Earnings Call Transcript
PAVmed Inc. (PAVM)
Earnings Call Transcript - PAVM Q3 2020
Operator, Operator
Greetings, and welcome to the PAVmed, Inc. Business Update Conference Call. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Mike Havrilla, Director of Investor Relations for PAVmed. Please go ahead, sir.
Mike Havrilla, Director of Investor Relations
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. Before we begin, I'd like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of PAVmed. I encourage you to review the company's filings with the Securities and Exchange Commission, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Factors that may affect the company's results include, but are not limited to, the uncertainties inherent in research and development, including the cost and time required to advance products to regulatory submission; whether and when products are cleared by regulatory authorities; market acceptance of products once cleared and commercialized; the company's ability to raise additional capital; and the competitive environment. PAVmed has not yet received clearance from the FDA or other regulatory bodies to market many of its products. PAVmed has been monitoring the COVID-19 pandemic and its impact on our business. PAVmed expects the significance of the COVID-19 pandemic, including the extent of its effect on financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately, many of them are beyond the company's control. For a further list and description of these and other important risks and uncertainties that may affect future operations, see Part I, Item IA 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 events, conditions or circumstances on which those expectations may be based or which 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?
Lishan Aklog, CEO
Thank you, Mike. Good afternoon, everyone and thank you for joining us on this quarterly call to update you on our business and discuss our recent financial results. As we will discuss in some detail, PAVmed has passed through a clear inflection period over the past several months. Despite ongoing COVID-19 related challenges, commercial activity is accelerating at an exponential rate. Traction and enthusiasm for our commercial GI Health products among physicians is growing. And as importantly, the reimbursement landscape for these products has solidified allowing us to look forward to revenue starting after the New Year. Our balance sheet remains strong from recent financing, providing us with sufficient capital to drive this commercial activity and advance our products towards commercialization. Our growing team of professionals, alongside a world-class team of consultants, advisors, and corporate partners continues to deliver on important milestones across our portfolio. As the COVID-19 pandemic continues with a fall and winter surge, let me once again, begin with a short summary of pandemic-related challenges we are facing and how we are addressing them. Despite this steady surge, there are no signs of a return to the complete shutdown of non-emergency, non-COVID-19 related care, that we experienced in the first four to five months of the pandemic. The healthcare system and the life sciences industry has gradually learned how to deliver necessary, but non-emergency care as the pandemic still persists. Although our commercial team does on occasion encounter waxing and waning hotspot restrictions to their access to physicians for sales calls and procedural training, they have successfully overcome these challenges through perseverance, creativity, and opportunity. Nearly all of our commercial activities have moved away from virtual contacts back to traditional in-person engagements. Clinical research headwinds do remain with some sites slowing or pausing enrollment, while others continue undeterred. The remainder of our product development, regulatory, financial, and administrative activities have been entirely unaffected by COVID-19. I would now like to provide more specific updates across our four divisions: GI Health, Minimally Invasive Interventions, Infusion Therapy, and Emerging Innovations. Our GI Health division is building a portfolio of complementary products designed to diagnose and treat conditions of the esophagus, including the spectrum of conditions arising from gastroesophageal reflux disease, also known as chronic heartburn. This can lead to highly lethal esophageal cancer. We are also pursuing applications for our product in a prevalent confirmatory condition called eosinophilic esophagitis. Two products, EsoGuard and EsoCheck, are commercially available. We aim to commercialize another product, EsoCure, in 2021. In addition to our other potential pipeline products, which are subjects of active research programs within this division, I’m proud of what our team has accomplished a mere 2.5 years after licensing this technology from our partners at Case Western Reserve University. It’s gratifying to know that every day patients across the U.S. are benefiting from these groundbreaking products, which the National Cancer Institute highlighted as one of the year's significant advances in cancer prevention and to whom the FDA granted breakthrough device designation. With regard to EsoCheck, it is designed to facilitate early detection of precursor conditions to highly lethal esophageal cancer in patients with chronic heartburn, also known as gastroesophageal reflux or GERD. Chronic heartburn can lead to benign changes in the surface cells of the lower esophagus called Barrett’s Esophagus or BE, which can transform into precancerous changes called dysplasia, which in turn can lead to esophageal cancer. Esophageal cancer is a scourge; it is one of the most lethal cancers and, unlike nearly all other cancers, its incidence has increased nearly six-fold in recent decades, while its mortality rate has barely budged. The most effective way to save lives from cancer is through early detection of cancers and their precursors. Although professional society practice guidelines recommend screening for BE in over 10 million high-risk GERD patients to detect and treat dysplasia before it progresses to cancer, tragically, fewer than 10% actually undergo screening using invasive upper endoscopy. Over 80% of these esophageal cancer patients will die within five years of diagnosis. EsoCheck is an FDA cleared cell collection device, which can perform targeted and protective sampling of cells from the lining of the lower esophagus as part of a 5-minute non-invasive office-based procedure. It serves as an alternative to invasive upper endoscopy performed under anesthesia in a hospital or dedicated endoscopy center. EsoGuard is a highly accurate, next-generation sequencing diagnostic assay that detects methylation changes at 31 sites on 2 genes, which correlates with conditions along the BE to esophageal cancer spectrum. EsoGuard has been performed on samples collected with EsoCheck and is commercially available as a laboratory-developed test, or LDT. These products are the first and only commercially available technologies that offer the opportunity for widespread screening of the over 10 million high-risk GERD patients currently recommended for screening. Based on very modest penetration of U.S. GERD patients already recommended for screening, we believe that the estimated addressable domestic market opportunity for these products is at least several billion dollars. We are commercializing EsoGuard using a hybrid model with internal sales management, marketing, and professional education, all working closely with a network of independent sales representatives. We now have 4 regional managers covering the United States, overseeing nearly 40 independent sales representatives. As COVID-19 restrictions at medical centers and practices lift and non-emergency care begins to reemerge, our team has rapidly shifted from the mostly virtual engagement to aggressive in-person engagement. Our commercial activity efforts have dramatically ramped up over the past couple of months, including in-person sales calls and clinician training, as well as educational and marketing activities targeting both physicians and consumers. These intensifying efforts are really beginning to bear fruit. EsoGuard testing and EsoCheck procedural volume are now growing exponentially, doubling about every four to six weeks, and we hope to continue to grow despite the pandemic surge. Once again, physicians are finding ways to perform these procedures, despite COVID-19. In fact, some have suggested that using EsoGuard on samples collected with EsoCheck may be even more attractive because short office-based procedures are easier to perform efficiently in the COVID era than endoscopies at procedural centers, which must be spread out to accommodate increased COVID-19 related safety measures. Some are even using EsoGuard as a risk stratification tool to prioritize the backlog of elective procedures caused by the pandemic. Our engagements with our primary targets, the gastroenterologists, are going very well. They are receiving this technology positively; they see EsoGuard and EsoCheck as important tools that they can integrate into their current practice to expand the funnel of patients diagnosed with BE, who must then undergo surveillance, monitoring, and ablation treatment if they progress to precancerous dysplasia. The response has been positive from both small and medium practitioners, as well as those in large medical centers. The small and medium practitioners tend to quickly focus on growing their procedure volume, both in the endoscopy suite and in their office. Conversely, large medical centers, especially academic centers, focus more on network-wide adoption, although this takes a bit longer to get up and running, the payoff is great as it brings in non-GI physicians into the fold for an integrated approach to managing the spectrum of disease. One notable example is NYU Medical Center here in New York City, where we have a very enthusiastic champion who is not just increasing his procedural volume, but standing up internal medicine clinics across the NYU network. Although our focus has been on gastroenterologists, large internal medicine practices remain an attractive target. One such practice out west is centralizing all screening and high-risk group patients into a single clinic setting where EsoCheck is performed, and samples are sent for the EsoGuard test. Our hard work over the past 18 months on the reimbursement front is also paying off. Final EsoGuard CMS payment determination of $1,938 has been secured and will become effective January 1. On that date, we will begin submitting claims and billing for each EsoGuard test performed. Local and Medicare coverage determination, which we hope to secure soon, will be the final piece of the reimbursement puzzle for the 60% of our target population, which is covered by Medicare. We are also beginning the payments and coverage process for private payers and hope to start securing these in the first half of 2021. As noted, we have completed the necessary audit and certifications to submit EsoCheck for CE Mark approval in Europe and pursue EsoGuard CE Mark self-certification. This would allow us to launch these products in Europe in mid-2021. On the clinical trial front, as previously noted, our two international multicenter clinical trials, EsoGuard BE-1 and 2, are back on track following a near-complete shutdown of clinical research due to COVID-19. If you recall, these trials support a future PMA submission for FDA registration of EsoGuard/EsoCheck as an In-Vitro Diagnostic or IVD. One is a screening study of high-risk GERD patients and the other is a case-control study of patients with known disease. Enrollment in these trials is accelerating; however, unlike non-research clinical activity, clinical research does remain vulnerable to COVID-19 and winter slowdown. We have 21 active U.S. sites enrolled with 33 patients across the two studies, assuming the pandemic doesn’t hold us back. We expect to have an additional 20 active U.S. sites and nine European sites in the coming quarter. Despite the slowdowns, we’re maintaining our end-of-2021 target to complete enrollment in these studies. Although we will not have EsoGuard performance data until the end of the trial, we have received very encouraging user acceptance results today. The EsoCheck procedure received very positive results, with over 90% patient satisfaction. Let me now briefly summarize some additional developments in our GI Health division. We’re making excellent progress on our EsoCure Esophageal Ablation Device. EsoCure is a disposable, single-use thermal balloon ablation catheter that uses our patented detect-on-Caldus Technology to ablate esophageal tissue. Once cleared and commercialized, EsoCure would allow clinicians to treat dysplastic BE before it can progress to cancer and to do so without the need for complex and expensive capital equipment comparable to current technologies from Medtronic and others. We expect to proceed with animal testing of prototypes soon, with FDA submission targeted for 2021. Additionally, the University of Pennsylvania has completed enrollment in a pilot trial exploring the role of EsoCheck in monitoring treatment in patients with eosinophilic esophagitis or EOE. EOE is a very common, but underappreciated allergy-mediated condition, which currently requires multiple invasive endoscopies during the course of treatment. Our partners at the Fred Hutch Cancer Center in Seattle continue to hold their trial due to COVID-19. This trial will explore the role of EsoCheck and biomarkers designed to detect progression from non-dysplastic to dysplastic Barrett’s, which could greatly facilitate the surveillance of various patients so they can be treated prior to the development of cancer. We secured the exclusive option to license these biomarkers if they prove effective in this clinical trial. Now, let’s move from GI Health to Minimally Invasive Interventions, which includes CarpX. CarpX is our patented single-use, disposable, minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery time. The balloon catheter device is inserted under the scarred ligament, tensioning it while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. We believe CarpX will dramatically reduce recovery times compared to traditional carpal tunnel release, targeting an estimated $1 billion immediately addressable domestic market opportunity. CarpX was granted U.S. FDA 510(k) marketing clearance earlier this year. After addressing the COVID-19-related supply chain issues, we were able to secure stock for commissioned inventory in late August. Our commercial strategy for CarpX remains steady and deliberate; unlike the EsoCheck procedure, the CarpX procedure is an interventional procedure. Although significantly less invasive than traditional carpal tunnel release, it does require technical skill, which comes with training and partnership. As with any interventional device, the critical first step before widely marketing the technology to hand surgeons is to establish a core group of well-trained surgeon ambassadors, who can participate in training, proctoring, and evangelizing to other surgeons. We have secured such a team of world-class hand surgeons who now serve on our CarpX Advisory Board. The first cadaver training session was successfully completed last week, and we look forward to our first U.S. commercial procedures in the coming week. Next, some brief highlights from our Infusion Therapy division, which includes PortIO and NextFlo. PortIO is our implantable, intraosseous vascular access device, which allows direct access to the bone marrow to deliver medications, fluids, and other substances, addressing an estimated $750 million market opportunity based on patients with poor veins and those with renal failure, whose veins must be carefully preserved for current or future hemodialysis. We are seeking an initial short-term implant duration indication through the FDA’s de novo pathway. Our current activity is focused on discussions with the FDA on our proposed IDE or investigational device exemption study in the United States to support this application. These discussions have progressed well, and we hope to have final IDE approval very early next year. The long-term PortIO study in Columbia, South America has been on hold due to COVID-19 related travel and clinical limitations or restrictions. These restrictions have now been lifted, and our team will travel to Columbia next month to initiate site visits with the goal of initiating enrollment in early 2021. Our NextFlo intravenous infusion system, which delivers highly accurate gravity-driven infusions, independent of the height of the IV bag, seeks to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated one million infusions delivered in the United States since then. We continue to advance the next launch of the intravenous infusion system through design and full development and testing. This work is going extremely well, with flow accuracy rates approaching those of expensive electronic infusion pumps. We expect to proceed with FDA 510(k) submission early next year. Once cleared, we plan a targeted commercial launch at large medical centers, focusing on the healthcare economics of our technology relative to electronic infusion pumps. We remain deep in active M&A discussions with several strategic partners to license the NextFlo technology for disposable infusion pumps, which are used in an ambulatory setting for outpatients. These partners are deep in their diligence process, including beginning to perform their own testing of our technologies in their own laboratory. We hope to complete this process and consummate a transaction. Once again, we don’t have enough time to cover the other exciting projects we’re working on in our emerging innovations division, but here are a few highlights. Our DisappEAR resorbable pediatric tubes, manufactured from our proprietary aqueous silk technology, seek to revolutionize the care of the estimated one million children who undergo bilateral ear tube placement each year. We are now fully partnered with global manufacturer Canon Inc.'s U.S. manufacturing and technology center in Virginia. That work is proceeding ahead of schedule. We have recently received commercial grade aqueous silk, fibroin molded ear tubes for bench top and animal testing, which we'll initiate soon. Our Solys non-invasive NDIR laser-based blood glucose monitoring technology is also progressing well. We completed initial animal testing of a first-generation prototype in a diabetic rat model. Those results were sufficiently accurate to allow us to achieve the R&D plan milestone as defined in our license agreement. We haven't developed a second-generation prototype with dramatically improved signal-to-noise ratio, which should be ready for human volunteer testing soon. Our emerging innovation team is also working on several exciting early-stage technologies, including in ECMO cardiopulmonary support and mechanical ventilation. I'll now pass it on to Dennis McGrath.
Dennis McGrath, CFO
Thank you, Lishan, and good afternoon, everyone. Our financial results for the quarter ended September 30, 2020, were reported in our press release that was published earlier this afternoon and also in our quarterly report on Form 10-Q, which was filed with the SEC on November 6, both available at sec.gov and on our website. With regards to the financial results for the quarter, research and development expenses for the third quarter of 2020 are $2.6 million, up from about $1.5 million for the same period in 2019, and about $500,000 higher sequentially, returning to the first quarter of 2020 level. As you might expect, the variation both sequentially and year-over-year is primarily related to clinical trial costs, the product development costs. Particularly, the sequential changes were positively impacted by clinics beginning to normalize operations given the slowdown in the second quarter related to the pandemic. General and administrative expenses were $2.9 million for the third quarter of 2020, compared to $1.7 million for the same period in 2019 and we’re about even sequentially. The year-over-year increase reflects approximately $700,000 increase in sales staffing levels and other sales-related costs, together with an increase of approximately $500,000 in consulting services related to patents and regulatory compliance, financing costs, and public company expenses. PAVmed reported a net loss distributable to common stockholders of $5.6 million or a loss of $0.11 per common share, also duplicating the net results in the previous quarter. Our 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 highlight these amounts along with interest expense and other non-cash charges, namely, depreciation, stock-based compensation, and financing-related costs to give a better understanding of the company’s financial performance. Notably from the table, after adjusting the GAAP loss by approximately $1.1 million for these types of non-cash or financing-related charges, the company reported a non-GAAP adjusted loss for the three months ended September 30, 2020, of $4.5 million or $0.09 per common share. PAVmed had cash of $8.3 million as of September 30. During the quarter, the company received additional net proceeds of approximately $7 million from the sale of convertible notes at a conversion price of $5 per share. With that, operator, we can now open up the call to any questions from our audience.
Operator, Operator
Thank you. Your first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question.
Lishan Aklog, CEO
Hey Frank. Good afternoon.
Frank Takkinen, Analyst
Thanks. Appreciate it. Congrats on the progress this quarter. Just a few questions for you here. Thinking about some of your early adopters of EsoGuard, sounds like you’re having some fantastic success with the initial adoption from patients. So, I’m just hoping you could take us a layer deeper into utilization trends that you’re experiencing, maybe how many sites are now stocking EsoGuard and overall patient receptiveness of the product.
Lishan Aklog, CEO
So, in terms of the adoption and the response from both physicians and patients, it’s been extremely positive. I think as I’ve mentioned before, we were prepared as we were entering into the GI space in our discussions with GI physicians for some pushback related to potentially cannibalizing their existing endoscopy business and so forth and that has just generally not materialized. We’ve had a much easier time than we had expected in making the case that this is a tool they should embrace that is ultimately to the benefit of their patients, but also to the benefit of their practice. There are patients within their practices just right there, patients who are undergoing colonoscopy are there for other reasons, who are high-risk patients who might not otherwise receive an endoscopy but are candidates for EsoGuard testing, and our joint activities targeting primary care and their referrals will ultimately increase the funnel of the patient. So, it’s really been nothing but positive. I mean, we obviously have some that have become real champions and are doing cases almost every day and are leading the charge. That’s always the case with the introduction of new technologies because early adopters become champions and bring others along. But it’s been steady and broad. And I don’t like to emphasize one of the things I said in my prepared remarks, which is that, although we’re focused on gastroenterologists, and we were doing so to centralize where the disease is most known among physicians who really own the disease, we’re actually receiving really good signals that there’s receptivity within the broader medical community, including internal medicine. One example is both at the academic center here in New York, as well as in the private large internal medicine practice out west, which are very encouraging times. The physician response has been good as well. I guess I’ve mentioned the formal data we are starting to receive from our clinical trial, which shows really high user acceptance, creating a 90% patient satisfaction and that’s borne out in the commercial clinical activity as well, where patients, some obviously have concerns about swallowing this and gagging, but we’ve trained our operators quite well to educate the patients before the procedure, and we’re achieving a high technical success rate, and so we’re able to administer it, and people appreciate the fact that they’re achieving some comfort level. These are patients with chronic heartburn, who now are becoming increasingly aware of their risk for developing esophageal cancer. In terms of specific numbers, I think, let me ask Dennis to maybe chime in on that.
Dennis McGrath, CFO
I think Frank, it’s early in the game to provide a data set to give some kind of predictive insight into what’s occurring today. I will give you some highlights, but we will be developing that data set. We’re seeing a little difference in each type of practice, and we’re also drilling down and honing our message to the type of practices we’re pursuing, which have dynamics that are slightly different. However, to give you just some high level, and first off I don’t want to provide any data set today that gives an indication of one way or the other when that dataset is evolving. The typical things you’d want to know are what’s the utilization per store and what’s the same-store sales quarter-to-quarter? Those metrics will develop, and we’ll start reporting on them as revenue starts to generate in the first quarter, and we start to provide deeper color. That way analysts like yourself can kind of figure out what that means presently and what that can mean prospectively as you build your models. But to give you some high-level insights, the month of October was significantly higher than the month of August, and the first 10 days of November are equal to what we did in all of October. We increased the number of sellers out in the field that are doing a lot of prospecting and that prospecting is starting to yield results today. I think by the end of when we report the first quarter, we’ll have a greater feel for what that dataset will mean and how it could benefit our shareholder community in terms of what the past results might mean in terms of future opportunities. We know the total addressable market, we know the response from the physicians; it all speaks well in terms of the potential opportunity. The granularity of how to report on that will evolve in the upcoming quarters, and we’d be happy to provide you with that color at that time.
Lishan Aklog, CEO
Yes, let me just add a couple of things. So, on accounts, we’ve reported previously hundreds of accounts that we’ve engaged with. That number has multiplied several folds since then, and in terms of accounts that have product on the shelf, we believe those numbers are approaching about 100. So, we have plenty of sites. Right now, we’re focused on procedural volume. And as Dennis said, the last two, two and a half months have really shown an early nice inflection, with cases doubling about every four to six weeks. We’re confident that we’ll be able to continue at a good pace. As I mentioned because we're plowing ahead despite the surge we’re seeing this winter.
Frank Takkinen, Analyst
Well, that sounds fantastic. Just switching gears a little bit to the reimbursement side. Congrats on getting the final scheduled test code determination for EsoGuard, effective January 1. I was hoping you could give us a little feel for revenue recognition with that, if there’s an opportunity to backfill some of these tests that you are doing right now. And how you expect to initially ramp revenues when the treatment option is a little bit uncertain?
Lishan Aklog, CEO
Yes, sorry, let me just start in terms of mechanics, and then maybe comment on the accounting side. So, we’ve been performing procedures this year, but we have cautiously chosen not to submit those until we had an effective CMS and Medicare payments determination. So yes, we will be submitting those starting January 1 under the new code, and we have a full year to submit. So, for the backlog that you’ve mentioned, it will start to kick in, as we begin billing under the effective payment by January 1. From that point on, we will be submitting claims and billing on procedures on an ongoing basis. Obviously, there’s a timeline between claim submission and receipt of payment, and that’ll affect the timing of revenue recognition. Dennis, would you like to chime in a little further on that?
Dennis McGrath, CFO
Yes, sure. The payment that Lishan mentioned, from CMS or Medicare, starts to take effect January 1. We can bill in 2021 for procedures performed in 2020, as long as those procedures were performed within 12 months of the date we invoice. It is our intent to invoice all of these procedures soon in January. The gap rules require us to have a definitive understanding of what the estimated collections are on each invoice to bill so we can recognize revenue based on the invoice. Most companies who go through this process experience a period of time where the evidence evolves, leading to the predictability of invoices translating to cash. Therefore, in the early stages of this, we will recognize revenue on a cash basis. Part of our targeted audience is the private payer bucket, and those patients are being tested. We will submit claims to various private payers. There will be some denials, some payments, and some clarifications in terms of coverage policies that will become clear throughout 2021, adding to the predictability of the invoice-to-cash collection cycle. When we achieve a level of predictability, we will start recognizing revenue based on invoices rather than cash basis. Keep in mind, our target audience for this disease and its precursors is a significant Medicare patient population; it's approximately 60% to 70% of our target audience. As Medicare’s definitive payment structure becomes clear and if denial rates remain low, we will start being able to recognize revenue for the Medicare patients likely sooner than that for private payers as that takes root in 2021. Hopefully that explained clearly the revenue recognition process we’ll undergo in early 2021.
Frank Takkinen, Analyst
Perfect. That makes sense. Just the last one from me to touch on the CarpX business a little bit. Some good commercial progress there, first manager in the door, surgeon group set, and starting to look toward the first commercial procedures. I’m hoping you could talk about the ramp of that business a little more and when you expect to maybe put the foot down on the commercialization throttle a little bit more aggressively with that offering?
Lishan Aklog, CEO
Yes. First thing, it’s a little bit hard to do quantitatively, but I can clearly map out the past from a qualitative point of view. So, as I mentioned, the goal is to have an initial network of well-trained hand surgeons who are not just key opinion leaders, but advocates or ambassadors, who can also serve as trainers or proctors for the procedure. We established a group of five; we’ll likely expand that a bit more in the coming months. We’re getting them trained and will begin to have them start performing procedures over the coming months. Once we reach that, it’s going to be fairly steady and deliberate, which you might say is slow during that early part. But once we have a core group of half a dozen to a dozen surgeons across the country who have done meaningful procedural volume, feel comfortable with the procedure, and are ready to participate in training and proctoring, then we can move out quickly. This is not a slow linear ramp; it's a slow and steady pace followed by a more accelerated phase once we have that core group up and running.
Frank Takkinen, Analyst
Got it. That makes sense. All right. Thanks for taking my questions, and congrats on all the progress in the quarter.
Lishan Aklog, CEO
Thanks a lot, Frank.
Operator, Operator
Your next question comes from the line of Anthony Vendetti with Maxim Group. Please proceed with your question.
Lishan Aklog, CEO
Anthony, how are you doing?
Anthony Vendetti, Analyst
Good, Lishan. How are you doing, Dennis? I just wanted to follow up a little more on EsoGuard, EsoCheck. So, I know you’re performing some of the procedures; billing won’t start until 2021. Is there any way you can provide a little more color on how many of those procedures so far? Just trying to get an idea of what the ramp has been? And then wanted to talk a little bit about COVID-19 and its impact?
Lishan Aklog, CEO
Dennis, I'll let you handle this.
Mike Havrilla, Director of Investor Relations
Dennis, are you still there?
Dennis McGrath, CFO
Yes, of course, I was on mute and I gave an eloquent answer. So, Anthony, I think we’re going to defer to the response I gave to Frank in terms of what that dataset looks like. We provided a high-level speed ramp in terms of November over October, and we really just got started here towards the end of August with clinics beginning to trickle open a little bit earlier than that. I think the number of clinics, the number of procedures per clinic, same-store sales, month-over-month, or quarter-over-quarter are all things we expect to report upon. That dataset will become clearer for us and can help with that kind of question and what it represents for the future. I think we’ll defer that until at least the next quarter to provide that level of detail as we see the different types of clinics and their service subsets become clearer in terms of our pursuit of future clientele. So I think we'll defer until the next call.
Anthony Vendetti, Analyst
Okay. Well, I'll just say that I thought that was eloquent as well, Dennis.
Lishan Aklog, CEO
That's why I referred to him.
Anthony Vendetti, Analyst
But I guess, Dennis, can you just talk about whether or not you're seeing an impact from COVID-19 or what Lishan said during the call, is that hospitals have figured out how to work during this pandemic now that we understand COVID a little bit better. Would it be accurate to say it's not having much of an impact on the uptake as far as you can tell at this point?
Lishan Aklog, CEO
I don't think that's an overstatement really. I think people have figured it out. People are doing procedures. As I mentioned, we have advantages with EsoGuard and EsoCheck as the procedure is simple and office-based. What used to be a 30-minute cycle time for endoscopies in an endoscopy center has likely doubled now due to the extra cleaning that has to happen between cases. We’ve seen some commentary that there might be advantages in a COVID setting for performing EsoGuard. Our ability to access physicians in the commercial setting has been quite good. If you recall, prior to this call, much of that activity was being done virtually, but that’s pretty much eliminated. We’re getting our folks in there. Occasionally, you’ll have a hotspot that comes up where things tighten, but our sales management team has been responsive to those occasional hotspot related restrictions. We've had a couple of examples of that this week. So far, it doesn’t seem like this surge is going to hamper the rapid exponential growth we’ve seen over the last couple of months.
Dennis McGrath, CFO
Sure, sure. Anthony, I would just add to that our people are now traveling and, with a few exceptions, are not able to get into certain clinics. We are compensating the independent representatives for valid tests that are being conducted throughout our process. So, as Lishan said, that is ramping up; we are seeing definitive results. As revenue starts to come in here in January, we will provide further insight. Look, the key is, Anthony, once you set a set of metrics, you're obligated to continue reporting on them. We want to ensure that the first set of metrics we provide on revenue dissection is something we’re all content with to measure performance and give guidance on future trajectories. By waiting until January 1, we will all be in a better position in terms of the reliable metrics that provide us insights.
Anthony Vendetti, Analyst
Sure. Understood. And then just following up on CarpX, you mentioned an initial network of KOLs before going to a full commercial launch. Approximately how many KOLs and how long do you think that feedback will be necessary before you feel confident to perform a full commercial launch?
Lishan Aklog, CEO
Yes, just to clarify one thing, it's not their feedback that's important, but rather their experience and their role as proctors and trainers, right? Some of it is feedback, and some of it is procedural development, but the primary purpose of establishing this early group is to have a core of folks who can serve as trainers and proctors and be general advocates. We have five, and we’ll likely expand that group in the coming months. We need to get them all trained, and they do need to travel to work at every lab to conduct the training, which went quite well last week. I don’t think it's a prolonged delay. I think once each of them completes a couple of dozen cases successfully and feels comfortable training and proctoring other surgeons, then we should be set for broader outreach. I don’t think that should take long to establish their clinical experience for us to be comfortable utilizing them for greater releases.
Anthony Vendetti, Analyst
Okay, great. Thanks very much. I’ll hop back in the queue. Appreciate it.
Lishan Aklog, CEO
Thanks, Anthony.
Dennis McGrath, CFO
Thanks, Anthony.
Operator, Operator
Ladies and gentlemen, we have reached the end of the question-and-answer session, and I would like to turn the call back to Dr. Lishan Aklog for closing remarks.
Lishan Aklog, CEO
All right, great. Thank you all for joining us this afternoon and for the great questions from our analysts. We look forward to keeping you informed of our progress via new releases and periodic conference calls such as this one. Please remember to stay in touch with us; contact Mike Havrilla at jmh@pavmed.com and continue to keep up with our news through our Investor Relations website, and by following us on Twitter, LinkedIn, YouTube, and the rest of our website. So, thanks again, everybody. Have a great day.
Operator, Operator
This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.