23 October 2018 | News
New AWAK Technologies and Singapore General Hospital study shows positive preliminary results.
Singapore – AWAK Technologies, a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, announced positive preliminary results from a recently completed Phase I study investigating the safety of AWAK PD in dialysis treatment for patients with End Stage Renal Disease (ESRD) led by the Singapore General Hospital (SGH).
A world-first, the AWAK PD is a wearable and ultra-portable peritoneal dialysis (PD) system that incorporates AWAK’s patented sorbent technology to disrupt the way in which peritoneal dialysis is currently administered. The AWAK PD is a compact device that weighs less than 2 kg and enables dialysis to be performed “on-the-go”, overcoming the challenge of long hours of therapy and connection to large-size dialysis machines in hospitals and clinics currently faced by renal patients.
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.
Conducted at SGH, the single-arm pilot study enrolled 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.
Preliminary results show that AWAK PD was able to efficiently remove the accumulation of waste substances from the body. Patients also did not experience any serious adverse events during dialysis with AWAK PD.
Suresha Venkataraya, Chief Executive Officer, AWAK Technologies, said: “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.
“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 commercialising our technology, offering an enhanced quality of life to end-stage renal disease patients worldwide.”
The full results from the trial are being analysed and will be announced in first half of 2019.