Direct Blood Volume Analyzer for Improvement of Combat Casualty Care

Hemorrhage is the leading cause of preventable combat mortality. Despite recent advances in care, sustaining adequate tissue perfusion remains a challenge. Current practice for determining fluid status to guide battlefield resuscitation and transfusion, including clinical assessment and surrogate markers, often lag symptomatic diagnosis or misdiagnose the severity of volume derangement. Care is further complicated by the risks of under- and over-resuscitation, high patient heterogeneity, and scarcity of resources, especially during prolonged field care, and multi-domain operations. Precise guidance of fluid resuscitation and blood transfusion therefor remain urgent unmet operational priorities. Blood volume analysis (BVA) [BVA-100; Daxor Corporation, Oak Ridge, TN] is the only FDA-cleared method utilizing the gold standard indicator dilution technique for quantifying intravascular Blood Volume (BV). Extensive peer-reviewed medical literature has validated BVAÆs enhancement of interventions through rapid, reliable, and accurate BV quantification. Daxor Corporation has successfully completed Phase I and II U.S. Army SBIR contracts to develop a rapid, portable, and robust point-of-care (POC) BVA system. The new diagnostic capability is designed to meet combat casualty care and civilian hospital clinical specifications, including demonstrated diagnostic accuracy and functionality for combat casualty and standard civilian clinical use. A prototype of the new device has been validated against the existing GS system to meet contract milestones, including to have greater than 95% accuracy quantifying patient BV, to provide patient-specific fluid resuscitation and red blood cell transfusion guidance. To complete requirements for the POC BVA system, the proposed sequential Phase II SBIR contract will support the completion of the following objectives: 1. Complete Design and Validation of POC instrument; 2. Obtain 510(k) clearance; 2. Pilot Build and Initial Rollout; and, 4. EMR integration. As a company publicly listed on the NASDAQ stock exchange with full time business, technical, and sales and marketing teams, Daxor is well positioned to complete the proposed technology development effort and successfully commercialize the resultant product.