Approximately 100,000 U.S. patients require a kidney transplant each year, with some waiting more than five years for a donor, and up to half of those dying in the interim.
And even for the “lucky” ones who receive a transplant, there are still hurdles. In fact, one in three patients experiences delayed graft function (DGF), a failure of the renal transplant to function immediately, which leads to longer hospital stays, a return to dialysis, higher rates of organ rejections and diminished outcomes for their new kidneys.
DGF has a devastating impact on patients and their families and presents a challenging problem for surgeons. One of two Stanford Biodesign Summer Extension projects hosted by Fogarty Innovation is focused on preventing this problem by developing a cooling jacket that facilitates organ handling during the transplant. The project is aptly called DIATIRO, which is Greek for “preservation.”
Complementary skills fuel the team
Originally from Indiana, Keith is a general surgery resident at UCSF who plans to specialize in transplant surgery. He received his BS in Biomedical Engineering from Purdue University and MD from Indiana University School of Medicine. He’s always had a broad range of interests, and disrupting the status quo has driven many of his endeavors and career decisions. His widespread achievements include founding a program that delivers children’s books to community health clinics across the state of Indiana and serving as a Senate intern in the Indiana General Assembly.
Keith applied to the Innovation Fellowship to leverage the two years of research time he was allotted as part of his residency. “I was fortunate to be accepted, and I immediately felt right at home with people who shared many of my passions,” said Keith. “The program was everything I had hoped for, and despite COVID, I was able to make connections as I learned about medical innovation through unmatched hands-on training.”
Victoria received her BS and BA in Materials Engineering and Visual Art from Brown University. With a passion for combining art, design and engineering, she started in medtech working in the advanced technology division of Edwards Lifesciences, designing and prototyping structural heart therapies. There, she developed technical design expertise, helped create the company’s human factors and usability engineering in-house resource, and proctored physicians in the use of experimental transcatheter products. Her experience in navigating the FDA approval process for medical devices has proven useful to the DIATIRO team during these early phases of their project.
Finding a large unmet need
Keith and Victoria partnered with George Korir, Alexander Sackeim and Nishant Doctor to find important unmet needs to address in the urology and nephrology field during their fellowship year. Their team ultimately focused on two needs: kidney transplant and kidney stones. Alexander and Nishant are taking the kidney stone project forward as team Anodyne, while Keith and Victoria are focused on kidney transplant.
“We were watching a kidney transplant surgery and realized that in addition to an elaborate orchestration of resources, hours were being spent on the sew-in of the kidney, which greatly intensified the atmosphere in the OR,” said Victoria. “This led us to ask questions as to why this was happening and how we could make it better for the patients and the surgeons.”
“What we later observed is that kidney transplant patients often wake up from their surgeries only to find out that the organ they received wasn’t working, which is devastating to all involved,” added Keith.
The team learned that the kidney starts dying as soon as it’s taken out of the donor, and while it’s rushed to the recipient as quickly as possible, time isn’t the only factor that impacts the viability of the organ; temperature matters more. Transplant teams put the kidney on ice immediately after the donor surgery and during transport. However, the greatest harm to the kidney occurs during the transplant itself as there aren’t any good methods to keep the organ cold. That means the temperature-related damage happens six times faster during surgery than during transport. Surprisingly, surgeons don’t focus on temperature change because it isn’t monitored in the OR.
That gave Victoria and Keith the idea for a technology that aims to improve kidney transplant preservation in order to improve outcomes and increasing the number of kidneys that can be used by making it possible to safely transplant more kidneys that are now rejected because of being functionally marginal.
“When we started investigating the issue, we realized we needed to make the procedure easier and alleviate the time pressure of sew-in,” said Keith. That’s how the team came up with their concept of a cooling kidney “jacket,” a single-use device that is applied right before sew-in and visibly tracks the temperature throughout the procedure.
While the market is relatively small, it would extend considerable cost savings to the healthcare system, estimated to be over $1 billion a year. This would be a first product for the team with the aim to expand into other opportunities, including heart, liver and lung transplants.
DIATIRO received $60,000 in extension funding to move the project forward over the summer, and Victoria and Keith are looking forward to working with the Fogarty Innovation team to receive feedback, identify gaps and address challenges in order to propel their concept to fruition.
About the Stanford Biodesign Innovation and Summer Extension Programs
The Biodesign Innovation Fellowship is a 10-month, full time, hands-on program for experienced professionals with backgrounds in engineering, medicine and business. During the fellowship, trainees learn and apply the biodesign innovation process to uncover and validate clinical needs, invent novel digital and device-based health technologies to address them, and prepare to bring those products to the market to improve patient care.
The Biodesign Summer Extension program provides qualifying teams from the Stanford Biodesign Innovation Fellowship and the graduate-level Biodesign Innovation course with additional funding and mentoring to pursue their projects through the summer. Recipients use this time to further de-risk their technologies, develop business plans, and line up additional funding to take their projects to the next level.
The Fogarty Innovation partners with these young companies to offer its signature hands-on mentoring from each member of the executive team, in addition to a dedicated mentor, along with a comprehensive development plan and opportunity to participate in educational workshops tailored to their specific needs.