AWAK- Automated Wearable Artificial Kidney

Renal disease Renal disease - temporary or permanent damage to the kidneys that result in loss of normal kidney function. - Acute and chronic renal failure Treatment: - Hemodialysis - Peritoneal dialysis -Market- in 2009-558,239 ESRD patients in the United States, with 397,000 receiving active dialysis, cost app $ 29 billions

Background - Developed in 2008 by an eponymous Singapore-based company - Targeted towards end stage renal disease patients - Wearable and waterless: patient's own peritoneal membrane is used as a filter, and spent dialysate is continuously regenerated from AWAK and reused - Mimics natural kidneys by operating 24/7, maintaining steady-state metabolic and fluid regulation - form of ambulatory (portable) form of peritoneal dialysis - The continuous cycling of dialysate through peritoneal cavity and the use of sterile connections hopefully reduces incidence of infections normally associated with traditional peritoneal dialysis.

Overview of Peritoneal Dialysis - dialysate pumped into peritoneal cavity, in abdomen - toxins and wastes cleared from blood through peritoneal membrane, which acts as a filter that allows wastes through but keeps important components of blood from leaking out into dialysate - after several hours, used dialysate containing blood toxins is drained from abdomen and replaced, operated by patient several times/day - the good: can receive treatment without a hospital - the bad: infection due to catheter, self-administered peritoneal membrane acts as filter that allows wastes through but keeps important components of blood (white and red blood cells, proteins) from leaking through

Peritoneal Dialysis Animation http://www.kidneypatientguide.org.uk/pdanim.p hp

AWAK dialysis - used dialysate automatically drained from peritoneal cavity and filtered through the sorbent cartridge, which removes toxins to produce regenerated dialysate. - the Enrichment Module adds electrolytes and glucose to dialysate before it is returned to the peritoneal cavity - These 3 steps are repeated until the Sorbent Cartridge is exhausted, at which point the old Disposable Module is replaced (2-3 times a day) - in Ultra-filtration mode, the dialysate from the peritoneal cavity is emptied into the ultrafiltration bag and some determined amount of dialysate is returned to the peritoneal cavity, at which point AWAK returns to dialysis mode. - dialysate pumped into peritoneal space - desired fluid volume to be removed is stored in a small bladder, which can be emptied periodically. - designed to continuously regenerate and reuse spent dialysate and ultrafiltrate in perpetuity, and so is "waterless"

Specifications - weighs about 4 lbs - includes cycler and cartridge - cycler has battery life of 16 hr - cartridge goes through 2L/hr - uses nitrogen batteries - change the disposable cartridge 2-3 times a day (each contains 750 ml) - zirconium used in cartridges.

Benefits - in traditional dialysis (haemodialysis), toxin and fluid levels fluctuate because dialysis is not continuous, leading to nausea, tiredness right after treatments - Most significant difference from peritoneal dialysis is that patients treated by AWAK do not have to regularly replace dialysate, because it is regenerated. - per week, HD uses 360 liters and PD uses 70 liters of dialysate, while AWAK uses 750 ml per month. - Dialysate inside machine can be replaced once every 2-3 months - Greatest benefit is the change in lifestyle: Device is portable, so patients can work, and move freely, and can be disconnected for several hours, allowsing for sports, etc. - allows for stable levels of fluids/electrolytes - challenge for normal patients is that they experience inconsistent levels of chemicals and waste in body between treatments, so lack control over blood pressure, anemia, etc. - with AWAK, don't need more medicine to treat those side effects - greatest benefit is change in lifestyle - patients can travel freely to go back to work

Challenges - chance of infection (as in traditional peritoneal dialysis) because of catheter continuously in peritoneal space - still have to change the cartridge a few times a day - must wear a bulky belt all day - need many sorbent cartridges

Video Wall Street Journal Video

Future - entered clinical trials in 2012 - working to allow doctors to tailor treatment using different strengths of cartridges for larger/more active people (Hi-Capacity cartridge) - develop waterproof version - hoping to submit clinical data in 2013 and get AWAK on the market in the U.S. and Europe - going through the 510(k) -> PMA route - Hi-Capacity cartridge weighs only 3.75 lbs and runs for 12 hrs battery, 4 liters/hour. Together with the 2.2 lb cartridge, the combination provides different operating modules to meet the needs of patients.

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References (1) http://www.awak.com/ (2) U.S. Renal Data System. USRDS 2011 Annual Data Report: Atlas of End-stage renal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011. Available at: http://www.usrds.org/atlas.htm (3) Ministry of Health, Singapore. Ministry of Health Information Paper 2006/013: Kidney Dialysis. Singapore: Ministry of Health, 2006 (4) Kalorama Information: The Worldwide Market for Dialysis Equipment Supplies and Services 2nd Edition Feb 2007 (5) Roberts, Martin; Lee, David B.N. (2006). "Wearable artificial kidneys: A peritoneal dialysis approach". Dialysis & Transplantation 35 (12): 780– 2.doi:10.1002/dat.20074