SBIR-STTR Award

The project goal is to develop an instrument for real-time monitoring of renal function for early detection of renal failure. Studies will be conducted with a phantom and with human subjects to validate the instrument's effectiveness. If successful, the project is expected to provide the means for early identification and treatment of renal failure and, thereby, prevent permanent kidney damage or death in patients at high risk of developing acute renal failure. The development of the instrument is made possible by recent research at Massachusetts General Hospital (MGH) and at Aurora Technologies Corporation (Aurora). MGH has demonstrated the efficacy of measuring renal function by monitoring (externally) the rate of disappearance of a radiolabeled agent which is cleared almost exclusively by glomerular filtration from extracellular space. Aurora's new semiconductor detector technology eliminates the need for bulky detection devices operating at high voltage and makes feasible the manufacture of a compact, self- contained instrument which will be worn in a cuff on a patient's arm. With no tubes nor wires attached, the instrument will measure the clearance of the radiolabeled agent without piercing the skin, thus, providing real-time measurement of renal function and reducing the need for repeat blood samples

The mortality rate for acute renal failure has not changed significantly during the last 25 years. This may be due in part, to the inability to adequately predict and identify the onset and causes of acute renal failure. Current measurement techniques cannot quickly identify changes in renal function; the time for measuring renal function is typically four hours. An accurate means for measuring renal function in real time (i.e.,measuring and seeing changes in renal function as they occur) should allow researchers to better understand the pathophysiology of acute renal failure and lead to significant reductions in mortality rate and in the number of persons requiring acute dialysis associated with acute renal failure. The goal of this proposal is: 1) to complete development of an instrument for measuring renal function in real time and 2) to validate the measurement accuracy and the response time for rapid changes in renal function. Making this instrument available to nephrologists should allow researchers to demonstrate the efficacy of real time renal monitoring in saving lives and reducing the number of those who require acute dialysis. This may lead to real-time renal monitoring of most intensive care and organ transplant patient. PROPOSED COMMERCIAL APPLICATION: The commercial motivation for this project is two fold. 1) the cost benefit to patients and healthcare providers derived from less time in Icu and from reducing the number of persons permanently needing dialysis and 2) commercial sales of renal monitors for use in ICU' s worldwide. Annual commercial sales should exceed $10 million, and savings in healthcare costs should be even greater.