Manish Chand, OstomySecure - Transcutaneous Implant Evacuation System (TIES) | LSI Europe '24

Manish Chand  0:00  
Manish, thank you very much. My name is Manish Chand. I'm the Chief Design Officer at ostomy secure. I'm also a practicing robotic colorectal cancer surgeon, and I'm thrilled to tell you a little bit about our innovative continent, stoma mechanism, the tires device. Every year, hundreds of 1000s of patients undergo abdominal surgery. Unfortunately, the vast majority of those do exceptionally well. They go home, go back to their lives, go back to their loved ones. Disease treated, they recover well, and they don't have complications. And largely that's down to people like yourselves who champion and support innovative products. You bring that to people like me who can then offer my patients optimal care and optimal outcomes. Patients like Tom. Tom has undergone a robotic colorectal cancer surgery performed by myself some weeks ago, and I'm glad to report he's doing fantastically well. He's gone back to his job. He's cancer free. He didn't have any problems during a surgery. He would be considered a clinical and statistical success of cancer care. We all pat ourselves on the back, because he's a marvel of modern medicine. But there are 10 million people in the world like Tom, 10 million people that have a stoma. And when we all pat ourselves on the back and we're all excited about curing this cancer, Tom has to contend with this for perhaps the rest of his life. And it's sad that in 2024 when we have so much wonderful research and innovation going on, even here in the two or three days that we're all together, that this is an underrepresented group, these patients have had no innovation in the few decades, these patients are underrepresented, and they're crying out for improved quality of life, and we at ostomy secure want to give them that because we know that patients that have stomas often have a lifelong burden and beyond the physical problems of having a stoma itself are the psychological, the hidden, cultural, socio economic issues that mean that Tom can't participate in society, perhaps as fully as he wants to. And we want to change that. We want to build a solution that allows these patients a quality of life that they deserve, and they're not limited to the only other game in town, which is a traditional limiting stoma bag. Our solution, the ties device, a printed hybrid titanium mesh implant with a connected digital lid, wrestling back that quality of life to patients and giving them the dignity and control that they so deserve. Our work is a culmination of 10 years of innovation we have learned from every implant that we have put in, we continually improve, continually iterate, so that we can offer our patients the best quality of life. And we've culminated with the ties four device. This is the pinnacle of implant technology. We use the most advanced implantation techniques so that we can continue to give our patients the best quality of life. And we look forward to testing this in a pivotal, randomized, controlled trial from University College London in q1 next year. And here's a little bit video of how one puts one of these implants in. You can put these implants in patients that have existing stomas or at the index procedure. And it's a state, straightforward, ambulatory, 30 minute procedure under general anesthetic, with patients going home the same day. In this instructional video, we show a patient having it put in at the index surgery when the stoma is first formed. So we use the sizer to get the right fit. Once we've made the skin incision, we undermine the skin, providing a pocket for the flange to fit into, checking this with the finger, and then we're able to bring the bow out from the abdominal cavity. And I know we're close to dinner, as you said, and perhaps I win on the on the nauseous pictures here, but this is a bit of ilium small intestine that comes out through the implant, and we fit it snugly just under the skin. This is a subcutaneous implant. We do not go into the abdominal cavity once in place. We stitch this around the perimeter of the device. This allows the bow to adhere to the stomal implant. These are dissolvable stitches. We next want to create a snug fit around the skin. This is one of the first implants that has a skin metal interface as a permanent implant. And we need this to be snug. This too is a dissolvable stitch. And finally, to secure it into position, we put non absorbable stitches around the skin. These are taken out by the operating surgeon at two weeks. I Yes, we check make sure there's a patent lumen so that the stoma works, and apply a tissue sealant to reduce infection and promote healing. Once done, two weeks later, we've taken the stitches out. We put the lid on simple, straightforward design, and when it comes to emptying, either you apply the pouch or the bag, and can directly empty it into the toilet or into the pouch itself, and then dispose of the pouch. Patient can do this when they feel like we are giving them back continents, and once you emptied, you want to clean the lid, straightforward, take the lid off and wash it under the tab. We'll talk a little bit more about the lid, and in the coming slides along with the implant, we have a portfolio of associated products. Now what we know is that per year, a patient with a stoma will spend 2500 euros, pounds or dollars, in appliances, and those patients often are going to have those stomas for years. So recurring revenue stream, the Julian R crown for the appliances is the digital lid. In a modern, connected world, our ostomates are telling us they want to be connected to their stoma, understanding what the effluent is, understanding when the waves of contraction are suggesting that you need to empty it. So we have a digital lid that connects to your phone, to your watch, or even integrates into the electronic health record, such as epic, for example. We have a strong, organization. The Clinical Advisory Board is led by myself and professor Stephen Wexler from the Cleveland Clinic, and we've assembled a strong team of clinical advisors who are able to then inform our even stronger board, perhaps directly from the coalface that's real life surgeons doing real life ostomy surgeries on real life patients. The market opportunities, appealing. Firstly, there's no competitors. You either have a bag or you have this. There are 10 million patients in the world that currently have a stoma, and perhaps a million procedures a year, and that's increasing. This device we can implant into the vast majority of those temporary stomas, permanent stomas, colostomy, ileostomy, urostomy, and we have this recurring revenue stream even at 10% share. It's a recurring revenue stream of $250 million a year. So from the business perspective, appealing our regulatory pathways well defined, we've been through animal testing phase one, phase two, and we're about to launch our phase three, Pivotal randomized control trial from a clinical trials unit at University College in London. We've had discussions with the FDA. This will essentially be an FDA trial run in Europe. It's a gray area, we know, but we're confident that this will bring us through that regulatory pathway, through the UK, Europe and the States. So big market, no competitors. We currently have 3000 patients counting that want to join our clinical study, extensive IP coverage. So come join us on this exciting journey as we try and improve the lives of these ostomy patients that have been underrepresented for so long. And I'll leave you with these quotes from these patients that have had their lives changed by this implanted device. Thank you very much. Thank.