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Complex Crystalloid Resuscitative Fluid

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH19C0061
Agency Tracking Number: H2-0417
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: DHA172-009
Solicitation Number: 2017.2
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-13
Award End Date (Contract End Date): 2021-04-12
Small Business Information
119 Washington Ave, Miami Beach, FL, 33139
DUNS: 080737529
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 David Steed
 (412) 989-9819
Business Contact
 George Sing
Phone: (917) 882-8001
Research Institution
Problem: Currently available resuscitation fluids have been shown to induce detrimental effects on trauma outcomes.Objective: The objective of this proposal is to use the data from the successful Phase 1 studies to guide the continued development and testing of the novel resuscitation fluid (GND-001), which has been designed to address the deficiencies of current resuscitation fluids.Proposed work and expected results:The proposed work will involve refining the GND 001 formulation based on data from the Phase I proof-of-concept studies and in vitro testing using an endothelial cell model.The refinements to GND-001 will be tested for efficacy in a small animal hemorrhagic shock model compared to a) the original prototype as a benchmark, and b) the standard-of-care control.We will also examine the effects of the resuscitation fluid in a large animal hemorrhagic shock model.The swine model is well defined and the size of the animal allows for a longer study period, additional studies such as coagulation assays, and more frequent assay intervals that are not possible in the rodent model due to volume restrictions.Based on the phase I results, we expect the results to show improvements in acidosis and base deficit, and improvements in outcome.

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

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