Noninvasive Monitor of Vascular Volume Fluid Shifts

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH18C0145
Agency Tracking Number: H2-0331
Amount: $999,984.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: DHA17-007
Solicitation Number: 2017.1
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-27
Award End Date (Contract End Date): 2020-07-26
Small Business Information
6712 Brooklawn Pkwy, Syracuse, NY, 13211
DUNS: 004238007
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 David Rice
 (315) 425-4045
 dave.rice@criticallink.com
Business Contact
 John Fayos
Phone: (315) 425-4045
Email: john.fayos@criticallink.com
Research Institution
N/A
Abstract
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.

* Information listed above is at the time of submission. *

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