Defense Advanced Research Projects Agency (DARPA) is soliciting innovative proposals to integrate the component technologies developed in the Dialysis Like Therapeutics (DLT) program. The goal of DLT is to develop a portable device that removes “dirty” blood from the body, separates harmful agents, and returns “clean” blood to the body in a manner similar to dialysis treatment of kidney failure. The envisioned device will manipulate key health parameters faster than the underlying disease process and drive the patient towards a stable, healthy state.
While development of such a device would have impact across a wide range of biothreats, the initial target application is sepsis. Combat wound infection and the overwhelming blood infection called sepsis are significant problems for U.S. military personnel. When sepsis is complicated by shock, approximately half of these patients do not survive for 30 days, even if effective antibiotics are used. The fatality rate from sepsis can be high, given that antibiotic-resistant bacteria are an increasing problem for injured warfighters and military treatment facilities.
Current culture-based methods of identifying blood-borne pathogens may take 48 hours or longer to identify the offending pathogen, and some blood-borne pathogens do not propagate in culture. Pending these culture results, septic patients are treated with protocol-based broad spectrum antibiotics. In the event the offending pathogen is resistant to the empirically chosen antibiotic, the fatality rate may increase as much as 9% per hour.
As a first step towards reducing the impact of sepsis, DARPA selected teams of performers proposing against a prior BAA (DARPA-BAA-11-30) to develop dialysis-like therapeutic technologies to treat sepsis by sensing and removing sepsis-related targets such as blood-borne pathogens or inflammatory cytokines. The focus of this solicitation (DARPA-BAA-12-36) is to integrate key component technologies (sensing, complex fluid manipulation architectures, separation technologies, and closed-loop controller) that are being developed under DARPA-BAA-11-30 into a functioning device that can effectively treat sepsis across the military health system.
Final program metrics require a device capable of removing at least 90% of unknown pathogens, cytokines, toxins, and activated cells from a patient in one day. In vivo experiments in a clinically relevant animal model will validate the device for use in sepsis. At the completion of the program the device will be expected to have adequate testing (bench and animal) completed and a clinical protocol prepared in order to gain Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA).
Multiple awards under this BAA are expected to be issued in October, 2012. Full details are available under Solicitation Number: DARPA-BAA-12-36. The proposal response deadline is July 13, 2012.