The U.S. Special Operations Command (USSOCOM) has opened a new 5-year Broad Agency Announcement for Extramural Biomedical and Human Performance Research and Development (HT9425-23-S-SOC1).
Technology investments have far-ranging application for CBRNE mass casualty response, natural disaster emergency medicine, and point-of-need diagnostic and triage tools.
A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research Program is to identify and develop techniques, knowledge products, and materiel (medical devices, drugs, and biologics) for early intervention in life-threatening injuries; prolonged field care (PFC); human performance optimization; canine medicine/performance; brain health; immune response; automation of systematic reviews and metanalysis; and novel post-traumatic stress, depression, and anxiety treatment.
Special Operations Forces (SOF) medical personnel place a premium on medical equipment that is small, lightweight, ruggedized, modular, multi-use, and designed for operation in extreme environments. The equipment must be easy to use, require minimum maintenance, and have low power consumption. Drugs and biologics should optimally not require refrigeration or other special handling.
Research proposed for funding must be relevant to the health care needs of the U.S. Armed Forces, family members of the U. S. Armed Forces, U.S. Veterans, and civilian populations.
This BAA is continuously open for a 5-year period and updated annually with focus requirements. Current highlighted research areas of interest include:
Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics Treatment, and Prophylaxis
Projects must research, apply, or develop novel approaches that will diagnose, treat, and protect SOF personnel from exposure to chemical, biological, radiological, nuclear, and high yield explosives in near real time.
Force Health Protection and Environmental Medicine
SOF personnel must often operate for extended periods of time in austere environments that expose them to extremes in altitude, temperature, humidity, wind, kinetosis, infectious diseases, toxic industrial chemicals, toxic industrial materials, and environmental hazards (including envenomation). In addition, the environment may be compromised due to chemical, biological, and radiological (CBR) contamination. The primary emphasis of this research area is to research, apply, and develop techniques, therapeutic measures, and materiel (personal protective equipment (PPE), medical devices, drugs, and biologics) to ensure sustained human performance and effectiveness while operating in harsh environmental conditions and/or wearing appropriate PPE. Additional research opportunities include identification and characterization of specific risk profiles/threats associated
with the SOF unique mission sets.
Thermostable Portable Lab Assays and Diagnostics
Novel concepts are sought for portable and environmentally stable far forward laboratory assays and diagnostics. Equipment should be extremely portable, ruggedized, use limited or no external power, and any reagents should be self-contained and stable in extreme environmental conditions. Preference will be given to proposals that are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements. Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or other noninvasive technologies are encouraged.
Medical Sensors and Devices
The primary emphasis is to develop medical techniques, pharmaceuticals, biologics, and field-sustainable, rapidly deployable medical sensors or devices for extended care beyond initial trauma resuscitation, to include austere/forward surgery while operating in disease endemic areas where casualty evacuation is delayed or unavailable. In addition, proposals that investigate or develop wireless biosensors should demonstrate physiological monitoring capabilities to include, but not limited to, heart rate, blood pressure, pulse oximetry, respiration rate, capnography, core temperature, heart rate variability and compensatory reserve index (CRI). Research and development of devices and sensors should include or plan for the capability to transmit (Bluetooth) to Android handheld devices and tablets.
Rapid Identification of Occupational and Environmental Health (OEH) Hazards
OEH hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures, food and water borne pathogens, toxins, biological agents, and radiological material exposures. Proposed projects must focus on development of novel methods and devices for rapid identification and analysis of exposures to OEH hazards. Research must support the development and analysis of handheld, field hardened, and environmentally stable analytical devices, monitoring devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Research consideration should be given to development of small lightweight and programmable unmanned underwater vehicles (UUV) and unmanned aerial vehicles (UAV) to conduct environmental analysis of OEH hazards in water, air, and soil. UUVs and UAVs must be capable of travel to designated locations, conduct point of collection analysis of OEH hazards, transmit data, and return to originating base.
Operational Monitoring (Biosensors, Dosimetry)
The proposed project must seek to develop wireless biosensors for monitoring SOF personnel in extreme environments (i.e., high altitude, whether in-flight or the environment itself, excessive heat or cold, etc.), and potentially hazardous material exposure. Sensors should address physiological measurements and/or chemical, biological and/or radiological hazards. For hazards monitoring, a personal dosimetry device is desired that can detect and alarm based on radiation and chemical presence. The alarming function can be pre-determined to account for known environmental conditions (i.e., natural occurring radiation levels that are below threshold/detrimental health levels) and Parts Per Million (PPM) counts that would trigger an alert. This detection device needs to be able to alarm differently to identify the “type” of hazards, and to trigger a back-off or donning of additional PPE. Monitoring should be capable of wirelessly communicating via Bluetooth to Android handheld devices, tablets, or compatible wrist-mounted displays.
Blast Exposure Brain Health and TBI Biomarkers
Brain Health research efforts include, but are not limited to: development and validation of fieldable Neurocognitive Assessment Tools (NCATs) and baseline testing, Comprehensive Symptom History (CASH) collection, blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure, development and validation of capabilities to easily identify/diagnose mild, moderate, and severe TBI, methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction, methods to prevent TBI from impact and blast such as redesign of helmets, body armor, and munitions, development of pharmaceuticals to prevent and/or treat brain injury, validation of brain injury prevention strategies, and development of return to duty decision support tools.
Research to determine which biomarkers are indicative of mild, moderate, and severe TBI; sequelae from TBI causing further injury; recovery status; and recovery rate from TBI. Testing and validating diagnostic biomarkers for TBI. Proposals should also consider incorporation of validated biomarkers onto existing or future diagnostic platforms. Use of machine learning and/or model development to interpret and report biomarkers that are indicative of TBI are of interest.
Global Treatment Strategies and Next Generation Wound Management
The proposed project must research, apply, or develop effective treatment strategies that address hypotensive resuscitation, optimal fluids, uncomplicated shock, noncompressible hemorrhaging, traumatic brain injuries, and austere damage control surgery. These strategies must be optimized for medics in austere, far-forward areas, with minimal logistical or specialty support, who must stabilize and treat patients for extended periods (days, not hours). Projects that research and develop an all-in-one traumatic wound care treatment that can achieve hemostasis, incorporate analgesia, deliver antibiotics, and start tissue regeneration are preferred.
Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatic
Projects must research novel strategies to increase the ease, efficacy, and safety of blood transfusions (i.e., person to person, pre-hospital blood banking, and blood substitutes) forward of normal logistics support; (e.g., evaluating blood for type/cross matching and for the presence or reduction of pathogens, leucocytes, and AB antibodies to improve safety of whole blood transfusion at the point of injury). Projects that will be considered also include other blood components such as freeze-dried plasma and platelets, cryoprecipitate, fibrinogen, prothrombin complex concentrate, and injectable medications to address the coagulopathy of trauma such as Tranexamic acid. Research should focus on extending shelf life of whole blood beyond current limitations. A long-term objective is a blood substitute that is comparable in size, weight of traditional blood products, and effectively functions like fresh whole blood without requiring refrigeration. Strategies to find the delivery of these prototypes individually or in concert will also be considered. Priority will be given towards projects that are oriented towards final solutions or prototypes that are shelf stable requiring minimal to no refrigeration as well as those that can carry oxygen in quantities similar to healthy red blood cells.
The use of modified and novel strategies to cause, strengthen, or supplement immunity through the use of, but not limited to mRNA vaccines, nanolipoprotein particles (NLPs), polyvalent vaccines, and phages.
Medical Simulation and Training Technologies
The proposed project must research, apply and/or develop improved pre-hospital tactical combat casualty care (TCCC) training with an emphasis on the SOF pre-hospital providers. Medical simulations should replicate all phases of the pre-hospital combat environment, including care under fire, tactical field care and casualty evacuation. Human-like simulators should bleed, breath, void, have a physiologically relevant temperature, pulse, and response to medical care with little to no operator/controller input, should be all-weather capable and should evoke an emotional response from those with whom it interacts. Medical training simulations should capture and be capable of providing a report on the timing, appropriateness, and effectiveness of medical treatment. All material solutions should meet joint airworthiness standards.
Additionally, there is interest in research focused on validating or measuring the effectiveness of current medical simulation and training technologies and in determining the best methods of acquiring and maintaining PFC skills as well as the impact of these skills on patient outcomes. In addition, the proposed project must research the efficacy of using stress inoculation training (vs traditional didactics or other instructional methods) to teach key TCCC skills (e.g., tourniquets, IV placement, etc.). Of particular interest are the effects on stress response, performance, and decision making of the student as well as best methods for optimizing performance in high stress situations as well as mitigating negative aspects of stress.
Diagnostics for Performance Sustainment
The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to provide actionable information on nutritional gaps, hormonal response to training, physiological response to performance interventions and recovery, and epigenetic predictors of potential injury.
Canine Medicine and Performance
SOF personnel rely on canines’ exceptional capabilities as combat multipliers. This research area explores alternatives and new approaches to preserve and enhance SOF canine combat performance. SOF medical personnel place a premium on canine-specific approaches that are effective in extreme environments and do not require significant additional logistical support (i.e., maximize use of available SOF Medic materiel). Areas include canine CBRNE PPE treatment and decon; acclimatization to environmental extremes; blast exposure brain health; sensory optimization and protection; trauma training/behavioral issues; and canine simulation technologies.
The USSOCOM’s supporting contracting office, the U.S. Army Medical Research Acquisition Activity (USAMRAA) will be the awarding and administering office for proposals selected for BAA T9425-23-S-SOC1 funding.