MTEC launched its first Multi-Topic Request for Project Proposals (RPP) in June 2017, which aimed to solicit white papers from prospective and current MTEC members. Although 40 specific areas of technical interest were included in the RPP, Offerors were invited to submit white papers on a broad range of medical technological solutions related to MTEC’s six technology focus areas. The Multi-Topic RPP mechanism operated as an “open door” between the MTEC community and the military, enabling the military to solicit solutions to specific problems, where the scientific community either meet those specified needs or recommended a solution to a different medical need with military relevance. The following projects were awarded under this MTEC funding mechanism (Solicitation Number: MTEC-17-08-Multi-Topic). Additional awards are pending.
Title of project: Fast Onset Abdominal Management (F.O.A.M.)™ Preclinical Studies
Project Team: Critical Innovations LLC
Award Amount: $654,043
Project Duration: 24 months
Project Objective: Critical Innovations is developing Fast Onset Abdominal Management (F.O.A.M.)™, a life-saving technology to control intra-abdominal hemorrhage in the out-of-hospital, forward surgical, and prolonged field care environments. A recent review of U.S. battlefield deaths demonstrated that around 90% of all injury mortality occurred pre-medical facility, with the vast majority of potentially survivable deaths due to non-compressible abdominopelvic hemorrhage. American military experts have declared this “a clear and persistent gap in medical treatment capability that has been present for the entire history of warfare.” Severe intra-abdominal bleeding currently requires operative treatment by trained surgeons, while F.O.A.M.™ task-shifts to allow earlier abdominal hemostasis by a wider range of providers. The product is an easily transportable medical device that can be used by non-surgeon providers within the battle area, before or during medical evacuation. F.O.A.M.™ is field-adapted for long shelf life, resorbable by the body with minimal risk for complications, and easily removable if needed for subsequent surgery.
Under this MTEC award, Critical Innovations will perform the next phase of F.O.A.M.™ testing in a porcine, non-compressible hemorrhage model to determine optimal dosage range (for formulation, volume, and intra-abdominal pressure curve), as well as evaluate the product’s safety and identify potential side effects. Tasks include:
- Regulatory Advisement Letter production
- Maintenance of regulatory documentation and initiation of the FDA pre-submission guidance process
- Formulation of several F.O.A.M.™ variations for comparative testing
- Additional laboratory testing of F.O.A.M.™ deployment agent characteristics
- Optimization of delivery system device with proof-of-concept use in a porcine model
- Small-batch testing of F.O.A.M.™ variations in a porcine, non-compressible hemorrhage model
The F.O.A.M.™ technology is INVESTIGATIONAL and NOT AVAILABLE FOR COMMERCIAL SALE. These statements have not been evaluated by the Food and Drug Administration and the technology is not currently approved for human use
Title of project: 4TDS: Trauma Triage, Treatment, and Training Decision Support
Project Team: Applied Research Associates, Inc.; Subcontractors: The Mayo Clinic; Ambient Clinical Analytics, Inc.
Award Amount: $3,128,384
Project Duration: 24 months
Project Objective: The 4TDS system is intended to support the evaluation, training for, and treatment of trauma patients at risk of shock, which is a high-risk threat to patient health and a challenge to diagnose. To do this, the project will integrate two decision support systems to improve the quality and efficiency of clinician performance of combat casualty care: ARA’s Cooperative Communication System and Mayo Clinic/Ambient Clinical Analytics’ AWARE system. Patient-worn sensors will provide real-time data, and machine learning algorithms will identify shock type, to make more accurate timely care possible. 4TDS will be fielded on a Nett-Warrior tablet and evaluated in both Field Hospital (Role 3) and Battalion Aid Station (Role 2) settings. The system will enable clinicians in the field to: 1) Learn and refresh clinical decision-making skills through simulation; 2) Reliably identify and differentiate cases of shock in real time; 3) Decrease diagnostic/treatment error and delay, reduce provider cognitive load, and increase provider efficiency and satisfaction; and 4) Improve compliance with appropriate treatment bundles and clinical practice guidelines, improve team safety, efficiency and satisfaction, improve patient outcomes, and better utilize resources.
Title of project: AugMedic: Augmented Reality for Adaptive, Effective Learning and Execution of Medical Care
Project Team: Design Interactive Inc.
Award Amount: $1,299,999
Project Duration: 18 months
Project Objective: Augmented reality (AR) is emerging as a realistic, low-cost immersive solution with great potential in improving and supporting performance of lifesaving resuscitation skills. The AugMedic effort will build upon an existing modular, medical AR prototype that superimposes synthetic imagery onto live patients and/or medical mannequins. AugMedic will focus on classroom Point of Injury (POI) wound training for medical novices.
The work includes system design, development and evaluation. System design requirements will be established to define how the existing system needs to be modified in terms of interface and functional features to support classroom training. An evaluation of hardware will support the selection of the hardware that optimizes capabilities to integrate with a “smart” classroom training system and provides a ruggedized, hands-free head-worn display. The design solution will include the implementation of a collaborative knowledge database to support the integration of other medical training and injury model content and data repositories. The knowledge database will integrate with the AR technology to support the recognition of injury state, the identification of associated medical tasks to be performed or being performed by the user, and to provide AI-driven guidance and adaptations to unique injury situations as well as dynamic user needs. The logic for the performance of lifesaving tasks, such as hemorrhage treatment and needle chest decompression, will be integrated with principles of instructional system design, to ensure effective learning and effective comprehension and execution of resuscitation skills. Bi-directional communication, between user and system, will allow real-time human-machine interactions in which user support may be (auto) adaptive to factors such as the environment, patient state, and user state; for example, providing prompts based on the performance quality of user interventions, telemetry captured on patient state, or the availability of expertise via telemedicine. The prototype system will be evaluated to determine the efficacy of interface, functional, and instructional features and to leverage findings for the refinement of the system to optimize user experience and performance.
Title of Project: A Clinical Trial Network for Adaptive & Comparative Testing of Trauma‐related Therapeutics
Project Team: Cohen Veterans Bioscience
Award Amount: $29,335,163
Project Duration: 3.5 years
Project Objective: Post-traumatic stress disorder (PTSD) is a mental health condition that some people develop after experiencing or witnessing a violent or life-threatening event, such as combat, natural disaster, terrorist attack, or sexual assault. PTSD affects about 7.7 million American adults in a given year and is the fifth most prevalent mental disorder in the U.S. with higher rates observed in veterans. Cohen Veterans Bioscience (CVB) will lead this program and serve as a Clinical Coordinating Center (CCC) to establish a clinical trial infrastructure for comparative testing of efficacy and safety of pharmacotherapeutics via a well-powered adaptive platform trial (APT). This innovative design is the most expedient way to advance therapeutics for trauma-related disorders and to streamline the clinical trial process while reducing costs and enhancing the information gained and translated to the clinic. Such a network can test and compare the currently available and often prescribed therapeutics in a methodical and resource-efficient manner providing level A evidence to guide their use or discontinuation in PTSD. The APT will also incorporate extensive biomarker testing to identify and enable the validation of more precise diagnostics, biomarkers that can predict response to specific treatments, or biomarkers that could be used for stratifying patients in clinical trials. The ultimate objective of this program is to inform precision-medicine based clinical practice guidelines by generating high-quality comparative evidence of treatment effect by diagnosis.