V. Gura
Wearable Artificial Organs Inc.,
United States
Keywords: kidney failure, dialysis, disaster
Summary:
We built a miniaturized wearable dialysis device that weighs only two pounds, works on batteries, and filters the blood 24/7 like normal kidneys do. Requires only 300 cc of fluid instead of 40 gallons Completed bench, animal and three human trials in four different centers of excellence around the globe. Won an FDA prize for innovation and awarded breakthrough status by the agency. Currently we have two applications using the same technology, one for End Stage Renal disease patients on dialysis and in another configuration using the same components for use in the intensive care unit or in the battlefield in military medicine. We already had our first sale to the Department of Defense for $3.6 M, and completed the buildup of a working prototype for the US army. This military application is planned to undergo a clinical trial in an ICU at Cedars Sinai Medical Center in Los Angeles. The next human trials of our product for chronic dialysis are planned dialyzing at home with Vanderbilt Medical Center and a pivotal trial at Harvard in the Brigham Hospital. We manufacture our devices in an FDA certified manufacturing plant for medical devices in San Diego.