Portable In-Home Hemodialysis Device May be in Clinical Trials by 2017

Debiotech (Lausanne, Switzerland), AWAK (Singapore and Burbank, Calif.), and Neokidney Development, an initiative of the Dutch Kidney Foundation, are joining efforts to develop the world’s first portable artificial kidney. They have signed a joint venture agreement to complete a functional model in 2015 and begin clinical trials two years later.

More than 3 million people worldwide suffer from end-stage renal disease (ESRD). A small percentage of them receive kidney transplants, but there are not nearly enough organ donors to meet demand and the procedure is rife with complications. The vast majority of patients suffering from ESRD rely on hemodialysis, an invasive treatment that requires going to a dialysis center three to four times a week for sessions that can last up to four hours at a time. Not surprisingly, the development of an artificial kidney has been the subject of feverish activity over the last few years, and in February 2014, the U.S. Food and Drug Administration (FDA) approved the start of the first human clinical trials for a wearable device designed by Blood Purification Technologies of Beverly Hills, Calif., via a special fast track to market pathway. An implantable renal assist device under development at the University of California, San Francisco, also has been awarded FDA fast track status.

The portable artificial kidney will enable frequent and longer home-based hemodialysis that significantly improves and extends patients’ lives, according to Debiotech. 

Scientific research has established that frequent and longer dialysis treatment limits side effects, such as dialysis hangover and cardiovascular stress, and increases patient autonomy and life expectancy, according to the company. It is also considerably more cost effective than undergoing dialysis at a center.

The system will be based on Debiotech’s DialEase, a system for peritoneal home dialysis that reportedly will soon be on the market. AWAK contributes a novel sorbent technology, which will enable the system to use only 4 liters of dialysate compared with the 40 to 60 liters required by existing technologies and eliminate the need for expensive purification systems. Neokidney Development provides access to the Dutch Kidney Foundation’s medical expertise and network of internationally acclaimed nephrologists and patient organizations. It also is expected to mobilize funding from public and private sources.

The partners have committed themselves to completing a functional model in 2015, and getting the device ready for clinical trials by 2017. Debiotech is tasked with securing a commercial agreement that benefits patients worldwide.

“Knowing how difficult dialysis at home can be, our team of scientists and engineers has worked intensively to make DialEase the most reliable and least intrusive home peritoneal dialysis system for patients,” said Debiotech COO Laurent-Dominique Piveteau in a prepared statement. “We look forward to adapting it for home hemodialysis with the same passion, enthusiasm, and relentless focus on the patients we serve.”

Debiotech has specialized for more than 20 years in the research and development of innovative medical devices, with a focus on implantable and external drug delivery systems for the treatment of severe conditions such as diabetes, renal failure, cardiovascular disease, and cancer.