AWAK Technologies and Singapore General Hospital (SGH) have announced the launch of a pre-pivotal clinical trial with the enrolment of their first subject to study the safety and efficacy of an “improved” Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device, according to a press release.
AWAK PD is a wearable and “ultra-portable” peritoneal dialysis (PD) system that allows patients with end-stage kidney disease (ESKD) to have dialysis on the go. It has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
The single site, prospective, single-arm study is a follow-up on AWAK’s first-in-human study, which reported no serious adverse events. The team of SGH researchers is now recruiting subjects to participate in this pre-pivotal clinical trial.
AWAK 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. We remain committed to redefining kidney care by bringing disruptive products to improve the quality of life of people with kidney disease. We thank our board of directors, investors, and clinical partner, SGH, for their unwavering support throughout our innovation journey.”
Marjorie Foo, (SGH, Singapore), principal investigator of both AWAK PD, added: “Although most patients with ESKD are on haemodialysis, peritoneal dialysis offers similar efficiency and cost effectiveness with the added flexibility of treatment schedule to accommodate ones’ lifestyle and offers patient another option to choose from. 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.”
