PAVmed Inc. Q2 FY2021 Earnings Call

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. 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 include forward-looking statements that are subject to known and unknown risks and uncertainties, which 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 that 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. These are very active and exciting times for PAVmed and its subsidiaries. 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 list of investors, and it is really gratifying and frankly remarkable that over five years later, nearly all of our IPO investors remain PAVmed stockholders. Many of our long-term shareholders have been with us through the ups and downs, 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 my usual more systematic comprehensive business update. About nine months ago in the fall of 2020, we decided that the time had 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 commercialization plans, lay the groundwork to take Lucid public, and seek out partnership licensing and M&A opportunities more aggressively. 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 organization, many of whom sought us out either through cold calls, 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. 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 factor in proceeds from the proposed Lucid IPO, which would extend PAVmed's runway even further. Most importantly, our shareholders have benefited from substantial growth in 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 among 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 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 as 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 network for all aspects of Lucid's business. These include various strategic matters such as potential engagements with large strategies, potential partnerships, licensing, and M&A opportunities, helping us develop our long-term clinical trial and practice guideline strategies, 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 supporting Lucid's expansion of its commercial efforts. As many of you know, we announced the launch of three Lucid test centers in Phoenix yesterday, 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's quality and compliance committee, has leveraged his experience in similar roles in large public companies such as Hospira to ensure 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 a 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, with many of whom she has done extensive business with, including Sodexo's CEO for Health 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 is based in the UK, has deep industry and professional ties on both sides of the Atlantic. She too has generously opened her network 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 that 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 PAVmed's Board in June, soon after he initiated the dialogue with me about serving on the Board. He too is heavily focused on the Board's long-term strategic planning initiative, and 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 sleek product overlap significantly with his experiences at Samsung, including battery technology, wireless communications, artificial intelligence, digital user interfaces, and cloud-based digital platforms. He organized and participated in a 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 a few important topics that I know are of keen interest to many of our investors. Let's start with the proposed Lucid 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 access to its growth capital to execute several major commercial initiatives we also announced at that time. During our May call, I reaffirmed that intent and 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 reaffirmed 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, it depends, as always, on how market conditions hold 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 regarding 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 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 gastroenterologists 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 to 96 EsoGuard tests performed in the first quarter after we review and improve 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 a 110% increase sequentially. Given the pre-IPO limitations we must now observe, suffice it to say that we continue to have good traction with gastroenterologists and look forward to realizing the complementary impact we expect our Lucid test centers will have, as we are now targeting and educating primary care physicians in selected locales to begin referring patients to these centers. I'm not going to get into 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 LDT. Our central laboratory partner is Research Dx, located in Irvine, California. Claim submission and billing is performed by Pacific Dx, a 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, and 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. 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 ensure that 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 and 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. 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 recognized 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 falls under that category. 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 that 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. 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 as it is a critical matter of keen interest to all of us. Finally, before handing the reins over to Dennis, I would like to address one more topic that remains a critical factor for us and all healthcare companies, which is 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 healthcare systems in many parts of the country as a result of the rapid spread of the highly transmissible Delta variant of the COVID-19 virus. The good news 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 the Delta variant is certainly a major test of these systems that they've implemented. Those with whom we interact seem to be holding up okay. Although we hope that the Delta surge is limited and that cases will start to follow that pattern, 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. This 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 compared to clinical care. Many companies are 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 over 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 briefly summarize our financial results for the second quarter ended June 30, 2021, which were reported in our press release published earlier this afternoon. Our quarterly report on Form 10-Q will be filed with the SEC in the coming days; at that time it will be available on sec.gov and our website. Regarding tests performed and revenue recognition, as you already know from our previous quarterly update calls, 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 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, which have not been disbursed by them. For compliance purposes, as Lishan outlined during this reimbursement transition period, we've negotiated a month-to-month fixed 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 that it will be adjusted based upon actual collections received for tests submitted for reimbursement by the laboratory. This obviously can result in a timing difference between revenues recognized and the time they are 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, and we will 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, four banking analysts have issued coverage on the company, and others are doing their due diligence. 2021 revenue estimates provided by the analysts are clearly 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 has still not yet been published. For 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 increases 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 and 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 a $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. 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 an $800,000 increase principally related to increased headcount in sales and marketing personnel, and a $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. Our press release provides substantially more detail related to these non-cash charges occurring in the current and prior periods. The press release also 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, the company reported a 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 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 are at risk of developing 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 in 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 financed its operations through working capital advances. This past June 1, Lucid issued a convertible promissory note to PAVmed in exchange for the cancellation of the $22.4 million in working capital advances and management services fees that have accumulated as of that date. 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, has shown greater than 90% sensitivity and specificity at detecting esophageal pre-cancer and cancer in published multicenter case clinical studies. EsoGuard is commercialized in the U.S. as a laboratory-developed test 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 patients already recommended for pre-cancer screening. EsoCheck is commercialized in the U.S. as a 510(k) cleared esophageal cell collection device. EsoCheck's 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 in clinical practice guidelines. A bit more 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, leading to an 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 early stages. 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. 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 cohort, which I previously mentioned, is estimated to consist of $13 million U.S. men over 50 with one additional risk factor. 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 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 high volume manufacturing at Coastline International, Inc. based in San Diego, which will increase our line capacity 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 contractors for Palmetto GBA and its MolDx program, culminating in our submission of CMS payment coverage dossiers for their technical assessment in May of 2020, which was 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, 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 that the COVID-19 pandemic and change of administration have 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, they 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 Q-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. In 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 of EseGuard's performance on samples collected with EsoCheck in detecting esophageal pre-cancer and cancer. 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 impacts clinical decision-making; most notably that patients with a negative EsoGuard test do not 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 will discuss in some detail 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 our planned studies, including a large EsoGuard registry we are launching. Another important topic regarding implementing mechanisms to ensure that EsoGuard testing is performed and billed is consistent with practice guidelines. We discussed our commitment to help control indicating testing, working collaboratively with payers through audits and risk-sharing arrangements as needed. The 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 unnecessary 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 tests 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 for their various plans. In terms of Europe, now that we've secured 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 GI specialists. Our initial EsoGuard commercialization efforts are focused on gastroenterologists. 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 gastroenterologists 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 at-risk patients ever see a gastroenterologist, 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. Fourth, that we will work collaboratively with them to engage their referring physician network and educate them on the relationship between GERD, esophageal pre-cancer, cancer, and EsoGuard testing. As I noted in my opening remarks, these efforts are working well and have been boosted by a well-received presentation this past May at the largest GI meeting in the world by our leading GI physician, Dr. David Poppers from NYU. Dr. Poppers has reported positively on his initial experience with EsoCheck and EsoGuard. Let’s now move on to our recent expansion of EsoGuard commercialization to include primary care physicians and the role of our Lucid test centers. As I previously noted, nearly all GERD patients are exclusively cared for by primary care physicians and only a very small portion ever see a gastroenterologist. In fact, very few PCPs understand that GERD can lead to cancer. Nonetheless, we believe that PCPs will be receptive to widespread esophageal pre-cancer screening of at-risk 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 PCPs. His early engagement with them in the Phoenix area has yielded positive results, driving early referrals to our test centers. He already has dozens of meetings scheduled with PCPs in the area in the coming weeks. Our Lucid test centers, the launch of which we announced this week, operate in leased medical office suites located in Scottsdale, Tempe, and Glendale, Arizona, and are staffed by EsoCheck trained practitioners 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 lease is 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 in states contiguous with Arizona, most likely Las Vegas, Salt Lake City, and Denver. We then hope to steadily expand into the remaining Western U.S. states that allow 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, which includes 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 to complete the development of the Lucid branded telemedicine platform, which should be ready to launch in the fall. In order to support these expanded commercialization efforts, we have significantly expanded our full-time sales and marketing team over the past quarter and recent weeks, initially at the senior leadership level, and now increasingly at the market development manager and sales representative level. 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 with EsoCheck as an in-vitro diagnostic indicator to detect non-dysplastic Barrett's Esophagus. The ESOGUARD BE-1 screening study will enroll 500 to 900 high-risk GERD patients over 50 years of age with one other risk factor, and the ESOGUARD BE-2 study will be a case control study enrolling 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 Spain and the Netherlands. Despite COVID, enrollment has been decent since we launched our reboot in April to enhance training and introduce a new preservative. The early enrollment numbers in Europe are particularly strong. We are still targeting completion of enrollment by the end of 2022 and PMA submission to the FDA in 2023. 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 surgical 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. However, we learned by the second quarter that our model of utilizing a contracted National Sales Manager to drive recruitment of key opinion leaders and 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 and enhanced surgery, specifically in Carpal Tunnel release. We hired 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 tenure at Trice Medical, where he played an important role in the successful launch and commercialization of a minimally invasive Carpal Tunnel release device. Kevin's early work is beginning to pay dividends. He has successfully recruited long-time hand surgeon clients to serve as early adopters and advisors and has completed cadaver training sessions with more scheduled, getting them to schedule actual CarpX cases. We remain committed to a steady and deliberate initial commercialization plan, focused on optimizing 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 a 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, and we should be in a position to conduct 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 look 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 receive clearance in Q2. We're going to start building our commercial infrastructure for this product this fall as we continue to advance this technology. This past quarter, we were solicited by even larger strategic companies and market leaders on the broader NextFlo portfolio, including the IV sets. As this engagement is just getting underway, I look forward to seeing where it takes us. Two updates on PortIO, our implantable intraosseous vascular access device. The long-planned human study in Colombia was getting ready to commence early this summer when the process came to a 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 of our 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 milestones 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 on human volunteers and a diabetic animal model before the end of the year. 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.

Very good. Lots of exciting new things here. Thanks for taking my questions. I wanted to focus in on EsoGuard and my questions here. First, for 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?

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. 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 patient volumes may trend? Obviously, huge opportunity, but I just wanted to talk about that. And then can you talk about 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. It really is a bit too early for us to assess this. This is a pilot program. It's a bit early for us to be able to come up with any 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 good engagement, with early referrals to the test centers. 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 our primary care physician sales and marketing efforts translate into actual procedure volume and testing volume that is happening at the centers. So it would be really difficult for us to say anything more than that. This is a 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 generating awareness.

Yes. So we've designed this as consciously as firmly as a two-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 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. The marketing materials and frankly, the ad buys and all of that are already in place, but we are not going to switch that on until the telemedicine platform is ready to go, and I expect that to be soon.

Got it. Okay. And then I'll just end with one more quick one. You guys were previously providing some metrics around sites trained and stocking EsoCheck. 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 can have counts 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, get trained, and not perform procedures, and then you're going to have others that perform 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? And then what are you seeing out there in terms of the 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. This has absolutely been our DNA at the parallel level, and it continued on the Lucid level; we are constantly, very regularly reviewing opportunities for licensing, partnering, and now more increasingly with acquisitions. So I don't have time to talk about some areas we are looking at, but one area, in particular, is in-licensing technologies for additional biomarkers. We can use not just for screening but for progression for identifying the progression from non-dysplastic to dysplastic Barrett's Esophagus, there's an exciting technology that we're pursuing out of Case Western and Johns Hopkins, for example. On that front, and that will have another opportunity to leverage the EsoCheck device as an alternative to endoscopy for monitoring patients who have non-dysplastic Barrett's Esophagus. We also are reviewing - we actually - on the diagnostics side, we see a lot of opportunities ongoing. We've had conversations with the National Cancer Institute on several technologies and others. So that's all full steam ahead, and we certainly are seeing these technologies coming across the transom.

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

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

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

Thanks a lot, 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 are you 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 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 when do you think we'll start to ramp up because procedures will really pick up?

Just to be clear, what I was describing, the COVID-related matters were really more historical in 2020 and in the early part of 2021. 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. The initial KOL and 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 reporting on cases up until now, but we really have good momentum with Calvin's 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 full commercialization remains unchanged. That was really about the importance of getting early adopter and KOL folks to help with procedural efficiency and procedural safety before going out to the broader community. 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 a 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 commercialization. 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.

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 and the periodic press conferences. The best way to keep up with PAVmed news, updates, and events is to sign up for our email alerts on our Investor Relations website and follow us on Twitter, LinkedIn, and YouTube. I also encourage you to contact me directly with any questions at 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.