Singaporean medical technology company Awak Technologies has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for its peritoneal dialysis device.
Based on the company’s sorbent technology, the Awak Peritoneal Dialysis (AWAK PD) device is a wearable and ultra-portable PD system that enables on-the-go dialysis.
The new device is intended to avoid long hours of therapy and connection to large-size dialysis machines that are currently needed by renal patients.
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 PD 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.”
The FDA decision is based on the results from a safety clinical trial of AWAK PD conducted at the Singapore General Hospital in October last year.
Findings demonstrated that the device was able to efficiently remove the accumulation of toxins from the body. No serious adverse events were reported during dialysis using AWAK PD in the trial.
Awak Technologies is primarily focussed on the research, development and marketing of new, sorbent-based kidney dialysis machine for patients with end-stage renal disease (ESRD).
ESRD, characterised by excess fluid and toxic wastes accumulation, affects 650,000 people each year in the US. The condition is treated with either dialysis or renal transplantation.
Dialysis is considered as the primary treatment since renal transplantation is mostly based on a patient’s health and age.