Approximately 15% of U.S. adults have chronic kidney disease (CKD), according to the CDC. Early stage treatment can slow CKD progression through the five stages of severity. For patients whose kidney disease continues to the fifth stage — called end-stage renal disease (ESRD) — and their kidneys fail, the only treatments are kidney transplantation or chronic dialysis.

A 2011 study estimated there were 2.1 million patients world worldwide on dialysis, of whom approximately 11% were on peritoneal dialysis (PD) and 89% were on hemodialysis (HD). Both types of dialysis require fresh dialysate fluid. HD uses a machine to filter uremic toxins from the blood. PD uses the lining of the patient’s abdominal cavity as a filter. In both dialysis forms, the dialysate removes the filtered toxins.

Singapore-based AWAK Technologies recently announced the U. S. Food and Drug Administration (FDA) granted Breakthrough Device status to the wearable and ultra-portable AWAK Peritoneal Dialysis (AWAK PD) device. The FDA grants Breakthrough Device status to speed the development of review of devices that diagnosis or treat life-threatening or debilitating diseases with no equivalent FDA-approved treatment available, or when the technology has significant advantages over existing technologies.

AWAK’s sorbent technology removes uremic toxins from used dialysis fluids to produce fresh dialysate. AWAK is developing sorbent for both HD and PD treatments. This makes it possible to greatly reduce the size and weight of the dialysis machine, making it so portable that it can be worn on a strap as the patient is busy with other activities. The FDA based its decision on a successful human safety trial of the AWAK PD device. The device removed toxins from patients in the trial efficiently with no serious adverse events. Patients who use AWAK PD can use the device while sleeping or during the day, without having to spend hours and hours connected to large dialysis machines, two or three days each week.

With the path cleared for relatively rapid development, AWAK is able to continue with clinical studies to bring its AWAK PD wearable technology closer to acceptance for marketing in the U.S.