CytoSorbents wins USAF contract to advance K+ontrol to clinical trials

24 October 2019 (Last Updated October 24th, 2019 12:37)

CytoSorbents has been awarded a contract by the US Air Force (USAF) to advance the development of the K+ontrol system for the treatment of severe hyperkalemia.

CytoSorbents has been awarded a contract by the US Air Force (USAF) to advance the development of the K+ontrol system for the treatment of severe hyperkalemia.

The two-year contract worth up to $2.95m has been awarded as part of the Rapid Innovation Fund (RIF).

CytoSorbents will advance its ‘K+ontrol Renal Support System for Reduction of Hyperkalemia’ programme towards a clinical trial and potential US Food and Drug Administration (FDA) approval.

Severe hyperkalemia is a medical condition with extremely high levels of potassium in the blood and is seen in military trauma.

Around 6% of US casualties in the Iraq and Afghanistan wars were afflicted with severe hyperkalemia.

Severe hyperkalemia is one of the most fatal complications of crush injury, trauma, and prolonged limb ischemia.

The medical emergency can lead to heart arrhythmias and sudden cardiac death.

CytoSorbents chief operating officer Vincent Capponi said: “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 US Air Force.

“This new $3m RIF award will allow us to further refine and optimise 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.”

The company was previously awarded a Small Business Innovation Research (SBIR) Phase II Enhancement award by the US Army.

Under the contract, CytoSorbents developed a blood purification system to treat hyperkalemia. The company was assisted by researchers at Travis Air Force base in this effort.

The system brings together the company’s K+ontrol potassium sorbent and existing medical equipment.

The RIF award from the USAF will enable the company to transition the K+ontrol technology to human clinical studies.

CytoSorbents Polymer Development senior director Dr Thomas Golobish said: “A tremendous amount of effort and innovation has gone into the current prototype, and we look forward to working with our collaborators at Travis Air Force base to finalise a robust and integrated design that can be set-up quickly with minimal effort.”