Joseph McGinley, McGinley Orthopedics - Orthopedic Medical Devices | LSI Europe '22

Transcription

Joseph McGinley  0:05  

Thank you very much. My name is Joe McGinley, I'm excited to be here today just outside of London. We're going to be talking about McGinley Orthopedics and some very big announcements for our company. But more importantly, what I'm going to talk about today is the journey I'm going to talk about a journey about how we started with an idea, and ended with a product that really changes the standard of care in orthopedics. As part of this, we're going to talk about an opportunity about how you can join our team and become part of the solution. The journey begins with orthopedic surgeries. orthopedic surgeries happen commonly every day in the United States is more than 4 million alone each year. Specifically with fractures, there's 12 to 15 million fractures a year treated in the United States, over the age of 50 40% of women and 13% of men fracture their hips, spine or wrist. This is a large market with an over $2.5 billion market opportunity. Specifically, we're going to discuss distal radius fractures. This is the most common fracture. Unfortunately, even as common as this fracture is the technologies that are used to treat these fractures are obsolete and have not changed significantly in the past few decades. And the United States alone there's over half a million distal radius fractures each year 20% of all fractures presenting to the emergency room or distal radius, and it represents 15% of all bony injuries within adults. Our mission is to lead medical innovation with technologies that protect patients improve outcome and reduce cost. This journey now takes us to the problem. If unfortunately, you or a family member experiences a fracture, let's just say you fall in you break your arm, what happens you really know what happens when you answer that operating room. Well, the problem is the tools that the surgeons are using to fix those fractures are obsolete. These technologies have not changed significantly in decades. If you go in and fix the wrist fracture, the surgeon will manually realign those fragments, they'll place a plate a flat plate on the surface of the bone, they'll then grab an orthopedic power drill, which is less advanced than what you would find at a hardware store. They'll then drill through the bone feeling as they go through. So tactile sense, they'll stop drilling when it feels like they get to the other side. Once that happens, we'll put the drill down and they'll grab a little hook they'll place it through that hole and then read a ruler to measure the size of the screw to fix that fracture. That's how it occurs. That's the standard of care that happens in the operating room every day. The images you see on the screen are the result of this manual process. The first image represents a spine surgery those are two screws right through the spinal cord. This unfortunate patient ended up paralyzed from an elective surgery. Next patient also the spine, that screw goes straight up through one of the vertebral bodies into the skull base. More common fractures on the right side of the screen. You see a femur fracture that's fixed with a screw that's hitting the femoral artery that patient required a vascular surgeon to come in and fix that injured artery acutely in the operating room. And finally, a young pediatric patient with several pins that went through the far side of the bone, we're contacting nerves on the other side of the bone. Without sensors without real time navigation without data surgeons are limited in their skill set. They're based on their tactile feedback only. We looked at this we surveyed the data. In a survey that we looked at with surgeons 53% reported in the past six months that they had some type of adverse outcome or problem within the operating room. There are numerous studies out there numerous published studies in various journals that show one in five orthopedic screws are misplaced and need to be replaced. We also looked at plunging meaning when you drill through the far side of the bone how well can you actually stop? We measured this and with over 40 surgeons we looked at this the average was 6.3 millimeters, I would challenge all of you to try this at home not with bone obviously but grab a two by four piece of wood drywall, something like that. Take your drill from the garage and try to drill through try to stop when you get to the other side. See what happens. I almost guarantee you'll plunge every time as you try to do that even when you're trying to prevent the plunging. So with risk fractures, specifically that problem is also just as large and just as problematic. Studies have shown that up to 80% 80% of distal radius of risk factors result in undesired outcomes 65% of which results in arthritis or reduce range of motion in your wrist after these particular surgeries. The most frequent complication is malunion or misalignment of those fragments and those fragments of the wrist are misaligned after that surgery that can limit your ability to use your wrist it can result in arthritis pain and problems that will last the rest of your life. Okay, so now the journey we're talking about a journey where does this journey lead us? This leads us to the solution that begins the solution. This is gonna sound stereotypical, but the solution was developed at a dinner conversation. Myself and our company co founders Dr. Scott codes and Scott Porter ran a dinner where ironically talking about a patient that had a distal radius fracture with a plate fixation. One of the screws was too long. This young 16 year old went home after the surgery, unknowing that the screw was too long. She started moving her hand normally ended up tearing the tendon on the other side of her wrist. This young kid had to come back in the operating room, go through another traumatic surgery have all that hardware taken out, and then had to have that tendon repaired again, she never did results in full out full successful outcome and had limited range of motion even after the repair surgery. So our solution resulted in a napkin sketch that night, we said we can do better. We talked about how we can fix this problem. We sketched out a design integrating sensors and orthopedic power tools and that resulted in our flagship product the IntelliSense drill. The IntelliSense drill has embedded handheld robotic technology that allows real time sensing of bone as you're drilling. These features have edge detection, integrated surgical lighting, and measurement that's automated, where you can get a precise measurement of the screw accurate two tenths of a millimeter every single time. Our second FDA cleared product or lever action Plate System took this a step further, we said we can we can realign these fragments better, we can make this a more successful surgery. By creating a 3d construct, we can take any surgeon and allow them to have the skill set of a textbook writing hand surgeon through the use of Mechanical Engineering you can rely on these fragments that have a perfect or near perfect outcome every single time. The features the universal you can use it with or without this 3d blade system, it could you could use it just the way you typically do just the radius fractures. Or you can have the advantage of the engineering system resulting in more positive outcomes. This is just the tip of the iceberg. We have several products in development, our company is backed by well over 125 patents. And this can result in integrating sensors beyond just power tools into navigation into hardware solutions into solutions in the operating room in general. We have a full management team, all of our management team members have been with us for more than five years. Also our team in house is vertically integrated. We have engineering software mechanical all in house, we have our quality systems where FDA registers ISO 1345 registered, we're an FDA registered manufacturing facility meaning we can take a product from concept to production, all within the same general vicinity. All within house, we're not dependent on a supply chain. We're not dependent on third parties to help us develop and build our products. This has resulted in results. We have over 125 patents within our company in various patent families. We have five products on the market, our two flagship products we talked about, we averted fully vertically integrated our company. And we have several additional products that come in and down the line. Now for the big announcement, we're here today because we not only innovate products, but we also innovate with investment. Historically, we've raised over 20 million in reg D financing. Today as of today, we have launched a reggae plus round for $40 million investment with a minimum investment of $100. It's very simple. You just go to our website, invest stop McGinley orthopaedics.com, you can fill out your information and literally buy shares in our company with a credit card, you can become part of the solution, you can become part of our team instantaneously. And you get to make a difference in the care of orthopedic patients all around the world. We're going to use these funds to grow our sales team and scale our sales effort across the United States. As I mentioned, we've had over 1000 successful surgeries to date. And we're looking to take that to the next level as we expand across the United States and worldwide. Our exit strategy is clear position for acquisition. But also we have options we can continue to organically grow the company. We are set up for licensure and acquisition, as well as continued internal growth, total market potential with similar companies of our area in the range of 500 million to a billion dollars. So very large market very large potential. So in summary, this company has market potential. We are live with investment and we shown success throughout the years. Very easy. You can scan the QR code, you can chat with me afterwards or go to our website invest at McGinley orthopaedics.com. Thank you very much