Michael Gardner Presents NSite Medical at LSI USA ‘23

Transcription

Michael Gardner  0:05  

Thank you very much. So I'm Mike Gardner, co founder and CEO of NSite Medical and an orthopedic surgeon at Stanford University. And we're leveraging AI to revolutionize scoliosis management. So this is Ali. Ali was 12 years old when she was diagnosed with scoliosis by her pediatrician. She lives about three hours south of Stanford, which happened to be the nearest scoliosis specialist. So this is her X ray at that time, and so you can see her spine is a little curved. Turns out this magnitude of curvature, she's very amenable to being placed in a brace and preventing her spine curve from progressing. Unfortunately, despite well intentioned parents, she was unable to get in to see a specialist. And so now she's 17. And she develops this big hump on her back that is particularly bothersome to her. And now you can see her curve is much more severe, so this is no longer able to be placed in a brace. And so her and her family undergo the tough decision to undergo a major surgery to fuse her spinal column with the with the plate with the screws and rods that you see here. So there are millions of kids like Ali all around the country. The system for scoliosis management from screening, all the way through potentially bracing in surgery is extremely antiquated and stressful. So starting with screening, this is literally the device used today. It's a carpenter's level, ball bearing in an arc, hundreds of complaints registered with the FDA. You see the false negative and false positive rates, this clearly leads to missed diagnoses. Now kids who do screen positive that need to get into see a specialist specialists are typically pediatric orthopedic surgeons who are focused and concentrated in major metropolitan areas at academic medical centers. So the up to 30 million kids in rural areas in the United States have really no feasible access to get in to see a specialist in a timely fashion, such as alley. So those who do get into see a specialist now, they are indicated for repeat X rays of their chest and spine throughout their adolescence. So on average, kids get 25 to 30x rays. These are clearly costly to the system. There are a number of studies showing the real quantifiable increased risk of cancer later in life, mainly breast and ovarian cancer. For kids who have undergone a scoliosis series of X rays when they were adolescents. Really overall, this system is extremely stressful and disjointed and difficult for parents and patients to navigate. So we have a two pronged solution. For this. First, we developed an AI based 3d scanning app of the surface topography of the back to very accurately assess the severity of the scoliosis, just on a smartphone. And this can be done in either a provider's office or at home by a parent. And then we're coupling that with a national scoliosis telehealth clinic to allow for access to patients all over the country regardless of how far they live from from a live specialist. So this solves many problems. First, we provide for the first time an accurate diagnosis of scoliosis, convenient and immediate care, we improve access to kids who live far away, we're eliminating a bunch of X rays and then ultimately, like alley surgery that was avoidable, we're going to be able to eliminate these surgeries and create a patient centric experience. So here's what the patient pathway looks like coming through the National scoliosis clinic. They get diagnosed early and accurately and then they can get monitored from home frequently and without radiation. And so kids whose scoliosis curve progresses, they can get placed in a brace in a timely fashion to predictably prevent their curve from progressing, improve outcomes later in life, avoid unnecessary surgeries. And this paper here was just kind of a landmark article demonstrating the effectiveness of bracing in kids with scoliosis. So our AI is 50% more accurate than current screening. We've enrolled about 400 patients in various trials at Stanford, we've got other universities coming online soon. This was kind of one of our research questions. We presented at multiple national prestigious meetings. And there are a number of peer reviewed publications in the pipeline. Scanning acquisition is easy and convenient. These are just some screenshots. So on a smartphone, you calibrate the patient's feet and the floor, and then the app places his AR guide over the patient, a Half Half Dome, essentially. And so you walk around the patient with the target and the ball filling in these facettes. When the cassettes are filled in it takes about 90 seconds the scan is complete and gets transmitted to our cloud environment or out algorithm that analyzes the scan computes the level of scoliosis deformity and returns a report back to back to the provider. The markets huge, there's actually a number of other really compelling use cases for surface scanning, we've actually done another pilot study at Stanford, in the Osteoporosis market to predict bone mineral density and fall risk and other things. Huge market their sports medicine is another one. We're focusing this year on our beachhead product and service in adolescent scoliosis, which is about a $1.5 billion market. We think we've configured a really unfair advantage in our go to market and our distribution. We're going to provide the screening version of the app for free to the screening providers who essentially are pediatricians, and school nurses. This solves many problems that they have currently. And again, they'll be getting it for free. And then we're configuring a really comprehensive direct to consumer campaign as well. And we've got some great avenues for to get in front of parents of kids with scoliosis. So we've got multiple validated revenue streams, we're starting with our telehealth clinic revenue. It's a subscription cash paid model currently with $90 a month and this cost us $35 per unit, and we're working on getting payer reimbursement automated next year. Currently, we provide documentation to the patients to submit to their insurance companies for reimbursement, and many, many payers do reimburse for these telehealth visits. We also offer enterprise software only subscriptions to large healthcare systems, who see value in using the software but don't necessarily want to refer us their patients out of their system. And then finally, the brace making component of the scoliosis visit is actually high margin business, we're going to have a large funnel of patients with early scoliosis, some of which will eventually need braces. So we're in talks with a number of brace companies. On this, we've got traction in all of these three channels where pre market curl or pre market currently 96% of parents are concerned about the radiation their kids get in their ongoing assessment of their scoliosis, the vast majority of parents would pay for a home base radiation free solution and a number of pediatricians have indicated their willingness to use it as well. And we've got some letters of intent from different institutions. We're starting a big multi center and surgeon study with the Shriners system soon as well. And really all stakeholders around the table stand to benefit from this system in this technology. So pediatricians, for the first time can screen confidently the result of the data then gives them a recommendation as to what they should do. So pediatricians now screen for dozens of entities, all of which get more complex as medical knowledge increases, and they're not often sure what to do with the screening results. They acknowledge they over refer patients, because they don't want to miss his scoliosis. So now we talked to the orthopedic surgeons who get the referrals and they they tell us nine out of 10 of their patients don't have scoliosis, because their pediatrician wasn't sure. So we solve a lot of problems like this, they decrease their liability. And then finally, we were able to streamline that referral into our clinic. So 60% of kids with scoliosis, live over 100 miles from their from the nearest scoliosis specialists like ally, so it's hard for pediatricians to find someone that doesn't have a two hour drive and a three month wait and so we've streamlined the referral for them. Turns out orthopedic surgeons aren't interested in having these patients in their clinic either their early scoliosis patients they don't add to the revenue of a surgical specialists. So they're happy to actually send us their patients before the time that they may need a surgery. And then maybe more than any other payer so scoliosis is extremely expensive for the healthcare system. You see, bracing is about $6,000 a patient. There are 37,000 spinal fusion surgeries a year in the United States, each one gets charged gets billed to payers 140k. And so that's $5.2 billion total conservatively, if we can eliminate 10% of these avoidable surgeries will save payers and the health care system $450 million so here's who we are myself and Malcolm Tobon are co founders at Stanford and Duke both orthopedic surgeons Kayvon saber and Steve Avila have deep digital health experience one as a previous CEO, and we partner with Genesis Innovation Group, Matt Miller is our CTO. Our clinical advisory board are really the who's who have scoliosis, thought leaders from around the country, and are actively involved in driving this forward. We've raised $3.7 million To date, we've made a lot of progress with that we submitted to the FDA about six weeks ago as a 510 K class one device. And so we're raising a $2 million seed round now, which will get us 12 Month 12 months of runway conservatively to capture about 0.3% of our addressable market and $4 million next year. So final slide. We're hearing loud and clear parents of these almost 3 million kids are desperate for a better way to do this without long drives long waits a bunch of X rays and unnecessary surgeries until we have a modern digital solution to improve access, convenience, and really overall care. Thank you very much.