Telesurgery, Telemonitoring, & Immersive Reality — Mark Carol MD, SonaCare Medical

Is remote surgery a growing trend? Are robot-assisted surgeries becoming the norm? Whatever happened to Google Glass? Is da Vinci’s market domination ending this year? Join our next live webinar with Mark Carol, MD, neurosurgeon of 30 years and CEO of SonaCare Medical. Discuss what is holding back surgeons from embracing telesurgery, telemonitoring and what’s happening in the surgical technology industry that’s getting us smaller, better, interconnected, self-learning devices.

2018 trends in telesurgery and augmented reality:

  • common blockers to telesurgery adoption
  • examples of remote surgery applications
  • new players to watch in the medical device industry

See Mark Carol’s Telesurgery, Telemonitoring & IR summary post here.

Transcript (click to expand)

00:14 Q: Great. Okay, thank you everyone for tuning in for another episode of telehealth failures and secret to success. This week, we’re really privileged to have Dr. Carol joining us. He has a very interesting background from being a urosurgeon, become extremely successful, an executive CEO, and so on. So, again, pretty interesting to hear on what he has to say. In fact, one of the things we know, a lot of our audience member are physicians who are interested to become entrepreurs. I think it would be interesting to dive into something like a startup. I’m pretty excited. I guess, uhm, Dr. Carol, before we officially start, can you just share with us a bit about your background and how did you get into the medical field, getting into the sound of medical?

01:08 A: Sure, I’d be glad to. I went to in the early 1970s with the intent of being a actual physicist. I thought that meant doing physics in outer space. I had no clue beyond that. I got to college and realized that my brain wasn’t exactly cut out for that and started to focus more in the area of brain function, brain activity, and understanding uromechanisms of learning. In the early 70s, if you were interested in going in science, there was a durf of science specific funding available for post-graduate training, so you can go to medical school. And since I was interested in the brain, i went to medical school to become a urosurgeon. I trained and went into practice for only a handful of years after my training. I knew even while i was doing my training that I wanted to get into the area of technology development. And shortly after going out of clinical practice, I founded a small urosurgery company that played a prominent role in the development of stereotactic applications for brain. That led to work in steoreotactic radio surgery, which was the concept of the time of radiation in very precise doses to the brain. And that led to more generic work in the field of radiation oncology where I was one of the pioneers in the filed called intensely modulated radiation therapy. This became prominent in the 1990s and now is the standard of care for the way that we deliver radiation therapy for cancers. About, shortly thereafter, in the 2000s, I got involved into looking at energy ablation of cancers and that led me to join sonic care medical which, at the time, was called the US Heightrate. This was in 2014 as a chief science and technology officer and became CEO of the company in the early 2015.

03:20 Q: Is there something that is normally not in your official bio that people might find interesting? Do you like climbing tall mountains or hobbies?

03:41 A: I’m in my 7th decade and I still play soccer, competitively and at a national level. So, I guess that’s my alter ego. In my early days, I was a bazoom player, but now, focus, anytime that I have that is not devoted to my two young kids, I got married very late for to the business, pretty much is devoted to the love of playing soccer. Especially in, we play, we get together for, 4 or 5 days, and play 4 or 5 90 minute games, without much rest in between. So, you can only do that periodically over the course of the year, and you need 6 months to recover.

04:42 Q: We’ll have you present and then we’ll open to the audience to ask their questions.

05:13 A: So, I’m gonna talk to you today about an application that we’ve developed based upon DC to work with technology that we have for the non-invasive ablation of cancer. The company is called SonaCare Medical and we are based in Charlotte. And, our premier product at the current time is something called sonnablade. It is a means of doing prostate cancer or prostate tissue ablation transrectally in a minimally invasive manner. It’s an alternative to surgey or radical surgery. It’s been used around the world for about 20 years. Recently, it was FDA cleared for ablation of prostate tissue in the United States and has been being used in the US for about two years now. We use high intensity focused ultrasound. So, we have acoustic lenses, if you will, that focus sound waves just the way that you would use a magnifying glass to focus sunlight. At the vocal point of the lense, intense amount of heat is created. And, with human tissue, whether it is cancer or non-cancerous tissue, if you raise the temperature of the tissue to 60 degree C, for a minimum of a second, you will destroy that tissue. Again, whether it is a desirable tissue or a non-desirable tissue, it will be destroyed and therefore, very precise and accurate treatment delivery is critical.

07:09 A: Our procedure, for simplistic purposes, for the purposes of this discussion, can be divided into two components. The first is the insertion manually by the physician of a probe into the rectum. The probe is about 30 mm in diameter at the tip and you can see in this picture that there is a black area, that is where the acoustic lens is. The motors that drive this lens in and out, up and down, and it rotates are based inside the probe body. The electronics are in a separate console. And when this probe in inserted into the rectum and positioned correctly, it is then demobilized. At that point, the physician no longer engages with the patient. The physician engages with a computer system, where a plane is created to deliver the energy treatment to the target audience. And the plan involves physician interaction with the computer to monitor the doses being delivered, monitor the amount of heat that is created, determine whether that heat is appropriate or not for the tissue and make adjustments to the amount of heat that is being delivered. Now, what should be appearing from this description is that if ever there was a procedure that could be done remotely, it is our procedure. Once the probe is in place, the engagement wiht the computer system can occur inside the room, outside the room, across the hall, in the doctor’s office, or across the country. The second factor that is critical to understanding why we find DC to be so valuable to us, is that this is a learning curve intensive process. As is any computer program, as is any video game that any of you have played. You have to learn the controls, you have to learn when to intervene, when not to intervene, you have to learn to assess what is happening, make judgements as to what to, whether to adjust what you’re doing based upon what you’re seeing and then interact with the system to do that. There’s a learning curve involved here and there is a comfort level that develops over 10, 20, 30, 40 cases as the treatments are being delivered. It is prohibitably expensive to send doctors elsewhere to be trained. It is prohibitably expensive to send proctors to the physicians sites to train them. To, therefore, we were looking for a solution that would allow us to take advantage of the fact that we have a video game as a medical technology. And, not have to send people around the country, or around the world, in order to train new users.

10:39 A: Therefore, we work with DC to create something that we call sonalink. Sonalink is an inherit part of our technology. It exists with every single one of our devices and, basically, it allows a remote participant to engage in verbal and visual conversation with the surgeon delivering the treatment so that guidance can be given from afar as to how to proceed during the procedure. We do not allow the remote individual to take control of the procedure. We don’t have regulatory authorization to do that. But we do have regulatory authorization that allows me, for example, sitting in Charlottesville, to interact with Milton in Kupuccino, if Milton was delivering a prostate ablation, to guide him around the screen, to alert him about alarms for notices that pop out of the screen, to make suggestions as to what to do, to how to do it. Each one of our consoles that has been installed in the treatment room is equipped with a camera, with audio input so that not only can we screencapture through using DC, the information that is being displayed to the surgeon in the treatment room, but the remote individual can also see the surgeon and also talk directly with the surgeon and the surgeon doing the procedure can do the same thing to the remote individual. We also use this technology for diagnostics. So, if there’s a problem with the machine, we can have one of our tech people dial in using DC through the console, see what the doctor is seeing on the computer screen, interact with the doctor or with a biomedical technician at the hospital and advice them and guide them.

12:47 A: In addition to using this as a support tool, as you see on the right where a remote user that is knowledgeable about the technology is interacting with the physician delivering the treatment. We also use it a marketting tool, as an educational tool, but again, it’s assumed that I am coming out to the west coast. We have a salesperson there, we have a couple of physicians that are interested in seeing a live case in order to be able to understand whether this is a technology that they wanna use in their facility. Rather than sending those physicians from California, let’s say to one of our very active users and North Carolina or in Florida, we can alert the doctor in California to know that there will be a treatment being delivered somewhere else in the country. Working through the DC dial-in service, we can set up the connection that allows that remote physician on the west coast to observe the case being done in Florida and to interact with the surgeon doing the case to case questions, to get guidance and an understanding of how to proceed.

14:04 A: This is the sonalink network, as you can see here, it is relatively complicated. But down the middle, we have the various uses that we make with the technology, tech support, training, case observations, referral assist, and case support and consultation, so the last one we haven’t covered but I maybe an experienced user but I’m seeing a case that I haven’t experienced before. So, I can work through Sonacare and through DC, reach out to a physician somewhere else in the country who is free at the time, have them dial into my case, look at what I’m seeing on the screen and advice me as to whether there is something that I should be doing differently or alert me so something that I am seeing and explain what it is that I have seen before. We have remote users, we have people from sonacare, medicals that dial into tech support, we have experienced users that can provide this case support. We have general urologists who might want understand and observe a case. And we have referring physicians who may or may not be a urologist, interfacing with urologist to be able to understand what their patients are going through and how they may be better able to help the patients at the time in the future. We have local users, we have surgeons in training and we have end-users, and these all integrate with this network to provide full coverage for all aspects of marketing, training, tech support, and patient consultation.

15:43 A: We’ve also developed a sort of a next level version of this. We have embedded the sonalink technology in a virtual reality system or a heads up display system. Right now, I’m using the oculus rift. So that, the, by replacing the matic to the camera that we conventionally with DC, with a 3D, 360 degree camera, we’re able to provide to the user a full room view. So, rather than just looking at the computer screen or just looking at the doctor’s face, there’re actually able to look around the treatment room and get a better sense of all aspects of the treatment as it is being delivered. As you can imagine this requires a tremendous amount of bandwidth which most places don’t have. We are working with DC to determine how we can streamline those process so we can make this reality aspect of the training and participation a much more prominent portion of our commercial offering.

16:55 A: And this is an example also of where one can imagine a local version of the DC in operation, so we describe, so far in this presentation, DC as a interaction between the person doing the case and people remote from the case. But, in order to untender the physician from the computer, on which the information is being displayed, there’s no reason why one couldn’t use a virtual DC-link between the physician in the room and the computer in the room so that, in fact, DC becomes the interface, if you will, undertedering the physician, allowing them to walk around the room, to sit, to be outside if they need to, and doing this all in an immersive environment where they feel as if they actually are in the treatment for themselves.

17:56 A: In summary, we’ve been very excited about using this technology for our clinical application. It’s really a significant part of what we do. It’s not just a aid. It is not just there if needed. It is actually part of our product offering. There is a disposable component included, which is required to be part of our treatment and with the purchase of the disposable component, the physician doing the case gets access through DC to this remote oversight at the company’s expense. We pay DC for the connection, and the physician using the equipment is free to perceive without worrying about the monetary costs. We use it as a selling tool for our products, not just as a way for a potential customers to view an application, but we actually sell the customer on the fact that DC and the sonalink technology that we have is part of our product offering and that there’re buying more than just a piece of equipment. They’re buying continuous perpetual access to skills and knowledgeable individuals through remote access while they’re doing their procedures. Thank you very much.

19:27 Q: That was really really exciting by the way. I think some other members may not know much, can you describe how you use your method versus the other treatment methods? What are the advantages? Everybody should know about your..

19:50 A: Traditionally, prostate tissue is destroyed through radiation therapy or through a surgical intervention where the entire prostate is removed. The problem with those approaches is that they carry with them significant morbidity. Radiation therapy has long term side effects to any tissue and surgery has near-time side effects, secondary to disruption of nerve system function, the urethrae which is the tube space that runs through the prostate that allows urine to pass out on the body and the side effect profile for these procedures is relatively high. So, somebody, for instance with prostate cancer, that walks in and has radiation therapy, has a greater than likelihood with coming out with some deficit, secondary to that procedure. It may be erectile dysfunction, it maybe urinary incontinence, it maybe both, the percentages vary depending upon the skill of the surgeon and the radiation anthologist, but there’s a reasonable probability that this will happen. The technology that we use has the unique ability to be delivered focally. That means is that rather than treating the entire prostate because there are cancer cells in a portion of the prostate, with focal ablation, you are able to destroy only a portion of the prostate. That portion of the prostate that may have tissues that is undesirable. And by doing that, you’re sparing exposure of the rest of the prostate to intervention. That, in enough itself is also a lower side effect profile to the point where men who walk into the hospital, let’s say with prostate disease and is treated with out technology with focal ablation, they walk out of the hospital with their disease controlled and with the high likelihood that they will have no side effects, they’re able to go back to work the next day, they’re able to dance and play golf and ride their bike the next day. And they are able to go back to work. One of the things that people fail to appreciate in terms of about prostate surgery, prostatectomy, people would rather work before the six weeks and with our technology, you can come back to work the next day.

22:16 Q: In terms of like the market share, today, what percentage to radiation, what percentage the other industry, and what percentage are using your procedure?

22:31 A: With prostate cancer in the United States, there’s about a 160,000 patients diagnosed annually, about 20 to 30 thousand of those will be watched. They won’t have anything done specifically. The urologist will observe and determine whether the cancer is getting worse, or more extensive, and whether an intervention is necessary or whether it can be ignored. Of the remaining patients, about 80,000 will get prostate surgery, a prostatectomy. Usually done with a robot, the De Vinci robot, and 60 to 70 thousand of those patients will have radiation therapy. Our device, focal ablation for prostate, is used in a very very very small percent of the patients, for two main reasons. One is, because it’s only been introduced in the United States within the past two years. And second of all, because the urology community in general has not embraced yet the concept of treating only a portion of the prostate. In many respects, the treatment of the prostate is where the treatment of the breasts was 20 years ago, therefor if a woman has breast cancer, she would come in and she would get a mastectomy, or what kind of a treatment they would have asked. And, nowadays, approximately 80% of women who receive surgery for breast cancer receive a lumpectomy.

23:53 Q: How about in terms of cost of your thing compared to the other treatments? Are you more expensive?

24:04 A: The cost of the equipment is significantly less by an older magnitude. The cost of delivering the procedure itself is less, because it takes, in general, less time, it’s less intensive. The cost to the hospital, the reimbursement to the hospital is less than it would be with surgey and much less than it would be with radiation therapy, but to put it in perspective, if our technology and technology starts with ours is universally used in the United States to treat diseases of the prostate for which is it appropriate to use it on, it would say the healthcare industry in the United States over 5 years, approximately 6 billion dollars.

24:54 Q: That’s amazing. This almost feels like one of those things that the whole world should know about.

25:02 A: Well, from your mouth to their ears.

25:06 Q: I just feel like if something is better and cheaper, I just feel like yeah, I do agree with, it’s just one of those things, unfortunately the healthcare system, everything just, the innovations are much more slower than we would like.

25:20 A: Physicians are conservative creatures. There’s a reason why they call medicine the practice of medicine. It’s because physicians and surgeons especially like to deal with a practice many many times over. And there’s an nature medicine to new technologies until patients start demanding it. And we believe that ultimately, that’s what will drive this technology. Patients demanding that their disease be treated without significant side effects.

25:54 Q: That makes sense.

Additional Q&A with Dr. Carol

Q: Thank you for your vision and innovation that helps many of us consider potential new uses for VSee and optimization of tele-medical applications. As many of my colleagues are pre-occupied with medico-legal concerns – liability, malpractice, privacy, etc. — how is that addressed in this model?
– Bradley Dreifuss, MD FACEP (Emergency Medicine and global healthcare capacity development)

At this time, most of our users are concerned only about HIPPA compliance when using SonaLink (our VSee-based “product” for remote interaction). This is addressed by turning on the screen share after the startup screen on our treatment software – from that point onward there is no patient identifying information that is shared. Hospitals, and especially academic centers, are more worried about firewall issues. This we have had to handle on a case-by-case basis, and in some cases have had to disable SonaLink because we could not satisfy the facility’s IT department. We have a cybersecurity initiative underway currently to develop a global solution that will satisfy all users.

So effectively, the way to think about what’s happening with our technology is imagine that a surgeon is doing an appendectomy, and they see something that they haven’t seen before, and they’re not sure exactly how to deal with it. So they get the nurse. He dials up the professor at the local university, and the professor gets on the phone, and the surgeon describes what he’s seeing; what he’s doing. And the professor says, “Oh, I’ve seen that before. This is how you should deal with it.” And then the surgeon goes back in post. That’s essentially what we’re doing. We have somebody remotely doing that by using VSee. We’re able to share with the remote doctor, everything that the local doctor is saying, but there are medical legal issues associated with the information. For instance, that patient’s treatment plan is traveling over the web to a remote position, remote user. And so there are HIPAA issues associated with that. The data from that treatment is being stored on the local computer. There are HIPAA issues associated with that. So we have to implement certain firewalls. We have to implement tartest1n, we have to implement certain ways that the data is managed and treated in order to protect the patients, privacy, medical, Legally, we haven’t anticipated for seeing any issues above and beyond that, which one would normally run into if a third party was advising the local doctor.

Q: Will Tele-supervision/ telementoring become a standard of care? Liability issues for failure to receive expert input if adverse outcome?[Dale Alverson, MD, UNM Health Sciences Center for Telehealth and Cybermedicine Research.]

Our hope as a Company is that this becomes a de facto standard and therefore competitors that do not offer something similar will be at a disadvantage. That said, the FDA did not identify it as a mission critical component of our product offering. In addition, many physicians are reluctant to use it (it is optional activated by request of treating physician) because, as is the case with most of us, they do not want someone looking over their shoulder all the time. We work hard at getting our users comfortable with the idea that we will not share, either internally or externally, information about their cases or their abilities, but not all of our users buy into that.

Q: Can SonaCare technology be used for treatment outside of prostate cancer?

By the end of this year, we will be applying in early clinical investigations the technology that we have – both the Sonablate, which is a non-invasive or minimally-invasive device and something called Sonatherm, which is a smaller version of that probe, which is an invasive device. We will be running early clinical trials in rectal cancer, cervical cancer, breast cancer, thyroid cancer, kidney cancer….And interestingly enough, we’ve only talked about using focused ultrasound in this conversation to destroy tissues, but if you dial the energy down and you change the pulse sequences, it doesn’t destroy, but it alters the local cellular environment – reversably. So we are involved in some early trials, looking at using low energy focused ultrasound in the treatment of peripheral arterial disease, using it to alter the blood brain barrier, etc. If you look up on the web, “the focused ultrasound foundation” it has a page on their website which lists all of the various applications that focused ultrasound is being looked at for clinical benefit. The ones that I described are specifically the ones that we’re looking at.

Q: Any future plans for utilizing technology to repair bone fractures and such (besides treating cancer, tissue abblation and such)…using Ultrasound?[Sarder Sohel Ahmed]

Bone interacts differently to ultrasound technology than does soft tissue. Our device currently is not configured correctly to impact bone repair/healing etc. However, we have been investigating using our technology to impact soft tissue function surrounding bone, for instance in conjunction with stem cells in the treatment of cartilage and ligament damage. We have had early success with this application and are planning on exploring in greater detail.

Q: SonaCare has some sort of Referral Assist function. Do they treat patients from other states & from abroad and what referral case management system do they use in those cases?[Vlad Kuznetsov]

Although we once were in the business of treating patients directly at off- shore locations, we no longer do so. We field inquiries through our website and other points of contact that we then refer to the users of our technology closest to the inquirer’s location of residence. We provide a map on our website with the locations of all users so the prospective patient can reach out to whomever he wishes.

Q: During the procedures, do you tend to see any issues around lighting or sound that are going on with the amount of other equipment in the OR? [John Kornak, Ellumen]

We have had no interaction issues to date. This makes sense since there is little else going on in the room other than the use of anesthesia equipment (no electrical surgery equipment being used). We did have one instance, during a combined robotic/HIFU procedure, where the electro cautery system used for the surgery caused interference with the ultrasound images while the electro cautery was being used.

Q: What are the primary ways in which surgeons are using telemedicine? What are the biggest blockers to using telemedicine in surgical post-op follow-ups?[Alex Zhao, RosettaMD]

Unfortunately I am not well versed in telemedicine in general. We look at our use of the technology as more tele-assist or tele-observation then delivering telemedicine. Based on my limited understanding, most telemedicine is used as a means of remote patient interaction – diagnosis, consultation, checkup, etc, rather than actually delivering a medical intervention.

Q: Are there age limitations to have this type of procedure?[Vicki Hitchcock]

No, albeit prostate disease is usually one of older men (age 55 and above). That said, there is no clinical determinate for age limitation on the use of focused ultrasound for the treatment of disease.

Q: What is the progress so far with resolving the issues with the low bandwidth for overseas market?[Sarder Sohel Ahmed]

Not sure I understand the basis for the question as most of the overseas market in which we operate have a greater bandwidth than we do. We use SonaLink to connect doctors in Europe with our users in the U.S. since Europe has more experience with our technology than do doctors in the U.S. We also have provided remote support through SonaLink for treatments in Turkey, Israel, Mexico, and South America.

Get more expertise on telehealth regulations, physician adoption, and more from our telehealth video podcasts or see talks from Univ. of Calif. Health, DaVita, Microsoft, Dell from our 2017 Telehealth Failures & Success Conference.

About the Speaker:

Mark Carol SonaCare CEO

Mark Carol, M.D.  is the Chief Executive Officer & President of SonaCare Medical. Dr. Mark Carol is a neurosurgeon with over 30 years’ experience in the medical device and health care services arenas in publicly traded and privately held companies. Widely viewed as the “father of IMRT” and a household name in Radiation Oncology, he has a proven track record of taking nascent disruptive technology, in multiple disparate fields, from conceptualization through commercialization.

He was the founder and CEO of NOMOS Corporation, the “first mover” in the development of 3 paradigm shifting technologies in radiation oncology, intensity modulated radiation therapy, inverse treatment planning and image-guided therapy. He was also the CMO of Xoft, Inc., and Alliance Oncology, where he developed clinical program strategies for miniature x-ray sources used to deliver therapeutic ionizing radiation (Xoft), and developed novel oncology treatments sites through JV or direct ownership (Alliance). Dr. Carol held development & consulting Medical Director positions with large NYSE and NASDAQ companies, such as Varian Medical Systems, Accuray Incorporated and Siemens Oncology.

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