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.