ANN ARBOR – Blaze Medical Devices has been awarded a $150,000 Phase I Small Business Innovation Research grant from the Food and Drug Administration, in collaboration with University of Michigan Health System Center for Circulatory Support.
The focus of this grant is to study damage to patients’ red blood cells caused by left ventricular assist devices, as measured by Blaze’s technology that profiles RBC mechanical fragility. Blaze is developing novel blood analysis technologies,
Blaze’s RBC Mechanical Fragility testing technology offers a more precise metric of blood damage. Current testing looks mainly at hemolysis (cell rupture) that occurs, whereas MF represents the remaining cells’ susceptibility to future rupture. Long known as a critical blood parameter, it has not yet had a standardized and commercially feasible means for routine testing. One area of applicability is in hemocompatibility testing for medical product research and development, including in both medical device and drug safety assessment.
Blaze has prototyped the first RBC MF testing system – the Fragilimeter – for use by medical device manufacturers, drug developers, and various clinical researchers. Commercial versions of the system could automate and standardize such testing, offer a range of stress parameters and types, and provide RBC fragility “profiles” for comprehensive characterization of MF. While a fully integrated system is in development, Blaze’s staff currently utilizes the core technology “in house” for its studies as well as offering testing on a service basis.
The research use only system would address an estimated US market in excess of 200 million.
This is Blaze’s second SBIR award overall. Last year, it received a Phase I SBIR from the National Institutes of Health (NIH) to investigate a separate application of its technology – pertaining to testing stored blood for transfusion.
