Jeremy Kwarcinski, iiShield - Improving Short & Longterm Transplant Outcomes | LSI USA '24

Jeremy Kwarcinski  0:01  
Good everyone. My name is Jeremy Kwarcinski, and I'm the CEO of iiShield, an Australian medical device company that's looking to bring our innovative transplantation product to the US. So think about how Pheidole a donor kidney is that the key thing is that one in four of these transplanted kidneys fail within five years 30% of transplanted kidneys experienced delayed function, the need to go back on dialysis post transplantation. And this occurs because of thermal injury, which happens during every transplantation surgery. And this is a key problem, it means that every transplantation surgery is a race against the clock. And there's a clear unmet need to keep the donor organ cooler. For longer. This has a significant impact on patient outcomes. For every extra minute, there's a 5% increase in the need for post transplant dialysis. For every extra 10 minutes, there's an 8% increase in the five year graft failure. And this need to rush leads to surgical complication, which is the leading form of early graft loss in 1/3 of all transplant cases. So it is a shield we've developed the kidney protective jacket or as we like to call it the kidney pajamas. the KPJ is a single use thermal regulation insulation device that aims to minimize the impact of this thermal injury on transplant kidneys. By keeping them nice and snug in a comfy set of PJs. The device works through temperature regulation that has an internal space for hypothermic processing, an internal texture for thermoregulation. It's been designed by a leading team of engineers and transplant clinicians to have an anatomical design that conforms to the kidney, a low profile to not impede on the transplant surgery, secure anatomical placement for manipulation and ease of use, and easy removal once all the vessels have been stitched back together. Fundamentally, all of these features come together in a device that does not change the way kidney transplantation is done. If anything, it makes it a little bit easier. So how does it work? Well, when a kidney is retrieved, it's placed on ice and transported to the hospital. Once it gets to the hospital, it's taken out of ice and put into the warm body where it begins to heat up and starts to die. The KPJ changes this by insulating the kidney from the heat of the body, keeping it cooler for longer, which pushes this thermal injury time too far past the average surgical time. And the best part is it synergistic with other emerging technologies which addressed risks at different stages in a transplantation process by using them in collaboration will only further improve Transplant Outcomes. This has a significant impact because the average surgeon takes 41 minutes to reconnect all the blood vessels. So through our preclinical studies, which have been completed with both poor sign and human kidneys, we've been able to show that at the same time point to KPJ can provide a 48% reduction in core organ temperature. We have IP protection for the device in 10 key markets with trademarks in both the US and Australia. And the KPJ is a class two medical device with a clear 510 K pathway. We've validated this three 513 G and pre submission meetings with the FDA. So the KPJ is a first in market product with a uniquely low adoption risk. It's unobtrusive, it doesn't change the way kidney transplantation is done. It's synergistic, it can be used in conjunction with emerging technologies. It has a low surgical risk, and fundamentally it's desired, it addresses a universally recognized unmet need. And we know this because we've got expressions of interest from surgeons at seven major US transplant centers, and from the heads of six of the top eight Australian transplant centers. We're gearing up to do our first inhuman trial by the end of this year starting next year, and we have surgeons from the both the US and Australia vying to be a part of this trial. So why is it good for the hospital for the surgeon and the patient? Well from the hospital, these organ shortages drive demand for organ optimization devices. And the limited availability of transplant surgeons means that institutional kidney outcomes matter. And the surgical liability of kidney transplantation can affect the entire hospital. For the surgeon, the primary driver is improved kidney outcome metrics. This is good for the patient, but it's also good for the transplant team. And the surgeons want a consistent and improved operative workflow, which is something that the KPJ delivers. Patients are anxious about surgical risk and the KPJ has no to very low risk and can improve Transplant Outcomes which will ultimately save lives. It's also good for the healthcare system for each pay for each patient. intraoperative thermal regulation can provide a lifetime economic value of over 12,000 US dollars, as well as 0.26 quality of life If you're improvement, the projected lifetime savings across one annual us cohort are over a billion US dollars. Now, transplants are primarily paid by Medicare. And we have a comprehensive reimbursement strategy to take care to capture as much of this value as we can. So why now, because there's an organ shortage, and more marginal kidneys are being used for transplantation. And these less than ideal kidneys need all the protection they can get. With emerging technologies, our device is synergistic, so using them in combination will only improve outcomes. Robotic transplantation is on the rise, but it takes longer than standard transplantation. So the use of hate the KPJ can help facilitate this transition. We've achieved our preclinical studies which have been completed and published in peer reviewed journals, and national phase patents are under examination, our regulatory pathway is confirmed, and we've established our manufacturing in Minnesota. In the short term, we're looking to complete our device validation activities, complete our feasibility first inhuman trial at a leading US hospital and achieve our FDA clearance. In the medium term, we're looking to launch a product in the US marketplace and create a registry to track our real world evidence. We're also assessing an N tap application. In the long term, we're looking at completing a pivotal randomized control trial, generating new codes for inpatient procedures and physician payment, and leveraging our clinical data to show not only the short term patient outcomes, but also the long term patient outcomes. And finally, generation of a gen two product which is a multi organ, customizable platform to protect organs beyond just the kidney. We're currently seeking $2 million in seed funding to complete our short and medium term objectives. Our vision is for the KPJ to become the new standard of care, in kidney transplantation and for kidneys to never again, be damaged during surgery. Thank you very much for your time.