Lishan Aklog
Analyst · Maxim Group
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 2 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 that time, we have 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 down -- have held us down for a while were removed. And we -- upon completion of this financing exercise, we'll have a very clean cap table. So with PAVmed now fixed, we believe we are 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 3 different buckets. The most prominent one, of course, is Lucid, which is a 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 physiologic 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 planned for later this year. We're poised to accelerate the execution of that strategic -- 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. So 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. So 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 has increased by 29% from the third quarter and revenue has increased by 24% over the third quarter. The volume exceeded our target range of approximately 2,500 to 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 health care 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 GERD and esophageal cancer. Another exciting development that we discussed is the announcement of positive data for the largest real-world experience of esophageal precancer detection that evaluated EsoGuard and EsoCheck. And 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. And we contrasted that with other technologies that purport to be capable of operating in this space. So now let's discuss Veris. So Veris is now well -- the commercial phase of our engagement with Ohio State University is well underway, and it just initiated when we -- during our last call. An important -- 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 bidirectional flow of information. So Veris data is available to the clinicians within Epic. But as importantly and perhaps more importantly, the patient -- the clinician and the patients can access their record within the workflow that we offer within our platform. And so that's been really helpful in improving engagement with the clinical team, and 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 physiologic monitor and expect to have a launch date in late 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 success -- all of the design work to capture the physiologic signal. We are -- and put us in a position to enter design freeze, completion of the development process and submission to FDA for clearance and subsequent commercial launch. 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. And in addition, we're expanding the offering to include clinical support services so that will -- 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 physicians -- sorry, 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. So that work is ongoing. And 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. And so 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 2 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. And with Joe, we now have that. We have previously announced that we had engaged with Duke University to license exciting technology in the endoscopic space, in the GI endoscopy space that allows the operator to diagnose late-stage precancer stages without the need for biopsy. That license agreement has now been fully executed, and it's now resides within a new subsidiary called [ Arcteris ], and we'll be providing additional details on that. And 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. And our vision here is goes beyond these 2 entities. So 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, and we are actively evaluating those and looking for ones that fit nicely within our pipeline, and those will enter our pipeline and our portfolio under Joe Virgilio's leadership. And with that, I'll hand the call over to Dennis for an update on the financials.