21-10-NavyMultiTopic – Advanced Biomedical Product Development in Support of Naval Operations
The purpose of the multiple topic area (“multi-topic”) Request for Project Proposals (RPP) is focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs identified in the focus areas listed below. Relevance to the enhanced readiness and resilience of Navy and Marine Corps health and performance is a key feature of this RPP. Focus areas include:
1) FOCUS AREA #1: COMBAT CASUALTY WOUND AND INFECTION CARE: This area focuses on patient care at and through the continuum of care as well as products and services that sustain patient health in austere environments such as expeditionary, littoral, and deep water. Specific areas of interest are as follows:
- Wound care treatments / therapies for combat injuries. Includes technologies suitable for use at point of injury and / or at medical facilities in theater.
- Wound care technologies for combat wound infections (e.g., bacterial and other infections of combat wounds)
- Innovative wound care technologies to treat and prevent biofilm formation
2) FOCUS AREA #2: ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) DISEASE RESEARCH: This area focuses on medical technology and solutions that support the prevention and solutions that treat and/or cure ETEC. ETEC may cause diarrhea, vomiting, dehydration, and other debilitating symptoms for several days or more that often result in an incapacitating symptoms. ETEC and ETEC-related illnesses may negatively impact duties and operations by reducing team manning, delaying movement, and increasing costs related to seeking medical treatment and potentially evacuation. Specific areas of interest are as follows:
- ETEC pre-exposure prophylaxis strategies that can be used prior to exposure and / or at the point of infection that may reduce risk, shorten the duration of acute illness and/or mitigate of ETEC and ETEC-related illnesses.
- ETEC therapeutic treatments that can be issued to symptomatic patients to treat the effects of ETEC that may be suitable for usage in in a forward environment.
3) FOCUS AREA #3: HUMAN PERFORMANCE / PHYSIOLOGICAL EPISODES: This area focuses on the prediction / improvement of health status and outcomes from various sources of combat related stressors that may include advanced biomedical electronics such as sensors and microelectronics and other medical technology solutions that mitigate the risk of physiological episodes (PEs). PEs may be a result of hypoxia, toxic exposure, decompression illness, hyperventilation, spatial disorientation, or other physiological conditions that occur in operational environments. Occurrence of PEs may result in physiological discomfort, loss of consciousness, loss of life, and/or failed mission. Specific areas of interest are as follows:
- Body-worn devices that detect changes in physiological conditions associated with the onset of PE including a risk alert to the user during tactical performance in time to implement corrective actions.
- Enabling capabilities that increase the effectiveness and fieldability of PE detection and alert systems including, but not limited to, physiological risk profiles, specialized device hardware components, improved wearability.
- Pre- and post-exposure treatments or biotechnology solutions that enhance / restore operator performance or reduce operator impacts /susceptibility from / to PE conditions, thus maximizing operator resilience / recovery.
The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (21-10-NavyMultiTopic).
Enhancing NIRSense’s Tactical Jet PE Monitor for Broader Navy Use
Project Team: NIRSense
Award Amount: $1.50M
Project Duration: 18 months
Project Objective: The NIRSense PE monitor tracks brain oxygenation and user accelerations in real time and has demonstrated hypoxia detection in reduced oxygen breathing device (ROBD), altitude chamber (up to 17,500ft), and human-rated centrifuge (up to 9G) evaluations. This system is currently optimized for measuring cerebral oxygenation (i.e., cerebral hypoxic hypoxia, anemic hypoxia, and stagnant hypoxia); adding additional IR wavelengths will enable not only an absolute measure of oxygenation but will also enable the simultaneous assessment of histotoxic hypoxia and acapnia.
Oral Biologics as Novel Pre-Exposure Prophylaxis Against All Major Pathogenic Enterotoxigenic Escherichia coli (ETEC) Strains
Project Team: MassBiologics
Award Amount: $4.52M (additional cost share = $293K)
Project Duration: 18 months
Project Objective: In this proposal, we will develop a cocktail of anti-ETEC nanobodies with cross protection against all major pathogenic ETEC strains as an effective approach for pre-exposure prophylaxis or treatment of ETEC related diarrhea diseases in U.S. service members. In the absence of a pan-ETEC vaccine, oral administration of a nanobody, prior to or during infection, could confer broad protection against all pathogenic ETEC strains. Our work is currently at TRL5. We will complete the pre-clinical work, Investigational New Drug Application (IND) enabling studies, and acquire IND approval by the end of proposed PoP.
Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
Project Team: General Electric Company, GE Global Research
Award Amount: $2.64M
Project Duration: 16 months
Project Objective: The GE team has discovered a novel method of modulating the neuroimmune interface within the spleen using non-invasive ultrasound. The team has shown initial (TRL5) translation of an ultrasound device in human studies demonstrating the capability to modulate the immune system away from prolonged inflammatory response and toward immune homeostasis and healing. Based on our current results, it is anticipated that daily (10 minute) splenic neuroimmune modulation starting one day after hemostasis and standard initiation of burn wound care will decrease time to epithelization. It is further anticipated that the secondary immune measures taken in both the clinical and pre-clinical trial will further demonstrate an ultrasound-induced shift of key immune cell type phenotypes from inflammatory to homeostatic/anti-inflammatory activity.
Terumo BCT Freeze Dried Plasma
Project Team: Terumo BCT
Award Amount: $7.00M
Project Duration: 17 months
Project Objective: Our proposed solution is an engineering and medical prototype. FDP is designed for combat casualty wound care (hemorrhage) at the point of injury in austere environments by eliminating the logistical challenges of conventional plasma requiring cold chain storage and long preparation time. Our distributed manufacturing system installed at ASBP sites will allow the military to match manufacturing supply to projected demand and reduce risk through redundancy and scalability. Additionally, the anticipated adoption of this technology by civilian blood centers would provide the military with contingency surge capacity and long-term commercial viability.
Pre-Clinical Evaluation of an Expanding Dressing for the Treatment of Non-Compressible Torso Hemorrhage at the Point of Injury
Project Team: RevMedx
Award Amount: $2.47M
Project Duration: 25 months
Project Objective: Aim 1 – We propose to gather data on ease of use (including application and removal) for treating high incidence trauma cases in pre-hospital and hospital settings and to generate a significant dataset of human-use outcomes with XSTAT Pouch. The program will collect de-identified retrospective data from ease-of-use surveys submitted by clinical users. Aim 2 – We will evaluate the safety and efficacy of the new FDA-cleared XSTAT Pouch for treatment of NCTH in a lethal swine model, with the goal of providing key information to the Food and Drug Administration for expanding XSTAT indication(s) to include treatment of NCTH.
Antibiofilm Bioresorbable Matrix to Stabilize Combat Burn and Trauma Wounds in the Field
Project Team: Imbed Biosciences
Award Amount: $2.34M
Project Duration: 30 months
Project Objective: Imbed Biosciences proposes an easy-to-use bioresorbable antibiofilm wound matrix, Microlyte Ag-Ga, containing silver gallium which synergize to prevent the formation of biofilms in combat wounds and eliminate biofilms in infected wounds. The Ag-Ga matrix a low-weight, low-cube (~25 μm thick), shelf-stable for at least 2 years, heat-stable and requires minimal training. It conforms intimately to wounds which are difficult to cover uniformly with bulky traditional dressings such as Silverlon (e.g., on the face, shoulder, elbows, knees, and pelvic region). It has potential to decrease morbidity and mortality at the point of injury, through prolonged care, and into hospitals.
Wearable Holistic Sensing and Warning System – Professional Version (HsPro)
Project Team: Athena GTX
Award Amount: $1.05M (additional cost share = 76K)
Project Duration: 13 months
Project Objective: The Holistic Modular Aircrew Physiologic Status Monitor (HMAPS) device(s) are proposed as a transitioning product called HsPro®. HMAPS is a compact, miniaturized arm-mounted monitoring system that records near real time vital signs at high altitudes and high G to track the overall physiology state of the pilots.
Evaluation of Latent Neurological Effects of Hypobaric Pressure Fluctuations
Project Team: Boston University
Award Amount: $1.00M
Project Duration: 23 months
Project Objective: The Boston University team will utilize unique research resources, analytical technologies, established protocols, and broad expertise to detect, localize, and quantitate microvascular dysfunction and BBB disruption in postmortem rat brains exposed to simulated PE-related pressure fluctuations derived from aviator flight histories. These studies will be conducted in collaboration with Karen Mumy, Ph.D. (Project Leader) and colleagues at the Naval Medical Research Unit at Dayton (NAMRU-D).