Greetings, and welcome to the PAVmed Inc. Business Update Conference Call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Havrilla, Director of Investor Relations for PAVmed. Please go ahead. 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 update 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. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer in our filings with the Securities and Exchange Commission. For a 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 statement 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. Good afternoon. Thank you for joining today's update call. For those of you new to PAVmed, welcome, and for those of you who are already part of this family, thanks for your support and commitment to our long-term vision to improve patients' lives while creating substantial shareholder value. I'm delighted to report that we've experienced strong momentum during the first quarter and in recent weeks as we seek to execute our bigger and bolder strategic plan and strengthen our foundation for long-term success. We continue to focus our efforts in several key areas, driving Lucid commercialization, strengthening our management and board, solidifying our balance sheet while extending our cash runway, taking Lucid public, and as always, exploring new partnership opportunities on groundbreaking innovations. Let me start with our successful efforts to reinforce the foundation of our company. As Dennis will describe maybe in a little bit more detail later, we have substantially strengthened our financial position over the recent months. We raised approximately $75 million of gross proceeds in straight common stock offerings between Christmas and Valentine's Day, including approximately $58 million during the first quarter. A heavily oversubscribed, underwritten public offering led by Cantor Fitzgerald generated approximately $45 million of those gross proceeds. We are very pleased that this offering was anchored by leading long-term fundamental institutional funds, including Fidelity, Vanguard, and Blackstone. We consider their participation to be a strong validation of our long-term strategic plan. We received and continue to receive meaningful additional cash from the exercise of our Series Z warrants. As previously announced, we decided to use approximately $15 million of the proceeds of the February financing to fully retire our convertible debt held by Arcam funds. The debt was due upon demand and paying it off in cash avoided further dilution as our stock price had exceeded the debt conversion price. The financings, warrant exercise, and convertible debt requirements have combined to substantially strengthen our balance sheet. We started the quarter with approximately $17 million in cash and $15 million in debt. We ended the quarter with approximately $49 million in cash and no debt except for a small forgivable PPP loan. PAVmed cash runway now extends into 2023 at our current burn rate, not taking into account the prospect of Lucid going public and raising its own capital. Another important area of focus has been to strengthen our management team and board. I will discuss the expansion of our commercial team a bit later. On the board side, I was very excited to welcome two prominent executives to the PAVmed and Lucid boards over the past few weeks. Debbie White, who joined the PAVmed board, is a prominent U.K.-based global industry executive who has led commercial entities with billions in revenue and tens of thousands of employees, including in healthcare. Debbie has already provided me invaluable guidance on long-term strategy and will play an important role in advising on commercialization and serving as PAVmed's audit chair. Dr. Jacque Sokolov, who joins the Lucid board, is a nationally recognized healthcare executive with expertise across all aspects of the healthcare industry. He established and chaired board compliance and quality committees for major healthcare companies, including Hospira. Dr. Sokolov has already established such a committee for Lucid and serves as its inaugural chair. His efforts will be of critical importance as we expand our commercial activities to include our own Lucid test centers, direct-to-consumer marketing, and telemedicine, all of which require meticulous attention to regulatory compliance. Let's dive into the details of our business, starting with our major majority-owned subsidiary, Lucid Diagnostics. Lucid is a commercial-stage medical diagnostics technology company focused on the relationship between chronic heartburn, which is ubiquitous, and esophageal cancer, which is highly lethal. Esophageal cancer is effectively a death sentence at the time of diagnosis in nearly all patients. Meanwhile, approximately 50 million Americans have its predisposing condition in the form of severe chronic heartburn. Risk factors for the development of esophageal pre-cancer and cancer in these chronic heartburn patients are well-established. The highest-risk subgroup are the 13 million men over 50 with one other risk factor, namely White race, obesity, smoking, and family history. Unfortunately, less than 10% of the at-risk chronic heartburn patients are screened despite professional society guidelines. The direct result of this lack of screening is a tragedy of over 16,000 esophageal cancer deaths per year. Our product, EsoGuard and EsoCheck, seeks to prevent esophageal cancer deaths through the early detection of esophageal pre-cancer and cancer in chronic heartburn patients. Lucid was created to license these technologies from Case Western Reserve University. In a mere three years and for less than $20 million in invested capital, we have advanced these technologies from research projects in an academic laboratory to commercial products with effective CMS payments and FDA breakthrough device designation. A little more detail, EsoGuard is a molecular diagnostic test which is commercially available as a laboratory-developed test performed at our CLIA-certified laboratory partner, which is located in Irvine, California. EsoGuard is performed on samples of esophageal cells collected non-invasively using our FDA-cleared EsoCheck device. The sampling procedure can be performed by a nurse in an office in less than five minutes without any anesthesia or sedation. EsoGuard is the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through early detection of pre-cancer and cancer in chronic heartburn patients. With CMS payment secured, the over 13 million patients already recommended for screening translates into an approximately $25 billion annual addressable market opportunity for EsoGuard. A mere 2%-3% penetration into this massive market would position Lucid among the largest pure medical diagnostic companies in the world by revenue. Lucid is also fortunate to work with several world-class advisors, including diagnostics pioneer Stan Lapidus, who co-founded and led Exact Sciences along a similar journey in colon cancer screening. Alberto Gutierrez, who led the FDA Office for In Vitro Diagnostics, and Dr. Nick Shaheen, an internationally renowned esophageal specialist and the lead author of the relevant gastroenterology society guidelines. During our last quarterly call, I announced that we intend to take Lucid public as a standalone medical diagnostics company, assuming market conditions remain favorable. The goal is to fulfill Lucid's extraordinary long-term potential and unlock its present value. We seek to have Lucid raise its own capital to drive its own growth strategy. This growth strategy is focused on expanding EsoGuard commercialization as well as the clinical evidence base to support inclusion in future clinical guidelines. Of course, we firmly believe that taking Lucid public under the right terms would also be in the best interest of PAVmed and its shareholders. PAVmed will retain a controlling majority interest in Lucid. We engaged Cantor Fitzgerald to assist us in this effort and have pursued both the IPO and SPAC paths in parallel. Cantor ran a process which had us engage in discussions with numerous SPACs targeting life sciences companies. Lucid's board ultimately determined that the best interest of its shareholders would be served by Lucid going public through an IPO and not a SPAC. Several factors contributed to this decision, including greater dilution from SPACs and uncertainty arising from the recent SEC staff statement on SPAC warrant accounting. Let me now update you on where we stand with EsoGuard commercialization. We're very encouraged that the pandemic-related restrictions to our commercial activities appear to be a thing of the past. With nearly all healthcare workers now vaccinated, moving forward, we anticipate unfettered access to facilities for sales calls, training, and procedural support, even if local and regional outbreaks occur in the future. EsoGuard testing has accelerated as these pandemic-related healthcare facility limitations have eased. Lucid processed 78 EsoGuard tests in the first quarter and 96 so far in the first half of the second quarter. We have EsoCheck devices and EsoGuard specimen kits on the shelf and have trained clinicians at approximately 180 accounts. Lucid has also significantly expanded its full-time commercial team to help drive EsoGuard commercialization, including, as previously announced, four industry veterans in senior leadership roles. We're very fortunate to have these highly experienced leaders with deep sector experience on the Lucid team. For example, our new director of sales has spent over a decade in the gastroenterology space, both at Medtronic and previously at Barrx Medical. He oversees what is now a growing full-time Lucid team of regional sales managers and independent sales representatives who currently call on gastroenterologists. He will lead the upcoming expansion of Lucid's sales team to include two groups of full-time territory managers, one calling on GI specialists and the other on primary care physicians. We've also hired two clinical specialists and are actively recruiting more. These specialists will train clinicians and support existing accounts while freeing up other sales personnel to focus on opening new accounts. Our new vice president of market access and reimbursement has over 25 years of experience as a leader in the complex area of market access and reimbursement for diagnostic tests. He has a proven track record of success seeking insurance reimbursement and driving revenue. He served as senior director of reimbursement and managed care at Exact Sciences at an important period during which he secured coding, payment, and coverage for its Cologuard early cancer detection test. Our new sales training manager and strategic account manager both hail from CDx Diagnostics. CDx markets a widely utilized upper GI endoscopic tool to enhance the diagnosis of esophageal pre-cancer. As such, they both have very deep connections with the community of gastroenterologists who specialize in esophageal disease. Let's spend a few minutes on reimbursement. As we've noted previously, last year, CMS granted EsoGuard an attractive CMS payment determination of $1,938. This CMS payment became effective January 1st. We began to submit EsoGuard claims later in the first quarter and are pleased that we have started to receive out-of-network private insurance payments. Although this is encouraging, it's important to remember that the claim cycle can be prolonged during the early commercialization of any new test, especially until contractual coverage has been secured. We are still awaiting CMS local coverage determination. As many of you know, last May, we submitted our final coverage determination to MolDX, the molecular diagnostic group of the Medicare Administrative Contractor, Palmetto GBA. We understand from our consultants and contacts at our trade association, PAVmed, that the pandemic and change of administrations has resulted in a significant backlog of local coverage reviews which persist, but we do hope to hear from them soon. Meanwhile, we are pushing full steam ahead on the private payer side. Our new VP of market access and reimbursement is working with two consulting firms to assemble the data package to support securing contracts with private payers for EsoGuard payments and coverage. Our first advisory board meeting with medical directors of the major insurers will be held this Friday in Orlando. During our last quarterly call, I announced a major new initiative for Lucid, which I believe represents the long-term future of EsoGuard commercialization. This program, which we have internally dubbed Project Phoenix, seeks to supercharge EsoGuard commercialization by simultaneously targeting multiple sales and marketing channels. What do I mean by that? Our sales efforts to date have targeted gastroenterologists. We are seeing good traction here because EsoGuard helps the gastroenterologist expand their funnel of new esophageal disease patients. Most of these patients will become long-term patients for the practice and will need periodic follow-up and procedures. We will continue to aggressively market EsoGuard to the gastroenterologist. As I have already noted, we are expanding our team to do so. This new initiative does not in any way represent a shift away from gastroenterologists. They remain our anchor specialty. It is clear, however, from the experience of Exact and others in the early cancer detection space, that fulfilling EsoGuard's potential requires that we expand our sales and marketing efforts to include primary care physicians and ultimately consumers as well. The reason is that the vast majority of chronic heartburn patients never see a gastroenterologist. As importantly, most primary care physicians and consumers still need to be educated on the relationship between chronic heartburn and esophageal cancer, as well as on the availability of a new, non-invasive, office-based alternative to endoscopy to detect esophageal pre-cancer. To accommodate referrals from primary care physicians and consumers, we need expanded EsoGuard testing coverage to assure that any physician or consumer who responds to our educational marketing outreach has access to EsoGuard testing as clinically appropriate. That requires us to create our own Lucid test centers to which patients can be referred for EsoGuard testing. We have made significant progress in honing the details of this program and operationalizing it over the past couple of months. There are fundamentally two phases to this program. Phase I is the creation of the Lucid test centers, and phase II is the establishment of a telemedicine program that can accommodate self-referrals from direct-to-consumer marketing. Preparatory work on the phase I pilot program has been completed. We've hired the clinical personnel and leased the medical office space to launch three Lucid test centers in the Phoenix, Arizona metropolitan area. We expect the centers to be ready to accept physicians' referrals for EsoGuard testing in the coming weeks. The only step remaining is to finalize the necessary regulatory and compliance infrastructure. This infrastructure is being overseen by the board's new compliance and quality committee, which, as I mentioned, our new board member, Dr. Sokolov, has established and leads. In addition to Lucid management and directors, this committee includes outside general counsel, outside specialized healthcare compliance counsel, our advisor, Alberto Gutierrez, who, as I mentioned, led the In Vitro Diagnostics branch of FDA, and his former colleague, D.C.-based attorney Jeff Gibbs, who previously served as FDA associate general counsel for enforcement. Excuse me. This high-powered team is making sure that we pay the meticulous attention to compliance and regulatory matters that this program requires. phase II of the pilot program in Phoenix will commence later this summer. We are finalizing contractual arrangements with a telemedicine company with extensive experience in handling these types of programs for pharmaceutical and diagnostic companies. The telemedicine company will receive and process self-referrals from patients who respond to our direct-to-consumer marketing efforts. More specifically, the telemedicine physician will perform a detailed intake medical assessment and refer the patient to a Lucid test center if EsoGuard testing is clinically indicated. The result of the test will be sent back to the prescribing telemedicine team, who will then refer those with positive EsoGuard results to the appropriate gastroenterologist for further evaluation. The long-term economics of both the Lucid test centers and the telemedicine program are very attractive. We estimate that one of our nurse practitioners can perform up to 20 EsoCheck procedures per day. The fixed and marginal cost of personnel, office space, and supplies are small relative to the potential revenue stream for each test sale. The marginal cost of direct-to-consumer marketing and the telemedicine program are also very reasonable given the projected gross margins for the EsoGuard test. A few comments now on European clearance, our ongoing clinical studies, and manufacturing. Earlier this year, Lucid passed its final stage 2 audit of the quality management system, this quality management system by our EU-based notified body. The notified body recently notified us that their review of the EsoCheck technical file was complete and the final summary report had been submitted. We therefore expect to receive EsoCheck CE mark approval under the current EU MDD regulatory regime before the EU transitions to its new MDR regulatory regime on May 26th. EsoGuard is classified as a general In Vitro Diagnostic under the EU's IVDD regulatory regime for In Vitro Diagnostics, and therefore only requires self-certification, which will be completed quite soon. In terms of our clinical studies, we're actively enrolling U.S. patients in two international multi-center clinical studies, EsoGuard BE-1, a screening study, and EsoGuard BE-2, a case control study, to support a PMA application for IVD to registration of EsoGuard on samples collected using EsoCheck. These studies were the subject of an FDA pre-submission meeting, during which we received positive feedback on the protocol and the proposed indications for use. We expect European sites to begin enrolling patients this summer. We expect the study to complete enrollment and submit the PMA application in 2022. As I mentioned, EsoGuard and EsoCheck received FDA breakthrough device designation, which entitles us to closed FDA communications and other benefits. We have contacted FDA to begin discussions pursuant to this breakthrough device designation. We will seek the agency's input on an extension of EsoGuard BE-1 screening study that's sufficiently powered for an expanded indication to detect dysplastic Barrett's Esophagus to support inclusion in future clinical guidelines. These FDA meetings are currently backlogged due to COVID. We expect them to open up in plenty of time for us to finalize the protocols for expanding enrollment in the expanded study in 2022 and beyond. On the manufacturing side, we're working to transfer EsoCheck manufacturing to Coastline International, a high-volume manufacturer that's based in San Diego with production facilities in Mexico. We expect to complete this process by the end of 2021. This will increase EsoCheck manufacturing capacity to up to one million units per year. Finally, before moving on to our other products, I'd like to spend a few minutes on the competitive landscape for EsoGuard and EsoCheck. These topics come up frequently in our discussions with investors and are worthy of some analysis. I've stated that EsoGuard performed on esophageal samples collected with EsoCheck is the first and only commercially available diagnostic capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of pre-cancer and cancer in chronic heartburn patients. This statement really has two parts as it relates separately to other biomarkers and to other cell collection devices. There are no commercially available biomarker tests other than EsoGuard that test esophageal cells for pre-cancer and cancer, much less one with sufficient accuracy to serve as a widespread screening tool in chronic heartburn patients. There have been a few abstracts and publications with preliminary data on biomarkers that purport to do so. One of these are a set of biomarkers being developed by Mayo Clinic, which has a relationship with Exact Sciences. We are aware of these data as are our physician consultants, including Dr. Shaheen and the Case Western faculty, who are all part of the same NCI-funded consortium on esophageal disease as the Mayo investigators. We do not see these biomarkers as becoming direct competition to EsoGuard anytime in the foreseeable future. We believe the data presented to date falls short in terms of power and accuracy compared to the EsoGuard data that was published well over three years ago in Science Translational Medicine. That data demonstrated greater than 90% sensitivity and specificity in a well-designed 408-patient case control study with proper training and validation sets. The ultimate barrier to entry, I believe, however, is EsoCheck. All other biomarkers, including the Mayo markers, have some variation of a Brillo pad sponge-on-a-string device to sample esophageal cells. These include the Cytosponge device, which Medtronic no longer markets in the United States, and its clone, the EsophaCap device, which the Mayo investigators use. These devices sample cells indiscriminately from the stomach to the mouth. They lack the key differentiating feature of EsoCheck, which is its patent-protected ability to perform anatomically targeted sampling of the distal esophagus while protecting the sample from dilution and contamination during retrieval. Picking up early pre-cancer changes is the proverbial needle in a haystack. The molecular changes can occur in as few as 1% of the sample DNA molecules. Any biomarker performed on a sample swamped by cells outside of the diseased region will struggle to replicate EsoGuard's performance on EsoCheck samples. We frequently get asked about the potential threat of liquid biopsy tests, which can detect minute amounts of tumor DNA in blood. These questions obviously arise from the intense attention and capital flowing into liquid biopsy companies looking to detect cancer in the blood. This is a complex topic. Let me briefly state that EsoGuard does not face any serious threat from liquid biopsy tests in my opinion. The fundamental reason is that the prognosis of early-stage esophageal cancer is very poor, with over 40% worse survival rates in stage I and stage II cases. This means that the only way to prevent esophageal cancer deaths is to detect early pre-cancer, such as Barrett's Esophagus. These pre-cancer cells have no cancerous mutations and don't invade blood vessels. Even in the unlikely event that their DNA ended up in the bloodstream, it would essentially be indistinguishable from normal DNA. The only way to detect these early changes is to collect actual esophageal cells. I'll now close with some brief updates across our other products. As with our last call, we don't have time for me to provide much background or context for those of you who are just learning about PAVmed. I would encourage you to refer to our website and SEC filings for additional information and contact us with any questions. Let's start with CarpX, our minimally invasive device to treat carpal tunnel syndrome. I'm excited to welcome our new full-time CarpX National Sales Manager, Calvin Roberts, who starts with us today. Calvin brings over a decade of experience in orthopedic sales. This includes an extended stint at Trice Medical. At Trice, he played an important role in the successful launch and commercialization of a minimally invasive carpal tunnel release device, which it acquired a couple of years ago. Calvin brings a vast Rolodex of contacts in the hand surgery space, including surgeons and distributors. Calvin has been tasked with reorganizing the CarpX advisory panel to accelerate procedural volume, which has stalled since the first case several months ago. We remain committed to a steady and deliberate initial commercialization plan focused on optimizing the procedural steps and safety and look to broaden our commercialization efforts later this year. Our EU-based notified body also recently notified us that their review of the CarpX technical file has been completed. We await the final summary report submission confirmation, but as with EsoCheck, we expect to receive CarpX CE mark approval under the current MDD regulatory regime before the transition to the new MDR regime on May 26th. Next up. I'm very excited by the progress we've made with our NextFlo infusion set, IV infusion set. Once commercialized, it will seek to radically transform the efficiency and cost-effectiveness of the million infusions administered each day in the United States. Our work to date clearly demonstrates that the NextFlo IV set works and is able to provide constant flow with accuracy approaching electronic infusion pumps. We believe it has the potential to replace these pumps in over 80% of infusions. We are in the midst of design freeze verification testing and expect to begin final verification validation testing soon. We are targeting FDA 510(k) submission by the end of the year, with clearance in the first half of 2022. We continue to engage in discussions and to support technological diligence with a large strategic partner to license the NextFlo technology specifically for disposable infusion pumps. Those discussions continue, however, we continue to advance the technology for this application and will be well-positioned to self-commercialize for this application next year. Our PortIO implantable and percutaneous vascular access device is currently awaiting regulatory steps in the U.S. and abroad. The PortIO study in Colombia, South America, is ready to commence. We have initiated four medical centers which are ready to begin enrolling patients once IRB approval is secured. The IRB process, however, was slowed by a severe COVID outbreak in South America, but we expect to get final approval and enrollment to start. PortIO's fate is similar to life in the U.S., and we're awaiting the FDA reopening of non-COVID pre-submission processes and meetings to discuss the protocol for our U.S. IV study based on an eight-week implant duration. We hope to get that meeting scheduled soon once they open up. In the meantime, we're performing long-term animal studies to strengthen our pre-clinical data set in anticipation of the pre-submission meeting, and these studies are going well. Next, a few highlights from products in our emerging innovations portfolio. Work on our EsoCure esophageal ablation device is progressing well. We recently completed a successful animal study with Dr. David Poppers of NYU. This was the first study which included animals who were survived after the ablation procedure. Histopathology is pending, but we demonstrated successful direct thermal balloon catheter ablation of the esophageal lining through the working channel of a standard endoscope using our proprietary Caldus technology. We believe we're on schedule for FDA submission and clearance of EsoCure in 2022. We continue to work closely with our research, development, and manufacturing partner, Canon U.S.A., in advancing our DisappEAR resorbable pediatric ear tubes. We're still expecting to initiate animal testing this quarter and targeting FDA 510 submission in late 2021. Next, as previewed during our last call, our subsidiary, Solace Diagnostics, recently terminated a third-party license agreement to develop non-invasive glucose monitoring technology. This was partly based on the fact that we had developed and advanced our own proprietary technology in the space, which we believe is superior. Work on our own technology is going well, and we expect the prototype to be ready for testing in human volunteers and a diabetic animal model later this year. Finally, I'd like to close with a few comments on our long-term vision for PAVmed, assuming Lucid does become a standalone public company. Again, this topic comes up frequently in my discussions with investors, and the direct question I frequently get is as follows: Since Lucid represents such a significant portion of PAVmed's activity and value, what is PAVmed post Lucid? In the immediate term, this is actually a pretty straightforward question. We have made it clear that we will only proceed to take Lucid public if PAVmed retains a controlling majority equity interest. As such, PAVmed will continue to report consolidated financials and will recognize Lucid revenue and revenue growth. Lucid will have access to its own capital to drive its growth strategy, but PAVmed will continue to play an important role and benefit directly from Lucid's successes. There's a deeper question about our vision for PAVmed over the medium and long term. Let me be clear about one thing. The future of PAVmed is not to be a holding company for Lucid. To the contrary, one of the fruits of our success at rapidly building value in Lucid over the past three years has been that PAVmed has built a powerful infrastructure to serve as an innovation and value engine across medical device diagnostics, and potentially even more broadly. This infrastructure consists of a greatly expanded PAVmed team with broad expertise and experience across all disciplines, which is tightly integrated with a network of best-in-class process experts and consultants. The infrastructure boasts deep expertise and skill sets in design and development, regulatory device manufacturing, commercialization, market access, clinical trials, and CLIA laboratory and molecular diagnostics. Our vision for PAVmed is quite simple. It's to feed this engine and generate value in the form of future Lucid. This can be from groundbreaking technologies already in our portfolio, such as CarpX and our suite of infusion products. It can also be from technologies we license or acquire, as we did with Lucid. Our success at Lucid in creating value, not just for our shareholders, but for our partners at Case Western, has greatly increased the number of innovators and academic centers who are soliciting us to consider partnering with them on very exciting technologies. We assess each of these opportunities very carefully, but we won't hesitate to pounce on the most promising, as we did with Lucid just three years ago. With that, I'll pass it on to Dennis to provide an update on our financials. Thanks, Lishan. Good afternoon, everyone. We brief summary financial results for the first quarter ended March 31, were reported in our press release that was published earlier this afternoon, and our quarterly report on Form 10-Q was concurrently filed with the SEC and is available at sec.gov and also on our website. As you already know from our update call in February, previously in November, tests performed in any given quarter will not result in recognized GAAP revenue until the cash is actually collected. As previously mentioned on several occasions, this will be true during the transition period of negotiating third-party private payer reimbursement contracts and related coverage policies. There was no recognized revenue in the quarter, as only recently were the first payments received by our Medicare and private payer billing agency. With regard to the balance of 2021, consequently, it's our expectation that throughout 2021, GAAP revenue will be realized only on actual collections received for tests submitted for reimbursement. This obviously can result in timing of revenues recognized versus the time they are submitted by third party reimbursement. As promised on our last corporate update call, EsoGuard tests performed and submitted for payment are now provided in the press release. Obviously, we're in very early innings. We continue to evolve our reporting metrics as our various sales and marketing efforts further influence adoption, particularly with Project Phoenix upcoming kickoff. Presently, there are now four banking analysts who have issued coverage on the company and others that are also doing their due diligence. The 2021 revenue estimates provided by the analysts are achievable, but quantity and collections are highly dependent upon the evolving reimbursement landscape. As you are likely aware from our last corporate update, the local coverage decision, or LCD, for CMS related reimbursement has still not been published. With regard to the financial results for the quarter, research and development costs. The first quarter research and development costs were approximately $3.3 million, as compared to $2.6 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, NextFlo, PortIO, EsoGuard, and our glucose monitoring project. G&A, and G&A not including sales and marketing expenses, which are now presented separately, were $3.4 million for the first quarter, compared to $2.2 million for the same quarter in 2020. The approximate $1.2 million increase is principally related to approximately $800,000 increase in compensation-related costs, principally related to staffing levels and also related stock-based compensation costs. In addition, about $300,000 in consulting services related to patents, regulatory compliance, and legal processes for contract review and public company expenses, and another $100,000 in general business expenses. Sales and marketing expenses were approximately $1.4 million for the first quarter, compared to $400,000 for the corresponding prior year period, with $800,000 increase principally related to increased headcount in sales and marketing personnel and $200,000 increase principally related to consulting and professional services with respect to increased commercial activities. PAVmed reported a net loss attributable to common stockholders of $9.5 million, or a loss of $0.13 per common share, versus a loss of $14.5 million and $0.33 per common share for the same period in 2020. A press release provides substantially more detail related to the non-cash charges occurring in the current and prior periods. Also, the press release provides a table entitled non-GAAP Measures, which highlights 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 will notice from the table that after adjusting the GAAP loss by approximately $3.6 million for non-cash or financing-related charges, the company reported a non-GAAP adjusted loss for the first quarter of $5.95 million, or $0.08 per common share. PAVmed has cash, as Lishan mentioned, of $48.6 million as of March 31st, after paying off our convertible debt in March in the amount of $14.5 million. During the first quarter, the company received additional net proceeds of approximately $53.7 million from the issuance of common stock and $1.4 million from the exercise of Z warrants. With that, operator, let's open it up for questions. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For those using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. The first question is from Kyle Mikson from Cantor Fitzgerald. Please go ahead. Kyle, good afternoon. Hi, Kyle. How are you? Good. This is Sean. How you guys doing? Thank you. Just wanted to confirm on the Lucid tests processed during the quarter, 78 EsoGuard tests. First, is that the number of tests that were performed and then submitted for reimbursement or just simply performed? I know Dennis McGrath talked about this a little bit, but I was wondering if you could provide a bit more detail on your expectation for the rate of claims denials for the rest of the year or even the pacing of the cash collections as well, because I know it's a little bit uncertain, but was wondering how we should be thinking about that. Thanks. The tests in the first quarter are submitted for reimbursement, and they have not been fully collected yet. The rate of denials is still uncertain in terms of what that would be. On the CMS side, we shouldn't expect sizable denials. Interestingly enough, so far on the private payer side, we have been receiving payments. There have been some denials, which will get appealed. On the private payer side, the reimbursement rate is at the non-network levels, which you would expect because there's not coverage policies on the private side yet. In terms of giving you any guidance on terms of denials, it's too uncertain to provide that at this time. I will tell you that I think it's known among our investor base that our targeted audience of patients is approximately 60% Medicare patients or CMS related, and we have the payment determination for that, 40% being private pay. The denials will likely be heavier on the private payer side until coverage policies are in place. We are encouraged by the fact that we are getting some payments on the private payer side. Again, too early to tell what the denial rate would be, but it's likely part of the evolving reporting metrics that as we have more experience to be able to project further, that'll be forthcoming. If I could just reemphasize one point, which is that these are the tests that were performed in the first quarter, those in the second quarter. The vast majority of those, we haven't gotten any response yet with regard to a submitted claim. We're just getting the early signal as to how things are going to break with regard to that, and we'll obviously have more color on that over the coming months. Makes sense. Thanks for that. Sticking with Lucid and EsoGuard, I was wondering if you can quantify the commercial team. I was wondering if you can provide any numbers around, I did hear a few of these, like two clinical specialists I think I heard. Yeah. Any numbers around sales reps or sales managers too? Let's just go through that systematically. We have a chief commercial officer, director of national sales, other support for folks at that level, including market access and sales management, and so forth. Below the director of sales, the new director of sales, we have seven regional business managers that cover the entire U.S. territory. Collectively, they currently supervise independent sales reps, approximately 50 independent sales reps. One of the things that we mentioned and one of the parts of our growth strategy is to expand to and start including territory managers under those seven. We have not begun. John just started a couple of weeks ago. That's one of the things he's tasked with doing is to start building the territory managers under the regional managers, as I mentioned in my comments, in two different flavors: one group that call on GIs and one group that call on primary care physicians. That process is just getting started. On the clinical cycle side, our goal is to hire seven to start, and we've hired two so far out of those seven. To be clear, that does not include the staffing of our test centers. This is strictly the sales and marketing team. The Lucid test centers are going to be staffed separately. Okay. That was helpful. I guess I'll ask one more, and I'll let others hop in. On Europe, I guess can you just walk through the commercial and the distribution strategy in Europe, assuming you receive CE mark approval for EsoCheck and you're cleared for the EsoGuard assay as well? Similarly, what kind of issues would arise, I guess, or headwinds would be presented if you don't get the CE mark approval by May 26th, by the time that the new regime begins? Yeah. Let me answer that. We're really pretty confident. Everything is being sort of down to the wire because there's a log of applications that these notified bodies are trying to get. We're pretty confident we'll do so. It's not the end. If it doesn't happen, it's not the end of the world in terms of the delay. Transforming our application to an MDR application will take some time, but it's not going to have any sort of long-term impact. Again, pretty optimistic, but if it doesn't make it through the 26th, then we'll just dust it off and then resubmit it as MDR. I think as you know, Kyle, in Europe, getting CE Mark is one thing, but getting commercial traction is a very different play than it is here in the U.S. Generally speaking, and this is what we would do, what you try to do is to target countries where you have expectations of having good traction with the opinion leaders and early adopters that can really drive this. What our plans would be to focus on the two countries where we're focusing our clinical studies. As I mentioned, we're about to start European enrollment in our clinical studies in the summer. As part of that, we've had strong engagement with centers in the Netherlands and in Spain. Both of those countries have very prominent, particularly the Netherlands, have very prominent positions in the esophageal space and in the Barrett's Esophagus space. Our efforts would be to get to, once we get CE mark clearance, to focus our initial commercialization efforts on those two countries. The other prospect would be in the U.K., where there's a very strong interest in this because of other technologies that have been developed in the U.K., and we also have some connections in the U.K. through our new board member, Debbie White. Just to reiterate, Europe is pretty much sorted over how about you do country at a time and get your commercial infrastructure set up. I don't know if it's clear, but I'll emphasize this, that the assay will still be performed in the U.S. The samples will still get sent by express mail to the U.S., and we'll continue to perform the assay there. Okay. That's perfect. Interesting. I will leave it there, but thanks guys for taking the questions and congrats on getting these first EsoGuard claims. Yeah, great. Thanks, Kyle. Take care. The next question is from Frank Takkinen from Lake Street Capital Markets. Please go ahead. Hi, Frank. Good afternoon. Good afternoon, guys. Thanks for taking my questions. Just a couple for you. I wanted to start with the approximately 180 U.S. accounts. Was hoping you guys could walk us through the process of an account being interested to trained and shelfing product to actually performing procedures? With some of your earlier accounts that you onboarded right at the beginning, can you just talk to how their utilization has trended since onboarding and launching their product? Yeah. The process is pretty typical. There's engagement by the sales team. There's a sort of an educational step. There may be a dinner or other opportunities to educate them on the technology or bring in other users to bear on the process. That doesn't typically take too long. Once we've been able to make the case to the gastroenterologist that they should be interested in this, that they have patients immediately within their practice that can benefit from this, particularly their colonoscopy patients, and that we would work with them to deliver referrals from their primary care network. The rest of the steps are pretty straightforward. Getting product on the shelf is straightforward. That's quite quickly just shipped EsoCheck devices as well as the EsoGuard specimen kits to their location. Training is actually quite straightforward as well. We come to their facility. All of our sales regional managers are capable of training accounts. They simply perform the procedure in an office setting and teach them the various steps of how to do either the physician themselves or if they're going to delegate it to a nurse, to that individual. I'd be hard-pressed to put a timeline on it. I think as you know, in any aspect of medical device or diagnostics businesses, you can turn an account in two days, or sometimes it takes willing, tend to have a longer education process to get them on board. I would say just one point that the private practices can move more quickly, as you might imagine, that some of the longer lead times. Ultimately the greater yields in terms of case volume are at the academic medical center. Our busiest account, I believe still our busiest account to date is NYU. That took quite a while to get through the complexities and the logistics of the academic large medical center. Once you get started, you actually can do a lot of cases. I'm not sure I have a good answer for you in terms of the metrics that you can hang your head on with regard to accounts. We just don't have enough data with regard to accounts, case lines of accounts, and sort of the reproducibility of that. We have some accounts that we contacted early on during the pandemic that expressed an interest, that have product on the shelf that we're going back to now that there's more access. We have other accounts that have moved more quickly, that are more recent. It really just varies, and I just don't think I can provide you with sort of much in the way of numeric guidance on that. I'm not saying if you have anything else to add to that. I think a predictable pattern still yet to be seen. I think you know, Frank, that through the early part of the first quarter was rather choppy as clinics were focusing on vaccinations, and that has picked up. The pattern's still too early. That'll be part of future metrics. I'll add one other thing which is important, which is that it's also hard to separate the trends from the expanding team. I'll give you one concrete example of that. Once you have an account open, as again, as I'm sure you know from other device markets, maintaining accounts and getting accounts to do procedures often requires a lot of face time and a lot of touches. Doing so, that's one of the reasons why we're expanding our clinical specialist team to provide sort of procedural support, so that the sales system, the sales reps, and the business managers can focus on new accounts. We haven't really had that until recently, where we've been able to put folks in the procedures for established accounts to provide support and free up some of our staff. I think some of that will start to declare itself over the coming months. Got it. That's helpful. Next for me, on the reimbursement side, I was hoping you could, and I understand it's very early days in the reimbursement conversations you have had to date, but I was hoping you could help us understand the expected out-of-network reimbursement level you could see in relation to the 1932 set by CMS and a little longer term, how you expect the commercial insurers to establish a reimbursement level over time. I think the latter is very hard to predict. As you said, we're just starting. We're really excited. We have our first advisory board meeting on Friday in Orlando. We have medical directors from many of the major payers that are going to be present for our presentation. We think we have a very powerful data set to present to them. I think it's too early to say. We certainly hope that the private payers will come in at or near the Medicare rate. We have a strong motivation with, I don't know how familiar you or others might be with the PAMA regulations, but we have a very strong motivation to not undercut our Medicare pricing in private payer contracts because that can have follow-on effects for Medicare. We're very attuned to that. The sample size is small. So far, we've been billing the private pay patients at the approximately $2,000 price. It's very small, but the ones we've received have been in the ballpark of about where you'd expect a 50% out-of-network payment to be. I wouldn't interpret that much at all because it's very early, and I'm not sure if that's really predictive of where we'll end up in the more substantive discussions from a contractual in-network point of view. Great. Okay. Last one from me. Given you guys have elected to go the IPO route, can you just give us a refresh timeline when we can see this filed as well as when we can see it become a standalone company? Dennis, I'll let you handle that. Sure. Frank, we're working through the process. It includes separate audited financial statements, which the auditors are working through, and we expect that to be done shortly. It requires an S-1 update, and we'll be filing that once the audit is completed. Bankers have been retained. The banker has been retained, and I guess the gating factor is going to be once we file with the SEC, how quickly they can turn around comments. We had filed a confidential one before, and the comments were light. We'll update that with the updated financing. We can't predict the timing. It really will be SEC related once we hand the document over to them. Just to be clear, we're moving full steam ahead. The gating item is once we're done. Perfect. All right. Thanks for taking all my questions, guys. Yeah. Thanks, Frank. Next question is from Anthony Vendetti of Maxim Group. Please go ahead. Yeah. Good afternoon. Hi, Anthony. How are you? Afternoon. Hi, Lishan. How you doing? Good. I just want to shift gears a little bit to talk a little bit about CarpX. I just wonder if you can give us an update on. Yeah. How that rollout is going. Yeah. We did our first case, and we were using external non-full time national manager as well as distributors. We had developed a panel of surgeons, which we were hoping could get us through the sort of initial commercialization phase and sort of working out procedural development and safety issues and so forth with the device before full commercialization. To be frank, that just hasn't panned out. Some of those surgeons that we put on that panel just did not have the clinical volume that we needed in order to start to get that experience. We decided to kind of reorganize the whole effort, frankly, and went out and spent some time recruiting a full-time national field manager with specific. One of the things we realized is we needed someone with specific experience working full time, that had done this before in the carpal tunnel space, and we have that person now. Calvin, as I mentioned, was at the center of the launch and successful commercialization of the Segway device by Trice Medical, which they acquired a couple of years ago. Calvin starts today, and he's raring to go, and he has his Rolodex of hand surgeons and distributors, and we look to sort of get back on track with regard to getting the advisory panel cases done and still looking towards a full commercialization later in this year. Is that full commercialization by later this year? Later in the year. Yeah, we're still hoping to get there and across the same timeline, but just with this initial commercialization under our belts with this new reorganization. Okay. Still by the end of the year. Okay. I guess any updates just on DisappEAR really quick? Yeah, DisappEAR is going well. Again, listen, I spent 30 minutes to get through everything, so I'm glad I had time to talk about the others. We've had a really great working relationship with Canon. We have the full force of their team and their expertise and their resources behind us now. We continue to receive samples from them for bench-top testing. We're close to being able to do animal testing on the actual samples that are manufactured by Canon, and that should put us in a good position to submit for FDA 510 by the end of the year. It's going really well. We're really happy with how that relationship has blossomed. Okay, excellent. Thanks for the updates. I'll turn it back over. All right. Thanks, Anthony Vendetti. The next question is from Ed Woo from Ascendiant Capital. Please go ahead. Yeah, also congratulations on the quarter. Lishan, thank you very much for giving us your vision of PAVmed post-Lucid. You mentioned that you're seeing a lot of different partners coming out with products for you to possibly work with. Do you have a set target in mind of how many products you can have at one given time? No, I don't think I can say that definitively. We look at each one at a time and look at the opportunity. I think the lesson here is it's not a theoretical one. The lesson and the template for this is Lucid. At the time Lucid was presented to us, we were not contemplating necessarily having a full-blown subsidiary. We were not looking in the diagnostic space, frankly. The opportunity was presented to us. It became quite clear to us that it had a big opportunity, and we pounced on it. We look at a lot of things. We'll only act on a limited number because we have limited capacity and capital, and we're not looking to outstrip either of those in the short or medium term. The good news is that we're seeing a lot, and people understand and they've read about Lucid. They know how things have played out in terms of the value created for Case Western. It's very diverse. It covers a lot of interesting areas that we're not directly involved in right now that have great market opportunity. I wouldn't come up with a hard number, to be frank. We certainly would do it responsibly based on our resources and our capital. Great. Just a follow-up to that question. I know you said that potentially it may be an area that you're not involved with now. What are some of the big key criteria you're looking for when you're evaluating opportunities? I really loathe to come up with a checklist, because if you'd asked me that in December of 2017 when I gave you a checklist of the kind of device companies we were looking at, that I would have had to eat my words three months later and said, "Well, we're going to do diagnostics because we have a diagnostic opportunity." I'm not trying to evade your question, but I'll say that the check boxes are pretty similar to what we've always looked at, which is, does it have an opportunity to have an impact clinically? Does it address some significant unmet need and have a significant clinical impact? Is it generally in an area where you can count on decent growth margins and not have to work within a commoditized space? Is the broader market opportunity large enough to justify the investment? I guess I would say that on top of that, there are just areas in the industry, in the life sciences industry right now that are sort of hot, and we'll pay attention to that. I think diagnostics got hot after we acquired Lucid, it's been more over the last couple of years, and perhaps others might disagree with that. There's clearly areas within the life sciences that are getting some attention in terms of capital and attention on the street. Those are the criteria. Then I guess finally, I would say we would look to products that synergize. Certainly, we'd look towards the top of the list, products that synergize or innovations that synergize with our existing technologies, whether it be within Lucid or within CarpX or Effusion Technologies. That would certainly be a criteria that would have an impact on what we would look for, or ones where we could aggregate certain innovations under an umbrella. That obviously would be useful as well. I think that's probably as much as I can say in terms of guiding principles about how we look at these technologies. Great. Well, thank you. That was very helpful. Thank you. Yeah, thanks a lot. Thanks. The next question is from Frank Ibarra from Morgan Stanley. Please go ahead. Yeah. I'm sorry, Frank Ibarra. Frank. How are you? Thank you so much for taking the call. Just to be sure, correct here, it's Frank Ibarra from Ibermac LLC. I was formerly with Morgan Stanley for 40 years, but I retired. A couple of questions. It doesn't seem as if any of the current PAVmed shareholders are going to receive any kind of stock in Lucid prior to the IPO. Is that correct? We have not stated that one way or the other. Oh, okay. Yeah. Well, thank you very much for answering that question. Secondly is, if that were to be the case, would it be possible, because we do have preemptive rights, would it be possible to allocate any kind of portion to current shareholders of PAVmed? I don't think we're ready to make any specific comments about that, except that at the time that we're faced with that decision, we'll make the decisions that we think are in the best interest of PAVmed and the shareholders. I can't provide you any more specifics than that. Thank you very much. I appreciate it. Best of luck. Sure. Well, thank you very much. Congratulations on a very good quarter, and I truly believe it's just the beginning. Thank you very much, Frank. Thank you, Frank. Super. This concludes the question and answer session. I would like to turn the floor back over to Dr. Lishan Aklog for closing comments. Thank you all for joining us this afternoon and really for a bunch of great questions and great discussion as always. It's a pleasure. We look forward to keeping you abreast of our progress in the future via press releases and conference calls such as this one, and I'd remind you the best way to keep up with our news in between our calls with updates and events is to sign up for our email alerts on our investor relations website or to follow us on social media at Twitter, LinkedIn, or YouTube. I also encourage you to contact Mike Havrilla directly with any questions at jmh@pavmed, pavmed.com. Have a great day. Thank you very much. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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