World's first wearable peritoneal dialysis device shown to be safe for end-stage renal disease patients: new AWAK Technologies and Singapore General Hospital study shows

SINGAPORE,Oct. 23,2018 -- AWAK Technologies (AWAK),a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease,today 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).

AWAK PD

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.

The full results from the trial are being analysed and will be announced in first half of 2019.

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."

Dr Marjorie Foo,Principal Investigator of the AWAK PD first in human trial,said: "The number of patients with end-stage renal disease continues to climb globally,largely due to diabetes. For these patients,transplantation is the best treatment but most are on dialysis to stay alive due to the scarcity of organs. Dialysis,however,can cause much disruption to their lives. Some have even had to stop work,resulting in a loss of income.

"We are therefore heartened by the favourable results of our Phase I trial. The wearable dialysis system has the potential to not only revolutionise how peritoneal dialysis can be delivered,it also gives patients the option of 'dialyse to live' and not 'live to dialyse'. This is as close as one can get to an artificial organ performing the functions of the kidney. A hospital-industry collaboration such as this is key to advancing patient care," said Dr Foo who is also Head and Senior Consultant,Department of Renal Medicine,SGH.

Media contacts

Emma Thompson / Clarinda Ng

Spurwing Communications

+65 6340 7287

awak@spurwingcomms.com

Mandar Gori

AWAK Technologies Pte Ltd

+65 6950 0925

mandar.gori@awak.com

Carol Ang

Communications Department

Singapore General Hospital

+65 6326 6085

carol.ang@sgh.com.sg

About End-Stage Renal Disease

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. People with ESRD undergo either renal transplantation or dialysis. Since renal transplantation is highly dependent on patient's health and age,dialysis scores over as the primary treatment. It was estimated as of 2011,there were 2.7 million ESRD patients of whom 2.1 million were on dialysis. Of these 2.1 million,10.8% of the patients are on peritoneal dialysis (PD) and the remaining 89.2% are on hemodialysis (HD)[1].

Dialysis treatment can be performed either at home,in a dialysis centre or at a hospital. In hemodialysis,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 dialysis patients and their caregivers by providing solutions to deliver better outcomes and improve their quality of life.

Headquartered in Singapore with an office in Burbank,California,USA,the company is dedicated to the research,development and marketing of novel,sorbent-based kidney dialysis machine for the treatment of patients with end-stage renal disease. For more information,please visit: www.awak.com

About Singapore General Hospital

Singapore General Hospital,a member of Singapore Health Services,is the public sector's flagship hospital. Established in 1821,SGH is Singapore's largest acute tertiary hospital with 1,700 beds and national referral centre offering a comprehensive range of 39 clinical specialties on its campus. Every year,about 1 million Singaporeans benefit from medical care delivered by its 800 specialists. As an academic healthcare institution and the bedrock of medical education,SGH plays a key role in nurturing doctors,nurses and allied health professionals,and is committed to innovative translational and clinical research in her continual strive to provide the best care and outcomes to her patients. www.sgh.com.sg

[1] Damien,P.,Lanham,H. J.,Parthasarathy,M.,& Shah,N. L. (2016). Assessing key cost drivers associated with caring for chronic kidney disease patients. BMC Health Services Research,16,690. http://doi.org/10.1186/s12913-016-1922-4

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