“We are going to prioritize a truly transformative goal: the development of an artificial kidney." - President Donald J. Trump
Last week, the Department of Health Human Services (HHS) and the White House announced a set of sweeping new policies, initiated by the leadership of HHS Secretary Alex Azar II, intended to improve the lives of the 37,000,000 people in the United States with kidney diseases. This is a nearly unprecedented level of government investment and national attention for kidney diseases. As a result, people with kidney diseases have real reason to hope that treatment options will improve for them and future kidney patients.
The announcement is a step towards fulfilling a statement from Willem Kolff, the inventor of dialysis, that “If we are going to keep patients alive by artificial means, we then incur the responsibility to see that it is a good life and an enjoyable life”.
In “Advancing American Kidney Health”, HHS describes its approach to pursuing this goal:
“Ultimately, the best way to improve care for people living with kidney failure is to support the development of novel therapies extending beyond the choices available today. Investing in foundational research at the NIH, catalyzing rapid product development through public-private partnerships, and creating clear and forward-looking guidelines for marketing approval for emerging technologies like organ preservation may unleash innovation for years to come.”
The report also highlights the significant role KidneyX will play in these efforts through its prize competitions, such as the KidneyX: Redesign Dialysis Phase II competition. The Kidney Health Initiative (KHI), with its “Technology Roadmap for Innovative Approaches to Renal Replacement Therapy (RRT)”, and KidneyX are well positioned to realize HHS’s goals and support the kidney community as it develops better options for people with kidney diseases.
The Executive Order calls for a “strategy for encouraging innovation in new therapies through the Kidney Innovation Accelerator (KidneyX)”. KHI’s roadmap can be that strategy. The roadmap builds on basic science, such as NIDDK’s ReBuilding a Kidney, and provides innovators across the country with technical guidance for developing an artificial kidney. The roadmap is a translational document, providing research strategies and solution pathways to more effectively and efficiently develop commercially viable RRT alternatives to current dialysis treatments. By offering multiple solution pathways guided by patient preferences, the roadmap offers a clear path to revolutionizing RRT.
KidneyX accelerates the application of the KHI Roadmap through a prize competition model. The Redesign Dialysis Prize Competitions aim to accelerate the development of next-generation dialysis products, including wearable or implantable artificial kidneys. Redesign Dialysis offers $2.6 million in prizes for cutting-edge treatments beyond what is currently available for dialysis and transplantation. Included among the 15 winning teams for Redesign Dialysis Phase I, were companies developing advanced nanofiltration for toxin removal, miniaturized wearable dialyzers, real-time infection and clotting sensors, cell-based implantable dialyzers, and regenerative kidneys. The second phase of the competition seeks testable prototypes with design targets and categories that were developed based on KHI’s roadmap. Redesign Dialysis Phase II will open on November 11, 2019.
While there were many exciting pieces to last week’s announcements that will improve the care of the patients we treat, the attention paid to the artificial kidney is particularly exciting. We believe that Advancing American Kidney Health will increase investment, interest, and innovation in improving kidney care and ultimately curing kidney diseases. Our patients deserve to see the hope generated by Advancing American Kidney Health realized. KHI and KidneyX are determined to do our part to achieve these goals. Our patients deserve no less.