PROJECT SUMMARY More than 500,000 Americans are living with end-stage kidney disease, and most of them require life- sustaining hemodialysis treatments three times a week. Despite major improvements over the past several decades, the average life expectancy for dialysis patients is still only 5-10 years. Moreover, the financial burden is significant: dialysis patients comprise about 1% of those on Medicare, yet their care accounts for over 7% of the Medicare budget. There is a pressing need to improve both patient outcomes and the cost-effectiveness of hemodialysis treatment; the single most important problem facing patients being treated with hemodialysis is safe and reliable cannulation. To address these challenges, we developed an implantable device that aims to improve vascular access. The device features a 3D-printed titanium shell that accurately guides the hemodialysis needle to the correct insertion point, while a titanium-nitride coated valve stops bleeding immediately upon needle removal. This new cutting-edge device minimizes the risks for infection, incorrect needle placement, and excessive bleeding, making hemodialysis treatments safer, more efficient, and easier to administer. In this phase- I SBIR proposal, we will use state-of-the-art materials and engineering techniques to refine the manufacturability and operational parameters of our device. Then through a large animal preclinical study, we will evaluate device functionality, tissue integration, inflammatory profile as well as infection and bleeding risks. Our results will pave the way for a comprehensive large-scale GLP-certified animal study and a first-in-human trial. Our device has the potential to be a disruptive technology in nephrology, improve the quality of life for dialysis patients, and possibly facilitate wider adoption of home-based hemodialysis treatments.