When donors give blood, the components of that blood most commonly used by hospitals, red blood cells, are refrigerated and stored for up to six weeks, at which point it’s thought that their ability to transport oxygen becomes depleted.
A growing debate, however, has emerged around the age at which blood becomes unsuitable for transfusion. Some research has suggested that the quality of stored blood actually degrades at different rates depending on the donor, sometimes long before the six-week mark.
Blaze Medical Devices is developing a tabletop device and disposable cartridges that hospitals would use to evaluate blood units by the strength of their red blood cell membranes rather than by age alone.
During storage, various biochemical and biomechanical changes occur in red blood cells. Blaze is hoping to capture how those changes have impacted the quality of the cells by measuring mechanical fragility, which the company says is associated with less cell viability and a decreased ability to deliver oxygen to tissue. The device does that, in simple terms, by subjecting a small blood sample to mechanical stress and seeing how the cells hold up. Ideally, that would give hospital blood bank directors a better idea of whether the blood is suitable for transfusion.
According to the U.S. Department of Health and Human Services, 24 million blood components are transfused each year in the U.S. to replace blood lost during surgery or injury, or to supplement inadequate red blood cell amount or function in certain diseases. Although they’re common, transfusions are also linked to rare but serious complications.
Blaze has completed a preclinical study at Mayo Clinic and an initial clinical study at Henry Ford Hospital, and plans to release a research-only version of the device late this year, according to CEO David Weaver. Then, it plans to start commercialization in Europe the following year. In the U.S., the company plans to follow the Class II De Novo pathway for U.S. Food and Drug Administration clearance and projects initial sales will occur in 2015.