The US Air Force Materiel Command has awarded CytoSorbents Corporation a 2-year, nearly $3 million Rapid Innovation Fund contract to advance the development of a simple blood purification system to treat hyperkalemia. Having previously demonstrated efficacy in a porcine model, CytoSorbents aims to use the award to move the K+ontrol Renal Support System toward clinical trials in humans to ultimately gain regulatory approval from the US Food and Drug Administration (FDA).
Severe hyperkalemia, or dangerously high potassium levels in the blood, affected approximately 6% of US combat casualties in the wars in Iraq and Afghanistan. The condition—a complication of trauma, crush injury, and prolonged limb ischemia—can be fatal if not treated quickly. While dialysis is the current standard-of-care treatment for severe hyperkalemia, the therapy is too complex and resource intensive for Role 1 and Role 2 medical care, according to a CytoSorbents press release.
The K+ontrol Renal Support System prototype was developed through an earlier $500,000 award from the US Army Small Business Innovation Research program. CytoSorbents collaborated with researchers at Travis Air Force Base to combine the company’s proprietary K+ontrol potassium sorbent with existing standard medical equipment.
“The development of a simple, easy-to-use renal support system to treat severe hyperkalemia is a major milestone in our collaboration with the US Army and Air Force,” said Vincent Capponi, MS, chief operating officer at CytoSorbents, in the company press release.
“This new $3 million Rapid Innovation Fund award will allow us to further refine and optimize the technology for human treatment, and advance the technology towards human clinical trials and potential FDA approval. Our goal is to meet the special needs of our warfighters and civilians in mass casualty situations and to help reduce preventable deaths.” —Jolynn Tumolo