Brian Thornes, X-Bolt Trauma Orthopedics - Trauma Surgery Devices | LSI Europe '22

Transcription

Brian Thornes  0:03  

Thank you very much. So being on stages is quite a dangerous occupation. For those who don't know, this is Dave Grohl of foo fighters. And in 2015, he fell off stage and broke his ankle and use only second sign to assess. But after he was patched up, as you see there, he comes in for another 26 songs, because the show must go on. The reason I tell you the story is because this implant here, the tightrope, the implant that holds the tibia and fibula together is my invention. I invented this 15 years ago. It has gone on to be a world success. Every 12 minutes, a tightrope has been planned around the world. It's a great growth and now most top player players who have an ankle injury anywhere in the world, and it will get a tightrope, and over half a million Tightropes have now been implanted. But I'm here today to talk to you about my current company, export orthopedics, which deals with the bigger problem in orthopedics. Osteoporosis, as you all know, is a huge impact on the elderly population. And it's a big impact on orthopedic surgeons as well. Not least when it comes to holding anchoring within the bone. As you see here with a wooden demonstration, if you put a screw into a soft fixation, it can pull out and cause problems. So the greatest manifestation of this is in hip fractures. So hip fractures are a huge problem worldwide, women have a one in six lifetime incidence of getting a hip fracture. And after hip fracture, the pain and suffering is rated worse than death. The impact is huge on health services around the world. Around 1% of all NHS acute hospital beds are occupied by hip fracture patients because after their they come in, they get their operation, they need care afterwards. These are very elderly patients, the average age is 84. And they usually have a number of intercurrent medical conditions. The numbers in the US are huge 180,000 fixations a year, that's about 500 a day. And the cost of this are enormous to just from an implant perspective. 11% of the $8 billion orthopedic trauma trauma market is taken up with hip fracture fixation, but the care costs are where the real winner and loser is here. So the cost per patient episode is around $50,000 for one patient going through and estimated that 2% of the NHS budget is goes on hip fracture care alone. So what if we have fractures go wrong, it's a disaster. So the additional costs for reoperation is $40,000. Because the patient needs a second operation, increased care and a lot more supports in terms of living living independently or with with care. Cut out what you see here is when the school is anchored in the femoral head, and that's the major cause of cut out it happened three and a half percent of the time in an all cause reoperation rate of 5%. Now all the big orthopedic players at the moment have a screw base system with cynthaiz, Striker, Smith and Nephew, Zimmer Biomet, Globus medical, orthofix, Arthrex, they're all screw based systems, and they all have a system as well, which necessitates putting a instrument into the wound to actuate the the nail and jig. So our value proposition for the export is to have an expanding bolt that comes into it goes into the head, which gives a much better Anchorage. And we've clinically proven this in large clinical trials to reduce and virtually eliminate cut out as a complication. Here you see the export of work, it's the same surgical technique as putting in a screw, however, use the screwdriver to expand out the limbs of the export into the cancellous bone, which compact and strengthens the fixation yet further. One of the main questions we get back from surgeons as well what if it gets infected or we need to take it out or whatever? Well, it's simple, you just put the screwdriver in again and collapse it back down and has the strength within it to compact the bone and to be able to take out the implant again. So it's very usable from a user perspective or perspective. We also have a patented metrologic which is a curved jig which allows all outside operation for for the surgery. And this is different to all the major players. And here you see the size of our export versus the market leading gamma nail screw. So you can see that it's a larger fixation device in the in the body. We've conducted biomechanical testing so that stronger and better torque resistance and better if it's now positioned, and we've done two big clinical trials, white one which was 100 patients, and right for which is over 1000 patients this is the largest ever hip fracture trial conducted in the world. So the results of both these trials show that we've halved the number of correct versus screws within the trial four versus eight. And if you compare our number of four compared to the literature, it's a 75% reduction on that three and a half percent normal cut out rate. So for hospitals, what's the value to it, so a typical hospital will do 200 Hip Hip fixations a year. And they'll have savings from the small amount of savings from the, the operating time with the metric. And they'll have fury operations because of the strength of it, and the patients themselves will be able to walk faster earlier and have earlier hospital discharge. Overall, a hospital will save over half a million dollars a year. So we have two products ready to go to market. We have our nailing product and our plating product for hip fixation. And we also have in the pipeline, a spinal expanding bolt, which incorporates a pedicle screws and expanding bolt. We have a femoral nailing system, a human railing system and a tibial nailing system within the humerus. So with the femoral nailing system, we are also producing limb lengthening nails. So the milestones we have right now we have granted a granted patents on it on a wide variety of products with freedom to operate expires in 2037. As I said, we got X excellent clinical data. We do have FDA approval for our first generation stainless steel device. And we are currently at day 64. Our titanium device expected to clear in November of this year. And our last funding valuation was $8 million. We are looking for institutional funding to help us commercialize next year, and we're starting off with a low revenue base of a million dollars targeted for next year, rising to $30 million in three years. We expect to double that revenue with the rollout of the other long nail portfolio. In conclusion, we intend to tip the balance from institutionalized patients to independent patients to save on care costs and help the health services worldwide. Thank you very much