Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time.

The project objective is to provide a non-invasive ultrasound device to MTEC and partners that decreases healing time and improves healing in burn injury patients. This will be accomplished in two tasks. Task 1 will directly test the ultrasound technology (using a GE LOGIQ E10 system) in a clinical test on daily splenic stimulation in burn patients (partial thickness; <20% TBSA). Task 2 will perform additional pre-clinical burn model experiments (both rodent and rabbit) that enable additional testing of the technology in full thickness burn wounds, and additional comparison of circulating blood versus wound site biomarkers during treatment. Outcomes: It is anticipated that completion of task 1 (clinical trial) and task 2 (additional pre-clinical work) will enable a post-program phase II clinical trial and testing in additional cohorts (of various TBSA and partial versus full thickness wounds). It is anticipated that this trial will be funded through continued partnership with the team and MTEC partners, and that GE will continue to support and seek funding for this commercialization step. It is also anticipated that the MTEC burn application will be able to seek 510K clearance, due to the on-going GE-funded trials in other disease/application spaces (which will seek de novo approval prior to MTEC project completion).