Advanced Scanners | Jeff Levine, CEO

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Jeff Levine  0:00  

Thank you. Now it tells me who I am. I'm Jeff Levine with Advanced Scanners. I'm here to introduce you to Orvis an optical scanning and data platform that creates data rich 3d digital surface maps of patient anatomy in real time for continuously reliable surgical navigation. The navigation systems track and display the position of tools and implants relative to patient anatomy, they help surgeons accurately place them or remove diseased tissue aligned bones. These are the images that are displayed by a visualization system. But according to the FDA safety notices from 2017, these surgical navigation systems fail to adequately track changes in the position of patient anatomy during surgery. Once anatomy changes position the maps are out of date, preventing or limiting the usefulness of navigation in certain scenarios. This is a 40 year old problem and manufacturers have been looking for a solution. This is a failure of technology that according to the FDA is leading to patient deaths, life threatening injuries failed, aborted and prolonged medical procedures. This is a failure of technology that requires a technological solution. Submillimeter errors can lead to misplaced implants and screws, followed by an avalanche of complications and costs. This is a failure of technology that leads to incomplete resections which means leaving cancer behind and removing healthy brain tissue. The status quo is to rely on the surgeons experience and intuition. To compensate for these failures. Surgeons are screaming for a solution. Hospitals are interested because they're the ones absorbing 10s of billions of dollars in related costs every year on these fixed reimbursement procedures. What the world needs now is something to fill this existing technology gap and enable the next generation of robotic AR and VR interventions. And here it is. This is Orvis it is the first commercial product being built on an optical data platform that we invented to track changes in the position to patient anatomy. It scans in a fraction of a second outputting a high resolution full color data rich 3d surface map. There is no other technology that does this. Every multinational strategic that sees our data knows that we're onto something special. Our first product is being built to continuously track anatomy in 11 million neuro e and t and orthopedic procedures that rely on surgical navigation. This is a $1.2 billion annual recurring revenue opportunity in the United States. Continuous navigation is also the key to enabling more intelligent and more automated robotic procedures. Our market goes hand in hand with surgical robots. This is an unbounded upside. And the financial opportunities are limitless as the market opportunities the cost for us to manufacture this device is about $1,800 a scanner. And we're about one year from submitting for our 510 K clearance, we'll make money selling or leasing the device plus charging for disposable drapes, annual software service and maintenance agreements. And catch this we're a year out from a 510 K and we've already negotiated a statement of work with a large multinational to develop a custom OEM device that'll be our first bit of revenue coming in this year. The magic our sustainable competitive advantage is uniquely capable hardware based innovation. There is no other technology that does what we do, we simply pick up signals that other systems cannot get to. US patents have been issued 15 remain pending. And we've already been granted patents in China, Japan and Israel. And it really works. We've demonstrated 100 times better precision when compared to the current spatial positioning technology on today's most popular navigation systems. Today, surgeons drag a pointer over the patient to collect about 350 data points that are then used to align the patient with their preoperative images. That's the data you see on the left. In the standard column. We perform this a statistics a statistically significant number of times, and that's the standard deviation of error reported by the navigation system. On the right is a single optical scan that uses 70,000 points to align. There is no contact with the patient, we scan in a fraction of second and we get the same exact answer every time. We can automatically track changes in the position of patient's anatomy and update the navigation system throughout the procedure. Nothing else does this we do it without any human intervention. Today, when anatomy moves, procedures are disrupted, while surgeons tried to reregister the patient, or measure the error and track it in their head. Sometimes the procedure has to be aborted it can't be done. We can also track the position of rigid tissue with or without having to add tracking arrays or fiducial markers to the patient. This is called automatic bone registration. If you can see it, we can map it into racket and getting rid of expensive arrays reduces costs while making surgery safer for the patient. This is a I need you to hit play. Thank you. So this is a pig's knee. And what you're about to see is one of our scans. Just hang on. That's a scan. Everything you're looking at is real time. And now you're navigating. This is a submillimetre full color, high density, 3d point cloud. And you can navigate on this as quickly as you just saw us do it. This can also be aligned with preoperative images if you have any. This is the same scanner same device. It's an example of the optical data that we're sensitive to. In addition to this 3d shape. This is a false color representation of oxygenation. Bench tests indicate that we can isolate and differentiate astrocytoma glioblastoma basal cell and squamous cell carcinomas. categoric studies and experiments with phantoms will allow us to characterize tissue in vivo without any contact radiation or designs or dyes to distinguish cancer from healthy tissue or bone from tendon. We're currently raising $8 million to buy us 15 months so we can productize the device and submit it for 510 K, we have additional IP to file more clinical studies to do. We're going to take our endoscope from bench to the clinic and further to develop these diagnostic capabilities, all while executing paid statements of work for large multinationals. We don't make navigation systems but we do make them more accurate and reliable. These companies make those systems that are called out in that FDA warning they need us. And we don't make robots we enable them to see as well as a move, allowing for more intelligent and more automated procedures. We don't make AI or AR and VR platforms, but we do enable them to line their images better. We're not a visualization company, but all of them rely on accurate navigation to do their job. This is the.com moment for medicine. The US healthcare system is on the verge of the largest technology adoption in history. With strong pull from surgeons, technical and industry validation. we're poised to be one of the very big winners in the space as we create an optical infrastructure. Thank you for your attention. come chat with me if you'd like to learn more. Thank you