which will increase capacity of our lines from about 10,000 units per year to over 1 million. We expect to complete the transfer by the end of this year. This will not only provide efficient long-term manufacturing capacity, but substantially lower the per unit cost of goods. We anticipate doing the same for the EsoGuard specimen kit manufacturing as demand dictates. On the reimbursement front let me start with a brief history of the CMS process that EsoGuard has gone through to secure Medicare reimbursement. In 2019, we secured gap fill determination for EsoGuard's PLA codes through the CMS clinical laboratory fee schedule process or CLFS. This allowed us to engage directly with the Medicare contracts for Palmetto GBA and its MolDx program. Culminating in our submission of CMS payment coverage student payment and coverage dossiers for their technical assessment in May of 2020, so over a year ago. Things moved according to schedule on the payment side and in October of 2020, CMS granted EsoGuard final Medicare payment determination of $1,938 which became effective January 1. They have moved much more slowly on the coverage side, we continue to await Medicare local coverage determination or LCD from MolDx. We understand the COVID-19 pandemic and change of administration's has resulted in a significant backlog of LCD reviews. We continue to believe that our dossier presented a strong case for coverage based on the well-established and well defined adverse population already recommended for screening by professional society guidelines. Our new VP of market access and reimbursement has been in regular contact with the leadership of MolDx and has confirmed that the delay is entirely due to their COVID workload and resulting backlog. The CLIA laboratory of Research Dx has not yet received payments or denials for submitted Medicare claims. Although according to our regulatory consultants, EsoGuard is currently in a bit of a Medicare reimbursement gray zone with national and CMS payment effective, but its LCD or coverage determination still pending. Although technically, Medicare is required by statute to pay claims on tests for which it has not issued a non-coverage determination in practice that may or may not pay claims for diagnostic tests awaiting an LCD through the MolDx program. The processing of Medicare claims to date has been slowed by the fact that EsoGuard just recently received a special code called a [indiscernible] code, which was introduced to streamline the claims processing process. On the private payer side, as I mentioned, the laboratory has begun to receive out of network payments for EsoGuard tests and we have begun the process of engaging with private payers during this past quarter. During May we held a successful advisory Board meeting with medical directors of major insurers, which provided positive feedback and indicated good alignment with our strategic approach. We felt that the feedback fundamentally supported the major unmet clinical need for widespread acceptance of pre-cancer screening to prevent esophageal cancer deaths, and have now acknowledged the existence performance state of EsoGuard on samples collected with EsoCheck in detecting esophageal pre-cancer and cancer. And that since our test addresses some major unmet clinical needs we can expect payment and coverage determinations to be based on cost effectiveness, not net cost savings. The dialogue focused on collecting two types of data. Clinical utility data to demonstrate that EsoGuard positively impact clinical decision making. Most notably that patients with a negative EsoGuard test don't also undergo a costly endoscopy. And healthcare economic analysis of the cost of EsoGuard testing in the target population, relative to the fully burdened cost of endoscopy with biopsies and the cost of caring for patients who develop esophageal cancer due to failure to screen for pre-cancer. We'll discuss in some detailed our expectations for the portfolio of clinical utility and healthcare economic data, which would be needed to secure payment and coverage and finally our expectations to align with our plan studies including a large EsoGuard registry we are launching. Another important topic regarding implementing mechanisms, to ensure that EsoGuard testing is performed and billed for a consistent with practice guidelines. We discussed our commitment to help control in indicating testing working collaboratively with payers through audits and risk sharing arrangements as needed. They medical directors indicated that by establishing strict evidence based criteria for who will undergo the EsoCheck procedure for EsoGuard testing, our proposed Lucid test centers had the potential to serve as an important check against on indicator testing. We have a second advisory Board meeting scheduled next month with a new set of Medical Directors and I am looking forward to additional validation of our approach. Once we have submitted sufficient test to a specific payer, often in a specific region to get on their radar, we will begin more direct contractual discussions to become an in network provider on their various points. In terms of Europe, now that we've secure CE mark certification we're proceeding with developing a European market strategy. We are engaged with a major Geneva based consulting firm to help us develop and execute a country-by-country strategy to secure reimbursement in Europe, leveraging strong existing relations with European key opinion leaders in esophageal disease who are participating in our clinical trials. Let me now move on to EsoGuard commercialization starting with our engagement with GIS. Our initial EsoGuard commercialization efforts are focused on DCI physicians. We are gratified that they have generally embraced the notion that EsoGuard has the potential to enhance their practice by expanding the funnel of esophageal pre-cancer patients. Our messaging to the GIS is now well honed and includes several important concepts. First, that unlike Cologuard, EsoGuard does not seek to compete with or cannibalize their existing endoscopy business. Since so few add risk per patients ever see GI, much less undergo an endoscopy. Second, that we believe widespread EsoGuard testing will dramatically expand the funnel of esophageal pre-cancer patients in their practice for definitive diagnosis, monitoring and treatment. Third, since there are many patients already in their practice, who are candidates for EsoGuard testing, including patients undergoing colonoscopy. And fourth that we will work collaboratively with them to engage their referring physician network, educate them on the relationship between GERD esophageal pre-cancer cancer and EsoGuard testing. So as I noted in my opening remarks, these efforts are working well and have boosted a well-received - have been boosted by a well-received presentation this past May, at the largest GI meeting in the world by our busiest GI physician, Dr. David Poppers from NYU. Dr. Popper has reported positively on his initial experience with EsoCheck and EsoGuard. Let's not move on to our recent expansion of EsoGuard commercialization to include primary care physicians and the role of our Lucid test centers. So as I previously noted nearly all GERD patients exclusively cared for by primary care physicians and only a small - a very small portion of them ever see a GI physician. In fact, very few PCPs understand that GERD can lead to cancer. That's not withstanding, we believe that PCPs will be receptive to widespread esophageal pre cancer screening of adverse GERD patients to prevent cancer deaths once they are educated on the relationship, clinical guidelines for such screening and the availability of a new simple non-endoscopic office-based procedure to screen at risk patients for esophageal pre-cancer. This past month we hired a dedicated Phoenix sales rep with extensive experience in marketing diagnostic tests to PCP. His early engagement with them in the Phoenix area has yielded positive results, that's driving early referrals to test centers. He already has dozens of one's meeting scheduled with PCPs in the area in the coming weeks. So Lucid test centers whose launch in Phoenix we announced this week, operated in a leased medical office suites and located in Scottsdale Tempe in Glendale, Arizona and are staffed by a EsoCheck trainers practitioner and medical assistants employed by Lucid. Our analysis indicates that the economics of these centers should be attractive. We estimate that a single nurse practitioner supported by a medical assistant will be able to perform up to 20 EsoCheck procedures per day. The number of procedures per clinician per center necessary to cover the personnel costs and medical office leases is very modest less than two tests per week. Assuming payer reimbursement becomes acceptable, once that threshold volume is reached the program economics should become strictly marginal. We hope to launch Lucid test centers in at least three more cities this year and states contiguous with Arizona, most likely Las Vegas, Salt Lake City in Denver. We then hope to steadily expand into the remaining Western US states which allowed nurse practitioners to fully practice without physician supervision and then eventually nationwide. These Phoenix test centers will also support the next phase of the pilot program, an EsoGuard telemedicine program operated in partnership with Upscript Health, our recently announced independent telemedicine provider to accommodate EsoGuard's self-referrals from direct to consumer marketing. We are fully engaged with Upscript and to complete the development of the Lucid branded telemedicine platform, which should be ready to launch in the fall. In order to put to support this expanded commercialization efforts, we have significantly expanded our full time sales and marketing team over the past quarter and recent weeks, first at the senior leadership level, and now increasingly at the markets development manager and sales representative level. So as I previously noted we expect to continue to make substantial additions to the team over the coming quarters. Finally, let me close out Lucid with a brief update on our clinical research and development program. This program seeks to expand the clinical evidence of our products efficacy to support our ongoing regulatory reimbursement and commercial efforts. We are actively enrolling patients in two international multicenter clinical trials to support FDA PMA approval of EsoGuard use of EsoCheck as an In-Vitro diagnostic indicator to detect non dysplastic Barrett's Esophagus. ESOGUARD BE-1 screening study which will enroll 500 to 900 and bail GERD patients over 50 years of age with one other risk factor and the ESOGUARD BE-2 as a case control study which will enroll approximately 500 GERD patients with a previous diagnosis of non-dysplastic or dysplastic, Barrett's Esophagus or esophageal cancer, along with normal controls. These studies have 68 sites in the U.S. and Europe, with 31 active sites in the U.S. and five active European sites in the Spain and Netherlands. Despite COVID enrollment has been decent since they launched - since we launched a reboot in April to enhance training and introduce a new preservative. The early enrollment numbers in Europe are particularly strong. We're still targeting completion of enrollment by the end of 2022, and PMA submission to the FDA in 2023. In order to support these and many more upcoming clinical trials, we have begun the process of bringing our clinical research infrastructure in-house, beginning with our data management system. Finally, I'll now close with some brief updates on our other products. I don't have time to provide much background or context for those of you who are just learning about PAVmed. So as always, I'd encourage you to refer to our website and SEC filings for additional information or contact us with any questions. Let's start with CarpX, our minimally invasive device to treat Carpal Tunnel syndrome. I'll be frank and state that the past year has been quite frustrating for CarpX as we faced repeated challenges building momentum towards a full commercial launch. It started with the COVID related supply chain issues and limited access to searching the cadaver training and early cases. I was hopeful that we would build momentum in the first half of this year following the first successful case in the U.S. in December. But we learned by the second quarter that our model of utilizing a contracted National Sales Manager to drive recruitment of KLOs and drive early adopter case volume was simply not working. We decided to fully reboot our CarpX commercial efforts and build a full time CarpX sales and marketing team with deeper experience enhanced surgery and more specifically in Carpal Tunnel release. We hired a CarpX National Sales Manager, Kevin Roberts who hit the ground running in June. Kevin brings over a decade of experience in orthopedic sales, including an extended at Trice Medical, and Trice played an important role in successful launch and commercialization of a minimally invasive Carpal Tunnel release device. Kevin brings a large number of contacts in the hands of specifically in the hand surgery space, including surgeons and distributors. His early work is beginning to pay dividends. He said he has successfully recruited longtime hand surgeon clients to serve as early adopters and advisors completed cadaver training sessions and has more scheduled and have gotten them to schedule a CarpX cases. We remain committed to a steady and deliberate initial commercialization plan, focused on optimizing the procedural steps and safety and look to expand our team and broaden our commercialization efforts before the end of the year. As frustrating as things have been I've remained very upbeat about the future of what I still believe is a groundbreaking product, including exciting R&D work on future generations of the technology which is underway. Next, Veris Health. Things are off to a really great start here and I am more excited than ever about the prospects for this technology. The core technology which we inherited with the Oncodisc acquisition includes the first intelligent implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist designed remote digital healthcare platform, that provides patients and physicians with new tool to improve outcomes and optimize the delivery of cost effective care through remote monitoring and data analytics. Things are rapidly moving forward on both the hardware and software front, the device design work is going well. And we should be in a position to do some initial animal testing this fall. The software design side is also going well. We are engaging with highly experienced digital health software developers to build both the Smartphone and cloud based applications. As I previously noted, Tim Baxter has been an important resource for us. And we are looking forward to continuing our discussions with Microsoft's healthcare and Internet of Things team on potential collaboration. On to NextFlo, the news here is very good. We expect to wrap up verification and validation testing of the groundbreaking NextFlo IV set in the fall and should be well positioned to file our FDA 510(k) submission in early Q1 and hopefully received clearance in Q2. We're going to start building our commercial infrastructure for this product this fall. Our engagement with large strategic interested in the disposable infusion pump application continues albeit be at a slow pace, while we continue to advance this technology. So we're well positioned to sell commercialize it, along with the IV set if a deal is not consummated. This past quarter we were also solicited by an even larger strategic company and market leader in the space on the broader NextFlo portfolio including the IV sets. As this engagement is just getting underway and I look forward to seeing where it takes us. Two updates on port IO our implantable, intraosseous vascular access device. The long planned human study in Columbia, South America was getting ready to commence early this summer, when the process came to a grinding halt as a result of a severe COVID outbreak across South America. Things appear to be back on track and we'll hope to finalize our FDA approval and begin enrolling patients soon. On the U.S. front, we've submitted our FDA pre submission package last month and expect to have a meeting to finalize a U.S. IDE trial in support de novo application this fall. Finally a few brief highlights from products in our emerging innovations portfolio. Work on EsoCure our esophageal ablation device is progressing well, histopathology and data from our second animal study earlier this year look very promising, and we continue to advance the design of the thermal ablation catheters and thermal infusion console forward. We hope to be in a position to submit for our 510(k) clearance in 2022. DisappEAR restorable pediatric ear tubes continue to progress in close collaboration with our research development and manufacturing partner Canon USA, despite some early challenges with the molding process. Our target date now for FDA for our 510(k) submission is the first half of 2022. I don't have any new data or milestone to report on our Solys non-invasive glucose monitoring technology. Work on our proprietary technology is going well and we expect the second generation prototype to be ready for testing human volunteers and a diabetic animal model before the end of the year. So thank you all for your attention. And with that operator, we can now open the call to questions.

[Operator Instructions] Our first question is from Frank Takkinen with Lake Street Capital Markets.

Hey, Frank, how are you. Good evening.

Very good. Lots of exciting new things here. Thanks for taking my questions. Wanted to focus in on EsoGuard and my questions here. First, for that the cases where you have heard back from private payers, can you speak to any reimbursement levels you've seen there as well as just a broader success rate for those that you have heard back on?

Dennis, why don't you take that?

Yes. Sure thanks, Frank. So the payments that have been received by ResearchDx billing agency are largely from the private payer side and out-of-network designation because there's not coverage policies in place. And the payment rate on that has been about half of what the CMS rate is, which you would expect for out of network, which typically is 50% of the asked price, which we find that encouraging in that they're paying out-of-network rates at almost 50% of what the CMS rate is.

Got it. Okay. That's great. And then I wanted to ask on the Phoenix opportunity. I think this is really exciting here. Can you just talk a little bit about how you think the patient volumes may trend? Obviously, huge opportunity, but I just wanted to one talk about that. And then can you talk to how - what kind of direct-to-consumer advertising you're doing in the area to just educate primary care physicians adequately enough to start generating that referral volume to get to some of those target volume ranges over time?

Sure. So let me start with the first question. So it really is a bit too early for us to - this is a pilot program. It's a bit early for us to be able to come up with any kind of sort of meaningful sense as to how cases will ramp up. I did mention that with one rep, who just started this summer, calling on primary care in the area. We've seen a lot of very good engagement, well quick early referrals to the test centers. And as I said, a lot of engagements with dozens of lunch meetings. I think certainly by the next quarter, we should have a better sense as to how these - how we could expect our primary care physician sales and marketing efforts to translate into actual procedure volume and testing volume that is at the centers. So that's really - it would be really difficult for us to say anything more than that. This really, really early stage in the process. Can you repeat your second question? I apologize.

Just related to the marketing efforts, that you have in market your generating awareness.

Yes. So we've designed this as consciously as firmly as a 2-step process, so we have not yet initiated any direct-to-consumer marketing through traditional media. We have some activity on social media because we wanted to - we needed to wait until two things happened. One, the test centers were up and running, so that those patients could be seen at the test centers and two, that the platform, the telemedicine platform that we're building with Upscript is also up and running so that they can undergo a telemedicine visit in response to the direct-to-consumer marketing. So as I said, the marketing materials, and frankly, the ad buys and all of that are all already in place, but we are not going to trying to switch on that until the telemedicine platform is ready to go, and I expect that to be so technical.

Got it. Okay. And then I'll just end with one more quick one at the end. You guys were previously providing some metrics around sites trained and stocking EsoCheck. So, can you give us the latest thinking around those metrics?

Yes. We decided we're going to discuss is on procedures moving forward because accounts, you can have accounts where we just think it's a more useful metric for clinic for commercial activity along with - and the one that will track future revenue and recognize revenue more directly. So for example, you can have centers that come on board, do a stock equipment and even get trained and not perform procedures, and then you're going to have others that the more procedures a week. So at least for the foreseeable future, we're going to focus on reporting on procedure volume and less useful, we'll avoid the less useful information on accounts.

Got it, okay. That makes sense, thanks for taking my questions. And again congrats on excellent progress.

Thanks Frank.

Our next question is from Ed Woo with Ascendiant Capital. Please proceed with your question.

Ed, good afternoon.

Talking about your product ramp up. I had a question in terms of potential new opportunities. Obviously, you're very busy, you got a lot of things going on. Will you wait until the Lucid IPO before you add new products on? And then what are you seeing out there in terms of marketplace? Are there a lot of stuff out there at a reasonable valuation? Or is the market still kind of too high?

Really, really intriguing question. So we're pursuing both of those processes in parallel. So this has absolutely been our DNA at the parallel level and it continued on the Lucid level but we are constantly, very regularly viewing and reviewing opportunities for licensing, partnering and now more increasingly with acquisitions. So I don't have time to talk about some of the, say, some of the areas that we're looking at, but one area in particular is in-licensing technologies for additional biomarkers that can be used, not just - not for screening but for progression for identifying progression from non-dysplastic to dysplastic Barretts Esophagus, there's an exciting technology that we're pursuing out of Case Western and John Hopkins, for example. On that front, and that will have a really another opportunity to leverage the EsoCheck device for - as an alternative to endoscopy for monitoring patients who have non-dysplastic Barretts Esophagus. We also are reviewing - we actually - on the diagnostics side, we see a lot of opportunities ongoing. We've had conversations with the natural cancer institute on several technologies and others. So that's all full steam ahead, and we certainly are seeing these technologies coming across transom.

Great. So it wouldn't be that much of a surprise if you found a good opportunity that we will hear about it before the Lucid IPO is complete?

I can't really comment on that because that sort of implied a little sort of be able to extrapolate this to the timing of the Lucid IPO. I think unlikely, it's that's unlikely. It obviously depends on how things proceed with the IPO. But I would just - let me just say that I expect the things continue to go well at the IPO was a nearer-term event than another transaction.

Great. Well thanks for answering my questions and good luck.

Thanks a lot, thanks Ed. Good to talk to you.

Our next question is with Jeremy Pearlman from the Maxim Group. Please proceed with your question.

Hey, Jeremy, how are you?

How you're doing, I am good. I'm on the line for Anthony Vendetti. I just had one quick question about the CarpX. So I know you mentioned there are some delays due to COVID and then from the sales side. And you're in the middle of a full reboot. Could you maybe just talk more to that? What does that commercialization now look like? And then in, I guess, and when do you think we'll start to ramp up because procedures will really pick up?

Yes. Just to be clear, what I was describing the COVID related matters that was really more sort of historical in 2020 and in the early part of 2021. The really the way to look at it is, I think we lost about 6 or 7 months between the end of last year and the first half of this year and sort of getting this initial KOL, early adopter, initial launch established that we can set a good foundation for a full commercial launch. As I said, obviously, we'd love to be sort of - reported having done cases up until now, but we really have good momentum with Calvin significant engagement through a much greater traction and significant engagement with a broader range of enhanced surgeons, and we look forward to being able to report on cases in the coming quarters. The fundamentals behind transitioning from an initial commercialization to hit full commercialization remains unchanged, That was really about the fact that it's incredibly important in the early launch of a surgical type device that you get early adopter and KOL folks to really help with procedural efficiency and procedural safety before going out to the broader community. And so that's where we still are committed to doing the initial KOL launch and then proceeding to full commercialization. But as I said, we probably lost about 6 to 7 months from our initial process.

Okay. All right. So just from my perspective just 6-7 month delay, but everything else, the whole other plan, just like you said, first right, okay, conduct with KOLs and then to move on to comment. I got it. Thank you very much for taking my questions.

Thanks Jeremy.

Ladies and gentlemen, we have reached the end of the question-and-answer session, and I would like to turn the call back over to Dr. Aklog for closing remarks.

So thank you all for joining us today and for the great questions. As always, we look forward to keeping you abreast of our progress via, our news releases, the periodic press conferences. The best way to keep up with PAVmed news, updates and events to sign up for our e-mail alerts on our new - on our Investor Relations website, follow us on Twitter, LinkedIn and YouTube. I also encourage you to contact me directly with any questions jmh@pavmed.com. So thanks again, and have a great day.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.