STTR Phase I: Non-invasive focused ultrasound treatment to modulate the immune system for acute and chronic kidney rejection

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a novel medical device therapy for improving the clinical outcomes of patients receiving organ transplants. Over 100,000 kidney transplant procedures are performed worldwide each year, with up to 20% of patients experiencing rejection. Existing drug treatments, including immunosuppressants, often entail significant side effects with a high financial cost of nearly $30,000 per year per patient. This project aims to develop an external system for reducing inflammatory responses thereby reducing adverse events associated with the transplant and extending the lifetime of the new organ. Beyond kidney organ transplantation, the technology provides potential extensibility for other organ transplants as well as addressing various chronic inflammatory diseases. This Small Business Technology Transfer (STTR) Phase I project aims to develop a novel ultrasound-based medical device therapy for reducing post-transplant organ rejection. The external system stimulates targeted nerves in the spleen to modulate the immune system through established physiologic pathways. The proposal aims to optimize various ultrasonic parameters in a transplant model to further development towards a functional prototype. The key objectives include 1) developing a pre-clinical transducer delivering the desired therapeutic ultrasonic waveform to the targeted splenic nerves, 2) optimizing the treatment parameters using an accepted preclinical skin allograft model, and 3) validating the reduction in pro-inflammatory cytokines in situ in accepted preclinical models. The results of this proposal will demonstrate the safety and feasibility of this technological approach toward eventual clinical patient translation. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.