SBIR-STTR Award

Daxor proposes an automated, ruggedized, portable system for calculating blood, red cell, and plasma volumes, based on a comprehensive adaptation and reengineering of the current gold standard for volume measurement, the Daxor BVA-100.Significant improvements in portability (size, weight, and battery operation), logistics, speed, and ease of use are achieved. Whole blood is sampled directly from the patient, eliminating the need for centrifugation and precision pipetting. Hematocrit measurement is integrated, allowing quantification of all blood compartments.The detection system (detector and shielding) is optimized for portability, and to allow the use of a longer-life tracer. Active technician time is substantially reduced with automated blood draws, with results available in fewer than 20 minutes. Individualized patient norms are displayed along with measured values; recommended corrections to volume derangements are displayed.Achievement of required 95% accuracy is demonstrated by parallel computation using the gold-standard BVA-100, in both laboratory and hospital conditions.blood volume,trauma,transfusion,Combat Casualty Care,Burns Care,anemia,Resuscitation,Sepsis

The objective of this SBIR Phase II project is to build a functioning ready-for-production prototype of a simple-to-use rapid, portable, and robust BV diagnostic device that meets or exceeds combat casualty care and civilian hospital clinical specifications, and demonstrate its diagnostic accuracy and functionality for combat casualty and standard civilian clinical use. The device will be validated against the existing gold standard blood volume test to have 95% or greater accuracy quantifying patient total blood volume, plasma volume, and red blood cell volume; will calculate excess or deficit of these volumes versus precise patient-specific blood volume norms; and, will provide patient-specific fluid resuscitation and red blood cell transfusion guidance. The proposed device will enable more efficient use of scarce combat casualty clinical resources, including clinician time and blood products. Importantly, the device will also have extensive civilian market potential for a range of diseases and syndromes affecting millions of US patients annually. Daxor, a New York-based advanced medical instrumentation company and the current market leader in direct blood volume diagnosis, will perform the task’s technical functions and is well positioned to successfully commercialize the proposed device.