Doctors may be able to identify signs and symptoms of kidney infections faster than traditional lab tests if a new monitoring tool from FAST BioMedical does well in clinical trials.
FAST BioMedical has developed a small and durable bedside device that detects acute kidney failure by monitoring the presence of in vivo markers that are injected into a patient’s bloodstream and fluoresce with use of the device. CEO Joe Muldoon said it can provide accurate measurement of glomerular filtration rate, or kidney function, in about 40 minutes.
The current standard for measuring GFR is based on blood or urine tests, which can take several days to deliver results and delay diagnosis and treatment.
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“It’s not going to be cheaper because the current method costs pennies,” Muldoon said. “The cost savings will come in diagnosing it sooner and starting to treat it earlier. Ultimately, you’re going to have better medical outcomes and shorten the length of stay in the ICU.”
During acute kidney failure, the kidneys lose their filtering abilities and allow dangerous levels of fluid and waste to accumulate in the body. This happens rapidly over a few hours or a few days, often during hospital stays when patients experience heavy blood loss, dehydration, sepsis or an injury that reduces blood flow to the kidneys. As many as 7 percent of general hospital patients and 15 percent of intensive care unit patients experience acute kidney injury, the company says.
FAST — short for Filtration Assessment and Surveillance Technology — has done enough preclinical work for the device to go into human trials, and the company has made multiple filings already this year, Muldoon said. It was granted expedited review by the U.S. Food and Drug Administration in 2009.
The device has several applications outside the hospital. As soon as a peer-reviewed article was published last year, Muldoon got immediate feedback on huge potential for the device to put more kidneys in the transplant pool. Half of kidney donors are cadaver donors, and since there is only a 36-hour time period to harvest those organs, current methods are practically useless, he said.
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The device also has applications in clinical trial monitoring and drug development.
Founded in 2006, the Indianapolis, Indiana medical device company has raised more than $12 million and received funding from nonprofits including BIOCrossroads’ Indiana Seed Fund, the National Institutes of Health and Indiana’s 21st Century Research and Technology Fund. It is also tied closely to several Indiana universities including Rose-Hulman Institute of Technology, Purdue University and Indiana University, which is incubating FAST at its Emerging Technology Center in Indianapolis.