Accuray Incorporated (ARAY) Earnings Call Transcript & Summary

Everyone who's on Zoom as well and joining this session. We have a very rich agenda today where we're going to hear from key opinion leaders -- hi, Marie, who will be talking a little bit about innovation and the future of radiation therapy over the coming years. So you can see from the agenda overall, we're going to start out with Dr. Jean-Philippe Pignol, who's our Global Chief Medical Officer, Chief Technology Officer. He'll be talking a little bit about clinical evidence. And then we're going to go into 3 different care areas and prostate breast and neurological indications. For prostate, we have Dr. Peter Orio, who's here with us. He's the Vice Chair of Radiation Oncology for Dana-Farber at Brigham and Women's. We also have Matthew Witten. He's our Chief Physicist, Department of Radiation Oncology and Director of the CyberKnife Radiosurgery at NYU Langone. Then when we're talking about breast, we have Frank Vicini, who's the National Principal Investigator at GenesisCare Oncology, as well as Brian Collins, Radiation Oncologist at Tampa General Hospital. When we speak about neuro, we have Dr. Joseph Neimat, who is the Chair of Neurosurgery and the Director of Functional Neurosurgery at University of Louisville Health. And we have with us live today, Chris Loiselle, who's the Director of Stereotactic Radiosurgery and the Tumor Institute of Radiation Oncology at Swedish Medical Center in Seattle. And then we'll follow up with Seth Blacksburg, who is our VP and Chief Medical Officer for the Americas region, who will be handling the Q&A. Just very quickly, just a cautionary statement. We'll be talking about the future. And so this presentation is really exclusively with that in mind. And just a reminder that we will be having an earnings call on November 2. A little bit about Accuray. Obviously, we are a global leader in technology for radiation therapy. And really, our mission and our goal is to ensure that we improve the lives of patients diagnosed with cancer and neurological indications. And we do this by prioritizing an investment back into research and development so that we are developing innovations and technology, so that we're expanding the curative power of radiation therapy and delivering differentiated solutions to advanced care. Many things happening, I think, in radiation oncology. We see this as an incredibly exciting time for radiotherapy. This is a noninvasive modality that the technology innovation and clinical innovation has progressed and advanced so much that radiation therapy is really becoming the potential as a first-line therapy. A number of different things that are happening within this space, the first one being shorter and more powerful treatment regimens. And so again, radiation therapy getting more sophisticated, so that patients don't have to have 35 sessions or fractions of radiation therapy, they can have it in 5 or less. What that means, though, is that we need to deliver ultraprecise technology that has the precision and accuracy to deliver safely. One of those areas of innovation is in imaging and improving the diagnostic quality of the image for both treatment planning and delivery, and that's something that we've introduced on ClearRT for the Radixact. Correcting for changes. Patients change, their anatomy changes in between sessions, but it also changes during delivery. And so being able to collect -- correct for motion management as well as changes that happen to morphology between sessions will be critically important to delivering SRS and SBRT. Powerful partnerships. Accuray has really prioritized industry partnerships to make sure that we have best-in-class solutions that we're putting together with our high-precision technology to make sure that we are advancing care by leveraging the expertise of other companies. If you were on the show floor today at ASTRO, you would have seen that we have introduced a comprehensive breast package in our partnership with C-RAD. We have an online adaptive partnership with RaySearch as well as treatment planning. And we also have a neuro partnership with Brainlab. We also announced on Friday a very powerful partnership with GE Healthcare and that will help us to put together precision diagnostics with precision treatment. But technology is not enough. Clinical innovation has to happen as well. And certainly, the importance of changing clinical paradigm through evidence generation but also advanced education will be critical to moving the modality forward. So with that, I'm going to introduce Dr. Jean-Philippe Pignol, who will talk a little bit more about clinical evidence and some of the work that we're doing with global key opinion leaders across the world.

Thank you very much, Suzanne. Can I have the next slide? So this slide, yes, thank you very much. So Seth and I, we have decided to put a little bit of context, a bit of framework about the intervention you're going to hear from key opinion leaders. Accuray, as a chain, who have 2 absolutely superb platform. One is Radixact who deliver probably the best conformal treatment from head to toe. And the second one is the CyberKnife, which initially was for intracranial and extracranial, and that can treat almost, in a strategic way, SBRT hypofractionation almost any tumor site. But there's a little bit more to this platform. The Radixact, as you can see, deliver in [ ethical ] fashion. Next slide. And the CyberKnife deliver on -- with a robotic on a nonconformal way. So our engineer has pushed with a couple of trick. And because it's [ ethical ], I've been able to obtain near CT image quality on the machine based on the ClearRT. And our engineer also, because we have a robot, have been able to implement on the CyberKnife Synchrony, meaning that the robot move with motion management and so you can really reduce the margin. Next slide. And the great idea, and this is the vision of Accuray, is actually those 2 visions are merging, meaning that we have now available on the Radixact the best image possible but also motion management. We have motion management on CyberKnife, and in the future, we also will have a very good CT image quality. And that's enabled us to be having the 2 platform being able for SBRT, ultra hypofractionment, but also because you have an image quality to do the plan when the patient is on the table. So real-time adaptive and online motion management, the [ RO ]. So those concepts seems a bit abstract. They seem to be complex. Next slide. And that's the same thing when you're a clinician, you say, "Oh, that's a great machine. But what I'm going to do for it? What's important is it's okay to have a [indiscernible] what kind of course are you going to make? And this is where, since the year, Accuray has engaged deeply with key opinion leader and organized a series of think tank, and we have way more to come, in order to really see -- to pitch what is the clinical narrative. So we had people from MD Anderson, from the Memorial, from Dana-Farber, from -- one is here in the room, from Stanford, from GenesisCare, [indiscernible], [indiscernible]. We always get the head of the department, the key opinion leader, the people who know how to think out of the box. And out of the think tank, what we try to have is to get some idea to fine-tune our product, to develop some advanced training to enable people to be bold and to dare using the technology to the maximum, but also to develop registry trials. Next slide. So where are we focusing our think tank? We focus our think tank on clinical application. And this is a typical example of the referral that you get into a relation [ course ] department. The vast majority is breast. About 1/4 of the patient that come are breast. Then you have prostate, you have lung. You have others, which is mainly palliative. Then you have GI, head and neck and everything. Next slide. What is important for us is our think tank, we are focused on 80% of the patient. The time where all those patients were treated with C-arm with the old technology is over. Now we want our best machine to be able to offer the best treatment to those patients. And the good news is that most of those treatment, we see more and more people delivering SBRT and hypofractionation. Next slide. For example, my friend, Matthias Guckenberger, who's the Head in Zurich, I was very proud in Erasmus when I treated 20% of my patient with SBRT, but he said, no, now 30% of my patient are treated with SBRT. Meaning 1 machine of 3 should be the ultimate SBRT machine. And Jürgen Debus, my friend from Heidelberg, say also, and that's for the ClearRT, that he believe that in 5 years, 100% of his patient would need to have some form of adaptive radiotherapy. Next slide. And that's why we are currently now starting and we want to offer and we're going to start this year to develop some registries on prostate, on breast and also on functional brand registries because we do believe that there's a way larger market for brain indication, not in tumoral, so benign indication. Next slide. So a last slide to tell you, why do we need registry? What's the purpose of a registry? We're not here to prove the benefit of radiation oncology because we know that radiotherapy work. We have some competitors that are trying some trial on the pancreas with chemotherapy with or without radiation. Doesn't make a lot of sense because we know that radiation work. In fact, what we want to do, next slide, is to test new domain. For example, if we consider that CyberKnife is good to treat tumor into the brain, maybe for functional brain disease like tremors or refractory opioid pain, which are resistant. Also, we do believe that -- next slide, that because there's so much more that the Accuray technology can offer, there might be something very bold we can do for prostate, like mimicking a prostate brachytherapy in 2 fractions, treating the patient with 2 fractions. Or -- and you're going to hear from my friend, Brian Collins, who's now online, why don't we use also our machine to ablate, to replace the surgery for breast. Last slide. Finally, the registry, they have the biggest advantage. They are easy to set up. I mean you can make them multicenter, so you can train a large number of people. And finally, they also help for adoption of the new technology because if you contribute to the development of evidence, ASTRO push for reimbursement as an SBRT, for example, of CyberKnife. And I think the best example of success based on registry, next slide, was the [indiscernible] registry. Now I would like to pass on to Seth because Seth, you're going to introduce our speakers.

Thank you so much. So as a brief review, there was an update that was published this month in The Lancet Oncology on the large Phase III PACE-B trial, and it demonstrated superiority in terms of long-term quality of life domain in those patients treated with CyberKnife-based prostate SBRT relative to linac-based SBRT. And so we'll now have Drs. Orio and Witten to speak about prostate cancer.

Hello. My name is Peter Orio. I'm the Vice Chair of Radiation Oncology for Network Operations to Dana-Farber and Brigham and Women's Cancer Centers. I'm an Associate Professor at Harvard Medical School. I'm a Director of Prostate Brachytherapy for the institution. So what is the status of prostate SBRT? Over the past several years, prostate radiation has moved from conventional fractionation to hyperfractionation as a standard of tier. [indiscernible] radiation given fewer fractions, and this curing paradigm has been proven to be noninferior to oncologic outcomes and toxicity. Data is now emerging on extreme hyperfractionation otherwise known as SBRT. SBRT, by definition, is 5 or fewer fractions of radiation we treat men with prostate cancer. How many people are eligible? Well, it's estimated that there's about 250,000 cases of prostate cancer diagnosed in the U.S. every year and probably about 150,000 of these patients receive radiation for cancer. SBRT has strong data to support treating men with low and intermediate risk disease. However, good data is emerging to treat high-risk cancers as well. You can envision that almost all men could have monotherapy SBRT or SBRT as a boost in combined modality therapy. How do I see SBRT evolving for prostate cancer patients? I really do believe it's probably going to be the predominant way we treat men with prostate cancer in the future. And my clinical opinion, the question often comes up, how small the margin can we safely use. So we encompass known disease, we encompass setup uncertainties and we don't miss tumor. The question is multifactorial in terms of it really depends on how many fractions we're doing. If we're doing very few fractions, each fraction is critical because there's no blend of radiation. You have to be perfect each and every time, especially if we move SBRT, say, from the 5 treatments we currently give to 2 treatments in the future. As we think into the future, I mean one of the questions which emerges, what is going to be the workflow? What are we going to be doing for patients? And I guess I'm getting to the age now I realize we all become patients. And I think your vision starts to change when you know you're going to be accessing some of the health care that you've been providing to your patients for such a long time. You start to realize the personal experiences and you start to realize when you're watching patients and you're talking that it's very difficult for people to make time to go to the doctor. That's why we see advanced stage diseases because there wasn't ever time to access the medical system. Well, the same thing goes for protracted radiation treatments. We don't want to have someone to come back and forth multiple times. It's financially toxic. They might have to miss work, they might have children they're trying to raise. It's very disruptive [indiscernible]. And so the workflows that one can vision is how do we make it more comfortable and more convenient for our patients. How can we get to one-stop shopping, if you will, when we can see a patient potentially simulate them? And if we have, say, CT-based linacs with diagnostic quality CT and the ability to take an MRI state to use it to that diagnostic quality CT and do that on the same day, you can envision a time we could do the simulation, we could actually do the planning and we can actually treat the patients all at once, one trip to the physician's office. And it might be that we have to do it again because there might be 2 fractions they require. But if it's just one, it's one and done. We've given them all the convenience that they require. And we also know, too, that prostate changes during treatment. So imagine just doing this real time, and we're getting the right target at the right time and providing the right tier to the right patient with the right technology. And we're doing it conveniently, but we're doing it so it's curative, and we also are going to minimize toxicities. To me, that's the win-win. So where do we go from here? We have all these incredible workflows that we're considering. We're considering tighter margins, quick treatments, daily, maybe 1 or 2 fractions or radiations to cure prostate cancer, doing such for meticulous motion management, paying attention to our margins and providing the right imaging to get the job done. We're also going to try to figure out which patients require adaptive planning. We're trying to figure out how to provide the best care possible to our patients. And this is what really speaks to the points of inventing -- investing resources, if you will, into registries and registry trials because there's so many questions that need to be answered, but they need to be answered with academic vigor. And we need to make sure that whatever outcomes are and what we decide to do, it's the right thing. So actually, soon, we're about to assemble an international panel of physicians from all over the world to really work through some of these questions to challenge them, to see where we need to go. Not any one individual is going to have all the right answers. When we put all these minds together, I know we'll find solutions and we'll go in the right direction.

I'm Dr. Matthew Witten. I'm the Chief Physicist in the Department of Radiation Oncology and the Director of CyberKnife Radiosurgery at NYU Langone Hospital Long Island. What's my impression of ClearRT? Well, it's a game-changer, really, because we're used to radiation therapy machines having these cone beam CTs, which are sort of subpar images. They're -- if you will, they're sort of a Polaroid, not a great -- sometimes the images can be blurry. They're not -- the image quality is pretty poor. But what struck me about ClearRT is the second we put a patient on and scanned it, it was pristine and sort of like you're looking through glasses that don't quite work and then you put on other glasses and everything is really sharp. And the ClearRT images are very, very sharp. So what's exciting about that is your treatment is only as good as how well you can image. And if you can image better, then you can position the patient better that leads to greater accuracy and the patient setup and greater accuracy than some weird radiation. So we're really excited about using ClearRT. There's no question that these images can be used for adaptive planning. And what we're doing with adaptive planning is each time the patient comes back, the tumor might have had a response and gotten smaller or the anatomy might have changed a bit. So you see this change each time the patient comes to be treated and we capture that by taking these ClearRT images. And certainly, once we calculate the dose distribution on these images, we can use that to treat the patients that day. And that's ultimately tailoring the dose distribution to how the patient's anatomy is situated that day. That's the key here. That's the golden ticket to adaptive radiotherapy and that's what we're going to do. But I see this -- this could be sort of a one-stop shop machine eventually, and that would be a paradigm shift in how radiation therapy is delivered. Because right now, what we do is the patient comes for what's called the simulation. So we put the patient on a CT scanner, the patient's scanned, then the patient goes home for a week or 2 weeks, while we do a treatment plan, generate a treatment plan on that CT that we just took. Then the patient comes back for the first treatment several weeks later and then we image the patient and we treat the patient. What I think is exciting is the potential here is to take the patient and have a one-stop shop. Patient would come in that day. We put the patient on the Radixact. And since the ClearRT images are just as good as any radiation simulation -- radiation simulator you'd ever buy, you could scan the patient on the Radixact, even leave them on the table, plan the case and then treat the patient right then and there. So there's no necessity of having the patient come back for multiple appointments before he or she commences radiation therapy. So that would be unique and exciting. What does Synchrony add to the picture in the context of adaptive radiotherapy? Well, I think that we need to expand. We have a very narrow focus, I think, for a long time on what adaptive radiotherapy is. Adaptive radiotherapy is considered now, well, what happens to the patient's interfraction, between fractions, when you come from one appointment to the next appointment? So where we would capture that by imaging the patient and doing a -- generating a treatment plan to capture the patient's anatomy that day. But really, that's only half the problem because adaptation is not only adapting to how the patient's anatomy changes between fractions, but also what happens to that anatomy during the patient treatment, intrafraction. So the potential here is to tackle both those issues and deliver adaptive radiotherapy not just how the patient changes between fractions, but actually during -- real time, during treatment, by imaging the patient during treatment with the ClearRT Imaging apparatus. So this is, again, a complete paradigm shift in the way we think about adaptive radiotherapy and what I think is really going to change outcomes here because we have the ability now to image the patient during treatment and adapt to how the patient -- how the anatomy changes during the treatment. So that is, I think, going to be extremely exciting.

So there are clinical and practice pattern trends, which favor treating a smaller region of the breast with radiation, that's referred to as partial breast irradiation. And there's even some data which suggest that doing so on a CyberKnife-based platform where the beams come from different angles may translate into improvements in long-term survival due to treating a smaller volume of heart and lung with radiation. We'll now introduce Drs. Vicini and Collins, who are speaking about breast cancer.

My name is Dr. Frank Vicini. I'm a Radiation Oncologist. I work for GenesisCare. I have been involved in breast cancer research and treatment for the past 30 years. So I've been actively involved in research to help to find better ways to treat patients after lumpectomy. When we see patients in the clinic, some of the first questions they ask us are -- I do partial breast irradiation. What are the advantages of partial breast irradiation versus traditional whole breast radiation? Is it just a convenience issue, in other words, shortening -- reducing the amount of time to receive their radiation therapy? And the answer is, it's not just convenience. When you focus the radiation on a much smaller area in the breast, we'll avoid treating large segments of the breast that don't need radiation and also the adjacent normal tissues, which are the lung, the heart, some of the blood vessels and some of the nerves and things like that. And so in effect, you are reducing significantly the amount of what we call nontarget breast tissue. In other words, the tissues that don't need radiation, partial breast irradiation reduces that area and in so doing reduces the side effects, as I mentioned. And also because there's less scatter radiation, the potential to reduce long-term side effects from the radiation and even potentially in some very rare cases, some second cancers, they're dramatically reduced. And certainly, so the heart doses are reduced, the lung doses are reduced, doses to nontarget tissues are reduced. So there's many advantages far beyond just convenience to partial breast irradiation. And so -- and that's really what we go over with our patients is it's not just a convenience issue. It's definitely a reduction in morbidity from the treatment. And we've seen this in pretty much all other cancers. We've seen a dramatic reduction in the areas that we treat as we develop more complex treatment schemes, 3-dimensional treatment. And so what we've done through the years is to improve the quality of the radiation that is delivered with the external beam techniques. When we first started to do the external beam techniques to deliver partial breast irradiation, we were very limited as to the angles that we could deliver the radiation from, and we were very conservative and we used traditional angles that we would use when we were treating the whole breast. But as we develop better and better technology and better and better techniques, we learned that we could come in from multiple different angles, not the traditional tangential fields as they were called. And the more angles you would come in, the less the dose to the normal tissues surrounding the target area. In other words, by delivering the beam from an unlimited amount of angles, you're focusing radiation only on the tissues that require it and only minimally delivering radiation to nontarget tissues. And you can do this now with some of the newer technologies, the robotic technologies coming in from noncoplanar angles, multiple angles. And what we've seen is that as you will increase the sophistication coming in from multiple more angles, you reduce the toxicity, you reduce the dose to the normal tissues that don't require radiation therapy. So as the technology has gotten better, as our techniques have gotten better, so have the results gotten better, not just covering the target but avoiding what we don't want to treat. And that's the real inherent value of some of the newer technologies such as the CyberKnife, such as robotic technologies, that's really changed what we're doing. And many times, we can focus the radiation to within millimeters, avoiding nontarget tissue and barely tell the patients receive their treatment. And again, it's done just in a matter of days as opposed to the traditional 6 weeks. And as I was mentioning earlier, doesn't require brachytherapy, an invasive procedure. So again, better technology, reduced toxicity, improved outcomes and reduced long-term effects of radiation therapy. And in so doing, of course, improving the quality of life for patients. And ultimately, where I see this going is down to perhaps just one day of treatment. In other words, we can go ahead and do all the planning and treat the patient the same day. And in some cases now, we're even exploring. This is a little bit more investigational, ,not even doing the surgery called ablative therapy. As I'm sure you may have heard in other cancers, just using the radiation without removing the tumor, just coming in with the radiation and getting rid of it completely and not requiring any invasive procedure for the patient. Now that's just a few more years away. But it just gives you an idea of the ability of this technology to reduce the side effects, to pinpoint the radiation therapy, just opens up a whole different way to treat breast cancer.

So my name is Dr. Brian Collins. I've been working with the CyberKnife for over 20 years, have published many, many papers on radiosurgery outcomes with the CyberKnife. I recently relocated to Tampa General Hospital, where I am a Professor of Radiation Oncology for the University of South Florida. And I'm also the Co-Director for the newly -- the new TGH Radiosurgery Center that's in development. So breast cancer is a very common illness in the United States. Approximately 300,000 women a year are diagnosed with breast cancer. About 20% of that 300,000 are elderly women with early breast cancer. In the United States, patients with breast cancer are screened heavily with mammogram. Therefore, the majority of tumors that we find are small spherical tumors. These tumors are perfect for radiosurgery. We can give very high doses to these small targets to eradicate the cancer and not find demonstratable damage from that radiation. So it's -- the ideal target is for older women with benign breast tumors that are small and can be treated well with radiosurgery. So I'm very excited about the registry that we're working on. I've been treating breast cancer for 20 years. And it just seems that there are some patients that have very curable tumors that are scarred from the treatment. So for the last 10 years, we've been working with the CyberKnife and SBRT to try to like develop a treatment that has the minimum toxicity with a very high success rate. We're very excited about this protocol because radiation oncologists, in general, feel like we overtreat elderly woman with breast cancer, and we'd like to lessen the toxicity, if we can, for such treatment. So we would -- the CyberKnife is an ideal treatment for this group of patients. And that's why we developed the registry in order to treat and track the outcomes of this group of patients with the CyberKnife treatment. It is our hope, by doing this, we can eradicate these highly curable tumors with the minimal toxicity for older women. But over the last decade, radiation oncologists have been using new technologies such as the CyberKnife to eradicate tumors with radiation alone. We have done that in lung cancer. We've done it in prostate cancer. We are now ready to do the research for breast cancer. We can eradicate these small tumors with radiation alone, and I don't see any obstacle to doing it now that the preliminary research has been completed. The name of the registry is the CyberKnife Geriatric Stage 1a Breast Cancer SBRT registry. We will likely start approving patients in the spring of 2023. Yes, so I'm very excited about offering radiosurgery to elderly patients. There are several reasons why -- there are several advantages to it. First of all, there's no surgery. Elderly patients don't tolerate surgery the way young people do. It takes them months to recover even from the smallest surgeries. This is a very exciting thing. And it actually simplifies the treatment. This is not a surgery, then radiation. There's just radiation. These are major advantages for the patient and the caregivers as well. The more complex, say, treatment is, the more expense there is for the health care system. With breast radiosurgery, we are hoping to treat patients with one therapy, not surgery plus radiation, just radiation alone. And that will be less expensive, dramatically less expensive.

Cancer-related pain refractory to opioid medication and benign tremor represents significant issues in the population for which there are limited therapies. The use of radiosurgery to manage these conditions is powerful and doing so on a CyberKnife unit has significant advantages over other radiation modalities with a frameless submillimeter precise treatment that can be directed to appropriate regions of the body. We'll now introduce Dr. Neimat, who will speak about managing neurological conditions with CyberKnife-based radiosurgery.

My name is Joseph Neimat. I am a Neurosurgeon, specifically a Functional Neurosurgeon, which means that I have focused my career on treating disorders of brain function, like movement disorders, like psychiatric disease, like different types of pain from various disorders. And so I think a lot about the function of the brain and how to intervene to improve that function when diseases take that away from us. So I was recently treating a patient who had essential tremor. Essential tremor is a disease where a movement disorder, where patients have uncontrolled shaking of their arm, their face, their voice, and it can be tremendously disabling, especially as it increases as you get older. And so this patient had not been able to feed herself, had not been able to speak clearly, often had difficulty drinking from a glass of water, had difficulty writing or typing. And so for all of those reasons, we were eager to treat this patient. Unfortunately, given her advanced age and her other medical problems, surgery was not going to be feasible for it was not going to be safe. And so in cases like this, CyberKnife therapy, a noninvasive radiosurgery, can really make a difference. It allowed us to target the right area of the brain that would let us treat that tremor, to control that tremor better. And so really what would otherwise have been an impossible situation allow us to treat her disease and make her happier. So we're very excited about that therapy. And the ability to do this in a noninvasive way, I think, is a tremendous innovation and really an advantage to this therapy. I was impressed with how easy it was, how quickly we were ability to -- we were -- how quickly we were able to adapt some of the targeting techniques that we've used for other surgical therapies and I think to arrive at really a wonderful target for this patient and a good therapy. So we performed that procedure just about 3 months ago. And although it's still early to comment on the overall ultimate response that you'll have, she's already seen substantial improvement, and we're very hopeful that she will continue to improve. In other patients, I've seen nearly complete responses in their tremor and tremendous control that can be achieved. SRS stands for stereotactic radiosurgery, which is really a wonderful innovation where you can essentially point beams of radiation from hundreds of trajectories in order to focus that radiation on a very precise point, as small as just a few millimeters. And in doing so, you're able to obviously treat tumors, as it has been done traditionally, but also to create small points of lesioning in the brain that alters the function of the brain. And that, I think, curiously, was one of the original designs of this system. The innovation of SRS was created before we had the wonderful MRIs and CT scans that we have today that allow us to treat tumors. It was originally designed to treat functional disorders, to treat movement disorders and psychiatric disease and chronic pain. And so the ability now to do that again and perhaps really leverage all of the wonderful imaging technologies we have to do that more precisely, I think, is a fantastic opportunity. So we have among the group of surgeons and radiation oncologists who have been discussing the possibility of using SRS and CyberKnife to treat functional disease. One of the really interesting possibilities is the ability to use that to treat very severe pain, pain from advanced cancer, and that otherwise is often not treatable and I think routinely goes untreated. You have so many patients now whose pain is treated with high levels of opioid therapies, medications that make them tired, but it really doesn't address the core pain that they're having. And that's a huge burden for those patients. It's a significant anxiety for them and for their loved ones who are taking care of them. And so the possibility of creating a registry where we actually begin to use the CyberKnife to treat that. There is a procedure called a hypophysectomy or radiosurgical hypophysectomy which is targeting a very small portion of the brain, at the base of the brain, that is known to contribute to the sensation of pain, to the interpretation of pain by the brain. And so we're adapting a very old literature on treating this surgically and now doing that in a noninvasive way so that we could potentially really help patients who are suffering from the worst kinds of pain. So to do that across many centers, across many providers would allow us to really gather information about the efficacy of that treatment, the ability to help patients. The reason I chose this field is, I think it is one of the most dynamic areas of neurosurgery really of any area in medicine. We have -- since the time I was a resident seen the innovation of deep brain stimulation of the application of stereotactic therapies, which are therapies where we sort of probe into the brain and intervene in the brain's function. We can now do that in many, many more diseases like movement disorders, psychiatric disease, chronic pain. We're even beginning to do that for things like Alzheimer's, like uncontrolled obesity, like problems with addiction. And so I think we are sort of on the precipice of a tremendous revolution in neurosurgery, which will be based on these therapies. And I think the ability to do that in a way that is noninvasive is very much what everyone is thinking about right now.

So we'll now welcome to the podium Dr. Loiselle. Dr. Loiselle is the Director of Radiosurgery at Swedish Medical Center and he'll be giving us a talk today on radiosurgery for the treatment of neurofunctional disease.

Thanks very much, Seth. It's a pleasure to be here today. We're discussing technology in the role of stereotactic radiosurgery in neurofunctional disease. May I have the... And many have asked me why CyberKnife for stereotactic radiosurgery. And I think it's important to rephrase the question as why not CyberKnife for stereotactic radiosurgery because CyberKnife is the ideal platform for stereotactic radiosurgery. Let me tell you why. It is a combination of nuts and bolts, hardware and software and other factors. But this is a recurrent theme that I've heard through many speakers today. CyberKnife delivers robotically unlimited angles of non-coplanar beams, with super fine collimation, real-time imaging, frameless immobilization. They have unparalleled treatment planning software with highly sophisticated inverse modulated treatment planning, a new release called VOLO that has optimized our patient throughput and our planning time. We have isocentric and non-isocentric treatment planning and targeting capability. And on the software side, Accuray is pioneering relationships with other software experts like Brainlab in order to bring us more technological capability in MR fusion, tractography and target delineation. From the patient standpoint, CyberKnife is an ideal noninvasive experience. I often joke with patients when they say, what is this treatment going to be like? And I say, "Well, it's going to be like going to a spa. And I say like they're going to cut the cucumbers and put them over your eyelids and they say, really? And I say, well, forget about the cucumbers, but it is like a spa. And from the delivery team standpoint, CyberKnife is an intuitive, safe, efficient tool for us to operate when we're doing high-dose image-guided radiosurgical treatment. In the landscape of radiosurgery, I just wanted to tell you my thoughts on where does CyberKnife stand. There are other dedicated radiosurgical platforms like Gamma Knife and more recently, ZAP. But I feel as though the CyberKnife has 99%, if not 99.9% of all of that capability now. And I also think that CyberKnife has a lot of overlap with traditional linear accelerators made by companies like Varian and Elekta, where we can do highly specialized SRS, but we can do some hyperfractionated regimens just like a LINAC. And I feel like CyberKnife has really closed the gap at both ends, and I feel like now is really the definitive full body stereotactic platform, still with some flexibility for some other applications. Let me tell you about stereotactic radiosurgery in the landscape of functional disorders where I specialize. I use radiosurgery a lot for the indications of essential tremor and sometimes Parkinson's-related tremor. I treat pain conditions such as trigeminal neuralgia frequently. And at other centers, many use stereotactic radiosurgery to treat conditions like epilepsy, depression, chronic pain or chronic cancer-related pain with a procedure known as hypophysectomy, that's what Dr. Newman was talking about. As a physician and user of a tool like the CyberKnife, I can also tell you that you can simply do things with the CyberKnife that you cannot do with any other radiation platform. You can put a very small spear of super high dose radiation anywhere in the body in a way that clinically is extraordinarily meaningful. So this is an example of a patient where we did a peripheral rhizotomy of a lumbar nerve route. I don't think this has ever been done before. But a referring physician called and said, "Hey, the thing you do for trigeminal neuralgia, when you treat this pain syndrome for a nerve coming off the brain, can you do that in the lumbar spine? And I said, "Well, yes, we can. And we did and it worked. And these are new indications that we come up with all the time because of the capability of the CyberKnife. We treat at our center a lot of patients with medically refractory essential tremor. And let me tell you this is a serious and severe condition. It is highly prevalent and patients have many choices for therapy, stereotactic radiosurgery, deep brain stimulation or another technology known as focused ultrasound. But overall, stereotactic radiosurgery is a convenient, effective, cost-efficient noninvasive treatment option that many patients increasingly choose. At our center, we have treated patients from nearly all 50 states in many countries with radiosurgery for this condition known as essential tremor. And here is a writing or drawing sample of a patient treated at our center. And on the left, you can see what their writing or drawing sample looked like before treatment and what it looked like after. This is like the hip replacement of radiation oncology. You're taking people who can't walk and who are confined to a wheelchair and you're bringing them out to play soccer with their grandchildren. So you're taking people who can't eat, who can't drink, who can't button their shirt, operate a zipper, put on makeup, handle a newspaper. These are mostly people from the generation who still read a newspaper, but they can't even read it. And you're reversing all of that. I mentioned other possible treatment options such as deep brain stimulation and focused ultrasound, and allow me to compare and contrast these different modalities with radiosurgery. And first, let's talk about deep brain stimulation. With radiosurgery, there is no hardware. And this is an important medical consideration for many people with other underlying health conditions such as diabetes and other common conditions that affect a more elderly population. There's no operative risk, there's no infection. There's no possibility of lead breakage or leads eroding through the skin. Once you have a DBS stimulator in place, you cannot have an MRI below the neck ever again. There are no battery changes, there's no maintenance. There are many work considerations for treatment of essential tremor. At our center, we have treated many from the fields of law enforcement. We have treated individuals from the FBI, the secret service, the police and even our local sheriff's office. All of these individuals had severe tremor, and we're no longer able to qualify with their service weapon because their tremor was so severe. Now they're not allowed to handle high-powered rifles with a DBS stimulator in place for concern of breaking the lead. So stereotactic radiosurgery is a potential optimal treatment option for individuals like this given these special work considerations. From a lifestyle standpoint, we treat individuals who are involved in jujitsu, kayaking. These are areas where you cannot have a pacemaker for the brain with leads running through your neck. Stereotactic radiosurgery is an optimal treatment option. We treat patients from all over the world where individuals do not have access to movement disorder neurologists to maintain the battery of their DBS system for the rest of their lives. And finally, our procedure is a convenient few-hour treatment procedure. Some have looked academically at a cost comparison of stereotactic radiosurgery versus deep brain stimulation. The conclusion of which is that radiosurgery of the ventral intermediate nucleus, which is the target in the thalamus for doing a stereotactic treatment for essential tremor, is 40% less expensive than unilateral VIM DBS. And this is only looking at the hospital costs of the initial procedure. This doesn't even take into account, no follow-up versus lifelong follow-up with a DBS stimulator in place, which would severely and drastically bring the cost equation in favor of stereotactic radiosurgery. Radiosurgery in comparison to focused ultrasound. Well, with radiosurgery, we do not see any typical short or intermediate term neurologic side effects, which patients often experience with focused ultrasound. We do not need to shave the head, which is necessary for focused ultrasound. We have no skull thickness considerations with stereotactic radiosurgery like one sees with focused ultrasound. Our procedure is a very straightforward process. If you live in Nicaragua and you want to come to us for treatment of essential tremor, we can generally guarantee the treatment and guarantee your dinner reservation somewhere in Seattle that night. It is a very easy process to go through. Radiosurgery is about 95% durable, which is a high watermark in comparison to focused ultrasound, and we have treated thousands of patients with stereotactic radiosurgery far more than ever treated with focused ultrasound. We have quite a track record. I would like to thank, and I think that Accuray inspires us with support of a tremor registry for the treatment of patients with essential tremor and other neurofunctional conditions. I think this kind of support is very important for a number of reasons. First, treatment standardization. I have treated hundreds, if not thousands of patients with neurofunctional disorders, but many have not. And I think it's important for Accuray to bridge users like me to users in other geographic areas who may not be quite so sub-specialized, I think that we need to continue to report results on many patients treated, and I think these registries help us identify next-generation treatment advances. Overall, CyberKnife is an ideal platform for the treatment of neurofunctional conditions, stereotactic radiosurgery indications for neurofunctional conditions are broad And from the physician user standpoint, that being my standpoint, Accuray continues to innovate stereotactic radiosurgery, treatment planning and delivery, really at a lightning pace. And with so much input from me and my team, which I think is really the secret sauce is that feedback loop between the development of the hardware and the software and how we're using it in terms of our clinical indications. Thank you.

So we're going to have some time for Q&A. I'm going to invite Dr. Orio also up to the podium. We have Suzanne, Dr. Loiselle. And we do have Dr. Pignol and Dr. Collins to be assumed to answer questions, which I'll help moderate. We have questions that are coming in right now, so I'm able to see them real time.

We do have a first question, which is how fast is SBRT growing in the United States. Will this be a catalyst for adoption of Accuray technology and I'm happy to actually feel that one. There was a recent publication in Practical Radiation Oncology. It's a white paper by ASTRO, which estimates that roughly 20% of radiation that is conducted is stereotactic body radiation therapy. And when we look at longitudinal trends over the last decade or so, seems to be roughly a doubling in the utilization of SBRT. Accuray and CyberKnife have virtually been seen as synonymous with stereotactic radiation. I think the technology itself really positions itself to remain a leader in that domain.

Josh J. from Cowen. Just asking you about the comments by one of the physicians about intrafraction adaptive treatments and modifying, being able to run the ClearRT, CT at the same time as radiation treatment delivery. I wanted to just better understand the engineering hurdles that are involved there and just how far along Accuray is in that process.

Yes. I think what Dr. Whitten was talking about really was Synchrony, which is the ability to adapt the treatment delivery in real time as a result of tumor motion. So that is a completed product on both of our platforms.

Okay. Is that a potential pathway in the future? I thought it may not be, but just in terms of having real-time imaging, CT imaging while the delivery.

We're looking to see if we have any of our engineering folks, but certainly, that's an area if it adds additional information to the treatment, we will absolutely do it.

Thanks for clarifying. And then just maybe a follow-up just on the recent...