Noninvasive Detection and Localization of Occult Hemorrhage | SBIR

OUSD (R&E) critical technology area(s): Applied Artificial Intelligence, Biotechnology

Objective: Demonstrate a capability that noninvasively detects and localizes occult (internal) non-compressible hemorrhage outside of a hospital.

Description: The goal of this development effort is to produce a noninvasive or minimally invasive capability that enables Role 1 medical personnel (specifically, a combat medic with no surgical or pre-operative imaging expertise) to rapidly detect, localize, and characterize the rate of life-threatening, occult, or non-compressible torso hemorrhage (NCTH) that cannot be precisely identified through routine clinical assessments available in the field. The proposed solution should integrate advanced sensing technologies with artificial intelligence to provide accurate, real-time detection, anatomic localization, and quantitative or semi-quantitative estimation of bleeding rate, distinguishing slow or self-limiting hemorrhage from rapidly expanding, exsanguinating hemorrhage, and should function in austere and contested environments. The capability should support serial or continuous monitoring such that changes in hemorrhage rate can be tracked to provide updates to the medic in near-real time. Solutions should provide intuitive, actionable visualization of both hemorrhage location and rate to support timely medical decision-making, triage, and evacuation prioritization when definitive surgical care is delayed or denied.

Phase I

Demonstrate the technical feasibility of a noninvasive or minimally invasive capability for rapid detection, anatomical localization, and characterization of life-threatening occult or non-compressible hemorrhage. The performer shall develop a proof-of-concept sensing and artificial intelligence framework capable of accurately identifying the anatomical source of bleeding and estimating hemorrhage rate for a limited set of representative injury types. Scanning may be performed manually or using an automated platform (e.g., robotic or assisted acquisition) and should provide clinically actionable results within a timeframe compatible with Role 1 medical decision-making.

Proposals shall describe the envisioned concept of operations, including sensor placement or access method (for minimally invasive approaches), data acquisition, user workflow, system-guided adjustments to sensor positioning or data collection, data processing, reporting, and, where appropriate, serial or continuous monitoring. Proposals shall describe the sensing technologies to be employed, their anticipated technology maturity, the proposed AI algorithms and training strategy, available datasets, and any additional data collection planned during Phase I. Representative testbeds may include retrospective clinical datasets, computational models, physical phantoms, ex vivo preparations, or controlled preclinical studies.

Phase I efforts should establish the technical capabilities and limitations of the proposed approach, including the minimum and maximum resolvable hemorrhage rate, localization accuracy, anatomical applicability (including challenging locations such as retroperitoneal hemorrhage or bleeding obscured by bone or bowel), and expected robustness across representative operational conditions. Proposals shall define quantitative performance metrics for hemorrhage detection, localization, bleeding-rate estimation, response time, and operational robustness under austere conditions, including environmental stressors, limited power availability, transportation, storage, and deployment. While field-ready systems are not required, proposals utilizing components with demonstrated field suitability will be viewed favorably. The Phase I effort should culminate in a proof-of-concept demonstration and a detailed technical development plan supporting maturation into an integrated prototype during Phase II. Phase I proposals shall present tasking and relevant milestones for a 6-month base period.

Phase II

Phase II will build upon the successful Phase I demonstration by developing, integrating, and validating a portable prototype capable of real-time hemorrhage detection, anatomical localization, bleeding-rate estimation, and longitudinal monitoring across a broader range of clinically relevant battlefield injuries. Phase II should emphasize engineering maturation, system integration, and operational validation rather than fundamental sensor development. The sensing hardware architecture established during Phase I should remain substantially unchanged, with improvements focused on optimization, robustness, algorithm refinement, and user-centered operation.

Performers shall expand system performance to encompass additional solid organs, vascular structures, and clinically relevant hemorrhage scenarios while collecting additional datasets to improve algorithm performance, robustness, and generalizability. The system shall support serial or continuous assessment of hemorrhage progression, enabling near-real-time updates of bleeding location and rate. The integrated prototype shall provide intuitive clinical decision support suitable for Role 1 medical personnel, including actionable visualization of hemorrhage location, bleeding rate, confidence estimates, injury implications, and recommendations supporting triage, treatment prioritization, and evacuation decisions.

Validation should be conducted using representative preclinical, cadaveric, clinical, or other operationally relevant test environments, with performance evaluated under conditions representative of austere military operations, including motion, environmental stress, limited logistical support, and communications degradation where appropriate. Proposals shall define quantitative Phase II performance metrics for detection accuracy, localization precision, bleeding-rate estimation, response time, longitudinal tracking performance, robustness, usability, and operational suitability. Phase II should conclude with delivery of an integrated prototype, validation results demonstrating operational feasibility, and a transition strategy supporting military evaluation, regulatory planning, manufacturing, and commercialization.

As with Phase I, proposals shall define envisioned Phase II metrics for success in the detection, localization, and characterization of bleeding. Phase II proposals should enumerate the planned list of injury targets planned for characterization. Phase II proposals shall present tasking and relevant milestones for a 12-month base period, and separate tasking and milestones for a subsequent single 12-month option period.

Direct to Phase II (DP2) Requirements:
DP2 proposers must provide documentation demonstrating they have already achieved the feasibility milestones expected at the conclusion of a Phase I effort. Specifically, proposals must demonstrate existing evidence of:

• Proof-of-Concept: An established sensing and AI framework capable of accurately identifying the anatomical source of occult/internal bleeding.
• Hemorrhage Rate Estimation: The ability to quantitatively or semi-quantitatively estimate hemorrhage rates to distinguish slow bleeding from rapidly expanding hemorrhage across various injury profiles.
• Performance Metrics: Tested parameters detailing the minimum/maximum resolvable hemorrhage rates, localization accuracy, and anatomical applicability (including challenging areas such as retroperitoneal hemorrhage).
• Operational Robustness: Preliminary data indicating the approach can withstand austere conditions, including environmental stressors and limited power availability.

Phase III dual use applications

Military Application (Battlefield):
The developed noninvasive hemorrhage detection system transitions directly to military operational medicine, specifically empowering Role 1 combat medics. In austere and contested environments where definitive surgical care or medical evacuation (MEDEVAC) is delayed or denied, this portable technology provides critical clinical decision support. By continuously monitoring non-compressible torso hemorrhage (NCTH) progression, medics can perform highly accurate triage, prioritize life-saving interventions, and optimize evacuation scheduling for casualties with exsanguinating hemorrhage versus those with self-limiting bleeding.

Civilian/Commercial Application (Remote Disaster Areas):
In the civilian sector, this technology holds significant dual-use potential for emergency medical services (EMS), search-and-rescue teams, and disaster response units. During mass casualty incidents or natural disasters (such as earthquakes or severe storms) where infrastructure is damaged and access to hospital imaging is impossible, first responders can use this tool to rapidly detect occult internal bleeding at the point of injury. It provides paramedics with real-time, actionable data to prioritize helicopter transport or specialized trauma center routing for critically internally injured patients in remote or rural environments, ultimately reducing preventable mortality outside of the hospital setting.

References

1. Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, et al. Death on the battlefield (2001–2011): Implications for the future of combat casualty care. Journal of Trauma and Acute Care Surgery. 2012 Dec;73(6):S431–7.
2. Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b. PMID: 21795876.

Keywords

hemorrhage detection, clinical decision support, medical device, austere environment

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