Medical Device Daily
Hemodialysis is the most common way to treat kidney failure, but it's a complicated and inconvenient therapy requiring three visits a week to a dialysis center for up to five hours each time. AWAK Technologies (Singapore) has developed a peritoneal dialysis-based wearable artificial kidney that provides 24/7 continuous dialysis, operating much like a natural kidney. Although the company's prototype is six pounds, it's estimated that the commercialized version will weigh just two pounds.
"The AWAK (automated wearable artificial kidney) is intended for all patients with renal failure," Neo Kok Beng, AWAK president/CEO, told Medical Device Daily.
The invention was the result of original joint research with the University of California, Los Angeles (UCLA) and the Department of Veterans Affairs, Neo said, adding that "Our chairman, Gordon Ku, is good friends with the inventors there and they decided to work together." What resulted was a license for the intellectual property signed last year.
The company is billing the AWAK as a device that provides "natural" kidney function because it maintains steady metabolic and fluid regulation. Typically dialysis provides intermittent function with a resulting "see-saw" pattern regulation. AWAK's continuous therapy cycles dialysate through the peritoneal cavity offering patients not only freedom from lengthy visits to dialysis centers, but also an assumed greater health benefit.
AWAK, which is about the size of two portable CD players, is worn on a belt around the waist. It was debuted at the American Society of Nephrology (ASN) – Renal Week, held in San Diego last month.
The AWAK is based on peritoneal dialysis, but provides regeneration of used dialysate with ultra-filtration. So in addition to providing mobility, AWAK is different from existing peritoneal dialysis or hemodialysis technology because it's also self-contained; AWAK continually regenerates the used dialysate through a sorbent cartridge rather than requiring replacement of the dialysate. Patients can expect to replace the dialysate every two to three months.
"It is truly a disruptive innovation that will change the landscape of the dialysis industry," Ku said. "Besides improving the quality of life for patients, the paradigm changes from 'facilities-based dialysis' to 'personal-based dialysis,' this is vital in lowering the cost of the national healthcare system. More importantly, it contributes to the economy by allowing patients to be economically productive."
Neo said AWAK will be seeking both FDA 510(k) clearance as well as the CE mark. "We hope to be able to commercialize AWAK by 2012," he said.
Although Neo said AWAK has been successfully tested in six patients, those data have not been released. Planning is currently underway to start clinical trials in both the U.S. and Singapore.
The company isn't currently working with partners, but it will seek collaborations for the commercialization process.
"We are exploring partnering with companies that can offer wide distribution," he said. "We don't have a manufacturing facility because we are a technology-based company, so we'll outsource our production to companies based in Asia."
He declined to disclose any manufacturing alliances.
Lynn Yoffee, 770-361-4789;