Resuscitation and Prevention of Ischemia-Induced Dysfunction (RAPIID) - TA3

Description

Please note that this announcement specifically solicits proposals only for Task Area 3 (TA-3) of the RAPIID program. Primary challenges with translating technological advancements from the laboratory to real-world usage include a lack of investment to ensure manufacturing scalability, and usability, as well as clinical, regulatory, and commercialization preparedness. Previous investments by DARPA to address potential blood shortages in austere, pre-hospital settings (i.e., the Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP) program) have derisked scalable, shelf-stable components that would provide the resuscitative functions of whole blood (i.e., oxygen delivery, hemostasis, and volume expansion) when used together. However, bringing those components through clinical studies and regulatory approval as well as the development of enabling technologies and guidance to facilitate their use outside of the laboratory were out-of-scope in previous DARPA efforts. RAPIID is designed to bridge the gap between the proof-of-concept achievements of the FSHARP program and actual clinical use by the military and civilians. With FSHARP demonstrating that shelf-stable blood products can be created, DARPA is now taking on the next challenge: delivering a complete, deployable, and authorized system that can save lives in the field. To achieve this goal, RAPIID will focus on pushing high technology readiness level (TRL)/medical readiness level (MRL) capabilities through the regulatory process by funding studies to demonstrate safety and efficacy of blood analog components and their ability to work in combination; manufacturing scalability of individual blood analog components; and developing and scaling associated fielding technologies.