AWAK Technologies has been granted a breakthrough device designation from FDA for a wearable and ultra-portable peritoneal dialysis (PD) device.
The Singapore-based company’s AWAK PD 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.
The company said FDA’s designation was granted after reviewing the results from the First-In-Human safety trial of AWAK PD device, which was successfully completed in October 2018 at the Singapore General Hospital, Singapore's largest acute tertiary 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.
“Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results,” Suresha Venkataraya, CEO of AWAK, said in a release. “The designation reinforces our belief that AWAK PD has the potential to revolutionize 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."
To date, dialysis procedures can be cumbersome for patients. Typically, these patients go to dialysis three times a week with a four-hour treatment. These treatments have significant impact on lifestyle, but even more than that the mortality and morbidity of these patients is very high.
There have been other attempts to create more efficient ways of dialysis care for patients. Nearly four years ago, FDA granted Expedited Access Pathway status to the Wearable Artificial Kidney (WAK) following a clinical trial at University of Washington Medical Center in Seattle.
Developed by Victor Gura, MD of UCLA/Cedars Sinai Medical Center in Los Angeles, the WAK weighs 11 lbs. and is worn around the waist on a belt. It continuously purifies the blood of toxins, freeing patients from sitting for hours every week hooked up to hemodialysis machines.
In 2016,Vanderbilt University researchers revealed their work on microchip filters that can help remove waste products and hopefully keep patients off dialysis. Each chip acts as a filter and can be inexpensively produced and precisely tailored to individual patient needs.
The device was designed to operate with approximately fifteen microchips and uses live kidney cells that will grow around the microchip filters to help imitate natural kidney functions.