CytoSorbents Medical Inc. SBIR Phase II Award, April 2021

Hyperkalemia is a serious concern in the treatment of combat casualties as it is a common complication of acute kidney injury, which prevents the excretion of excessive plasma potassium released from damaged tissue. The risk of death from hyperkalemia-induced cardiac arrhythmias is significant in the absence of renal replacement therapy (RRT). Rapid evacuation out of Iraq and Afghanistan ensured that most instances of hyperkalemia occurred further up the evacuation chain, thereby limiting the need for non-RRT hyperkalemia treatment options for austere conditions. to prepare for future theaters of operation, the military research community is preparing for prolonged field care and extended evacuation times by investigating treatments that can be deployed and utilized in resource limited environments. One implication of the delay is that complications of combat injury, including life-threatening hyperkalemia, will be more frequently managed in the far forward deployed setting where RRT is not practicable. To address this unmet medical need for the military, we are developing a forward care intra-abdominal mesh packing device to reduce systemic potassium levels in austere medical treatment environments to treat hyperkalemia. The benefits of our forward care medical device are three-fold: 1) stabilizes hyperkalemia patients to endure prolonged field care and delayed evacuation, 2) is logistically feasible to implement for field use requiring nominal dialysate fluid and medical training, and 3) expands hyperkalemia treatment options to include transport on aircraft with limited medical capability. This program will yield crucial advances with efforts focused on refinement and optimization of the device to ensure safe and effective treatmetn. Successful completion of this project will be demonstrated by the production of an effective advanced prototype that is ready for manufacturing scale-up and subsequent clinical testing to provide a real-life solution for combat-related hyperkalemia treatment in austere environments.