SINGAPORE, Oct. 23, 2018 /PRNewswire/ -- 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).
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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
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Mandar
Gori
AWAK Technologies Pte
Ltd
+65 6950
0925
mandar.gori@awak.com
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Carol Ang
Communications Department
Singapore General Hospital
+65 6326 6085
carol.ang@sgh.com.sg
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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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