Jason Winder, Sonogen Medical - Ultrasonic Solution for Bone Fracture Healing | LSI USA '24

Jason Winder  0:05  
Well, good morning, everybody. So I hope it'll shock everybody. First thing here. If I tell you that Americans just aren't that terribly healthy, we don't eat well, we don't exercise. And about 40% of us have some kind of vascular insufficiency, a comorbidity like diabetes, congestive heart failure. And when you don't circulate good oxygenated blood, you tend not to heal very well. Now, that also means your ability to heal from a bone fractures is compromised. In fact, there are 560,000 people a year who end up with these delayed and non union fractures. These are fractures that just aren't healing after 90 days of fixation. And you know, these patients are in pain, they can't work. They can't play with their kids and grandchildren. And they're all headed towards expensive and risky orthopedic surgeries like the one you're seeing here, which honestly, everybody wants to avoid the the providers, the patients and most of all the payers. Now, there are some products already on the market in this $8.4 billion space to try to kick start the healing process when it fails. Some of these products had been around when Abraham Lincoln was president. Many of them have incredibly unreliable healing rates. Some of them require between 10 to 24 hours a day of usage. And not one device in this space gives any feedback on usage or the healing process. In summary, this is old tech that doesn't work that great that patients don't like and nobody but nobody can tell if any of its working. We can do better. What you're seeing here is a rendering of Sonogen's next generation bone fracture healing device based on our patent pending acoustic shear wave signal. It's a small little cylinder about two and a half inches tall and about an inch and a half in diameter that just snaps into a cast. We've already shown in preclinical testing that it heals 30% faster than the best of breed technology on the market today. That translates into fewer complications, and ultimately leads to better outcomes for patients avoiding up to $12 billion a year and unnecessary surgeries. The device itself is also fully telehealth enabled so that we can actually get the doctor and the patient connected and involved in their treatment process and at the same time, put up to $50 million a year in orthopedist pockets through remote patient monitoring using established CPT codes. Here's how it works. When the orthopedist realizes that the patient isn't healing. She prescribes the device, it's shipped to the patient's home, the patient uses it for just 20 minutes a day. This is a home use device. When they're done with the device, we grab the data off the device, send it up to our HIPAA secured cloud, analyze the data and send that usage and healing data back down to their mobile and web applications. Ultimately supporting those regular telehealth sessions, which all conspires to create an environment of patient compliance. And let's be clear, it's all about compliance. Right? There have been studies that have actually shown that if patients just use ultrasound technology, the healing process tracks that usage almost perfectly. And we designed this device from the ground up to maximize patient compliance through a variety of mechanisms, both including the healing assessment and some fun gamification, which I'd like to think that we're all immune to, but I'm the same guy who has been seen walking around his house at 1130 at night trying to get my fireworks display, so it actually does work. Now I mentioned there are some products on the market. There are four companies with six products, four of which are used antiquated electromagnetic technology. There are two products in the space that use ultrasound that we tested against and demonstrated superiority over it's a enormous and growing market. Unfortunately, it's $1.7 billion a year easily just for the delayed and non union fracture space. With some opportunities and fresh fractures at risk. We are coming to market with a much better mousetrap. We have the best of breed technology in the space, our shear wave fracture healing signal. There's decades of literature that show that acoustic shear waves appear to be really the key behind stimulating effects inside the human body with a device again that's completely designed for patient compliance. Now in addition to our primary markets, there are also some great adjacent markets we're excited to explore after lunch. We know this technology works for spinal fusion healing. We strongly suspect it works for wound healing. And it could be that it turns out that the data is the most important part of what we're doing. We expect that our fracture healing assessment capability will eventually grow into a more general assessment of bone quality, allowing us to actually use our technology for bone mineral density assessment for early detection of osteopenia and osteoporosis. Now, fantastic team. I myself am a serial entrepreneur and Risk management specialists with decades leading small companies to exit. My business partner Robert Muira tour is a powerhouse biophysicist with 20 years ultrasonics experience and my father who actually invented this technology is world renowned expert in acoustics, spent the first half of his career in anti submarine warfare and the second half in medical ultrasound, he has 11, soon to be 15 patents to his name. And we are supporting those capabilities with a really fantastic team of advisers helping us out with strategy, marketing and sales, legal and regulatory, and also a team of orthopedists and radiologists representing some of the best medical institutions in the world. Our pathway to Market is a predicate device pathway, we'll be inheriting the entire label of our main competitors device will be going to market using a pharmaceutical sales approach has proven very effective in this space, but bolstering that heavily with medical education and social media marketing for additional push and pull. Again, all using established billing codes, both for therapeutics, diagnostics and telehealth. It's been a fantastic ride so far. You know, in the early days, we did our initial testing, we had a small raise, managed to finish up our pre clinicals. Once the technology was validated, we did a small friends and family raise filed all of our patents there for worldwide PCT patents. Last year was the year that's when everything started coming together. We won three regional pitch contests. We also got a commercialization grant from M Tech, thank you very much, Rick for Antex tremendous support of sonnigen and its mission, and also secured a lead investor, which allowed us to really get off to the races to start building out our capabilities. brings us to the ask, you know, we're working a 15 month program in order to get ultimately to to FDA approval, we're well down that path. We've currently closed $700,000 out of our $1.2 million raise, still looking to circle in an additional 500k. I know we are a Maryland biotechnology company, which means that actually the state of Maryland will give you back 33 to 50% of your investment. During this particular round that's valid for investors anywhere in the world doesn't have to just be Maryland, after we get our FDA approval. And we intend to do a one year market beta, validate our pricing approach and sales approach. And assuming that all goes well, we get some good product market fit established. We'll either exit to a strategic at that time, or saddle up and push towards a more meaningful exit slash IPO after maybe an additional three years. Scale the company ultimately to about 130 million in revenue on 40,000 units sold. That is about it for me. I really appreciate you guys all taking the time to take a look at us this morning and hope you enjoy the rest of the conference. Thank you