AWAK Technologies, a Singapore-based medical technology company, recently received FDA Breakthrough Device designation for their wearable and portable dialysis device. Called the AWAK Peritoneal Dialysis device, or AWAK PD, the technology uses AWAK’s patented sorbent technology and offers a convenient means of dialysis for renal disease patients.
Peritoneal dialysis is a common means of treating kidney failure, with hemodialysis being another method. Hemodialysis requires the patient to attend a dialysis center and be handled by trained healthcare providers, making the experience very inconvenient. The patient has more control over the scenario if they opt to use peritoneal dialysis, however this method still requires supervision.
This new device from AWAK aims to make the peritoneal dialysis process even more convenient. The AWAK PD tool allows patients to perform dialysis on the go, eliminating the inconvenience of hours of therapy and trips to and from dialysis centers. The FDA qualifies a technology to be a Breakthrough Device if it has no approved alternatives currently on the market, or if the technology offers a large advantage over existing alternatives. This designation was created to speed up the process by which these beneficial products hit the market.
The FDA deemed the AWAK PD device worthy of this status after reviewing a safety trial conducted with a human using the device. This trial was done at the Singapore General Hospital, which is the largest acute tertiary hospital in Singapore. The pilot study involved 15 adults between 21 and 80 years of age who were undergoing regular peritoneal treatment. Each of the patients competed 9 dialysis treatments with the AWAK PD for 3.5 hours a session over a three-day period. Results of this study showed that AWAK PD removed accumulated waste and filtered blood sufficiently, and the patients experienced no adverse events during treatment.
Full results of the trial are currently being analyzed and will be announced in the first half of this year, as per the Singapore General Hospital.
“Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results,” said AWAK Technologies CEO Suresha Venkataraya. “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.”
— Am Soc Nephrology (@ASNKidney) January 10, 2019