Austin-based developer of novel x-ray sources Stellarray has been awarded $1.1 million, granted by the Department of Energy to develop and bring to market a new generation of irradiators to ensure the safety of blood transfusions.
Stellarray’s Self-Contained Blood Irradiator (SCBI) will establish itself as a reliable alternative to the radioactive isotope irradiators now used to inactivate leukocytes for the prevention of graft-versus-host disease (GVHD). These irradiators use cesium 137, which has been identified as a national security hazard since it is the most likely material for a radioactive dispersal device (dirty bomb). The grant has been awarded under the DoE Small Business Innovation Research Program as a combined Phase I and Phase II Fast-Track project and will be administered by the National Nuclear Security Administration.
Stellarray’s patented Flat Panel X-ray Source (FPXS), the heart of the company’s Self-Contained Blood Irradiator, uses a specially engineered array of cathodes, instead of the single cathode in an x-ray tube, to make x-rays across a broad anode target which can be externally cooled. This makes FPXS several times more efficient than an x-ray tube in this kind of application and can be made in various sizes and formats. SCBI uses pairs of FPXS above and below the blood bags, transported into the irradiator on a tray or conveyer belt, to deliver the FDA recommended dose for GVHD in approximately four minutes.
Designed for low-cost, reliable operation in a shielded cabinet about one-third the size and one-fifth the weight of alternative irradiators, SCBI requires no special electrical power or cooling connections are required, and, since it is not radioactive, there is no need for the elaborate security measures (truck barriers at entrances, retinal scan devices, full background checks) that burden users of isotope irradiators.
According to Mark Eaton, CEO of Stellarray, the company has designed SCBI with extensive input from potential customers in blood transfusion practices. “Their response to the small footprint, ease of use and elimination of security concerns continues to be very positive. Our market research shows that in addition to the current operators of isotope irradiators who would like to replace them, there are even more transfusion practices that would like an irradiator but have not bought one because of the security concerns.”
Stellarray, which began operating in 2008 to make novel radiation sources and system using them, plans to offer SCBI in three sizes to suit the needs of different blood establishments. The small model will be best suited to smaller or more remote practices, while the large model will be able to accommodate the needs of oncology centers, which irradiate all their blood, and metropolitan hospitals.
The company has developed manufacturing systems for FPXS and SCBI according to ISO 13485 medical device standards in a fully-equipped laboratory and manufacturing facility in north Austin. Besides FPXS and SCBI, the company is also developing digital versions of its x-ray sources that can be used in next generation stationary computed tomography systems and in phase contrast imaging. Stellarray has been funded by the SBIR and ARRA programs of the National Institutes of Health and received an early investment form the Texas Emerging Technology Fund.