PAVmed Fourth Quarter 2025 Earnings Call - Capital Structure Cleaned, Lucid Momentum and Medtech Relaunch Set the Agenda
Summary
PAVmed says the long, painful chapter of toxic convertibles is over. A February recapitalization and financing left the company with a clean cap table, roughly $30 million of new equity, $15 million of long-term debt, and a set of operating subsidiaries positioned to raise capital on their own. That structural fix is the headline. Management is pitching a two-track story now: capture near-term value from Lucid Diagnostics, where EsoGuard volume and a VA contract are building momentum ahead of potential Medicare coverage, and relaunch a medtech portfolio led by a newly hired device chief and a Duke licenseed endoscopic imaging technology.
Operationally the other pillar is Veris, the majority-owned digital health arm. Epic integration at Ohio State is live, a commercial roll-out targeting at least 1,000 patients in year one is underway, and an implantable physiologic monitor is on a funded path toward a 510(k) submission later this year. Management emphasized steady, deliberate commercialization while they prioritize getting the implantable cleared. The tone is optimistic but cautious on timing; value depends on milestones that still need to be delivered and on warrant/dilution dynamics tied to Lucid coverage developments.
Key Takeaways
- Recapitalization completed in February removed legacy toxic convertible securities and produced a clean cap table, converting $30 million of short-term preferred into common and adding $15 million of 3-year, 15% interest-only debt.
- PAVmed now shows pro forma total assets north of $100 million after the financing, with $15 million of long-term debt on the balance sheet and a $30 million warrant package tied to the Series D.
- PAVmed remains the single largest shareholder of Lucid Diagnostics, holding roughly 31 million shares (equity method investment approx. $34 million) and about an 18% ownership stake, with ~25% voting interest.
- Lucid EsoGuard Q4 2025 revenue was approximately $1.5 million on 3,664 tests, up 24% and 29% respectively versus Q3, and testing volumes exceeded internal targets.
- Lucid won a U.S. Department of Veterans Affairs contract for EsoGuard, expanding access across the VA system and targeting a high-risk population of roughly 9 million enrolled veterans.
- Lucid announced positive real-world results from the largest real-world EsoGuard/EsoCheck dataset, ~12,000 patients, showing strong technical performance and appropriate physician use.
- PAVmed expects Lucid to be a near-term value inflection point driven by VA access and a pending Medicare coverage decision; related $30 million warrants are callable 30 days after CMS publishes the draft EsoGuard coverage policy.
- Veris completed full Epic integration with Ohio State University, and the commercial engagement targets a minimum of 1,000 patients in the first year, with early feedback reported as very positive.
- Veris is advancing an implantable physiologic monitor toward a planned 510(k) submission in the latter part of 2026; development vendor engagement is on budget and funded by prior Veris financings.
- Veris raised targeted financings in 2025 (roughly $2.3M in Q1 and $2.5M in Q2) to support implantable development; Q4 standalone cash burn was roughly $1.5M, including ~$600k of outside R&D contractor costs.
- Veris is pivoting from pure remote patient monitoring to include AI-based clinical decision support and clinician triage services to improve adoption and reduce clinician alert fatigue.
- PAVmed has hired Joe Virgilio as Senior VP and Chief Business Officer for medical devices; he will run the medical device subsidiaries and lead the relaunch of PortIO and the new Arcteris subsidiary.
- Arcteris now holds a fully executed license from Duke for a combined OSC and a/LCI endoscopic optical imaging technology that discriminates dysplastic versus non-dysplastic Barrett's esophagus in real-time, potentially enabling in-procedure ablation without biopsy.
- The Duke-derived optical probe is undergoing sponsored research to optimize form factor; next steps are additional clinical evaluation with UNC, design freeze, 510(k) pathway planning, and downstream commercialization.
- PAVmed reports near-standalone cash-flow breakeven post-Lucid deconsolidation, with incremental OpEx increases tied to Veris implantable R&D funded by dedicated financings; Q4 OpEx benefited from a one-time $1.2M Lucid reimbursement.
- Shares outstanding including unvested RSAs are approximately 6.4 million after recent conversions; GAAP shares reported at year-end reflect 900,000 (does not include unvested RSAs).
- Warrants linked to Veris (~2.5M) become exercisable after the implantable device receives FDA clearance, creating potential future dilution tied to regulatory milestones.
- Management stressed measured commercialization for Veris until implantable clearance, noting OSU has sophisticated triage infrastructure; PAVmed may provide clinical support services to compensate centers that lack similar resources.
- Analysts were told that inbound deal flow accelerated immediately after the restructuring, with interest from bankers and asset owners across diagnostics, devices and pharma, and management is screening opportunities consistent with its GI and broader medtech focus.
Full Transcript
Operator: Good morning, and welcome to PAVmed’s fourth quarter 2025 business update conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Monday, March 30, 2026. I would now like to turn the conference over to Matt Riley, PAVmed’s Vice President of Investor Relations. Please go ahead.
Matt Riley, Vice President of Investor Relations, PAVmed Inc.: Thank you, operator. Good morning, everyone. Thank you for participating in today’s business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and CEO of PAVmed, along with Dennis McGrath, Chief Financial Officer. The press release announcing our business update and financial results is available on PAVmed’s website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update press release and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC.
For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part One, Item 1A, entitled Risk Factors in PAVmed’s most recent annual report on Form 10-K filed with the SEC and any subsequent updates filed in quarterly reports on Form 10-Q and subsequent Form 8-Ks. Except as required by law, PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed. Leshan.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before we get into our recent operational highlights, I’d like to kind of frame where PAVmed is today. On our last quarterly call, I described how over the past now two years, we’ve undertaken a series of very deliberate and systematic actions to effectively permanently fix PAVmed’s legacy capital structure and ultimately strengthen its balance sheet and improve our ability to execute on our strategic plan. I had mentioned at that time we had one more step to go, and that step was completed in February with the completion of a restructuring, recapitalization, and financing.
The toxic convertible securities that had held us down for a while were removed, and we, upon completion of this financing exercise, we’ll have a very clean cap table. With PAVmed now fixed, we believe we’re now very well-positioned, exceptionally well-positioned to execute on our founding mission. What’s that mission? It’s to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries that are operating under a shared services model. With that work now complete, we’re executing that model across our core businesses, which you can see here in three different buckets. The most prominent one, of course, is Lucid, which is our publicly traded diagnostic company. Lucid continues to succeed at raising its own capital. It’s obviously our strongest and most advanced asset.
As we discussed in the Lucid earnings call and we’ll highlight later today, Lucid is on the cusp of transformative milestones, which include a very important recent VA win and a pending Medicare coverage. A reminder that PAVmed remains Lucid’s largest shareholder, holding approximately 31 million shares of Lucid common stock, and as such, it’s positioned now under this new capital structure to benefit from Lucid’s upcoming major value inflection points. Moving on to Veris. Veris is our majority-owned digital health company that’s advancing a cancer care platform that’s designed to enhance personalized cancer care, along with an implantable physiological monitor. As again we’ll discuss in more detail, we are continuing to see early commercial traction with our major strategic partner and are advancing the implantable towards FDA submission plan for later this year.
We’re poised to accelerate execution of an expanded strategic plan, as we’ll discuss in a bit. Having completed the steps to fix PAVmed with the new capital structure and resources available, a very important part of our future plan is to relaunch our MedTech portfolio. For those of you who’ve been with us for a long time, we started in medical devices, and we’ve always intended to reengage in that sector.
We’ve taken a couple of steps towards doing that, the most important of which is that we’ve engaged a new leader, Chief Business Officer, that will have oversight over this portfolio, and that will involve bringing in the technology that we’ve licensed from Duke, an endoscopic imaging technology, reinvigorating PortIO, and looking at an exciting pipeline of opportunities in the medical device space that we really do believe will enhance long-term shareholder value. Again, more on this in a bit. Let’s start with Lucid’s operational highlights from the fourth quarter and recent weeks. As always, I encourage you to listen to Lucid’s business update call for greater detail on each of these areas, and I’ll keep these comments high level.
Lucid reported fourth quarter 2025 EsoGuard revenue of approximately $1.5 million and EsoGuard test volume of 3,664 EsoGuard tests. The volume was increased by 29% from the third quarter, and revenue was increased by 24% over the third quarter. The volume exceeded our target range of approximately 2,500-3,000 tests per quarter, and we’re entering 2026 with really solid momentum on that front. A very important highlight that we’re incredibly excited about at Lucid is that Lucid was awarded a U.S. Department of Veterans Affairs contract for EsoGuard that expands our access across the nation’s largest integrated healthcare system.
That gives Lucid the opportunity to engage with numerous medical centers across the country and target the 9 million enrolled veterans who have a particularly high, elevated risk of gastroesophageal cancer. Another exciting development that we discussed is the announcement of positive data from the largest real-world experience of esophageal pre-cancer detection that evaluated EsoGuard and EsoCheck. As we discussed, in these 12,000 patients, we were able to show excellent performance across multiple metrics, technical success, the procedural times, safety, et cetera, and also the appropriateness of physician use. We contrasted that with other technologies that purport to be capable of operating in this space. Now let’s discuss Veras. Veras has...
The commercial phase of our engagement with Ohio State University is well underway, and it just initiated during our last call. A very important step of that in recent weeks, we completed the full Epic integration with OSU. The feedback in this early phase has been extremely positive, starting from the senior leadership all the way down to the clinician leaders and the clinicians in the individual departments within OSU. The integration with Epic is really a critical part of this. This is a bi-directional flow of information, so Veris data is available to the clinicians within Epic.
As importantly, and perhaps more importantly, the patient, the clinician and the patients can access their records within the workflow that we offer within our platform. That’s been really helpful in improving engagement with the clinical team. We expect to really leverage that and show increasing growth and increasing adoption across an increasing number of departments within the OSU Cancer Center. In addition, as we discussed at the last earnings call, we’re making really solid progress with the implantable physiological monitor and expect to have a submission in the latter part of this year to the FDA under the 510(k) designation.
Right around the time of our last call, we had engaged with a new vendor that was capable of not just the design and development of all aspects of the electronics and the structure of the device itself of the implantable device, but is also the entity that will be the early manufacturer of this device. That work is going extremely well. It’s under budget, and it’s focused on completing all of the design work to capture the physiologic signal and put us in a position to enter design freeze, completion of the development process, and a submission to FDA for clearance and subsequent commercial launch.
The Veris is sufficiently capitalized to fund that development as Veris raised capital last year to do so. In addition, to highlight again the topic we’ve discussed before, as we’re gearing up to on the commercial phase with our strategic engagement with OSU, and as we’re making solid progress on the development of the implantable device, we’re developing and looking forward to executing on an expanded strategic vision for Veris. Really fundamentally, this is a transformation of Veris from a pure play remote patient monitoring company to one that’s more broadly focused on AI and AI-based tools, clinical decision tools. We have a project that we’re launching on developing a risk stratification tool for cancer patients to identify those at risk of developing complications and readmissions.
In addition, we’re expanding the offering to include clinical support services so that our own clinical team will be able to provide the ability to offer triage services for alerts as they come into the system. We’ve learned that that’s an important part of adoption as the clinicians are already somewhat overwhelmed with data. That activity as well as the learnings and our experience with OSU will put us in a position later this year to begin leveraging that commercial success to additional systems, initially additional large cancer centers in the form of OSU. We’re also looking to explore engagements with PE-backed networks of smaller oncology practices. That work is ongoing.
Again, we’re really excited both on the development of the implantable, on expanding our activities with OSU and putting us in a position to execute on this expanded strategic vision as we enter the latter half of the year. Now let’s talk about some details of our relaunching of our medtech portfolio. As I mentioned, we feel like a key aspect of this, a key element of this has been hiring the right leader for this.
We’re excited, and we’ll announce this in more detail in the coming days that Joe Virgilio is joining us as Senior Vice President and Chief Business Officer for medical devices for PAVmed, and he will lead as Chief Executive Officer the medical device subsidiaries under PAVmed. That will start with two companies, PortIO, which we’ve talked about before. We’ve made some effort to raise capital there, but we clearly realized that in order to do so, in order to reboot PortIO, and reengage on the IDE study that will lead to FDA submission clearance and commercial launch, that we need a dedicated leadership for that. With Joe, we now have that.
We previously announced that we had engaged with Duke University to license exciting technology in the end-endoscopic space, in the GI endoscopy space that allows the operator to diagnose late stage precancerous stages without the need for biopsy. That license agreement has now been fully executed, and it now resides within a new subsidiary called Arcteris, and we’ll be providing additional details on that. Joe Virgilio will be running that project as well, which is now proceeding along a sponsored research agreement with the laboratory at Duke that’s been developing this technology. Our vision here goes beyond these two entities. We have an active and expanding pipeline.
I do have to say, upon completion of the restructuring, that we immediately started getting inbound inquiries from bankers from other companies that have sought to partner with us on various medical technologies. We are actively evaluating those and looking for ones that fit nicely within our pipeline. Those will enter our pipeline and our portfolio under Joe Virgilio’s leadership. With that, I’ll hand the call over to Dennis for an update on the financials.
Dennis McGrath, Chief Financial Officer, PAVmed Inc.: Thanks, Lishan, and good morning, everyone. Our summary financial results for the fourth quarter and the year were reported in our press release that has been distributed. On the next four slides, I’ll emphasize a few key highlights from the fourth quarter and the year, but I encourage you to consider those remarks in the context of the full disclosures covered in our annual report on Form 10-K as filed with the SEC. A couple of reminders as our financials, particularly the income statement with year-over-year comparisons, will, for this last annual report, illustrate periods before September 10, 2024, with Lucid’s operating results being consolidated into the presented PAVmed results. First, the 2025 periods without Lucid’s operating results being consolidated into the PAVmed financials. We do present some supplementary information in footnote 4 of the 10-K that will provide some help in the comparisons.
With regard to the balance sheet, you’ll recall from our investor update call since this time last year that the company is engaged in a multi-step process to regain compliance with the Nasdaq listing standard for minimum equity, which it did in February of last year, and again this year in January for compliance with the minimum bid price standard. Our focus throughout was to position the company for longer term financial stability. This was a multi-step process that Lishan highlighted that spanned nearly 18 months with 3 key recapitalization steps landing PAVmed on firm financial footing with its recent financing that closed on February 3.
The steps included deconsolidating Lucid from PAVmed’s consolidated financial statements in September 2024, and an interim phase of restructuring our convertible debt in January 2025, whereby we exchanged about 80% of our outstanding convertible debt for a new Series C preferred equity. Lastly, just recently in February, redeeming the convertible debt and the Series C with an infusion of equity capital plus some long-term debt. This slide reflects the balance sheets for year-end 2025 and 2024, both after deconsolidation, which occurred on September 10, 2024. A couple key things to point out on each of these balance sheets.
Cash burn rate of $1.5 million for the fourth quarter reflects the Veris operating costs, including approximately $600,000 of outside contractor development costs associated with the implantable device, which has been funded by the two Veris related financings, namely $2.3 million in the first quarter of 2025 and $2.5 million in the second quarter of 2025 to support the development toward the FDA submission of Veris’s implantable device. Additionally, there was approximately $200,000 in Delaware franchise taxes and $300,000 of annual compensation expenses that were paid. The equity method investment balance of $34 million at the end of last year reflects the $31.3 million Lucid shares mark-to-market and shows an $8.5 million year-over-year increase consistent with the 33% increase in Lucid stock during 2025.
At present, PAVmed continues to be the single largest shareholder of Lucid Diagnostics, with ownership of approximately 18% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed, together with its board and management, still have significant influence over Lucid with approximately 25% voting interest. Shares outstanding today, including unvested RSAs, are approximately 6.4 million shares, including approximately 4.6 million shares issued upon the conversion of the Series D upon the approval from the shareholders this past Friday. The GAAP year-ending outstanding shares of 900,000 are reflected on the slide as well as on the face of the balance sheet in the 10-K. GAAP shares do not reflect unvested RSA amounts. Approximately 433 shares were issued, reflecting conversions of the Series C preferred prior to the redemption on February third. Next slide, please.
We thought it might be helpful to walk you through how the recent financing changes the financial strength of the company. We put this non-GAAP pro forma balance sheet together to illustrate the changes. What you see in the first column is a condensed balance sheet derived directly from the published 10-K without change. Next, we highlight the two securities and their balances that were redeemed and replaced with $30 million of equity in the form of short-term preferred security that has been converted into common concurrent with the shareholder approval. Additionally, $15 million of long-term, 15% interest-only three-year debt was put in place to complete the redemption of the convertible securities. Accompanying the Series D preferred security is a $30 million warrant with an exercise price of $6.50 per common share.
The warrants are callable 30 days after the CMS publication of the draft EsoGuard coverage policy. Additionally, Veris has about 2.5 million of warrants that are exercisable after the implantable device is FDA cleared. We added a Veris column to show the recent pre-money value of $35 million, reflecting the valuation at the time of the direct financing into the subsidiary. Comparatively, the GAAP financials in the 10-K reflect $38 million of assets, which are completely offset by the sum total of the convertible debt and the Series C preferred. After the financing in February, the far right column now illustrates a company with total assets over $100 million and $15 million of long-term debt. There were 6 key investment themes that were attractive to the investors in this transaction, including valuation disconnect, which presented an opportunity.
PAVmed’s market cap did not reflect the sum of the parts of the underlying assets. Second, there was an overhang from legacy securities driving mispricing. The structure of these legacy securities no longer aligned with the company’s future development plans. The investors also saw that with recapitalization, they believed that it would unlock value. A clean cap table would align market cap and enterprise value combined with a limited supply of stock in the market. Fourth, inexpensive leverage for Lucid Diagnostics. This was a pure arbitrage opportunity in advance of the Medicare announcement. Fifth, additional optionality across high potential healthcare assets was a driving interest. Verus, Actaris, PortIO and others. Lastly, a balanced capital structure to maximize strategic flexibility.
The right mix of equity, $60 million in this case for the exercise of the warrants and debt, $15 million, was a key premise in financially engineering for future success while extending the cash runway of the company to be opportunistic while also developing and commercializing the non-Lucid asset portfolio. Next slide on the P&L. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year and quarterly and annual comparisons. As cautioned earlier in my comments, there are some significant differences in how the information is compared between the comparative periods given the changes in PAVmed’s financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on September 10, 2024, which somehow somewhat blurs the historical understanding of the information for PAVmed as a standalone entity.
GAAP does not allow the presentation for prior periods on the face of financial statements to be similarly adjusted. Although as mentioned, there are some supplemental information in the footnotes of the financials in the 10-K. On a pro forma basis and purely for illustrative purposes on this slide only, the Veris revenue and the Lucid management fee are combined. Collectively more than $3 million per quarter. It visually aligns PAVmed’s income sources versus its operating expenses. For SEC reporting purposes, the MSA income is below the line item. Furthermore, for the fourth quarter, you see on the slide a GAAP net loss of $2.8 million before NCI, non-controlling interest, and preferred dividends. This includes non-cash charges of about $1 million, which then reconciles to a non-GAAP loss of $942,000.
That loss is comprised of about $500,000 of various contractor R&D development costs for the implantable device and about $200,000 in annual Delaware franchise taxes that occurs once a year. I’m happy to answer any detailed questions on this slide in the Q&A, but I think it’s more informative to look at the fourth quarter standalone information presented not only in the slide but in the full fourth quarter information presented in our press release. That shows a company baseline basis of operating at near cash flow breakeven and incurring incremental PAVmed expenses for development activities that are offset by dedicated financing or funding. Next slide. With regard to the non-GAAP operating expenses.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: On this slide, you see a graphic illustration of our operating expenses over time as presented in more detail in our press release. Total non-GAAP OpEx since the Lucid deconsolidation in 2024 has been nearly flat for the four previous quarters. The fourth quarter OpEx were offset by approximately $1.2 million in a one-time reimbursement for Lucid for annual compensation expenses applicable to Lucid, with the balance reflecting the franchise taxes and the Veris R&D costs just mentioned. OpEx increases moving forward are likely to simply be tied to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA, for which the 2025 Veris-related financings are supporting. With that, operator, let’s open it up for questions.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Jeremy Pearlman with Maxim Group. Your line is now open.
Jeremy Pearlman, Analyst, Maxim Group: Good morning, Dennis.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Morning, Jeremy.
Good morning, Lishan. Thank you for taking the question. Just first, I wanted to focus on the commercial relationship with OSU. You know, you said you’re well underway. What are some of the key metrics you’re trying to keep track of and learn before you feel comfortable rolling this out to other large institutions? Is there a timeframe for that? You know, maybe help us understand how what you hope the current commercial relationship to become before you roll it out to other institutions. Thanks.
Yeah. That’s great. Thanks for the question. Happy to elaborate on that a bit. You know, in terms of the clinical value of the Veris platform, we established that during a pilot that occurred, and that’s actually when last year, and that was what led to the commercial engagement. The commercial engagement has fairly high expectations. It involves a target of 1,000, minimum of 1,000 patients within the first year, and a very structured plan on rolling out the platform across various departments, starting with the 3 departments that were under the pilot program and then expanding to new departments along the way.
Our internal engagement with OSU as to how that’s proceeding. It really relates to executing on that project plan, bringing on the new departments, and according to that plan and also the trajectory towards that goal of 1,000 patients during the first year. We call this a strategic partnership because beyond just simply utilizing the platform in a commercial setting, it’s also, we’ve also developed a registry, so those patients will be enrolled and data will be collected, and we’ll be able to provide future target commercial targets data on you know on this adoption during the commercial phase beyond the pilot phase. That’s that.
We’re not, you know, we haven’t been reporting sort of hard, you know, sort of month-to-month numbers with regard to that, but I can, you know, tell you at a high level that we’re on track and on schedule to do so. That the planning on that was in fact based on when we completed EHR integration. As should be clear to everybody, being integrated, you know, the EHR is really a central depot, you know, for the flow of information within, particularly within large medical centers.
Now that we are on the platform, there’s a full visibility of the Veris data on Epic as well as our preferences for the clinicians to use our platform as their primary portal to the patient’s care because it provides the real-time physiological data that comes through our platform, and it does so in a cancer-specific way beyond what they can get using Epic. That launched fairly recently, and we expect with that launch that we’ll be able to now start accelerating the trajectory towards that target of 1,000. Again, their goal, that’s the minimum, the goal and expectations that we will exceed that. I would just add to your second point about how that relates to expanding our commercial team.
We have the information that we need. We have the data, initial data from the pilot program in terms of the clinical benefit that we would need to expand to other sites. What’s holding us back on that is really we’re focusing our limited capital resources at this point to getting the implantable across the finish line to FDA submission and clearance. That’s what the capital that we raised last year was really targeting that. Although we have some legacy engagements with some other, about a dozen or so other academic cancer centers, we’re not deploying kind of the commercial resources and hiring the commercial resources that would be necessary to really do a broader commercial launch.
We would expect to do that in full force after the clearance of the implantable. Although we’re not ruling out some limited expansion of that over the interval of time between now and then now that things are well off the ground. One aspect of that that we think will be important, and I’ve mentioned this in engagement with other centers, and will require substantial resources, although we believe we can charge for this service, is the clinical support side of things. OSU has a very sophisticated call center mechanism, so they already have resources in place that can triage and screen alerts and information so that the individual caring clinicians are not overwhelmed. Many other centers, including major other cancer centers, and so on, and so they have that full-fledged system.
One of the things that we’ve concluded and we’ve learned from our experience with OSU and in previous discussions with other cancer centers is to have that functionality available so that we can offer our members of our own clinical team to provide sub-level to various levels, depending on what’s desired by the center, various levels of triage. That’s something we do have a clinician already on our team that’s helping us build that’s learning from her engagements with interacting with OSU as to how to develop that. That’s something that would be a really a predicate to a broader expansion, and that’s something we intend to develop over time.
A bit of a long-winded answer, but hopefully it gives you some perspective on how we’re viewing our future commercial expansion.
Jeremy Pearlman, Analyst, Maxim Group: Yeah. Yeah, thank you. That was really helpful. Great information. Maybe just one more question related to the. You said you mentioned there’s new risk stratification tools and other tools that you could integrate into the system, to the Verus platform. Are those. Whenever these tools, when they’re ready, are they part of the contract with OSU to allow them you to integrate them into already the patients that are using the device, or do you have to amend, or you’re planning on finalizing those and then rolling those out maybe further down the line?
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Oh, yeah. There’s, I think there’s two aspects to your question. One is kind of the development work, and that’s not trivial. I don’t want to give the impression that we have we have these tools to you know ready to go and to implement and to integrate within our platform. Those AI-based tools require data, extensive data. We are in discussions with OSU on how exactly to utilize the data that we’re collecting as well as legacy data they have to inform the development of these technologies. Part of our strategic engagement with them contemplated a partnership on the development of these kinds of tools.
The way I would view this perspective is really a broader kind of strategic vision to evolve Veris from its original vision of being, you know, primarily focused on remote patient monitoring, which is really just serving as a conduit for important physiological and symptomatic data from the patient to the clinicians to do so in a very timely way to bring up to highlight potential risks that may arise. We know from our experience to date that Veris works extraordinarily well at doing that. We believe that in this era, the value added from going beyond just being a conduit for information, but to provide truly sophisticated AI-based clinical decision support tools are really, you know, becoming standard practice when it comes to digital health offerings.
That’s what we’re seeking to do. That requires time and resources and capital. We’re in the early stages of that. I would view that as articulating sort of a near-term and medium-term vision, partnership with OSU on the development of that. Certainly, at the time we would launch that, whether it’s in a preliminary phase, you know, on the research side, any patient that was already on the platform would be obviously we would integrate it within the platform and they would have or their care could be impacted by those additional support tools.
Jeremy Pearlman, Analyst, Maxim Group: Okay. Understood. Great. Just maybe just last question, jumping to the new, you know, imaging technology that you licensed from Duke. I know you mentioned you’re gonna provide some more information in shortly, but maybe you can just right now on the call, you know, what-
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Yeah.
Jeremy Pearlman, Analyst, Maxim Group: Is there anything clinically that needs to be done with that technology? Before you could roll it out, and then maybe what type of commercial plans you might have for that? Thanks.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Yeah. That’s still in the early phases, so let’s be clear about that. That’s a technology as we described in sort of the press release when we entered into the letter of intent. We will provide a full press release announcing the full license agreement that was executed and Joe Virgilio’s role in overseeing Arcteris, well, what falls under that. Just as a reminder, that’s a little bit more detail on that technology. The technology is an optical technology that combines well-established technology called OSC with newer technology called a/LCI.
The combination of the two, implemented at the end of an endoscope, a tool that can be deployed through an endoscope, can, at the time of an endoscopy of the lower esophagus, can image abnormal tissue that has that appears to have Barrett’s esophagus, the precancerous condition, in order to discriminate between early and late precancer. Non-dysplastic Barrett’s esophagus, which is the early, earliest precancer, to Dysplastic Barrett’s esophagus, which is the later precancer that requires intervention to prevent cancer. Obviously, those of you who follow along on Lucid understand how important a part of the paradigm of the management of esophageal precancer that that distinction is, that when someone has this precancerous condition, it’s critical to distinguishing early and late because late is where we intervene.
Right now, that distinction is made purely on a biopsy. The patient gets a biopsy, and then they come back. If the biopsy comes back for dysplasia for the late-stage precancer, they undergo a definitive ablation or eradication therapy to prevent cancer. The promise of this technology is that it’s capable with a very high sensitivity in their early clinical experience as a part of a partnership between Duke and UNC, aids detecting using these optical techniques dysplasia. It does that by measuring the diameter of the nuclei in a very clever and sophisticated way with incredibly excellent performance that, frankly, will likely outperform any molecular diagnostic test based on initial data.
The advantage of that is that if you can diagnose it on the spot, endoscopy, then you can in the future prove that you can bypass biopsies and do an ablation on the spot. That would be very transformational for how esophageal pre-cancer is managed. You would look, you’d have visible evidence of pre-cancer. You would use this technology, the Arcteris technology, to image and determine whether that patient had a high likelihood of that area being dysplastic and then right off the bat, right there, do the ablation, the procedure on the spot. That’d be transformational. This work is still in the early phases. You know, it was used in a clinical setting that documented in real patients with real pre-cancer its efficacy.
That data is published now. There is work to be done to modify the technology to be more where the form factor, size and form factor can be more applicable to a broad commercial launch. That was the first step, and that’s happening under a sponsored research agreement in the laboratory, Dr. Wax’s laboratory, at Duke, where those revisions and that redesign of the probe is underway. Once that’s done, the probe will be deployed in another round of patients in partnership with Dr. Shaheen at UNC.
Once we have design freeze and have demonstrated that, then we’ll complete the product development process, secure what we believe is a 510(k) FDA pathway for clearance and then subsequent commercialization. That’s a bit down the road.
Jeremy Pearlman, Analyst, Maxim Group: Okay, great. Thank you so much for all the information. I’ll hop back on the queue. Have a nice day.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Yeah. Great. Thanks, Johnny.
Operator: Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Edward Woo with Ascendiant Capital. Your line is now open.
Edward Woo, Analyst, Ascendiant Capital: Yeah. Congratulations.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Good morning, Ed.
Edward Woo, Analyst, Ascendiant Capital: on all the progress. I had a quick question. You mentioned that you guys are now ready to kind of engage in expanding your medical device portfolio with you know new technology. Is there any particular areas or products that you might be interested in?
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Yeah. Thanks, Ed. I’m glad you gave me a chance to kind of maybe flesh out my previous comment about that. It was really quite remarkable, honestly. After we closed the last restructuring and financing, frankly, within days, we were getting calls. I’ll actually highlight something that wasn’t clear in my prepared remarks. It’s not just in the medical device side, it’s actually across the board. We’ve gotten inquiries on really interesting diagnostic companies, electrodiagnostic companies, medical devices, as well as pharma assets. A good number in just, I believe it’s just been a month since we completed that transaction.
It’s really because this really goes back to the roots of PAVmed, where we were also in a position where people contacted us as possible partners. That’s what led to Lucid and Veris as well as us having access to those technologies. It’s really exciting that folks now view us in a position to be able to continue that legacy that brought those other assets into the fold. I would say on the medical device side, we are. There’s obviously interest in technologies that align with the GI space, right?
Our interest in Arcteris and the interest of the folks at Duke in inquiring about that obviously has to do with the fact that we have in Lucid extensive experience with esophageal disease, with Barrett’s esophagus and otherwise. I would say we’re open for inquiries across the board. I mean, PortIO is in the vascular access space. There’s been you know, activity in a broader sense. We’re not limiting ourselves to any particular specialty, but certainly GI things related to gastroesophageal reflux, to Barrett’s esophagus and so forth obviously capture our attention because we have obviously a substantial amount of internal expertise there.
Edward Woo, Analyst, Ascendiant Capital: Great. Well, thanks for answering my question, and I wish you guys good luck. Thank you.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Okay. Thanks, Ed. Appreciate it.
Operator: There are no further questions at this time. I will now turn the call over to Dr. Lishan Aklog for closing remarks.
Dr. Lishan Aklog, Chairman and Chief Executive Officer, PAVmed Inc.: Great. Hey, thanks, operator, and thank you all for taking the time and for your attention this morning. We appreciate, as always, the thoughtful, informed comments and questions from our covering analysts, and hopefully you found our discussion useful as well. Really, I hope my goal and our hope is that you leave today with a, you know, pretty clear set of takeaways here, that PAVmed’s corporate structure and balance sheet is now fixed. It was a long and somewhat painful process to get here, but we’re here. Its two subsidiaries, commercial subsidiaries are both making strong commercial progress and approaching key milestones. Obviously, they’re at different points in their corporate life cycles, but really good progress on both of those.
Both of them have been also capable of showing their ability to raise capital independent of PAVmed over time. The news, obviously, that we’re focused on today is that our medical device portfolio is relaunching. We’re really excited to have Joe on board, and his leadership not only to move Acterys and PortIO forward, but also puts us in a really good position to evaluate the inflow of opportunities that have been brought to us already in hardly a month after we’ve been in a position to do so.
The fact that we’re getting those inquiries both from banks and from innovators and from academic medical centers, I think is a testament to you know the hard work that’s gone into fixing the structure and the balance sheet and the sort of sense of confidence that we’re in a good position to go back to our roots there. All I can say is that you know we believe PAVmed’s back that our founding mission and this the star structure of subsidiaries and their shared services model and the economies of scale that go with that that we really feel like we’re now in a really good position to take advantage of that structure of that history and of the opportunities that are coming before us.
With that, as always, we encourage you to continue to keep abreast of our progress. Please, follow our news releases, our quarterly updates, calls in the future, as well as through our website and social media. Of course, always feel free to reach out to us if you have any specific questions. With that, I’ll hope everyone has a great day. Thank you very much.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.