Sujit Dike, Gyder Surgical - Navigation Solution for Total Hip Replacement | LSI USA '24

Sujit Dike  0:00  
Sudhir, good morning. My name is Sujit Dike, CEO of Gyder surgical we have developed the world's first commercially available non invasive and imageless technology for improving surgical accuracy during total hip replacement. This is a big deal, as vast majority of surgeons globally do not use any technology when they are placing the cup into the hip socket. They simply freehand hammer it in. Miss the target angles more than more than half the time, leading to patient complications and costly revisions. We are raising $3.7 million and we have already pulled in half of that to looking to close the balance. In the last 12 months, since the LSI presentation last year, we made a lot of progress, including receiving Australia's TGA approval, doing first in human cases successfully in India and Australia, as well as collecting additional data for FDA, 510, K submission, we have had multiple conversations with the agency looking to submit sometime in junejuly this year, and anticipate approval by end of this year. We have a strong IP in place, three patent families already granted in most major markets. We are starting with hips, but the technology has potential to go beyond it. We are currently raising 3.7 mostly to get through our 510, K and support initial commercialization. Incorrect cup placement is a major issue. There's a lot of literature around long term complications. For example, you see on the top left when a cup is misplaced, sometimes it can lead to dislocation. The Complete prosthesis comes off, and many times. Imagine a wheel with a non aligned wheel, a car with a non aligned wheel. In the long term, the wheel will come off. That's exactly what happens when you don't place a cup accurately. So there's wear and tear, and in the long term, it leads to cup failure, revision surgeries to fix those problems cost $2 billion in the US health system alone. And obviously this is a bigger problem globally. There are existing technologies, but they are expensive, time consuming and complex. All of them use some combination of metallic pins inserted into the patient's pelvis, leading to potential patient harm, adding time, and obviously no surgeon likes that. Also. Many of them use CT radiation or intraoperative fluoro increasing radiation exposure. There's data which says female orthopedist, for example, have four times higher risk of breast cancer because of radiation throughout the lifetime. So this is a major problem. Guiders technology has addressed this in a meaningful way. So the core technology has this handheld navigation unit, which is attached to this tripod looking orthopedic brace. Before this is pretty much the entire system. Before the start of the surgery, the surgeon places this instrument on the patient's pelvis to capture the anatomical plane using standard landmarks, and they can size it based on different patients. They input the target angles based on patient profile and their surgical philosophy. Once they have done that, they attach it to the brace, keep the entire system on the side. They then proceed to prepare the patient using their normal workflow. So we are not asking them to change their surgical process at all. Once they're ready to place a cup, they put the entire system back on the patient to actually now capture the patient's anterior pelvic plane using a very simple registration process, which takes barely 15 to 30 seconds. This is where we have eliminated most of the time compared to competitive systems, and it's just a simple button push to register the patient's pelvic plane. Once that's done, the system can be moved off the patient, the navigation unit is moved to a standard instrumentation which is used to insert the cup and essentially, the surgeon then uses this combination to align the target angles with the desired angles, and essentially aligning the small ball with the larger ball and hammer it in. So this is very simple to use. We are addressing a large growing market, $1.4 billion for hip alone, driven by aging demographics and increasing use of technology and surgery in growing markets like India and China. And as I said, the technology has the potential to go beyond that. We've done first cases with four different surgeons, highly experienced surgeons as well as Nova surgeons. Very consistent feedback, remarkably efficient, easy integration into existing workflow, and obviously, surgeon and patient friendly. We continue to build our data set. We have tried this device on a large, large range of profiles, large, BMI, small BMI, large, hip to waist ratio, small hip to waist ratio, a wide range of angles, and this is just a snapshot. There's a strong correlation. Between guided, reported angles and independently measured CT angles, one of my biggest learning selling medical devices for 12 plus years in Johnson, Johnson and synthesis clinical accuracy in this space is table stakes. What really drives adoption is speed, ease of use and cost effectiveness. And we really have killed it in all these fronts. So, for example, competitive systems add anywhere from 10 to 30 minutes to a procedure. We barely take a minute and a half. Every surgeon who has seen this device wants to use this device in the outpatient center. Similarly, it's very we have made a step change in the complexity of use. What you see here are traditional systems, including robotics, which require a dedicated or specialist, long set up time, complex reviews, rigid workflow, and not open systems. We are actually open system. Can be used with any implant, simple to use, no specialist required to support the cases during a surgery. Also, we are very cost effective. We can be 75% more cost effective than competitive systems with a simple razor, razor blade model, placing the equipment at no cost or selling it, and then charging per procedure at a competitive ASP, and still maintain 80% gross margins. Super attractive again, to ASCs, where they see a humongous cost when it comes to robotics, both on a variable basis, as well as initial capital, upfront investment. Just to close this out, it's very simple learning curve. I'm not a professional trainer, but I was successful in flying to India, training two surgeons, two hours each, two hours of or operating times training, and they were up and ready to use this device. That's as easy it is to use great feedback from us surgeons, most of them want to try it in the outpatient surgery center. We are growing. We are going after the fastest growing segments of the space, anterior approach, already half of, more than half of all procedures growing twice the rate of procedure anticipated, anticipated to be 70 to 80% of all procedures done in the hip space. And you have heard a lot of talks yesterday around ASCs and outpatient centers. We're definitely going after that. We believe we are well suited for that strong leadership in place. Bill Hill, 25 years of product development experience. Sheila is leading our sales and marketing, originally in Australia with and also has a nursing background board with Chris wills is the founder CFO of a ten billion Sonic healthcare company. Lawrence represents the third largest private Family Fund. Nick is a former surgeon as well as used to be a VP of Ma and licensing for j&j. We continue to build our roster, backing by surgeons in royal, Adelaide, Stanford and many other well known institutions. And we have the entire system in place in terms of manufacturing and commercializing this product. Just to close it out, large, attractive market, strong unit economics, we are addressing a major unmet need, clear competitive positioning, patent protected experience team, and I'll just leave it with this that we believe this system has the potential to address the vast majority of the market that is not using any existing technology, and enable surgeons to perform every single surgery with the same level of accuracy and precision that, frankly, all patients deserve. So thank you. Applause.