Medical technology firm Awak Technologies has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its peritoneal dialysis device.
Awak peritoneal dialysis (AWAK PD) device is a wearable and ultra-portable PD system, which integrates the patented sorbent technology of the company.
The new enables dialysis to be performed on-the-go, helping to address the challenge of long hours of therapy and connection to large-size dialysis machines currently faced by renal patients.
End-stage renal disease (ESRD) is said to affect 650,000 patients per year in the US.
As per the FDA, breakthrough device designation is provided to enhance the development and review of certain devices, which show potential to offer an effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
The designation was based on data from the first-in-human safety trial of Awak PD device, which was completed in October last year at the Singapore General Hospital.
The results of the study demonstrated that Awak PD device’s ability 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 the device.
ESRD is the fifth stage of chronic kidney disease (CKD), which affects the functioning of kidneys, and accumulates excess fluid and toxic wastes in the blood. Dialysis treatment can be carried out either at home, dialysis centre or at hospital.
Awak Technologies CEO Suresha Venkataraya said: “Breakthrough Device Designation is an important milestone in the development of Awak PD following the recent positive clinical study results.
“The designation reinforces our belief that Awak has the potential to revolutionise the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway.”
Based in Singapore, Awak Technologies is engaged in the research, development and marketing of novel and sorbent-based kidney dialysis machine for the treatment of patients with ESRD. The company also has an office in Burbank of California, US.