bioAffinity Technologies, Inc. (BIAF) Earnings Call Transcript & Summary

All right. Welcome, everybody. I hope everyone is having a great day. I want to thank you for joining NAVREF for today's discussion on the future of lung cancer screening for veterans. My name is Rashi Romanoff. I am the CEO of the National Association for Veterans Research and Education Foundations, also known as NAVREF. NAVREF represents the network of VA affiliated nonprofits who are responsible for facilitating and executing VA's extramural research program. We have a really exciting session today coming up focused on one of the biggest challenges facing our nation's veteran community, lung cancer. Lung cancer remains one of the leading causes of cancer-related death in the United States. And unfortunately, veterans face an even greater burden due to higher rates of smoking, chronic lung disease and service-related environmental exposures. While the VA has made significant advances in expanding lung cancer screening and treatment, too many veterans are still diagnosed after the disease progresses at advanced stages when treatment options are more limited and outcomes can be challenging. The VA has built one of the nation's largest integrated health care systems, creating a unique opportunity to rethink how we deliver lung cancer screening at scale, especially for a population with some of the highest risk factors of this disease. So the opportunity before us is not just to find more lung cancer, but is to find them earlier when we have the greatest chance of saving lives. Earlier diagnosis can mean more curative treatment options, fewer invasive procedures and a better quality of life for our nation's veterans. Today's webinar is going to dive in and explore emerging technologies that have the potential to change the trajectory of lung cancer among this community. We'll discuss innovative approaches that build upon VA's existing low-dose CT screening program, including mobile screening, advanced functional lung imaging and AI-enabled noninvasive diagnostics to help detect lung cancer earlier, reduce unnecessary invasive procedures, improve access for veterans and eventually streamline care across the VA health care system. We're fortunate to be joined by experts who are helping to advance these innovations, and we're excited to explore how these technologies can improve outcomes for veterans, while making lung cancer more efficient and affordable for all Americans. First up, I'm very pleased to invite Dr. Amy Rohs from Philips to talk a bit more about how Philips is leveraging mobile CT imaging to advanced lung cancer screening for veterans. Dr. Rohs, I'm wondering if -- before you dive in, if you want to give the audience a brief introduction as well, that would be great.

Fantastic. My name is Dr. Amy Rohs. I am a pulmonary critical care doc as well as a veteran. So veteran care and the issues that follow them through their lifetime are really special to me and something that I strive to eradicate as much as possible and find ways to eradicate it across the globe in all populations.

Excellent. Do you want to dive in?

Absolutely. So without wait, just introducing myself again. I'm Amy Rohs. I'm a pulmonologist, critical care doc and a veteran. I want to talk to you today about something near and dear to my heart and that's lung cancer and shortness of breath and that overlap in the veteran population. Veterans are a really tough bunch. And when we are serving, we believe we are unstoppable. And I think we are, but while we may base our identity a lot throughout our lives on the service that we performed, it is not all we are, who we will become. It's only a chapter in our lives. And we move on to the next one. But not all veterans are that lucky that the impact of their service is still telling a story in their bodies long after they've completed their service. Two of these stories veterans bodies can tell are lung cancer and breathing difficulties and these go hand-in-hand. Historically, not only do veterans have a higher rate of smoking, but they also have an increased risk for chronic lung disease and inhalational exposures to toxic agents. Veterans have a 25% to 76% higher risk of lung cancer than the general population as well as a lower survival rate due largely to the stage of the cancer when it's diagnosed. Across the VA, 67% of lung cancers are diagnosed at Stage III or IV, substantially higher than late-stage presentation rates for any other screen detected malignancies such as colorectal cancer. Advanced stage diagnosis limits your curative options and it also increases the mortality, morbidity as well as higher utilization of invasive procedures and greater strain on oncology and pulmonary services. Further, they are at increased risk for COPD, interstitial lung disease and coronary artery disease. And if you look at the younger veteran population, there's an increased prevalence of shortness of breath and dyspnea on exertion. In the post 9/11 veteran population, up to 8.3% have reported clinically significant shortness of breath. These veterans sit at an intersection of the lung cancer screening and symptom evaluation, and we'll talk about why this is important. And it's that intersection between screening and symptom workup where the symptoms can take the driver's seat and where a whole lung CT scan strategy can improve the speed to actionable clinical data and improve clinical coordination. So what do I mean when I say they sit at that intersection of screening and clinical work out? The VA lung cancer screening tool is for asymptomatic patients. It is predominantly based on -- if you go back a slide, please? Perfect. Thank you. It is predominantly based on age and smoking history and aims for those patients between 50 and 80 years of age with at least 20 years of smoking history and that's been smoking -- either are smoking or are -- have been -- quit within the last 15 years. That goal is a decision-making process that is shared, that includes smoking cessation counseling, lung-RADS reporting registries and programs for coordination. However, veterans being at increased risk for shortness of breath as well as other concomitant lung diseases can present with symptoms or possibly other lung diseases. Now they are no longer in the screening pathway, but the diagnostic pathway. Now it involves more appointments with studies of the heart and lung as well as radiographic evaluation and when necessary specialty work up. But what happens is that lung cancer screening falls off to the side, and they're no longer a part of that registry with or the follow-on. Next slide, perfect, stay right there. While lung cancer screening is a strong push from VA, annual screening only counts if the veteran can actually get to it. Unfortunately, it is not universally available within the VA and still many are being sent out to the community. There are an estimated 86,893 veterans that live in areas where they do not have lung cancer screening. Further, there is a thirtyfold variability from [indiscernible] screening rates. What makes this concerning is that only 35.1% of veterans diagnosed with lung cancer have undergone screening at all. And this highlights that gap in risk identification, patient engagement and longitudinal follow-up. Next slide, please. Now before it has taken to mean that I think the system is faulty, it is not. It is an evidence-based and well done. It just has obstacles, and these obstacles are 2 intersections, and those are where screening need symptoms and where care and screening goes out into the community. Next slide, please. Just like in real estate, location, location, location. As we discussed before, screening access varies dramatically across VA regions and states with some areas having no VA lung cancer screening sites despite substantial number of eligible veterans. Further, rural veterans were less likely to complete annual repeat screening than nonrural veterans. What is the operational impact of this? It means that distance leads to decreased likelihood of screening, adherence to screening, follow-up of that screening and those patients are more likely to have incomplete evaluations. So what can we do? Well, one of the things that we can look at is mobile CT scanners. And those mobile CT scanners can add some very -- care to those areas that do not have access to CT scanners. And the way I like to look at it is we take what's there and then we augment those assets, right? Because what they've done, they've worked very hard for it in those areas. We don't ever want to say that they're not doing the best they can. But sometimes we all need a little bit of help in how can we do that? We can do that with mobile imaging and virtual or cloud-based resources that increase veterans access to care in multiple ways. First, the obvious is we bring the imaging to the veteran, not the veteran to the imaging. Second, with virtual imaging platforms, an example being Philips Radiology Command Center, you can augment the VA's ability to have these studies read and interpreted within the system. This means they don't go out to the community. The care doesn't get fragmented, everything stays within the VA doors. Third, if needed for further evaluation of symptoms and more disease processes, a clinical application or overlay to those films can be done, which may allow for a more robust evaluation of both patients being screened as well as those requiring diagnostic workup. Next slide, please. In conclusion, veterans carry a high burden of lung cancer and dyspnea related pulmonary disease. This means those patients fall at that intersection with the lung cancer screening that can make it possible that the screening for lung cancer could fall to the side as we're working up their diseases. But with a whole-long approach as well as a mobile approach and a virtual and cloud-based technology approach, we can make a difference, which may also lead to diagnoses that have not been found that may lead to better cares for these patients. Thank you.

Thank you so much, Dr. Rohs. That was fascinating. And I want to ask any attendees, if you have questions as we go, we're going to do all the questions at the end. But if you look at the bottom of your screen, you should see something that says Q&A, you click on that. I know -- I see we already got a question. So feel free to use that and then we'll hold and sort of go through the presentations and then do the questions towards the end. So next up on our panel of experts, I'm thrilled to introduce Dr. Michael Nicholson with Robert Wood Johnson Barnabas Health Medical Group. Dr. Nicholson is going to talk a bit about how noninvasive testing allows veterans to engage in a home-based approach to early detection. Dr. Nicholson, over to you. And if you want to just say like next slide as we go, I think that will help the folks kind of help drive from behind the scenes.

Sure. Absolutely. So I'm Michael Nicholson. Thanks, Rashi, for the introduction. Pulmonary and critical care doctor, trained at Temple Lung Center, specialized in advanced lung disease and lung transplant and at a high-volume pulmonary practice university affiliated in New Jersey with a lot of oncology and thoracic surgery connection, a lot of exposures in our area, smoking veterans as well. So a lot of high-risk patients and high-risk nodules. And when we're talking about this topic, the #1 step is exactly what Dr. Rohs touched on, which is getting that -- those surveillance numbers up. All of the people who meet the criteria, that is our goal, to get them their CT surveillance. When you do that, you do have an influx of nodules, and you need to know what do we do with these nodules then? And that's kind of where CyPath comes in. It's a noninvasive test to help you detect which patients and which nodules are more worrisome and require more work up. So next slide. That's my disclosure statement and next slide. So CyPath serves an unmet need currently in the pulmonary field. Nodules are becoming more prevalent. Lung cancer surveillance programs are becoming more robust. We're finding incidental CT findings from ER visits. Coronary artery calcium screening are revealing nodules. And clinical guidelines are really lacking in what the next steps are when we find nodules. There's basically repeat CT, get a PET scan or biopsy it. The question is not finding the nodules, the question is what do we do when we find them. Next slide. And what we want to do is we want to increase our pretest probability. Every decision we make in medicine is deciding on our pretest probability of what the best next step is, what is the probability this is cancer in order to go for a biopsy or a surgery. And so a patient that a lot of pulmonologists would be familiar with, the gentleman who's high risk, had a low-dose CT, had a 6-millimeter lower lobe -- left lower lobe lesion, he has emphysema, high risk for a pneumothorax from a transthoracic needle biopsy, difficult location for a robot and a patient who is 85 years old and may not want to do more work up unless you can prove its worth his time. Next slide. And so when we're risk stratifying this patient, currently, our tools are lacking, and they give us a lot of different information. So there's multiple calculators you can use. There's the Mayo Clinic Solitary Pulmonary Nodule calculator, Brock University Bayesian inference calculator. And when you look at just for this patient all of these different numbers anywhere ranging from 1% to 12.5% chance of malignancy, all recommending different next steps for the nodule. And when you're committing someone to a biopsy, it's a big decision. So you go to the next slide. So for example, what are our typical next steps? A PET/CT is not going to be sensitive or specific for a 6-millimeter nodule. A robot-assisted bronchoscopy is going to have a 60% to 70% yield, which may be less in a 6-millimeter nodule. That data is from nodules altogether with a 3% pneumothorax rate. And a CT-guided biopsy is going to have a 60% to 90% yield, probably at the lower end of that based on the size for this patient and almost a 30% pneumothorax rate, which is probably on the higher end for this patient with his emphysema. So before committing to them to this procedure, which takes up health care resources and may expose them to unnecessary risk, CyPath serves a role in helping to risk stratify this nodule. Next slide. It's going to give us another data point. It's independent of imaging. It's not replacing our imaging, it's saying we have our imaging, let's get some more information to base our next decision on. Next slide. And so the way that CyPath Lung works is it's a sputum test and it's not actually looking for cancer in the sputum, what it's looking for is it's looking for changes in the lung chemistry and microbiome that reflect that cancer may be in the vicinity. It's run through flow cytometry and powered by an AI, which has been trained to detect changes in epithelial cells of the lungs associated with lung cancer being in the vicinity. Next slide. What's really wonderful about CyPath Lung, as physicians, sometimes it's difficult to get our patients the tests and the care that they need. When it comes to CyPath Lung, in my office, I fill out the requisition form. I send it to CyPath, and they take care of the rest on their end. They assign each patient a patient coach. They mail them the kit for collecting sputum, and they talk them through how to do it over the course of 3 days, and then they collect the package from the patient and bring it back to their own lab. So it's one of the few things in medicine that you can just kind of sign the form, know that you're getting good data and it's being taken care of. It doesn't require much effort on the side of the patient, which is something that they like as well. As you can see, the numbers there, we'll talk more about, high sensitivity, high specificity and specifically very high negative predictive value. Next slide. And this is kind of our flow as we see a patient in the clinic, if they have a chest CT, it gets sent to their home, the CyPath kit, it goes to the lab and then you as the physician who ordered it gets a report. Next slide. And these are some of the parameters that we mentioned. We won't go into a lot of detail about that. When the sputum goes through the flow cytometry, it's looking for different things such as the amount of apoptosis occurring, porphyrin uptake, which is associated with cancer cells, and making sure that cells like debris and mucus are washed away and we're only studying viable lung epithelial cells. Next slide. When you send the CyPath, after you get the report back, it will give you a reference range, and it will show you where your patient is on that reference range based on the AI algorithm and tell you what the likelihood of the malignancy is. If you're to the left of the 0.5, it's unlikely to be a malignancy. If you're to the right of the 0.5, then it's likely a malignancy. Next slide. So if we go back to our patient James, in our case study here, he had a CyPath Lung done, which showed unlikely to be lung cancer. He had serial CT scans instead of a robotic biopsy. And on follow-up CT scans, there was no nodule. So in this case, CyPath served exactly the role that I've seen in my practice it served many times, and that can be helpful when we're getting so many nodules on our low-dose CTs, preventing an unnecessary procedure. Next slide. What's great about CyPath Lung is that in the studies, it's been shown to be consistent across nodule sizes. The best numbers are in those nodules between 6 and 20 millimeters, but there is no size cutoff for the nodules. That's important because that 6 -- especially 6 to 1.2 centimeters, you see the sensitivity of 100% specificity near 90%. Those are the nodules that PET/CT may not be sensitive or specific enough to pick up. So when you're not able to rely on PET/CT, CyPath is a great adjunctive test to give you some more highly respectable data on the nodule. Next slide. It's also shown to be consistent across types of tumors and stages. Our goal is to catch them all at Stage 1. Unfortunately, that doesn't happen, but CyPath still performed equally as well regardless of the stage. Next slide. When you compare CyPath Lung to a PET/CT itself, you can see that the sensitivity, specificity are close with the specificity better in CyPath Lung and the negative predictive value being very powerful in CyPath Lung, almost 95% if we're assuming a lung cancer prevalence of 10%. And that's what was assumed in the PET/CT studies as well. So you don't have the same restrictions in terms of the nodule size as you do in a PET scan and you're not sending the patient for an image that they have to schedule, may not show up to, and wait months to have done. It's a test that can be collected from them in a week and sent back to them with your results to give you some really good data on what the next step should be. Next slide. This is just some data comparing it to other diagnostic tests and other organ systems, things you'll be familiar with. So the FIT test, which is like our Cologuard test, mammogram, obviously, and then a PSA with our normal cutoff there that's usually used for PSA. And it's showing that in most cases, specificity, sensitivity, negative predictive value, positive predictive value, they all line up pretty equally with these other highly utilized tests in other organ systems, cancer-related screenings and surveillance and that nature, and performing better in some cases. Next slide. An important part of this is the savings to the healthcare system. So this was actually a study done by a VA Medical Center, and it showed that incorporating CyPath Lung into a lung surveillance program following low-dose CT scan could save significant amount of money to the healthcare system, about $370 million for Medicare patients and almost $900 million for commercially insured patients. So covering both the clinical patient and financial aspects. Next slide. When you compare it to other tests available for lung cancer, noninvasive tests. Nodify Lung is one of the main ones. That's a serum test. And it does have a lot of limitations, including it's limited to use in nodules 8 millimeter or larger. Patients may have specific risks that they can't use. There's a cancer diagnosis within 5 years. It excludes it, but none of these apply to CyPath. You can use it on any nodule size. The patients can have had other cancers in the past. They can have type of risk factor for lung cancer. And it's never going to give you a -- we're not sure indeterminate result. It's always going to tell you, as long as the patient produced an adequate sample, is this unlikely or likely to be malignancy. Next slide. This is a practice algorithm that a lot of the pulmonologists who have been using CyPath in our area have begun to adopt and kind of where it can fit in very well for your nodule program. And you can see in the corner there, we talk about the negative predictive value of nodules less than 20 millimeters is 99%. Positive predictive value is 61%. So whenever you are finding these nodules on a low-dose CT and a CyPath Lung is ordered, it's helpful both in the setting of nodules that PET/CT is not working up or nodules that PET/CT is working up. What it really does is gives you another data point to help make our next decision better and supported by more evidence. It serves many purposes. It helps the patients to have peace of mind when there is a negative result. If they're waiting 6 months for another scan, this is not on their mind for the next 6 months. I wonder if that nodule is growing. It's more of, okay, this said it's unlikely to be malignancy. It's 99% accurate. So I feel good about this. On the other end of it, the more nodules we get, we can find as many nodules as we'd like, but we are limited in our capabilities of biopsying and intervening on these nodules. We need to reserve biopsies for patients who are high risk for patients who need them, who have a higher risk for malignancy. So CyPath helps you to stratify which patients need a biopsy or a surgery more acutely and utilize that resource of interventional pulmonology and thoracic surgery better than just biopsying any type of nodule that shows up, not exposing our patients to excess procedures, adverse effects and allowing us to make the right decisions for next steps for them. Next slide. So in summary, it's a noninvasive test. The patient produced sputum over 3 days. That's the extent of what they have to do for the test. It has a very high negative predictive value depending on what nodule size you're using, but overall, 96%. It's especially useful in those nodules that are less than 20 millimeters. It gives you crucial diagnostic information to help you decide the next step, understanding what your patient's probability of having lung cancer with their nodule is. It provides them with a lot of peace of mind, and it informs your shared decision-making. There is a lot of resistance to pursuing procedures. But if you have a positive CyPath Lung, sometimes patients are more willing. Even though you tell them, hey, this is not 100% accurate as a 61% positive predictive value. But the fact that it's positive moves you, in my mind, into a higher risk category that we should intervene instead of just watching and waiting. And the final step is that it makes the lung cancer screening programs more efficient and more cost effective, allowing us to serve more patients better from a clinical and financial perspective. Next slide. Thank you. I hope that was informative for everybody. Looking forward to taking some questions.

Thanks so much, Dr. Nicholson. That was great. [Operator Instructions] Our final panel of experts, we're going to turn things over to Dr. Greg Mogel with 4DMedical. Greg is going to be talking about the latest in advanced imaging for lung cancer screening. So Greg, over to you.

I hope you can hear me well. Thank you so much, NAVREF, for inviting me to speak. And it's an honor to follow the presentations that I just heard. I am Greg Mogel. I am a practicing radiologist. I am a former Army Major trained at Tripler Army Medical Center and have been involved in active duty and veterans care my entire career. So to everyone on the phone, and Amy, thank you for your service, of course, which is continuing. My passion around population health and the use of imaging in reducing human suffering is the thread of my career, and I'm lucky to be the Chief Medical Officer of 4DMedical. Next slide, please, where we've gone from the possibility of expanding access to advanced diagnostic images specific to the lung, the heart and the lung, but I'm going to really focus on lung today. In this age of AI and AI companies and imaging, there's a lot of noise, a lot of excitement. I just want to establish that, that as a company, we've been doing this a long time. We are utterly committed to pulmonary health. We will not be -- we will not have a stroke algorithm next week or an ankle fracture algorithm next month. Everything we make and everything we do is based on extending people's health in cardiopulmonary sense. So we've been at this quite a long time. Everything I'm going to be presenting to you today is our FDA-cleared commercially available techniques and technologies as a former military physician, very sensitive to the idea that we are not suggesting experimenting on our service members or our veterans. These are tools that are currently available in the real world. Next slide. Have some really basic core mission principles here, which is that we need to meet the veteran where they are, the service member or the veteran, that where you find yourself with an illness should not represent anything to do with your course of care or your outcomes. Secondly, that with veterans, we need to provide care that's based on their service. We have information about veterans. We are lucky to have shared information systems, and to enter into the care of veterans with knowledge about where they've been deployed, what work they've done and everything that Amy described very clearly about some of the lifestyle issues that impact veterans and the fact that they are widely spread geographically throughout the country. It's important for every physician to realize that you are providing veteran care, not just physicians in the VA. Many, many of your patients are veterans. You may not even know if you're a radiologist or if you're a pulmonologist or whatever your specialty is. Every physician in this country is providing care to the people that have served. And I think we all need to be more mindful about that. Given the previous 2 facts, especially the fact that many veterans live in traditionally underserved areas, we have to maximize every visit. Every time we get hold of a veteran who's come in for any care, screening, treatment, we want to make sure to do everything possible to provide them as much service as we can to extract as much information as we can that might support them later without providing unnecessary tests or unnecessary radiation exposure, obviously. But our principles at 4DMedical are based on these issues. We produce software that takes existing imaging that's delivered in most cases, by a CT scan, by the CT scans that Dr. Rohs showed inside those trucks, and we leave nothing unturned. We take every piece of information that is on that scan from the veteran's lung function to its structure to the presence of nodules to future information that may be useful should that veteran have other historical facts in their record, such as having been exposed to toxic -- having toxic exposures during deployment. So we want to make sure that when we take that scan, we leave nothing behind on that scan that we bring it all forward. Next slide, please. So we've been talking about lung cancer screening here. I'm a passionate supporter of lung cancer screening. I actively read lung cancer screening to this day and have been involved in it since the NLST in 2014. As a country, we have about a 15% to 20% acceptance of lung cancer screening. That means 80% to 85% of patients who could get -- who are eligible for -- who have it indicated and who could get a lung cancer screening scan today for no cost are not getting it. That's way too complex a question to address in this issue. And the VA proudly has done much better than that, much higher numbers than the VA, but still less than half. And no one believes that the existing recommendations for who should receive a lung cancer screening today will be the recommendations in 1 year or 5 years or 10 years. There are publications everywhere that suggest subpopulations and veterans, first responders, firefighters, these are populations who are clearly at higher risk, as Amy has pointed out. So not only should we be getting more information and getting them more available for lung cancer screening using great technologies like CyPath that Dr. Nicholson talked about. But there's a lot of information on that scan, and we can't leave any of it behind when that veteran makes their way to the scanner. Please, next slide. So when I look at the CT scan of the chest, just a low-dose non-contrast CT scan of the chest Yes, there may be nodules. But less than 2% of patients who come in for lung cancer screening have fully actionable nodules on that screen. That's not bad. That's the way it should be. That's what screening is. But well over 10% to 30% have coronary artery disease, have signs of COPD, have other causes such as interstitial disease that may lead to breathlessness symptoms, which over 30% of veterans experience post deployment because there are so many causes of this. Some are pulmonary, some are not. Next slide. So we think it's absolutely critical to, along with the evaluation of nodules, which we've been discussing here, to make sure every veteran has clear quantitative reproducible documented evidence of the existence of emphysema. We have a specific technology that will do that. The existence of coronary artery disease, any underlying signs that suggest early or undiagnosed interstitial lung disease and of course, nodules. Each one of these is a tool that can be applied passively in the background and support the radiologist who's performing the reading. There's unfortunately a lot of variation among my guild radiologists and what's mentioned, what's not mentioned. These are very subjective findings that aren't always reported exactly the same way. And so having reports, next slide, please. For example, this is the analysis that comes from a coronary artery calcification score. You'll see it produces an Agatston score. This is from a low-dose traditional non-contrast CT of the chest, non-gated acquired on any CT scan, perfectly acquired on the scans from Dr. Rohs' mobile units. These can be -- these are calculated in the cloud, and these reports are returned immediately and the information can be included and actionable steps can be taken. I don't have time to show you every report for all of the conditions, but we have documented FDA-cleared reports for interstitial lung disease risk for quantitative evaluation of emphysema. Next slide. Along with that, we produce for smoking cessation, we produce personalized reports for patients that -- because really for a lot of people find lung cancer screening to be a powerful smoking cessation tool. And in many cases, this is one of the most effective ways to reach that point. Although many of these patients have quit, most of them have not quit and providing them actionable direct reports that can show them the impact on stopping smoking and support smoking cessation counselors in the large percentage of patients who have evidence of emphysema without a nodule. We don't want people who have significant coronary artery disease, who have significant emphysema, who happen to have come in for a lung cancer screening scan, who may be remote to a VA. I'm not particularly interested in visiting the doctor -- to go away and not realize there are other things they can do to improve their health long-term. That's good for the VA. That's good for taxpayers, especially bottom line, that's good for veterans. So we're passionate about not leaving any information behind, no additional radiation exposure. Next slide, please. Almost done. But the reality is that beyond lung health screening, that same CT scan, a CT scan that can be acquired on a traditional CT scanner, a mobile CT scanner without the use of contrast can actually be used to begin the treatment planning and even post-treatment assessment for patients who have already been diagnosed with diseases. They may have lung cancer and they may have a nodule that's identified. That is a patient who eventually is going to require a lot more testing that may require many other advanced imaging tools like nuclear medicine, ventilation and perfusion scans to determine the health of the lung for planning surgery, for identifying lung-sparing opportunities in radiation or therapy, patients with COPD who can now be treated with devices that didn't exist 10 years ago, endobronchial valves that they can't even begin to get assessed for without visiting an academic medical center that may be 4 hours from them. We acquired this information from their first CT, then multidisciplinary teams that may be located at a great remove from these patients now are going to have access for the first questions that need to be asked about treatment. And ultimately, something that I simply don't have time to address today, but a huge issue is the issue of toxic exposure of veterans, burn pit exposures, the issue of what is largely called deployment-related respiratory disease, variably called deployment-related constrictive bronchiolitis. This is a massive problem for veterans and the VA. Many patients, millions have been exposed, have signed up for PACT Act benefits. Triaging these patients, determining which ones have more traditional lung diseases like COPD, asthma or actually have deconditioning or cardiac disease. One of the greatest constraints that the VA has is its access to pulmonologists who have the kind of information and the advanced tests to take care of patients who may actually have toxic exposure. This will not be the majority of patients with symptoms because common diseases are common. But these patients take years and years to diagnose and currently are often only diagnosed with a biopsy. And I don't mean the kind of biopsy that Dr. Nicholson was talking about, talking about a surgical biopsy that has significant risks, significant impairments to the veterans. Next slide. So with these same CT scanners, we have additional technologies in the right cases where there's a history that's relevant, where there is chronic shortness of breath that has not been explained, where we can actually use these FDA-approved technologies, next slide to, for instance, show ventilation and perfusion maps just like a nuclear medicine V/Q scan, which is a difficult, expensive study to acquire that no one likes, not even nuclear medicine doctors in many cases. On an inspiratory, expiratory noncontrast CT scan, we can show quantitative and qualitative regional ventilation and perfusion. These are incredibly important facts to know about a patient to determine treatment options. Biomarkers are being produced that show specific patterns of ventilation and perfusion heterogeneity. We've recently published this in the Blue Journal, heterogeneity that suggests underlying primary lung diseases or suggest someone's success in treatment. Next slide, last slide. Well, actually, this is just another slide showing the traditional nuclear medicine scan on this patient, which was acquired weeks later, thousands of dollars and a great personal expense to the patient. Below is a perfusion. On your right, my -- your right, and a ventilation scan derived from the exact CT scan that the patient already had and shows areas of decreased perfusion, decreased ventilation that match the nuclear medicine scan. Next slide. So the message here is that these veterans deserve our care. They deserve all the care they can possibly get at every single visit. They deserve the information to be centralized, acquired close to where they are and acted upon in a centralized fashion by the best team. I think all the technologies you've seen today represent the future of pulmonary health for veterans. If we have only 20% to 30% of the patients currently being screened who should be screened and people believe it's much more, you're going to need every one of these technologies to actually see us get to the point of 100% penetration, which would be a dream come true for our veterans, for the VA itself and for the country. Thank you.

Thank you so much. I want to thank our panel of experts. I feel like I could talk to each of you all day long about the research you did. But that was a nice sort of like teaser of each of your areas of expertise, and I think sets us up for really great discussion. And I really want to thank Doctors, Rohs and Mogel additionally for your service. And I think feel free to answer the question sort of professionally wearing those hats or I have a couple of -- I might go off a little script from what I sent on some other veteran perspectives on all of this work. One question we received, and Dr. Nicholson, this is for you. The VA system it's been in the news a lot, right. It's facing significant demand. And some of this, I think, Dr. Mogel, you mentioned, with things like the PACT Act and having such a surge of veterans now coming into the VA. We know that this surge in demand can lead to challenges getting appointments and just getting in and diagnostic procedures. How do products like CyPath really help address some of those access challenges? And what role do you see it playing as we think about improvements to the patient care journey in this environment?

Yes. And that's a huge issue is the access to the appropriate technologies that Dr. Mogel touched on in detail. And it's funny, an oncologist in my area said something similar to me when I first started speaking to him about it. He said, and this is not a way that it's been studied or approved, but it's a way that people are using it. The oncologist said, I see this as the Cologuard of the lung. When I have people who don't feel like going to get a CAT scan of the chest, when I have people who aren't reliable for that, I can order this for them. I know it's going to get sent to them, someone is going to call them. It's minimal effort on their part. And at least I have a point of information in that. And if it's positive, I have a little bit more gusto in which to convince them, "Hey, you really need to get that CAT scan." So CyPath is not designed in a way to replace our standard screening, but it serves as an adjunct in each patient the way that benefits them and adjunct to each patient is different. So if that's then encouraging them to get a CAT scan, if that's encouraging them to get a biopsy, if that's avoiding a procedure, if that's avoiding unnecessary next steps, that's great. And it's a huge -- CyPath is huge for patient access the way that it's set up to be delivered.

Yes. And I wanted to ask, and this might be -- this is sort of a patient question because I think what was really interesting, Dr. Nicholson and Dr. Rohs, this might be more for you all since with the mobile screening and the at-home testing. Like what has the patient response been, right, to -- like, Dr. Nicholson, you said from the provider experience, you're like, this is great. I ordered it, it sort of all happened behind the screen and then was brought back to it. I'm curious if you could speak a little bit to how patients feel about interacting with this? And Greg, maybe even something for you to loop in. I love that sort of reporting back to the patient on like the state of your lungs, if you will. So just curious how -- not only patients and then maybe for Greg and Amy as veterans, how are veterans feeling about these new kinds of technologies? And in many ways, sometimes being first in line for them. But, Dr. Nicholson, I'll go to you first.