PAVM Q3 2026 earnings call transcript, November 13, 2026

Good morning, Jeremy.

Training the nurses on onboarding patients. And then, again, this is really the primary goal of this effort, in addition to just driving adoption, is to really learn. How to optimize workflow to minimize friction with regard to getting patients on the platform and a whole variety of... ...creative ways to insert our platform into the complex workflow of these cancer centers. So the acceleration is bringing on other centers, but also a high degree of... ...adoption within each department. This is all part of a strategic engagement is the building of a registry of the first thousand patients within. OSU, the target for that was to do so by the end of the first quarter of next year, and we're on pace to do that, particularly with the acceleration moving forward. Once we have the... and plannable, cleared, then we'll be able to take the lessons learned, take the template in a sense of how we engaged with OSU, with the James at OSU, which is the third largest cancer center in the country. and then rinse and repeat at other commercial centers, but this time with the implantable as a major value multiplier, force multiplier with regard to the power of the platform. Okay. Yeah. Understood. Great. And maybe, yeah, so you just touched on it at the very end, just to segue to my next question. You know, are you seeing interest from other health, large cancer centers? Are you being proactive?

Or you're just going to wait until you have enough data from this, from the OSU to start maybe, you know, commercializing it into other institutions? And what do you think the timeline might be? Yeah, we are getting interest. There have been some contacts, there have been some discussions with a handful, but we have not been aggressively pursuing it because at the end of the day, this platform is a combination, the Veris. The value, opportunity, the clinical value comes from a combination of this cancer-focused platform that's designed specifically for oncology patients. Undergoing systemic therapy, chemotherapy, with the implantable as the proprietary feature that can feed the platform continually. So, although we have had conversations with a handful of other centers and there is strong interest, our strategic approach to this enterprise has been to focus our efforts on OSU. Get the data, but it's not just data, it's just the institutional knowledge within Veris on how to best optimize engagement, how to best optimize adoption, and package that all up so that when we... Proceed to a full commercialization after the clearance of the implantable, we can do so in a way where we have a high likelihood of success at each of the individual cancer centers. Okay, understood. Great. Moving to Port.io, I know you touched upon this a little on your prepared remarks about the two potential regulatory pathways, either at 510K or de novo. Maybe just if you could flesh out a little bit what each of those would look.

Like in terms of you know timeline and maybe you know capital needs. Thanks. Yeah so look I'm but let's we can get a little bit in the weeds on that for for I. You know for those who are students of 510 versus de novo. So just as a reminder the 510 pathway is the lowest hurdle for medical device to go through FDA approval. FDA clearance and it just requires substantial equivalence to an existing predicate device. The next stage is the de novo which has a higher is between 510K and the PMA and has somewhat higher requirements with regard to the clinical study design, the size, and so forth. When Port I.O. was actively being pursued before we paused the project several years ago, our engagements with FDA had led to a determination at that point that this was likely, that this needed to go down. And so that's how we were proceeding before we paused the project. What's happened since that engagement with the FDA are two things. One, we had our first in human study. This is a successful human study in Columbia, South America that demonstrated the safety of the device in humans. So that wasn't available at the time of the original engagement with the FDA. Also, on further analysis with our team as well as with external regulatory consultants, some of whom were actually aware of the previous application, it's become clear to us that the major consideration with regard to moving this down the de novo pathway had to do with the predicate device was used for urgent and emergency situations, and PortIO is not really intended for that. The purpose of PortIO is to be on long-term vascular access device.

to existing ports and existing long-term catheters. And so we have a possibility, and I think a reasonable possibility, that we This time around, we can proceed on a 510 basis by simply saying that we're not, that the intended use does not include emergency and urgent insertion, which is system with sort of the commercial strategy anyway. We had an initial call with the FDA, and we have a formal pre-sub meeting in January, and that will determine, that will give us a strong sense. as to whether each direction, both of them will be fine. We have a, you know, we're confident based on the previous data and based on the previous conversations that we have a clear path to completing a, study and, and getting this cleared, but obviously our strong preference would be to be able to do so through the 510k pathway, which would be shorter. And, less capital, and with less capital requirements, and potentially might not even need additional human data, but that's still to be determined. Okay, great. And then just lastly, moving to off tires, maybe, you know, help investors understand, you know, what is it, what type of, what problem is it trying to solve? Is it creating a better mousetrap? You know, what, is there any other standard of care current competitors that would, that are tapping? The same issue and maybe that would be really helpful. Thanks. Yeah. Excellent. So, you know, I, I, I obviously meant most folks who have had to understand have.

Some understanding of, of the detection of esophageal pre-cancer and its management to prevent esophageal cancer, obviously, because ESOGARD, the ESOGARD test is designed to identify patients. Esophageal pre-cancer and send them to a confirmatory endoscopy to determine the subsequent management of that patient, whether it be surveillance or an ablation treatment to treat the late stage. So, that's the paradigm under which these patients are being managed. So, you can consider this basically the Octaris defect. fit in, in the post-ESA-GARD steps. So, ESA-GARD identifies these patients with pre-cancer. They go for an endoscopy. And then, at the time of endoscopy, what are the variables?

The direct answer to the question is that Octaris does compete with some existing technologies. Most of them are molecular tests that seek to risk stratify patients. So to determine at the time of confirmatory endoscopy whether the patient needs more aggressive surveillance, whether there's a likelihood that they have the later stage pre-cancer and maybe should be... Directed more towards an urgent, more immediate treatment with ablation. So there's a lot of, there's a variety of technologies that are out there. And electric, molecular tests that are out there that seek to be supplements to the confirmatory endoscopy. Octaris has the opportunity to make essentially most of those obsolete because what it does. Instead of using a molecular test, it uses imaging, a combination of optical coherence tomography as well. As well as an additional more proprietary optical method to assess the areas of abnormal abnormality at the time of. And so I can look at those cells and it's able to measure the size of the nucleus, which correlates very closely with the likelihood with the likelihood that they have late stage precancer. Which would need to be treated more directly. That's a bit in the weeds, but the bottom line is that when Octaris is finalized and commercialized, it will provide the opportunity to take a patient. Who has suspected pre-cancer, suspected Barrett's esophagus, hopefully from having gotten an Isigard test, and during the endoscopy to determine whether that patient has a late-stage pre-cancer.

And whether those areas should be biopsied more aggressively, and then if it does come back as dysplasia, the later-stage pre-cancer, whether that patient should go straight to the definitive. Over the long-term, you know, later versions of this device, the goal would be to have it be a one-time procedure. So you go in for your confirming. Endoscopy, and the endoscopist assesses the area, and using the supplemental imaging from Octaris, they can decide to ablate and destroy those. Abnormal cells on the spot, eliminating the need for multiple other, multiple other interventional procedures. So that's the, that's the paradigm that we're operating within. And if it does. If it is successful, it really, it really will shake up the way these patients are managed after they're identified as having pre-cancer. Very well. That's, that's great information. Thank you.

Thank you for all that color. I'll have back in the queue. Yeah. Thanks a lot, Jeremy.

Thank you, Jeremy.

Thank you, Ed.

Then for the questions at this time, I will turn it back to Dr. Lishan Aklag for some closing remarks. So, great.

Hey, thanks, operator, and thank you all for taking the time. And for your attention this morning. We obviously appreciate the questions. We enjoy the opportunity to discuss the business, and in particular, the technology, and be able to get a bit in the weeds.

Thanks to...

Great questions from our covering analysts. Hopefully you found that informative, and that the additional color was very helpful. I think as we look at PAVMED, clearly... The main focus with regard to near-term inflection points relates to Lucid and IssaGard and the Medicare milestone for IssaGard is obviously a turning point for Lucid. But as Lucid's largest shareholder, PadMed clearly stands to benefit from this near-term revenue opportunity at Lucid. But as we discussed, you know, there's really great progress. On multiple fronts with Veris, the progress with our strategic engagement with Ohio State, the progress on the implantable monitor. We're really looking forward to FDA submission in the first quarter. Next year, and then clearance thereafter, and obviously the progress with regard to Port Iowa and Octaris, both on the development side with Octaris and with both of them. As we head towards getting definitive regulatory pathways from the FDA on both of those. So, as always, you know, PAVMED has been, you know, designed from scratch to give our shareholders the opportunity to have more. Multiple shots on goal, extending here from a commercial company that's at an inflection point to a second commercial company in the digital health space. But poised for broader commercialization in the second half of next year and then to earlier stage but promising technologies. So with that, as always.