AWAK Technologies and Singapore General Hospital (SGH) have commenced a pre-pivotal clinical study of a wearable peritoneal dialysis device.

The first patient has been enrolled in the trial designed to assess the safety and efficacy of an improved automated wearable artificial kidney peritoneal dialysis (AWAK PD) device.

The single-arm, single-site and prospective trial is a follow-up of its first-in-human study, which showed no serious adverse events.

AWAK PD trials principal investigator associate professor Marjorie Foo said: “We have collaborated with AWAK Technologies on this project since its early years of development.

“Despite Covid-19 slowing us down, we have continued to improve on the device and are now ready to embark on a pre-pivotal trial, one step closer to what our patients are hoping and looking forward to – a life on dialysis that will minimally affect their lifestyle and yet provide good quality dialysis.”

AWAK PD is a wearable and ultra-portable peritoneal dialysis (PD) system, which helps conduct dialysis for on-the-go end-stage kidney disease patients.

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Weighing roughly 3kg, the compact device integrates the company’s patented sorbent technology to change the way of administration currently used for peritoneal dialysis.

The device is expected to help address the challenge of facilitating connection to large-size dialysis machines and long hours of stationary therapy in clinics and hospitals.

The company secured breakthrough device designation from the US Food and Drug Administration for the device.

AWAK Technologies CEO Suresha Venkataraya said: “Entering the pre-pivotal trial with the enhanced version of our device signifies a significant step in our mission to revolutionise the dialysis industry.

“The invaluable insights and feedback from the initial first-in-human trial have been vital in refining and enhancing our product.”