SINGAPORE, June 20, 2023 /PRNewswire/ — AWAK Technologies (AWAK) and Singapore General Hospital (SGH) announce 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.

AWAK PD is a wearable and ultra-portable peritoneal dialysis (PD) system that allows patients with end-stage kidney disease to have dialysis on the go and 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 of its 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.

Suresha Venkataraya, Chief Executive Officer, AWAK Technologies, said: “Entering the pre-pivotal trial with the enhanced version of our device signifies a significant step in our mission to revolutionize 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, Singapore General Hospital, for their unwavering support throughout our innovation journey.”

Associate Professor Marjorie Foo, Principal Investigator of both AWAK PD trials and Senior Consultant, Department of Renal Medicine, SGH, said: “Although most patients with end-stage kidney disease 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. 

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About AWAK PD

AWAK PD is the world’s to-be-first 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. AWAK PD is a compact device that weighs around 3 kg and enables dialysis to be performed on the go, overcoming the challenge of long hours of stationary therapy and connection to large-size dialysis machines in hospitals and clinics, a challenge currently faced by patients who need dialysis.

AWAK’s patented technologies not only regenerate and reconstitute waste dialysis fluid into fresh usable fluid thus reducing the amount of dialysis fluid needed by up to 90 per cent, but also enable the miniaturisation of the dialysis machine to fit into a small carry bag.

AWAK PD has undergone First-In-Human (FIH) trial following which this pre-pivotal clinical trial will test the enhanced version of the device before advancing to a pivotal trial aimed for regulatory approval and market authorization of AWAK PD. 

About End-Stage Kidney Disease

End-stage Kidney Disease (ESKD) 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. People with ESKD undergo either kidney transplantation or dialysis. Since kidney transplantation is highly dependent on patient’s health and age, dialysis scores over as the primary treatment.

As of 2022, estimates indicate that about 4 million people with kidney failure are treated with dialysis or live with a kidney transplant worldwide. Of all dialysis, 11 per cent of the patients are on peritoneal dialysis (PD) and the remaining 89 per cent are on haemodialysis (HD).

Dialysis treatment can be performed either at home, in a dialysis centre or at a hospital. In haemodialysis, blood is drawn out of the patient’s body into a synthetic filter called dialyser. In the dialyser, there are two spaces separated by a membrane, with blood passing on one side and dialysis fluid on the other side. Waste products and excess water passes from the blood through the membrane into the fluid through diffusion process. The fluid containing the waste products is then discarded while the clean blood is returned back to the patient’s body.

In peritoneal dialysis, the lining of the abdominal cavity acts like the external filter to cleanse the blood. Dialysis fluid is introduced into the abdominal cavity through a permanent tube. The fluid remains in the abdominal for a certain period of time before it is drained and discarded.

About AWAK Technologies

AWAK Technologies Pte Ltd. is a pioneering, patient-centric medical technology company with a mission to enhance the lives of people with kidney disease and their caregivers by providing solutions to deliver better outcomes and improve their quality of life.

Headquartered in Singapore with subsidiaries in Burbank (California, USA) and Bangalore (Karnataka, India), the company is dedicated to the research, development and marketing of novel solutions for the treatment of patients with kidney disease. For more information, please visit: www.awak.com

About Singapore General Hospital

Singapore General Hospital, established in 1821, is the largest tertiary hospital in Singapore and ranked among the world’s best. It provides the most comprehensive patient-centred care with over 50 clinical specialties on its campus. As an Academic Medical Centre, it takes pride in training healthcare professionals and conducting cutting edge research to meet evolving needs of the nation as well as the region. Driven by a strong sense of purpose, SGH is committed to give of its best to heal and bring hope, as it has for over 200 years. For more information, please visit www.sgh.com.sg

 

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SOURCE AWAK Technologies