A study investigating the safety of AWAK PD, a wearable peritoneal dialysis (PD) device in treatment for patients with End Stage Renal Disease (ESRD) led by the Singapore General Hospital (SGH), has shown positive preliminary results.
End stage Renal Disease (ESRD) is 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.
Peritoneal dialysis is a procedure to discard waste products from your blood when your kidneys can no longer do the job properly. A cleansing fluid flowing through a catheter into part of your abdomen filters waste products from your blood. After a prescribed period of time, the fluid with filtered waste products flows out of your abdomen and is removed. What makes PD different from hemodialysis (a more commonly used blood-filtering procedure) is that with PD, you can give yourself treatments at home, at work or even while traveling.
AWAK PD is the world’s first wearable PD system that incorporates AWAK’s patented sorbent technology to disrupt the way in which peritoneal dialysis is currently administered.
Peritoneal dialysis is a procedure to remove waste products from your blood when your kidneys can no longer do the job adequately. A cleansing fluid flows through a tube (catheter) into part of your abdomen and filters waste products from your blood. After a prescribed period of time, the fluid with filtered waste products flows out of your abdomen and is discarded. Peritoneal dialysis differs from hemodialysis, a more commonly used blood-filtering procedure. With peritoneal dialysis, you can give yourself treatments at home, at work or while traveling.
Weighing only 2 kg, the AWAK PD enables dialysis to be performed “on-the-go”, overcoming the challenge of long hours of treatment and connection to large-size dialysis machines in hospitals and clinics currently faced by kidney disease patients, said a press release.
The sorbent technology regenerates and reconstitutes used dialysis fluid into fresh fluid while removing the uremic toxins from the spent dialysate. The AWAK PD device requires between 1.5 and 2 litres of dialysate to perform a patient’s entire daily therapy, compared with 8 to 12 litres required by traditional PD methods.
For their study, the SGH researchers recruited 15 adults between the ages of 21 and 80 undergoing regular PD treatment. Each patient had to complete 9 dialysis sessions of 3.5 hours each with AWAK PD over three continuous days.
The findings showed that AWAK PD efficiently removed the accumulated waste substances from the body. Also, patients didn’t experience any negative side effects during dialysis.
“We are excited by the encouraging results from this important Phase I (first-in-human) trial of AWAK PD. The findings provide positive clinical evidence of AWAK PD’s safety profile as a wearable device with the potential to truly disrupt the administration of peritoneal dialysis treatments. With the continued support of the National Medical Research Council, Singapore and Singapore General Hospital (SGH), we can now bring the technology closer to patients,” said Suresha Venkataraya, CEO, AWAK Technologies.
“The AWAK PD has been designed to empower ESRD patients to take control of their treatment in their own time and adapt therapy to their lifestyle rather than the other way around. We look forward to continuing our clinical work and commercializing our technology, offering an enhanced quality of life to end-stage renal disease patients worldwide.”