Critical Link, LLC — Department of Defense SBIR Phase II: DHA17-007

Description

We are developing a physiological monitoring tool, PV[O]H, to simultaneously and continuously record hematocrit and vascular volume. The Phase I SBIR established the feasibility of producing an Army useful PV[O]H. Specific Phase II objectives are 1. Complete manufacture of 10 portable units, 2. Finalize FDA discussions to develop the device as a Medical Device Development Tool (MDDT), 3. Finalize/initiate with FDA input a non-inferiority pivotal clinical trial demonstrating the utility of PV[O]H vs. the currently used CritLine device as a predicate, 4. Finalize a blood withdrawal protocol in blood banks supporting PV[O]H use as a precise and accurate monitor of blood loss with a defined quantity of blood removal and 5. Establish PV[O]H statistical and analytic benchmarks using a normal student population as a surrogate for Army personnel to develop algorithms for interpreting PV[O]H measurements in Army relevant contexts/situations. Three routes to market for PV[O]H include 1. An available MDDT for development by anyone for any indication e.g. diagnosing/treating blood loss and/or vascular response, 2. A less expensive more portable competitor to CritLine, and 3. A monitor of blood loss in blood banking and other settings to monitor blood withdrawal/loss rates and small vascular response.