PAVmed Inc.

each nurse per day. Each nurse will be deployed to one of three types of venues. First, in exam rooms, leased from a partner physician. Second, once there is sufficient volume, we will consider setting up our own freestanding Easter Guard testing centers and local house where the economics can support them. Finally, we will seek joint ventures with well-known national laboratory testing companies, as well as national pharmacy companies with many clinics to establish Easter check testing capacity at their facilities using our staff or training there. In addition to ESA check operators, the program will require a physician to evaluate self-referring patients and order an ESA guard if clinically indicated. This will be done via telemedicine or in-office visits by a physician who does so full-time or within a broader practice. The physician will bill for these visits. Of course, this all will not happen overnight, but we do believe that we need to start the billing process now. Our plan is to start with a pilot program this spring in one major metropolitan area. We will locate one of our new clinical specialists one or two days a week in a leased exam room at a local physician's office. We will then launch a local direct-to-consumer marketing campaign using digital, radio, billboard, and a cost-effective TV advertising. Patients who respond will be evaluated by our partner physician, who will order e-cigar testing if clinically indicated. Our nurse will then perform the e-cigar check procedure and send it for e-cigar testing. If the test comes back positive, The physician will refer the patient to a partner gastroenterologist for confirmatory endoscopy and long-term follow-up. Once we have established geographic coverage in a locale, we'll proceed with another separate sales and marketing channel directly targeting primary care physicians. We will use a hybrid sales model staffed with personnel with experience calling on primary care physicians, such as pharmaceutical reps. We may also seek joint ventures with a pharmaceutical company to market to primary care physicians, as Exact Sciences did with Pfizer with great success. So speaking of exact sciences, I would like to now introduce you to Stan Lapidus. Stan is a medical diagnostics pioneer and prominent industry advisor whose company has created billions of dollars of value for their investors. I was introduced to Stan by acclaimed cancer geneticist and Lucid partner, Dr. Sandy Markowitz. I learned that Stan had founded and led two of the apparently only three successful cancer detection startup companies in history. Although he spoke with complete humility, my first thought was the classic Muhammad Ali quote, it ain't bragging if it's true. My next thought was that I had to convince this legendary figure to help us make Lucid Diagnostics the next such company. Apparently, I made my case, and Stan has been an invaluable resource as Lucid's strategic advisor for the past seven months. Stan's first company, SciTech, revolutionized early detection of cervical cancer, preventing countless deaths through its FinPREP pap test, which he invented. Hologic acquired SciTech for over $6 billion. Stan went on to found and lead Exact Sciences, whose Cologuard test revolutionized early detection in colon cancer. Exact is arguably the most successful startup company in the history of the diagnostics industry and has reached a market cap of $25 billion under Kevin Conroy's leadership since 2009. My team and I were students of the exact story and its value in selection milestones long before Stan joined us. The similarities in the core technologies are obvious even to the casual observer. Esagard and Coligard are both molecular diagnostics screening alternatives to endoscopy, targeting large populations at risk for gastrointestinal cancer and with similarly massive market opportunity. In fact, where the stories diverge, the major differences favor Esagard. Isogard faces certain lower hurdles compared to what Cologuard faces. For example, compared to Cologuard, Isogard faces minimal competition for endoscopy, is positively aligned with the interests of gastroenterologists, and requires smaller, less expensive clinical trials. So let me now pass the mic over to Stan to offer you his perspective on our efforts.

Good morning, all. Thanks, Lishan. It's good to be here. I look forward to sharing my perspectives on Lucid and on Isogard. Before I start with regard to financial disclosure, Lucid pays me a modest monthly retainer for my time. I hold no equity in Lucid. I did purchase a small number of PavMed shares in the open market some time ago. As Lisha noted, my major professional quest has been to save lives through early pre-cancer detection. Although my companies have been commercially successful, I'm most proud of the lives that have been saved by Psychic and by Xacto. Lishan and Lucid, the Lucid team, are on the same quest. This team is quite impressive. They're real pros who have a deep understanding of the opportunity, the history, and the challenges. Lucid's a great story. It took me about a millisecond to understand the implications of what Lucid is doing. Its potential to be big and important, actually historically important, is the reason I've linked Lucid linked elbows with Lucid. I believe this is the best time in my 30-something years in the industry to be doing what Lucid is doing. Cytic was a success, Exact was a success, and I believe the next company that can catch biological changes before they become malignant is Lucid. Exact underwent explosive growth because it could keep patients from getting colorectal cancer, same with Cytic and cervical cancer. In these two cancers, cancers of the cervix and colon, the goal of cancer prevention was achieved. Cancer prevention, on the other hand, for example, in breast cancer, has not been achieved. Only early detection has been achieved. This is not a small accomplishment, but ask any woman who has undergone surgery, radiation, and chemo if she would be better off having never had a malignant tumor in the first place. Cancer prevention in the prostate has not been achieved. Again, early detection has, but ask any man who has undergone a prostatectomy if he'd have been better off by not having had a malignant tumor in the first place. In contrast, cancer prevention has been achieved in the cervix and the colon. The attendant morbidity and the attendant expense incurred in treating precancerous lesions is much lower than treating early cancer. The optimum cancer detection strategy is preventing cancer. Lucid is now doing the same in the esophagus. Cancer prevention through pre-cancer detection. I led Cytic, I led Exact, and now I'm part of Lucid because I believe cancer prevention is the way to have greatest impact. Let me comment on the decision to spin off Lucid as a standalone public company, which Lishan is announcing for the first time today. I've been advocating for this strategy since I joined Lucid as a strategic advisor last summer. I've long believed that Lucid's an undervalued asset within PathMed and would prosper as a standalone company. Lishan and I have regularly conferred about the appropriate time and conditions for a successful Lucid spinoff. I believe the time is now. Time is now for early cancer detection companies to make their move. There has never been an equity market more receptive to the message. There has never been an FDA more favorably inclined to consider early detection. This is the exact opposite of what I dealt with at CITIC when the FDA and organized medicine were borderline hostile to anything that had to do with early cancer detection. This would be in the late 1980s. I'm a true believer in the e-cigar technology. Sandy Markowitz, whose lab developed Esagard, has been a friend and colleague for over two decades. In fact, we collaborated extensively during the early exact days. What Sandy and his colleagues have developed addresses a critical need. Let me be as plainly spoken as I can. Esophageal cancer is a death sentence in over 80% of people in whom it is diagnosed. You get it and you die. The question is when. It hardly matters what your doctors do. The outcome is foregone. The prognosis is grim, in part because unlike most cancers, finding even earlier stage esophageal cancer does not reduce our mortality by very much. Finding precancer in the esophagus, however, can save the life of a patient. Precancerous esophageal dysplasia is entirely treatable. It's curable. It is not just delaying the inevitable. If you ablate the dysplastic esophagus, you cure the patient. Because of the effectiveness of early intervention, no one should die from esophageal cancer. But unfortunately, people do die because upper GI endoscopy has failed as an early detection tool at a population level. The E-Cigar value proposition is very compelling. The market is large, and it has no established competitors. We're looking for pre-cancer in the esophagus while everyone else is looking for early cancer in blood. So Exact is not a competitor. Grail is not a competitor. Freenome is not a competitor. And Gardent is not a competitor. The liquid biopsy companies, in fact, are all surprisingly similar. They're common, apparently multi-billion dollar messages. We're looking for early cancer in blood. Our results so far for early stage cancers are discouraging, but they may become encouraging in the future. And here I refer you to the S1 that Grail had published before its acquisition by Illumina. None of these companies can and almost certainly never will detect pre-cancer via blood-based approach at clinically meaningful levels. In contrast, Esogar does detect pre-cancer and is based on the same premise I built my companies on, preventing the progression from pre-cancer to cancer. You detect the pre-cancer, you prevent the cancer. You save lives. This is the exact formula and the psychic formula, and now is the Lucid formula. Lucid's long-term success depends on messaging and clinical data. The key message to the public, which the team is starting to get out, is the relationship between gastroesophageal reflux and esophageal cancer. A 10-year exposure to gastroesophageal reflux to GERD increases your esophageal cancer risk enormously. It's a simple message and the public needs to hear it. For the medical community and especially for the experts who produce guidelines, what matters most is published clinical data. I've learned over the decades that what moves the needle over the long term are well-published, well-conducted studies. Lishan and the LUCID team understand this and are off to a great start. Sandy Markowitz and his colleagues published outstanding data in their seminal study of these technologies in one of medicine's most prestigious journals. LUCID is clearly committed to building on that data. It is actively enrolling patients in two international multi-center trials that are powered to demonstrate that esogar detects nondysplastic Barrett's in a screening population. This pivotal study will support pre-market approval submission to the FDA planned for 2022 for registration both of ESO Guard and ESO Check as an in vitro diagnostic. The publications of these studies will be important drivers of long-term value. EXACT went from about where Lucid is today in 2012-13 to a multi-billion dollar company in 2014 upon completion of its pivotal study and FDA IVD registration. The next step, which Lucid is already planning under the FDA's Breakthrough Device Program, will be to extend the screening study until it has sufficient statistical power to demonstrate that IsoGuard affects esophageal dysplasia. That will be the final piece of the puzzle. And I believe at that point, the company might well be a very attractive acquisition target for one of the large diagnostics companies. Finally, we know that large sales and marketing programs and high quality clinical studies require ongoing access to growth capital. This is the reason I strongly support the plan to spin off Lucid into a standalone company with access to public markets. A few months ago, I thought Lucid might consider waiting to go public until another milestone, such as obtaining LDT local coverage, a publication, or completion of the pivotal study. I no longer believe that. The story is already very strong. Given the data they have, the logic of what they are doing, the strength of the IP portfolio, and the favored competitive environment, these are all factors that support the spinoff. I believe the spinoff will be successful, and I believe that Lucid will thrive as a public company. I'll stop here and hand things back to you, Leshawn.

Thanks so much, Stan. I'm so happy that our listeners had the opportunity to get a brief glimpse of the precise analytic thinking and highly actionable advice that I've benefited from over the past several months. I will now close with some rapid-fire updates across our divisions and products. We don't have time for me to provide the usual background and context For those of you who are just learning about ADMEDS, I would encourage you to refer to our website and SEC filings for additional information and contact us with any questions. So let's first close out some items with Lucid and GI Health. On the clinical trial front, as Stan mentioned, our E-Cigar DE1 and 2 studies in support of future PMA submission and FDA IVD registration continue to enroll, although the pace predictably slowed during the winter COVID surge, and European site initiation remains delayed due to travel restrictions. That said, 40 of our 60 sites are active, and we have enrolled approximately 70 patients across the two studies to date. Although we expect enrollment to return to full pace next month, the cumulative COVID-related delays have pushed our target completion date into early 2022. We've taken advantage of the COVID-related shutdown to introduce a new improved preservative buffer and a more user-friendly and precise e-sit check accessory. We've also strengthened our operator training program during this time. On the European front, we've successfully completed all of the necessary audits by the European notified bodies and expect to receive ESOCHEC CE mark approval and complete ESOGARD self-certification in Europe next quarter with a limited commercial launch in select countries later this year. We continue to make excellent progress on our ESO CURE esophageal ablation device. Based on input from our medical advisors, we've added some features and and plans several accessories to the product, pushing our animal testing forward a few months and the target FDA submission date into early 2022. We also continue to pursue opportunities to apply e-subject to the very common allergy-mediated condition eosinophilic esophagitis. We are waiting to print out of the results from the University of Pennsylvania pilot study and continue to explore licensing opportunities in this space. So next up, CARPEX and our Middle Invasive Intervention Division. As we announced last week, the first US carpal tunnel syndrome patient recently underwent successful CARPEX minimally invasive carpal tunnel release. In marked contrast to typical recovery times following conventional surgery, the patient returned to work as a truck driver within one week of the procedure. We continue with a steady and deliberate commercialization plan with a small team of world-class hand surgeons focused on optimizing the procedural steps and safety. This group will serve as ambassadors, trainers, and proctors when we launch a broader more aggressive commercialization effort later in the year. We have also successfully completed all of the necessary audits by the European notified bodies and expect to receive CARPEX CE mark approval next quarter as well. We are evaluating potential European distributors and do not have a specific time table yet for European commercial watch. Next briefly, our infusion therapy division. The Port IO study in Columbia, South America is almost ready to commence. Our team was able to recently complete in-person site initiation visits at four Columbia medical centers after travel restrictions were loosened. We're waiting for final IRB approval and expect to begin enrollment next quarter. We also continue our discussions with FDA on our proposed U.S. IDE study and are considering a more aggressive regulatory strategy to go straight to an eight-week implant duration indication instead of the current proposal for a seven-day indication as a bridge to longer duration. Our NextFlow intravenous infusion system continues to successfully advance through design control development testing with FDA submission targeted for the third quarter. Our M&A discussions to license the NextFlow technology for disposable infusion pumps continues in the deep diligence process with benchtop testing being completed by the large strategic partners that we're engaged with. We continue to advance the technology while this M&A process continues, and we hope to reach a final agreement in the next quarter. Finally, our emerging innovation division remains very active. Our partnership with Canon on the disappear-resorbable silk pediatric ear tubes is going very well, and we expect to be in a position to initiate animal testing with Canon-produced ear tubes next quarter. With regard to SOLUS, in addition to advancing the non-invasive glucose monitoring technology we licensed in 2019, we've been developing and advancing our own proprietary technology in this space, which is not subject to the license agreement. Although the R&D work on the licensed technology produced data in human volunteers and a diabetic rat model consistent with the milestone accuracy parameters, we ultimately determined that it would be in PavMed's best interest for us to focus our future efforts solely on our proprietary technology to terminate the license agreement and seek a mutually agreeable unwinding of the relationship, which is currently being negotiated. Our emerging innovations team continues to work on several other exciting early-stage technologies, including ECMO, cardiopulmonary support, and ventilation. We also continue to evaluate exciting, commercially promising innovations, which are regularly presented to us by academic medical centers, clinical innovators, and early-stage startup companies. So, thank you all for your attention, and with that, operator, we can now open the call to questions.