Hey everybody, this is Joe Sasson with MedAxiom and I appreciate you tuning in to our webinar this afternoon. As you can see, people are logging in very quickly right now. We want to make sure everybody has an opportunity to log on before we begin. So we're going to wait just another minute or two, thanks. Thanks everybody, that's logged on. We're going to wait just about one more minute and then we're going to kick off today's webinar. Thank you so much. Okay everybody, I appreciate your patience while we waited for a few more folks to log on. My name is Joe Sasson, I'm the Executive Vice President of MedAxiom Ventures and I'm thrilled to have this esteemed panel here today to bring to you a webinar on PET-CT and low-cost daily rubidium. So we're going to get a little bit of clinical education and the importance of using PET and PET-CT as well as how to effectuate that in your practice with a lower startup cost and a full-time rubidium generator. So really excited for that here today. Before we get started, I want to make sure that we do an overview of how your webinar platform looks. So if we could flip to the next slide. So in the chat area, what you'll find is an access to the presentation. So you'll see now, and we may do a couple of times throughout this webinar, we may be adding that same link. That link is to download the slides, but if that is posted and then people log on after it's been posted, then they won't actually see that link. So for that reason, we may post it a couple of times throughout the webinar. And if you have any technical difficulties or questions, you can also chat with a host through that and we'll be able to hopefully resolve any of your connection issues or if things are not coming across well for you, we may be able to troubleshoot that with you. On the other side of your screen is going to be Q&A. And so if you have any questions throughout this presentation, then feel free to click that button, add them. If it seems as though it's something we should interrupt the speaker for to have answered, we will do that. And if not, we will hold your questions until the end of the webinar and want to make sure that they all get answered today. So I'd like to introduce our speakers. Today we are going to be hearing from Dr. Delcizian, he is a professor of medicine and radiology in the Division of Nuclear Medicine at the Maryland School of Medicine in Baltimore. And he'll be talking about the clinical components of doing cardiac PET with rubidium 82. We're also going to hear from Don Elting, who is with the Hackensack Radiology Group and New Century Imaging. And his discussion is going to be on implementation of a daily rubidium generator. So instead of a full-time generator, how do we actually implement and operationalize bringing in one day a week, two day a week, rubidium. And then we're going to hear from Brendan Loisel, who is in charge of business development and is the chief business development officer at CDL Nuclear. And his discussion is going to be about how do we make all of this possible and how do you create a business arrangement around doing cardiac PET on a part-time basis? Is that feasible and how do we operationalize that? So with all of that being said, I want to thank each of the three of you for being here with us today. And I'm going to turn it over to Dr. Delcizian to take us away. Dr. Delcizian, thank you. Thank you, Joe. It's for the kind introduction. It's really a pleasure to be here talking about an important topic, transitioning from SPECT to PET and all the clinical advantages of PET using rubidium-82 over SPECT imaging. Next slide, please. I am a consultant to CDL Nuclear Technologies, and I'm not going to be talking about non-FDA-approved products. Next slide, please. So we start with talking about the CMS, Center for Medicare and Medicaid Services' vision of how to optimize patient care and make imaging cost-effective. So with that in mind, they've asked major societies to come up with guidelines such as the one was recently developed for cardiac PET, myocardial perfusion imaging, to share with relevant stakeholders, referring physicians, cardiologists, radiologists, nuclear medicine physicians, hospital administrators, and patients so that we can come up with appropriate use of these modalities. Next slide, please. So the Appropriate Use Committee came together and established 210 clinical scenarios, that is indications for PET, and these clinical scenarios were evaluated based on independent systematic review of the literature, outcome data, clinical expertise, clinical practice, and accordingly, the committee scored these clinical scenarios as appropriately indicated with a grade 7 to 9, maybe appropriate grades 4 to 6, or rarely appropriate with grades 1 to 3. Next slide, please. And so when you look at the PET, myocardial perfusion, appropriate use criteria sections, you can see there are 11 sections, and of course, we're not going to be able to cover all of them today, so we're going to be focusing on the most common indication for PET, myocardial perfusion imaging, which is, number one, symptomatic patients with suspected or known coronary artery disease. I do also want to highlight that even though we are not going to discuss item number seven, coronary microvascular dysfunction detection is a unique capability that can be done with PET, myocardial blood flow assessment, to identify that difficult subset of patients. Next slide, please. And so if you look at this section one for the clinical symptomatic patients with suspected or known coronary artery disease, you can see in red if the patient's symptoms are such that they have intermediate pretest probability or high pretest probability, PET is appropriately indicated for this subset of patients. In contrast, if the presentation is low pretest probability, PET is rarely appropriate. Next slide, please. Now what are the CMS quality initiatives that we need to follow? What are their goals? And how does PET meet those goals? So CMS quality initiative goals include, on the left-hand side, the test that you are performing should be effective, should be safe, efficient, patient-centered, equitable, and timely care. Now if you look at all of the PET imaging properties on the right-hand side, they meet all of these CMS quality goals. Effective, high diagnostic accuracy, it's safe, low radiation exposure, efficient, studies are done within five-minute acquisition times, patient-centric, accommodates all patients, ill, high-risk, large-body habitats, equitable, we are able to interpret it independent of the patient characteristics and condition, and timely care, image acquisition, and interpretation are completed in 30-minute time or slightly longer. Next slide, please. So when we assess myocardial perfusion imaging, we are trying to understand what is the actual physiology of myocardial blood flow through the coronary arteries that is seen by the myocardium. So when we think about coronary arteries, we have to think about them as conduits that where blood flow is flowing through, that is the conductance vessel. This is where atherosclerosis develops, 50%, 75%, 90% of complete occlusion. And as the vessel tapers down to resistant vessels or the arteriolar vessels, the purpose of these resistant vessels is to vasodilate when there's significant coronary artery stenosis in the conductance vessel in order to maintain blood flow. Now this is nature's way of compensating for atherosclerosis. This is the reason why a lot of patients, a lot of people are walking around with 70%, 80% stenosis and are not necessarily having angina. That's because there are adequate compensatory mechanisms put in place by nature in addition to collateral formation distally. So the purpose of myocardial perfusion imaging, unlike anatomical imaging, anatomical imaging will very nicely tell you whether there's a 50%, 70%, 90% stenosis, but the question is do we really need to open that vessel with angioplasty or bypass surgery or is the compensatory mechanisms that are in place adequate to maintain blood flow? Because ultimately if the myocardium is seeing enough blood flow, there's no reason to put in any procedural stents or bypass surgery to the conductance vessels. Next slide please. So here's what we do in nuclear imaging, whether you do SPECT imaging or PET imaging, the patient comes in and assume that this is the left vein, the circumflex and LAD, and this is a short axis tomogram of the myocardium, of the left ventricle. So in the setting of stenosis, we're trying to determine whether there's ischemia there or not. So on the resting condition, if there's been no prior myocardial infarction, myocardial blood flow is normal despite there being such as 90% stenosis. For as long as myocardium is viable, there's been no prior infarction, on the resting condition, narrowed coronary vessels will not demonstrate resting hypoperfusion. That's because as I said before, there are compensatory mechanisms that will maintain blood flow on the resting condition. However, when we exercise the patient, we increase myocardial oxygen demand and thereby the compensatory mechanisms can no longer maintain blood flow, and this is why patients get angina chest pain with exertion. Now we are trying to reflect what is happening to the symptomatic correlate of that patient with stress. In this case, myocardial blood flow will increase three-folds in the area that's normal flow. There's no stenosis, that is in LAD area. In contrast, the area of stenosis will increase blood flow but not as much. So if we look at the schematic diagram above these cartoon diagrams, you can see in blue resting blood flow in the normal and stenotic vessels are normal and equal. In the case of the normal vessel with exercise, you increase blood flow three-folds. In contrast, the area of stenosis will increase blood flow only by one-fold, let's say one and a half folds, and therefore there's a disparity between hyperemic blood flow in the normal region versus stenotic region, and so when we inject the radiotracer, it will reflect that delta difference between the normal and stenotic territory, and that's how we will see a perfusion defect on stress that's not present on rest, and therefore that's a reversible perfusion defect indicating myocardial ischemia. Next slide, please. So here's an example of what we do with SPECT imaging. You have paired images of stress and rest in short axis, vertical long axis, and horizontal long axis views, and when you first look at the stress images, you can see that there is, relatively speaking, hypoperfusion in the anterior anteoceptal and the lateral region with relatively preserved perfusion in the inferior anteoceptal region. On the stress images at a vertical long axis, you can see that the anterior and apical regions are hypoperfused relative to the inferior wall, and when you look at the horizontal long axis views, all septal, apical, and lateral regions are hypoperfused. When now you compare these set of images at rest, you can see that all of the regions are normal, and therefore these represent reversible perfusion defects indicating extensive ischemia. In addition, you can see that the left ventricular cavity looks smaller on rest compared to stress. That's called transient ischemic left ventricular cavity dilatation, which suggests multivessal disease or extensive ischemia. Next slide, please. Now, unlike those SPECT images, when you look at these rubidium PET images, there are high resolution, very clear images, it's a normal study, of the left ventricle and the right ventricle. Now, I just want to emphasize that while you may see others represent rubidium PET images looking slightly more fuzzy than the ones that I'm presenting, those differences are related to the technology, the equipment, and not necessarily the radio tracer. The radio tracer can appear very sharp, and this is not an atypical example from my laboratory. This is the type of images that I read every day, and it almost looks like high-quality contrast on an MRI, very high resolution images, and I don't have to deal with attenuation issues, breast or the affirmative, because they're all CT attenuation corrected. Next slide, please. Now, beyond looking at the perfusion visually, we have come to learn that if you quantitate blood flow in absolute terms, that is cc's per minute per gram, on stress and at rest, the ratio of stress blood flow to rest is called coronary flow reserve or myocardial flow reserve. So, how do we use this data? Now, this is physiology, and we're going to compare it to anatomy. Now, a lot of times anatomy and physiology are concordant. You have a normal blood flow, there's no stenosis, coronary flow reserve, which means the ratio of stress divided by rest, most of the time, resting blood flow is one. And so, if you see 4.0 flow reserve, it means that the stress flow augmented with pharmacologic basal dilation by four falls. Four divided by one is four. In contrast, when you have an 87% isolated stenosis, coronary flow reserve in this case was only one, meaning that resting flow is one, stress flow is also one. There was no pharmacologic basal dilation augmentation of the blood flow with stress. Therefore, coronary flow reserve is abnormal. Now, these are concordant with the anatomical information. However, you're going to see a variety of different anatomical combinations where flow reserve and anatomy may be discordant, and this is where physiology will trump anatomy. In looking at number three, this is a 63% stenosis. Without coronary flow reserve measurement, you would be tempted to put in a stent here because it's about 50%. However, by measuring flow reserve, you realize that it's 3.4, and certainly that's very normal, and therefore you don't need to revascularize this 63% stenosis. Next slide, please. So with that background, let's look at some cases. This is a patient with normal study, and I just want you to look at the flow data. We have global flow, and we have vascular territory blood flow, LAD, left circumflex, and RCA. Now, starting with rest, as I said, usually in the absence of prior transmural myocardial infarction, blood flow is usually in the range of 1, plus or minus 20%. So resting flow is one in all three vascular territories. With pharmacologic vasodilation, you can see that it increases from 2.7 to 3.5, and anything above 2 is normal. Anything about 1.5 is also normal. 1.5 to 2 can be some range of some physiological differences. But as long as the resting flow is one, flow reserve will be the same as the hypermic blood flow, and this is perfectly normal study. In contrast, next slide, please, here's a patient with LAD, one vessel ischemia. You can see on the bullseye, it's involving the septal, anteroseptal, and apical regions. And when you look at the resting blood flow, you can see that it's not 1, but it's 0.7 to 0.8 range. Remember, I said to you, plus or minus 20%, and 0.8 is in that normal range. When you look at the hypermic blood flow, RCA and circumference territories increase to 2.1 range. In contrast, the LAD only increases to 1.2 range. So the ratio of stress over rest is only 1.5 in the LAD, while it's normal in the left circumference and RCA territories, confirming what you would see visually. Next slide, please. Here's a patient where resting flow is increased. It's not 1, it's not 1.2, it's 2, and you can see this in patients with concentric left ventricular hypertrophy. And with stress, you can see that there's no significant increase from the resting blood flow, such that flow reserve are all in the 1.0, 1.2 range, which is all abnormal. Visually, you can see that there's a multivessel disease hypoperfusion, suggesting that there is multivessel disease. Next slide, please. Now, what I want you to remember is that in that previous example, if the floor reserve is only one and you don't see any reversible perfusion defects visually, you need to entertain the possibility that the patient had caffeine intake or some xanthine derivative medication on board that did not allow maximal vasodilation with pharmacologic stress. Or there are some patients who have adenosine receptor variances genetically. So in those cases, quantitative blood flow would be very, very helpful. Instead of saying normal, now you would say maybe the study should be repeated after the patient stops the caffeine or the xanthine derivative medications or even change the stressor from adenosine let's say to dobutamine to make sure that the receptor variances are not there. And then you now can read the study whether it's indeed normal or is it a multi-vessel disease patient. So again, an advantage of PET over SPECT is that you would not know this if you were doing SPECT imaging because you don't have the access to absolute blood flow. Next slide, please. And so here's a patient example. It's a bullseye. If we read things in a form of SPECT, you would say that, well, the green area here, anterior anteroseptal apical is hypoperfused compared to the lateral inferior interoseptal region. And therefore you would say there's LAD stenosis. Same patient looking with PET. Now you add the hyperemic blood flow data. You'll see that LAD territory, instead of being two, it's 1.3, therefore it's hypoperfused, confirming the visual findings. However, while circumflex territory, orange is better than green, is relatively better, but 1.65 is still below 2.0, and that may not be normal. And by the way, our reference region is 1.9, which is also below two. So this patient actually had three-vessel disease with the culprit most significant stenosis being the LAD territory. While SPECT identified the critical stenosis, it will identify this patient as a single-vessel disease patient. In contrast, PET will identify them as three-vessel disease patients, worse in the LAD vascular territory. Now this patient, next slide, decided not to undergo revascularization and underwent aggressive risk factor modification with exercise, and returned about a year later, where now we reproduce the images on the lower panel a year later without revascularization. And you can see that not only the LAD territory improved, as you would have identified on SPECT imaging, with PET imaging, now you can identify that hyperionic blood flow normalized in all three vascular territories, suggesting that risk factor modification and exercise actually can improve perfusion. You don't necessarily have to revascularize everybody. Obviously, if the patient is symptomatic, surgery is still the first-line indication, but PET will allow you to follow risk factor modification and medical therapy and exercise. And this is a very nice way of objectively following quantitatively what is happening to hyperionic blood flow. Next slide, please. So if we think about what we're showing now with PET and reflecting that of some of the key multicenter clinical randomized trials that were published in 2007 and 2009, where the FAME trial showed that if you use FFR in the cath lab and physiologically identify whether a lesion is significant physiologically or not versus anatomical-based PCI, physiology trumped anatomy. And you can see here in 2007 that if the patients were followed on medical therapy for over a seven-year period versus PCI, just purely on anatomy and not based on physiology, there was no significant difference between medical therapy and PCI. And the question is, do we need to revascularize everybody or can we follow patients on medical therapy? And if we are going to do that, how are we going to monitor them? Are we going to be monitoring them with relative uptake or are we going to monitor them with absolute blood flow as I showed in the prior patient example? Next slide, please. Next slide, please. And so there's clear... No, I'll go back. So there's clear shift in patient management from anatomy to functional imaging. And functional imaging will allow us to identify disease earlier rather than in the end-stage advanced flow-limiting disease and also identify microvascular dysfunction. Next slide, please. So as we transition from SPECT to PET microhyperfusion imaging, we need to remember that stress-induced perfusion defects have been firmly established as an important diagnostic and prognostic technique for identifying flow-limiting epicardial CAD, both with SPECT and PET. However, instead of the primary interpretation being qualitative or semi-quantitative with some stress scores, we are going to be moving towards absolute blood flow assessment, which will then give us the opportunity to monitor responses to lifestyle and or risk modification, as well as therapeutic interventions. Next slide, please. So again, there are multiple papers in the literature published in this where you look at the summed stress score as assessed with SPECT imaging, which is semi-quantitative. When you add absolute blood flow data, you can further risk certify patients with absolute blood flow within the summed stress score categories. Next slide, please. So in conclusion, what are the advantages of PET-CT over SPECT, and why should we consider moving our lab from SPECT to PET-CT? One, we are able to measure absolute blood flow in quantitative terms, and this is part of the accepted and now reimbursement CPT code for PET imaging. Two, undoubtedly PET-CT has higher diagnostic accuracy compared to SPECT. Three, undoubtedly the radiation exposure with rubidium, which is only one to two millisievers, is significantly lower than any of the SPECT perfusion tracers. Four, acquisition time, five-minute image acquisitions, which minimizes patient discomfort, less patient motion artifact, and interpretation is completed within nearly 30 minutes. Stress rests data, reprocessing, interpretation. You call down to the emergency room or the CCU with the result. Accommodates ill, high-risk, large-body hepatitis patients. I won't even know how big the patient is because of the robust CT attenuation correction. And plus, with CT, you can also look at the choriotic calcification in the localizing CT that's used for attenuation correction. And most importantly, unlike SPECT imaging, if the study is normal, you won't know whether it's normal because the patient is on caffeine, xanthine-treated medications, or there's some receptor variances from blood flow measurements. PET will give you an insight into that, which will allow you to repeat the study without the caffeine or some different vasodilator or vasostressor. Thank you very much for your attention. Next slide, please. Now, I would like to pass the speaker to Don Elting, who's gonna be talking about implementation of a daily rubidium generator. Don? Thank you, Dr. Dilsouzian. Now that you know why you need to do PET-CT over SPECT, I just wanted to go over a little bit about how to do it in the outpatient center. So once again, my name is Donald Elting, and I'm the director of operations for Hackensack Radiology Group. We have three outpatient locations, and we also serve three area hospitals here in Northern New Jersey. Today, I'm gonna talk a little bit about our new century imaging location and the steps we took in order to start performing rubidium PET. We currently perform rubidium about one to two days a month, and each day we perform it, we do between eight and 10 patients each day. Next slide, please. So the first step is you have to make sure you have radiologists who are familiar and willing to interpret the images. In addition, you're gonna have to have a referral stream for these patients. For us, we already had cardiologists rotating through our location, so we knew that we'd be able to turn patients who are unable to run on the treadmill would automatically be considered candidates for rubidium PET. So we already kind of had an in-house referral stream. We were able to use that to determine whether it was worthwhile even doing. Another consideration was your scanner. Is your scanner able to perform the exam? For example, does it have the appropriate cardiac software? So in our case, we were performing gated calcium scoring and CTA, but we did need to purchase some additional software for our scanner. So just make sure you engage your vendor before you even start down the road and make sure you have the appropriate software. Aside from the scanner, you'll need some ancillary equipment. If you're already doing stress tests on the premises, you can use the same EKG machine. Most sites have an auto BP machine. If not, that's another smaller piece, but just again, equipment you'll have to purchase. This was a big one for us. Your RAM has to be updated, and not only do you have to list rubidium, but the byproducts of the generator, which are strontium-82 and strontium-85 must be listed as well. Here in New Jersey, it took us about eight weeks to update our RAM license, so start that process as soon as you can. Next slide, please. Insurance carriers. Carefully review your contracts. If you have a carve-out for PET, which a lot of practices do, make sure that you have the correct CPT codes added. If you have an outside billing company, engage them right from the beginning. This is one, I've been doing this about 20 years, this is the one time that Medicare was actually the easiest to work with. The private carriers took some massaging, but Medicare was absolutely the easiest to work with. As far as staffing, we perform about eight to 10 patients a day with two nuclear attacks and an RN. Worth mentioning is in the morning, you need about an hour to perform QC on the generator, so just be aware of that, that's typically longer than what you would normally do for your regular PET CT machine. If they came from a practice who was using the same dose as you, the QC takes a shorter time, but plan on about an hour. We have a radiologist processing and reading the cases real time, and a cardiologist monitoring the patient. Worth noting is we had applications from both CardioNavix and Siemens, our vendor, when we started our program, so make sure you engage them both. We had them both there on the same day when we started the program. Final consideration would be simply where and how the generator will be delivered. We put a lockbox outside our door and the generator gets delivered the night before. We have them wheeled directly into our PET CT room. It's about the size of an old photocopy machine, so it fits easily in the back of the room, and then it gets picked up at the end of the day. If anybody has any questions, I look forward to the QA, and Brendan is up next. Thank you, Don, and a big thanks to you and Dr. Dilsizian for being here on our behalf today. As you see on the slide there, my name is Brendan Loisel, business development for CDL CardioNavix, and you got a taste from Dr. Dilsizian, well, more than a taste, of why you should be doing cardiac PET from a clinical standpoint. Don shared a glimpse of how he made it happen at his practice. I'm gonna take a little bit of a different track to get to both of those outcomes in my slides here. The point that I really wanna drive home, not only is PET worth doing, but that it's worth doing with CDL CardioNavix, and I'll explain why. Next slide, please. So clinically, I think we understand at this point why PET shines. You know, it's a faster, more accurate, lower radiation test than some of the alternatives. And what I'm trying to convey in this slide here is really that the growth trajectory of PET, it started earlier than we're showing here, and there was that blip in 2020, of course, but, you know, projecting out, I think that it's fair to say we're gonna project a pretty solid growth rate in cardiac PET, and it's kinda easy to understand why, right? I mean, you need to only look at the demographics of the United States right now. So in 2011, the first boomers started applying for Medicare. By 2030, I think Medicare expects something like 26 million new baby boomers to be signed up for the service. Add to that that approximately half of Americans are considered to be obese, and you can do the numbers to really get a sense of the universe of patients that you as providers are gonna be called upon to treat, and to be called upon to treat in a cost-effective way. Not shown here are the existing number of spec studies, which is around 5.5 million today in the U.S. So there's a lot of room to run here for cardiac PET. It fits nicely into the niche that Medicare is looking for of a test that provides early and accurate detection of disease, therefore mitigating downstream costs by providing you the tools you need to prescribe the correct treatments, hopefully at a lower cost and less invasive, less risky to the patient, and ultimately saving everybody a lot of money. Next slide, please. I won't harp on the clinicals. Again, this is something that's worth doing purely on the merits of its clinical prowess, and I think Dr. Dilcisian covered that wonderfully. Next slide. Talking about the positioning of cardiac PET. So as a clinical tool, it's right where it needs to be. We also have robust society support. So just showing here in brief, ASNIC and S&M, the two societies that represent you all to the payers, and in particular, Medicare, have endorsed this test. Next slide. Furthering that point, the ACC has ascribed a class one designation to cardiac PET. Next slide, please. And coming back to Medicare. So Medicare has always been very friendly to PET. I've been doing this for about 10 years, but I know that for even a while before that, Medicare's policy was essentially, do a SPECT or a PET, we don't care which, just don't do both unless the SPECT was unreadable. And that policy has continued through to today. So again, Medicare has teams of actuaries that know pretty much exactly what they're doing, and PET has a higher reimbursement than SPECT for very good reason. They know that in a long enough timeline, PET is where they want the providers to be. Next slide. A little backstory on the company here, CDL Nuclear and CardioNavix. We've been in business for almost, actually a little over 30 years now, excuse me, in diagnostic imaging. And more recently in the last 12 or so, we've been in cardiac PET. We've been fortunate to grow across the country. Now we're the largest provider of turnkey fixed and mobile cardiac PET labs in the country, which is great. We have a number of MedAxium clients, which we're very proud of. The management team, a lot of them are nuclear techs. They've got over 150 years of combined experience in cardiac labs. So we've been around the block a few times. We know what we're doing. We've seen a thing or two. We're very passionate about this test, and it's that passion and bringing this test to more people that actually led us to the idea for CardioNavix, which I'll talk about now. Next slide, please. So as we were servicing accounts, primarily our bread and butter was private practices that had robust volumes that could support some of the items that you see on the right. They could get over these barriers to entry in cardiac PET, which used to be high equipment cost, the cost of the isotope, whether you're getting it from a generator or a cyclotron. Staffing, you need a more specialized staff. And on down the line, space is actually a big one that the camera takes up significantly more space than a spec camera. So we cobbled together a suite of solutions that addressed nearly all of these, particularly for private practices. The one missing link though was getting the isotope to the practice, because as you might be familiar with, positron emitting isotopes don't have long half-lives, typically, at least the ones that we use in medicine. And so you can't spit them out of a generator offsite, put them into a vial and then send them to the site because they'll decay too quickly. So there had to be some kind of a solution. It's a very complex process. The OEMs that are out there do a good job with the full-time solution, but that is very limiting because of the cost of implementing a full-time solution. Again, you have to have really robust volumes or deep pockets or both. So we set out to solve the radioisotope cost and availability problem, and that's how CardioNavix was born. Next slide, please. We've got two avenues to a solution for you. So we've got the turnkey fixed in mobile labs, as I touched on before, so certainly would welcome any discussion around that. And if you wanted to follow up with any member of our team after to talk about that, always open to those. What I'm here to talk about today, though, is on the right there, CardioNavix, the mobile rubidium solution. So that van there, that's really how we make it all happen. There's sort of a Russian nesting doll situation going on there. So we partnered with Brocco Diagnostics as Don alluded to, they have this infusion system. It's about the size of an office printer. It's a big lead line box that holds a strontium core from which we elute doses of rubidium. That goes inside of our proprietary transport device to keep it well-shielded, protected from changing environmental conditions, vibrations, things of that nature. Goes in a van like that, and then it goes from site to site on a daily basis, delivering rubidium on a kind of an on-demand use basis. Next slide, please. It's important to note that this is a patented product. So right now in the market, we're the only ones that can provide rubidium on an as-needed or a daily use basis. Next slide, please. In the program, it's almost comically simple how it works. So you pick your days of service. We show up on that day, you do your patients, and then we take care of the rest of the day. And then we take the infusion system at the end of the day. It really is that simple. And of course, in the lead up to that, we're not just gonna throw you to the wolves. We have a very robust training program that you're gonna be engaged with your technologists, your administrators who are gonna need to clean up some things in documentation related to RAM and accreditation. We'll help with all of that. And of course, for the providers, the clinicians themselves, we provide training in the form of perfusion training if necessary, but usually it's CFR training, running the protocols, things of that nature. So we're gonna make sure that you feel very comfortable, your staff feels very comfortable, everyone from the techs and the physicians to the billers and the schedulers. Everyone's gonna know exactly what they're doing on day one of doing patients under our program. Next slide, please. And we've got a short video here. This probably conveys it better than I could. So we're just gonna show this to you about two and a half minutes long. Would you like to offer Cardiac Pet, but aren't sure how or where to begin? Does your institution have a pet or pet CT camera that you could access, but you don't have access to a rubidium generator or thought it was too expensive to acquire one? CDL CardioNavix has the solution. CardioNavix is America's only provider of on-demand rubidium isotope for Cardiac Pet. Our fully licensed patented technology lets us bring a rubidium generator into your lab only on the days you need it. This means your lab doesn't need to commit to a costly full-time rubidium generator. CardioNavix makes offering Cardiac Pet simple, convenient, and economical. Our program allows you to scale according to your patient volume needs, improve the utilization of your existing pet or pet CT camera, improve your operational efficiencies, and most importantly, deliver the highest quality cardiovascular imaging to your patients. CardioNavix means accessible Cardiac Pet for everyone. Here's how it works. Just schedule which days you want to have a rubidium generator available. Our team will securely deliver and set up the rubidium generator with infusion system before your clinic opens. After your imaging day is complete, CardioNavix will return to take the rubidium generator away until your next day of service. We offer flexible scheduling, including weekends and onsite clinical support and training for physicians and staff. We make getting started in Cardiac Pet simple and hassle-free. CDL CardioNavix. You can perform Cardiac Pet whenever and wherever you need it. All right. Every time I watch that video, I wonder why I even bothered to speak before I showed that because it really does such a great job of encapsulating everything that we want to convey related to the CardioNavix program. It's something that you can do. We're here to help you with it. And this lays out a list of criteria that these aren't necessarily gatekeeping criteria, but they're certainly good to have on hand before you start to consider whether you're right for a program or you can have a program. Obviously, the first thing is you need access to a pet or a pet CT system. I think nowadays we're really just talking about pets CT. It's not too often we run into pet systems out there, but certainly those will work. As Dawn alluded to, a lot of times those are oncology systems, right? And so you need to upgrade those or make some type of a modification or a tweak to them to make them cardiac capable. So we're happy to work with you and your OEM to get that set up. There's a wide range of volume that really qualifies you for our program. So we put eight to 96. Eight is reflective of a once a month program. So you do eight patients once a day, once a month. And then 96 is more indicative of a twice a week program doing up to 12 patients a day, which is possible if you have your protocols really dialed in and your patient workflow. So wide range of criteria there for volume. Obviously you need a competent staff to man the camera in the lab. And then a physician is required to be onsite during imaging. Next slide, please. Just a quick nod to the economics. They are pretty good. Again, this is, in my opinion, this is Medicare kind of incentivizing a shift in this direction. We're looking at a number that is a little over two times specced in most areas. The HOPS national average is shown on the left there. Our typical rate is a $6,000 a day charge for access to the infusion system. That's tending to be the vanilla scenario. We find that most of our partners in this settle in at that number, whether they start at once a month or every other week, they kind of grow to once a week and stay there, which is great. And that puts your break even at around 2.3 studies, a little shy to 2.3 studies per day. Next slide. Actually, that might be it. Yep, that's it. So let's open it up to Q&A. First off, thank you, Brendan, and also to Don and Dr. Dilsizzi. And I mean, just really appreciate you guys taking the time to educate us all and bring us along from a clinical perspective and operational perspective and a financial perspective. So thank you for that. I do have some questions that have come in. Before I answer those, I wanna remind everybody that you have a Q&A button at the bottom of your screen there. And if you would like to click that and send in questions, feel free, that would be perfect. We'd love to take those at this time. The first question I have, and I'm not sure even who this would be to, but it's what is the minimum camera and software that would be recommended to be able to do cardiac PET inside of your program? So what does that look like in terms of minimum requirements of the equipment? I can take that one. I put it in the Q&A. So basically the short three prompt checklist would be you need PET gating software, you need EKG, and you need PET dynamic acquisition software. Obviously each vendor would tell you what you need or what you're missing. You let them know what you wanna do, but that was just a real simple checklist we had. For us, we also needed to update our single via, which is where we read the rubidium PET, and we had to update our software just to be able to do this as well. But basically the vendors are gonna be the best to tell you what you're missing, but you definitely need gating software, PET dynamic acquisition software, and EKG. And for the second part of the question, I would need to defer to Dr. DelCizian. Yeah, that's definitely a Dr. DelCizian or even a Brendan question. And that is how will PET CT compete with CCTA with FFR? So do you do PET with coronary flow reserve or myocardial blood flow or CT with FFR in terms of moderate or high risk patients or low risk patients, patient selection? You could even touch on the clinical aspects as well as maybe the reimbursement aspects of the two different modalities. And maybe from the clinical perspective, we'll go to you, Dr. DelCizian, and then Brendan, maybe you could follow up with your thoughts on the clinical as well as the operational and business side of that. Dr. DelCizian. Thanks, Joe. It's a tough question because as you know, you have to follow the guidelines and CTA, FFR has also been recommended as an alternate way of looking at anatomy and physiology. The experiences vary from readers and sometimes with CTA, you have to send it out and get the floor reserve information a little bit delayed. Where with Ravidium PET, as I said, it's done within 30 minutes, quantitation blood flow images and report is done immediately. And so the patient throughput and patient management is much faster. There's been several direct comparisons between CT, FFR and PET. And just to kind of remind everybody, the FFR criteria itself used nuclear as the gold standard to come up with the criteria of FFR. So at this point, I think that it's tough to say which one to use or not. Obviously, those of us who are very familiar with nuclear have used it and transition from spec to PET, see a lot of advantages in physiology and transitioning is much easier and quantitation is done pretty promptly, as I said, within 30 minutes. But others who have not been in nuclear at all have started with CTA and they may feel more comfortable with CTA and FFR. Okay, thank you so much. Brendan. Yeah, I certainly wouldn't dispute any of what Dr. D just said on the clinical side. There's obviously a cohort of patients that perhaps are going to be better served by going straight to CCTA. However, what we found with the partners of ours that utilize both of the modalities, a lot of times the patients go from the CTA to the PET camera. And so, take of that what you will. But just a quick synopsis of the economics, I think that CTA has a little bit of a ways to go, I think to be really practical, particularly in the outpatient setting, just the way that it's reimbursed right now, particularly in comparison to PET and even in comparison to SNAC. So that's a factor as well. Okay, well, thank you both for that. Again, all questions available through the Q&A tab at the bottom of your page. There's a question I have, which I think maybe it should go to you, Don, because you've been through this process from startup to actually seeing first patients. So you make the decision, you say, we're gonna do PET and then to being able to actually get patients to start to flow through. What does that look like in terms of time and what does it take for your organization to make that happen in terms of operations or workflow or investment? What does that look like to get started? So for us, it took us about six months from start to finish. We had to learn a couple of things along the way because we were already doing SPAT. We didn't think we needed to do certain things like update software and things of that nature. We thought, okay, well, we already do stress tests. We already have cardiologists rotating through. We thought it was gonna be just an easy conversion. I will say we're also a practice that does CCTA with FFR. And with PET, we were able to get up and running and the carriers had, believe it or not, a better understanding of herpedium PET. We're still teaching them about FFR and that there's a cost associated with us sending those images out. Whereas with PET, the majority of our patients were Medicare age and Medicare kind of, by the time we started doing it, even though we were somewhat of an early adopter, we weren't the first. Medicare already had a familiarity with submit with the claims and all that. So it was pretty easy from that perspective. So I would say if a place is already doing, spec, if they already are doing stress tests within their facility, it can be done between three and six months. And the more organized you are and the more buy-in you have, the closer to three months it can be done. Got it. I appreciate that. That gives some perspective in terms of the lift and getting your organization aligned around it. Another question we have here is about, and maybe this references some of your final slides, Brendan, so that's why I'm gonna steer it to you. It says, how many patients do you see your sites do a day on average? Good question. They probably average out somewhere between seven and nine. We tell folks when you're starting, just try and take it easy and do a patient per hour. And that's totally achievable with a new tech, someone who prepares the patients and gets them on and off the bed. As you get your feet under you, you build better workflows around the pet lab. And certainly when you have more buy-in from everybody in that office, you can get quicker. And so on some of the newer snappier pet CTs with the faster electronics and processing, that time can be shrunk down to, I don't know, as little as like 32-ish minutes per study, maybe even a little bit less if you're really humming. Okay. So about a patient in an hour getting started and you can certainly shrink that as you develop competency. So that's a good answer. Thank you for that. And so Joe, I mean, I can just stop in. Since I'm the chief of the division of nuclear medicine, we are fortunate that we do both cardiology, oncology. So places like ours with Rubidium, given that we can do images in five to 10 minutes, we can do patients between oncology patients within 30 minutes. So we actually use the camera very efficiently. As the oncology patient is leaving, you bring in the cardiac patients. And by the time you're injecting FDG, you're gonna wait for the FDG to recirculate. You finish the Rubidium, the patient comes in. So if you're running both oncology and cardiology, Rubidium is an ideal tracer to complement to your oncology volume. So now I'm gonna ask a question that's not been asked yet. If you do that, and if you're splitting cardiology and oncology, how many cardiology patients can you do in a day when you're trying to balance it with the oncology imaging? So Joe, I mean, obviously, the oncology is a huge driver of PET-CT. So we have several weeks of waiting period for oncology patients. So it's tough to answer that question because obviously you wanna balance both cardiac patients and oncology and not favor one over the other. So a pure cardiology practice, obviously, doesn't have that dilemma. But for us, we have to balance both demands because both of the information are critical. One starting with chemo radiation as soon as possible, cardiac patients needing the cath or investigation as soon as possible. So you have to use the facility as efficiently as possible. Wonderful. And just briefly, what we've seen out in the field, there's cases like Dr. Dilsizian's where they're using it intermittently between oncology. The Goldilocks scenario really is if you can condense that oncology volume and just free up a day. And like I was saying, it could be even as little as a day a month. I think a day a week works best for people just from a logistics and scheduling standpoint. And then we've had folks that even just kind of started there. They knew they didn't have the budget maybe for a cardiac only PET CT lab, but they started there and they've since gotten the budget for the lab because they proved the concept with this daily video. So you can do it as an adjunct to oncology where you're sliding patients in between throughout your day. You can stratify it across just one day and you have just cardiac on that day, which is kind of convenient to sort of get everybody thinking about cardiac one day a week at least. And then it can be a walk before you run type endeavor. Well, that's very helpful. Let me ask another question that's come across here. And we've had a few actually come in. So I don't know that we have the time to answer all the ones that we're not going to be able to get to. I think maybe I could ask you guys to provide some answers too and we'll send them out in a follow-up email. But one that I would like to is talking about camera upgrades. Do you need to do typically camera upgrades to do coronary flow reserve? And what does that look like? So if you walk into a situation like Dr. D's where you've got the shared camera, what is it that we need to do to make sure that we can do CFR or a shared scanner? What do we need to do? And then not only what do you need to do, but do companies like CDL help with that? Yeah, we absolutely help with that. And to answer your first part of that question, it's more of a processing upgrade than a camera upgrade. So the camera has all the hardware, of course, that it needs. And you can kind of think of CFR as almost like a first pass study if you're familiar with that modality. And so it's just collecting the counts and sending them to a different piece of software to process them. And so that's like a terminal that we'll put in your lab. And yeah, we absolutely can get you through that process. Last question, and then we'll part. I guess this would be for Don and Dr. D and Brendan, maybe from what you've seen other programs do, but do you do, the question is, do you do cardiac inpatients or just outpatients for PET-CT? So are you operating on both sides, inpatient and outpatient with your imaging for cardiac patients? Well, I'll take that. For us, it's all inpatient at this point. We have an outpatient cardiac MRI, PET-MRI that is, and we haven't started there yet, but obviously, again, we're trying to prioritize patients that would need PET-MR for brain imaging, for example, for pediatrics, for oncology versus cardiology. Since PET-CT is already well-established, it's hard to kind of transition there except for research purposes as an outpatient. So at this point, we're doing all the cardiacs as an inpatient. Don? Yeah, I'm the exact opposite. So we have a true dual-use PET-CT machine. We do about 25 to 30 diagnostic CTs in a day, and we sprinkle in oncology PET. We condense our schedule so that we have a dedicated day for rubidium. And I just wanted to mention, if I failed to mention it earlier, is that we commit to one day a month, but there's a lot of flexibility because we're working with cardiologists and there's a lot of schedule changes. So there's months where we might do two or three days, and there's months where we might have to skip a day. So when you're planning this, I don't want anyone to think that it's like a set in stone the second Tuesday of every month, and if the cardiologists are on vacation, I'm stuck with the generator. So we do all outpatients, and I think you just have to think about volume, but understand that there's a lot of flexibility. And when you need to add a day, which is an exciting time, it's pretty easy. We've never not been able to add a day. Got it. Well, any parting thoughts? I appreciate all three of you joining us here. We are at time. We're actually over. So thanks to everybody who stayed. If there's any final thoughts, otherwise we'll close out and terminate today's webinar. Sojo, I just want to say that this was a fantastic webinar, and I appreciate to be part of it. I want to remind those who are participating that if you want to expand your practice, cardiac PET is growing beyond perfusion imaging. I showed you 12 different scenarios, microvascular dysfunction, cardiac metabolism for sarcoidosis, for viability, and there's new traces for cardiac amyloidosis. So if you transition from SPECT to PET, not only are you going to do what you're doing already with SPECT, but you're going to expand other applications that you couldn't do with SPECT imaging. Thank you for that. Don, any parting comments? No, just thank you. And if anybody has any questions, they can reach out to me direct. Also, we're in Northern New Jersey. If anybody ever wanted to come and check out, do a site visit, see how we do it. I know it's a little intimidating. The main thing is you have to have your med techs excited about it and having radiologists or cardiologists who are also interested. It was an exciting time for us. Nobody felt like we were pushing something new. We wanted to be the first in the area and we embraced it. And CDL CardioNavics helped us along with Siemens, who's our equipment vendor. But everybody was excited about it. And I think it's worth a shot. It's not a huge commitment when you're talking about a rental versus purchasing a generator. Thank you, Don. Appreciate it. Brendan? Just to say thank you to all the people that attended. Thanks to Dr. Dilsizian and Don for being a part of this. And thanks to you, Joe, and to MedAxiom. Very well done. Well, thank you all so much. Appreciate you sharing with us today and telling your stories and to the rest of the MedAxiom community and guests. This will conclude today's webinar and we will send a follow-up email with a link where you can access this and share it with others inside of your organization. And thanks again for attending. Bye-bye. Thank you, everyone.

webinar

cardiac PET

rubidium-82

PET imaging

SPECT imaging

diagnostic accuracy

myocardial perfusion

coronary flow reserve

CDL CardioNavix

imaging techniques