ANN ARBOR, MI – 21 Oct, 2015 – Blaze Medical Devices, an Ann Arbor-based company developing novel blood analysis technologies, announced today that it has been awarded a $150,000 Phase I Small Business Innovation Research (SBIR) grant from the Food and Drug Administration (FDA), 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 (RBC) caused by left ventricular assist devices (LVADs), as measured by Blaze’s technology that profiles RBC mechanical fragility (MF).
Blaze’s RBC Mechanical Fragility (MF) 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 200M.
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.
“We’re pleased to have support from the FDA in the form of this grant. Our technology has the potential to provide a more sensitive metric of blood damage than standard hemolysis testing alone, as well as facilitate calibrations for those existing tests,” said Michael Tarasev, COO/CSO of Blaze. Dr. Tarasev is a Principal Investigator (PI) on the SBIR, along with Dr. Francis Pagani of the University of Michigan. The work is being financially supported by the FDA, though this release does not necessarily represent official views of the FDA.
About Blaze Medical Devices
Blaze is an early stage company in Ann Arbor, MI, developing technology to facilitate comprehensive and standardized blood measurements – particularly for red blood cell (RBC) hemolysis and mechanical fragility (MF). Blaze’s testing services and products offer profiling of RBC MF adaptable to various users’ needs, with applications in industrial and clinical research. Blaze also collaborates with leading institutions in evaluating various causes and treatments of blood damage, and to explore clinical potential of in vitro RBC properties in blood-banking/transfusion and diagnostics.
Questions & Answers
Q. How will Blaze Medical products be used?
A. Blaze’s first market is the medical R&D industry (medical device and pharmaceutical companies) that needs to assess the hemocompatibility of products that interact with blood (both for regulatory and for internal R&D purposes). In some pharmaceutical applications, RBC MF analysis can be useful in assessing potential efficacy as well as safety. Clinical researchers are also interested to be early customers, to explore potential future applications of the technology in various areas such as transfusion medicine or disease diagnosis/management.
Q. What are the consequences of not having this new level of information?
A. Current hemolysis testing does not account for RBCs that were “partially” damaged (i.e., not to the point of membrane rupture). Cells with such “sub-lethal” damage nevertheless may not survive in circulation, and thus represent a well-known health hazard. FDA acknowledges that there is a need for better ways to assess blood damage beyond current hemolysis tests alone.
Q. How is the University of Michigan involved?
A. We are very fortunate to have Dr. Pagani as a PI on the study. The Center for Circulatory Support (VAD Program), under his direction, is one of the most recognized and well-respected programs in the nation. His research focuses on the use of mechanical circulatory support in the treatment of end-stage heart disease and use of stem cell transplantation for myocardial regeneration. Blaze rents its lab space from the University, which has conveniently facilitated certain collaborations such as this joint project.
Q. What’s the market size for your blood cell testing device?
A. This initial market is estimated to be in excess of $200 Million (including academic institutions). There is no regulatory barrier to entry for such research-use-only systems. As a first mover in meeting the need for integrated and standardized RBC MF profiling, Blaze has the opportunity to become the standard for industrial R&D applications. We also have potential clinical applications for the technology, to follow later.
Michael Tarasev, COO/CSO
Blaze Medical Devices
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