Fast BioMedical Inc., a Carmel-based biotech firm developing technologies to measure blood volumes and kidney function, said it has crossed a significant hurdle by achieving the endpoints of mid-stage clinical trials.
The company published Phase II clinical data this week in the journal CardioRenal Medicine, and said it met the primary and secondary endpoints for pharmacokinetics, safety and accuracy.
The study was conducted at two sites in healthy subjects and patients with varying levels of chronic kidney disease.
Fast BioMedical, founded in 2006, is developing technologies to help patients with congestive heart failure, major surgery, sepsis and kidney disease. The company’s technology is designed to measure the plasma volume, or PV, of a patient’s blood in 30 to 45 minutes, and provide updated measurements for up to six hours.
The technology uses a patented fluorescent injectable that works with a patented measurement device.
“This technology can allow the clinician to have new understanding for both diagnosis and therapy,” Dr. Bruce A. Molitoris, the company’s medical director and co-founder and a professor of medicine at Indiana University, said in written comments. “Congestive heart failure, sepsis and acute kidney injury are conditions where the value of accurate PV is critical to understand.”
The company also had a peer-reviewed paper recently published in the journal of the American Society of Nephrology, highlighting the kidney-function data from the Phase 2 clinical study.
Two years ago, Fast BioMedical secured $8 million in venture capital and grant funds to help it advance in the trials.
Of the money raised, $5 million is coming in the form of early-stage, Series A2 venture capital from one investor, F&M Investment Office LLC of Indianapolis. The other $3 million is coming from a grant from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health.
Earlier investors include Elevate Ventures, Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, Purdue Foundry Fund, Ellipsis Ventures and StepStone Partners.