Medical technology company AWAK Technologies (AWAK) revealed on Friday the receipt of the US Food and Drug Administration (FDA) Breakthrough Device designation to expedite the development and review of AWAK Peritoneal Dialysis (AWAK PD) device.

The company added that the world's first AWAK Peritoneal Dialysis (AWAK PD) device is a wearable and ultra-portable PD system that incorporates its patented sorbent technology. The AWAK PD device disrupts the mode of delivery in which peritoneal dialysis is currently administered. In peritoneal dialysis, the lining of the abdominal cavity acts like the external filter to cleanse the blood. Dialysis fluid is introduced into the abdominal cavity through a permanent tube. The fluid remains in the abdominal for a certain period of time before it is drained and discarded.

According to the company, the device allows dialysis to be performed "on-the-go", overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients.

This US FDA designation follows the company's First-In-Human safety trial of AWAK PD device, which was successfully completed in 2018 at the Singapore General Hospital. The trial results showed that AWAK PD was able to efficiently remove the accumulation of toxins from the body and patients in the trial did not experience any serious adverse events during dialysis with AWAK PD.

End-Stage Renal Disease (ESRD) is reportedly the fifth stage of Chronic Kidney Disease (CKD) that affects the functioning of kidneys, leading to accumulation of excess fluid and toxic wastes in the blood.