New innovation for PD patients

By EMILY VEACH
Awak Technologies, an Asian Innovation Awards finalist, has created a portable device used for treatment of end-stage renal disease. It's "dialysis on the go," explains Chairman Gordon Ku.
The millions of dialysis patients around the world may soon gain greater freedom and cost savings through a portable, wearable artificial kidney device developed by Singapore outfit Awak Technologies Pte. Ltd.

The product—currently undergoing animal and lab tests in Singapore and preparing for clinical trials in the U.S. and Germany—performs peritoneal dialysis using a small amount of liquid and has been named a finalist in the Asian Innovation Awards.

Awak Chairman Gordon Ku displays the wearable artificial kidney in Singapore. In collaboration with Temasek Polytechnic, Awak is hoping to submit clinical data to regulatory bodies in the U.S. and Europe by 2013.

Gordon Ku, Awak's chairman, said he had been frustrated that in his 41 years as a nephrologist, or kidney doctor, dialysis treatment for end-stage renal disease saw no significant advancements.

"In the past 40 years the only development is that the machine has become half the size," Dr. Ku said. "It may be easier to operate. As far as the delivery of dialysis is concerned there are no major improvements."

The theory behind Awak came from Drs. David Lee and Marin Roberts at the University of California, Los Angeles. Dr. Ku joined with them to found Awak in 2007. In the past four years, the device has morphed from a torso-sized vest to the size of a small purse.

Only about 7% of kidney patients use peritoneal dialysis, with the majority undergoing hemodialysis. But in Hong Kong, where the majority of patients use peritoneal dialysis, "we have proved that PD works very well," said Dr. Lo Wai Kei, honorary clinical associate professor in the University of Hong Kong's Department of Medicine. "It's more economical, and patients enjoy it." The city also lacks two factors necessary for hemodialysis clinics: nurses and space for equipment.

One of the drawbacks of home treatment home is patients have to conduct interchanges themselves. Sometimes germs enter the body, leading to infection. Dr. Lo said some of the new trends in treatment are toward giving dialysis patients more freedom.

Hemodialysis cleanses the blood by running it through a machine and back into the body, while peritoneal dialysis works in the abdomen. "The sorbent in the process removes all the uremic toxins and all the electrolytes," Dr. Ku said. "That takes place in our device. We put back in the necessary electrolytes and glucose."

The company has conducted lab tests using spent dialysis fluid, running it through the wearable machine and testing it afterwards. The findings show that the resulting fluid was cleansed of toxins.

Awak patients change the disposable cartridge in their device once a month. It contains 750 milliliters of fluid solution, compared with 8 to 10 liters a day required for traditional peritoneal dialysis machines, and 120 liters used for a four-hour hemodialysis session.

By requiring so little dialysate, the expensive mix of water and chemicals used in dialysis, Awak hopes to reduce costs for patients, providers and treatment centers.

Awak patients change the disposable cartridge in their device once a month. It contains 750 milliliters of fluid solution, compared with 8 to 10 liters a day required for traditional peritoneal dialysis machines, and 120 liters used for a four-hour hemodialysis session.

There are a couple other companies working on wearable hemodialysis machines in the U.S., but so far they have not reached the market. Awak believes its product will create a paradigm shift in treatment, forcing providers to change long-standing practices. Awak plans to price its product at or below the monthly reimbursement rate for patients in the U.S., currently $1,800. According to the 2010 annual report from U.S. Renal Data System, in 2008 there were almost 550,000 dialysis patients in the U.S. with a total cost of $39.5 billion.

A challenge for patients is that they experience inconsistent levels of chemicals and waste in the body between treatments, resulting in lack of control over blood pressure, anemia or phosphate retention. With a device like Awak, patients won't need the additional medications to treat these side effects. Dr. Lo of the University of Hong Kong said the trend toward continuous dialysis will help solve this problem. But the greatest benefit, according to Awak, is a change in lifestyle, allowing patients to travel freely and go back to work. Moreover, Dr. Ku said, doctors will be able to tailor the treatment using different strengths of cartridges for larger people, or more active people.

Now, Awak is preparing for certification in the U.S. and Europe simultaneously.

In collaboration with Temasek Polytechnic, Awak is hoping to submit clinical data to regulatory bodies in the U.S. and Europe by 2013. The institute has been instrumental to Awak's research, development and business plan. The Awak team is currently setting up a kidney-research institute in Singapore, and future plans include making a waterproof version.

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