MTEC-24-01-MPAI - SAM Summary Posting Attachment.pdf

Request for Project Proposals MTEC‐24‐01‐MPAI Number W81XWH‐15‐9‐0001

Solicitation Number: MTEC‐24‐01‐MPAI

“Fiscal Year 2024 Military Prototype Advancement Initiative (MPAI)”

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for the Request for Project Proposals (RPP) to solicit current MTEC members for a broad range of medical prototype technological and knowledge solutions related to the Focus Areas of Interest (also called “Focus Area(s)”) listed below. Proposed solutions may include medical techniques, knowledge products, and materiel1 (medical devices, drugs, and biologics). Military relevance is a key feature of this RPP, especially is it relates to the USAMRDC’s Combat Casualty Care Research Program (CCCRP), Military Infectious Diseases Research Program (MIDRP), and Military Operational Medicine Research Program (MOMRP), as well as the U.S. Air Force School of Aerospace Medicine. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. § 4022 (Authority of the Department of Defense to carry out certain prototype projects).

As stated at the end of this announcement, the full RPP is posted to the MTEC website (mtec‐sc.org); this notice is intended only to notify interested parties of the available solicitation.

BACKGROUND:

Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space and cyber superiority. Future conflicts against peer and near‐peer adversaries are expected to be layered stand‐offs and fought across multiple domains. Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategically and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses, and re‐compete to consolidate gains. Medical capabilities play a critical role in each aspect of the future battlespace and must modernize rapidly to maintain Force readiness and increase soldier lethality.

TECHNOLOGY FOCUS AREAS:

To meet the intent of this RPP, each Enhanced White Paper proposal SHALL specifically address ONLY ONE Focus Area of Interest described below. Offerors are not limited to a single Enhanced White Paper submission. Projects that fail to align with only one of these Focus Areas of Interest may not be considered for funding.

FOCUS AREA 1 – COMBAT CASUALTY CARE: Because battlefield conditions impose severe constraints on available manpower, equipment, and medical supplies available for casualty care, there is a need for medical interventions that can be used within the battle area or as close to it as possible, before or during medical evacuation. This Focus Area prioritizes technologies that are easily transportable (i.e., small, 1 Materiel is defined as equipment and supplies of a military force.

lightweight, and durable in extreme environments and handling), easy to use and require low maintenance. The following are Focus Areas of Interest (not listed in order of importance):

o FA 1.1 ‐ Blood Product Development: Next generation resuscitation technologies and strategies to extend the shelf‐life and/or minimize the cold chain for whole blood and other blood products. This may include optimization of storage techniques or development of novel technologies that function similarly to blood products in terms of volume expansion, hemostasis, and oxygen carrying capabilities. Potential technologies may include infusible hemostatics (i.e., nanoparticle solutions), oxygen carriers, and combination blood products. Technologies should effectively manage hemorrhage with attributes that include ease of delivery/use, extended shelf‐life, and storage in extreme conditions. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum Technology Readiness Level (TRL) 4 and describe the pathway to clearance or approval by the U.S. Food and Drug Administration (FDA) in sufficient detail (where applicable). See the full‐length version of the RPP for more information related to TRLs.

o FA 1.2 ‐ Anti‐shock Pharmacology: Evaluation of drugs to mitigate the pathophysiology associated with hemorrhagic shock. Therapeutics should address metabolic acidosis, mitochondrial dysfunction, and/or trauma‐induced coagulopathy. Priority will be given to evaluation of existing pharmaceutical technologies that can be repurposed for this indication. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA approval in sufficient detail (where applicable).

FA 1.3 ‐ Battlefield Pain Control: This focus area of interest is seeking novel solutions (i.e., analgesics and anesthetics) to manage acute battlefield pain that are devoid of performance‐limiting side effects.

Therapeutics should address the management of pain following traumatic injury (i.e., hemorrhage) and impacts to cardiovascular and respiratory responses. Solutions may include systemic therapeutics, as well as next generation regional analgesia techniques. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable).

o FA 1.4 ‐ Organ Support Devices and Therapeutics: Novel technologies and optimization of current technologies are required to provide renal support in the austere setting and treat ischemia reperfusion injury in severely injured casualties. Solutions may include pharmaceuticals or medical devices. All solutions should prioritize ease of delivery and the need for reduced size, weight and power (SWAP). Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable).

o FA 1.5 ‐ Surgical Support Technologies: This focus area of interest is seeking novel solutions to extend surgical capability and enable surgical procedures to be safely performed at Roles of Care 2‐3.2 Current surgical capabilities are relatively cumbersome and more mobile surgical capabilities typically have significantly reduced patient capacity. Novel solutions should increase surgical capacity and decrease SWAP requirements, contributing to improved mobility. This focus area includes both surgical

2 For more information on Roles of Care: ROC_Ref_Card_V12 June_2019.pdf (mtec‐sc.org) technologies as well as technologies that enable forward surgical capability such as advanced imaging, surgical sterilization, and intelligent anesthesia capabilities. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient

FA 1.6 ‐ Complex Wound Management: Advanced wound management therapies and solutions for operationally relevant trauma injuries such as complex soft tissue, open fracture, penetrating torso, and blast injuries. Additionally, development of solutions for delays in care of penetrating abdominal injuries and prevention/management of deep space infections are of particular interest. Proposed solutions should be optimized for far forward use with low SWAP requirements. Priority will be given to technologies that can be applied early in the treatment course following injury or initial debridement in order to impact the trajectory of wound recovery. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient o FA 1.7 ‐ Burn Wound Recovery: This focus area of interest is seeking safe, effective, field deployable, topical and/or systemic treatment capabilities (i.e., best practices/Clinical Practice Guidelines) to promote rapid recovery of skin functions following deep partial thickness and/or full thickness burn injury, agnostic of mechanism. This may include novel and/or repurposed therapeutics capable of initiating/accelerating burn wound healing and closure (including temporary or permanent coverage).

Prioritized candidate solutions will reduce follow‐on medical care required for full functional recovery, improve burn‐injured Warfighter function far forward in austere or prolonged care scenarios, avoid post‐burn complications, as well as improve long‐term clinical and functional outcomes. This topic prioritizes capability development other than antimicrobial treatments. Studies focused primarily on developing a delivery platform are of significantly less interest compared to studies of the efficacy of the novel or repurposed therapeutics themselves. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4, where proposed clinical trials and translational studies are of high interest.

Enhanced white papers must also describe the pathway to FDA clearance or approval in sufficient o FA 1.8 ‐ En Route Care: This focus area of interest seeks advanced methods and/or materiel solutions to enable high volume or prolonged patient movement. Technologies should be supported by preliminary, published data with a focus on mitigating the potential negative effects of patient movement in an operational environment while also optimizing care to multiple patients simultaneously. Additional considerations include functionality and effectiveness under conditions of vibration, acceleration, altitude and extreme environments. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See the full‐length version of the RPP for more information related to TRLs and KRLs.

o FA 1.9 ‐ Autonomous Care and Evacuation: This focus area of interest seeks advanced data‐driven solutions for the optimization of provider(s) treatment based on dynamic monitoring of available resources and casualty status. Solutions should present an analysis of critical factors (e.g., casualty status, casualty location, number of providers, medical supplies, environmental constraints, etc.) and an artificial intelligence/machine learning (AI/ML) algorithm which optimizes casualty priority and provider alignment/assignment to increase clinical capacity at the point of injury. Solutions should focus on the clinical aspects of optimizing triage, patient management, and medical regulating, rather than logistics or re‐supply. It is encouraged that the algorithmic solution be compatible/capable of being deployed with existing field medic platforms (such as BATDOK, MEDCOP, etc.). Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable).

o FA 1.10 ‐ Semi‐autonomous Procedural Support: This focus area of interest seeks technologies that enable semi‐autonomous assistance for resuscitative procedures using AI and robotic technologies.

These technologies should optimize the technical completion of the necessary task through speed, efficiency, and accuracy in order to improve the safe completion of the procedure while mitigating training decay and differences in provider expertise. Example technologies include facilitating venous and arterial access, as well as regional analgesia. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable).

o FA 1.11 – Military‐Civilian Partnerships for Trauma: This focus area aims to develop and implement a pilot program that expands an already existing military‐civilian partnership focused on training and sustainment of military personnel for the care and treatment of traumatic injuries and the conduct of military‐relevant research and development. The Enhanced White Paper shall briefly outline the proposed methodology to demonstrate a course of action that: i) evaluates return on investment for military‐civilian trauma partnership models, including clinical productivity, financial metrics, skill acquisition metrics and academic/research productivity; ii) evaluates, optimizes, and validates training and sustainment methods for military personnel within these partnerships; and iii) optimizes partnership models for successful conduct of military relevant research and development in the care of traumatic injuries. The Enhanced White Paper shall briefly outline the proposed methodology to the extent possible that demonstrates the Offeror’s capability and its understanding of the resources (to include subject matter experts, subcontractors, and potential prototypes under development) required to address this technical requirement. This focus area of interest will prioritize already existing military‐civilian partnerships with the aim to optimize them for trauma training and military relevant trauma research, rather than establishing new partnership sites. It is encouraged that proposed projects include the following:

o Access to study populations and existing data already collected from human subjects that support the goals of this program and the ability to maintain and interpret these data;

o Ongoing relationships with both non‐Government and DoD organizations that comprise the military‐civilian partnership;

o Experience with care and treatment of traumatic injuries in civilian populations that translate to military‐relevant use cases;

o Access to prototypes in development for the care and treatment of traumatic injuries;

o Access to human patients with traumatic injuries [to compare with military patients to build the capability of predictive models and strategies for clinical interventions]; and, o The focus to be metric‐driven with requirements for prototype development toward clinical interventions, endpoints, policy and processes for the care and treatment of traumatic injuries.

It is expected that outcomes will be transitioned to inform prototype development for military‐ relevant use cases, clinical practice guidelines, training, and clinical trial endpoints.

o FA 1.12 – Studies in Ukraine: The current conflict in Ukraine provides an unprecedented opportunity to understand medical care and challenges associated with modern large scale combat operations.

Section 736 of the Fiscal Year 2023 National Defense Authorization Act has directed the U.S. DoD to seek partnerships with Ukraine in the area of trauma education and research. This funding opportunity prioritizes both capability development and study of medical care challenges within the current conflict. NOTE: Enhanced White Papers submitted to this focus area of interest must provide a clear benefit to the Ukraine system of care, as well as providing lessons learned for the U.S.

military medical system in anticipation of potential future large‐scale conflicts. At the time of proposal submission, Offerors must provide documentation of: 1) Ability to conduct work within Ukraine without U.S. personnel entering the country; 2) Evidence of a capable Ukrainian partner and any necessary support from the Ukraine Ministry of Health or Ministry of Defense; and 3) Where appropriate, a clear plan for necessary regulatory, ethics, and human protections approvals within the U.S. and Ukraine.

The following two focus areas of interest are listed in order of priority:

o FA 1.12.1 ‐ Clinical Trial Capabilities: Development of observational or interventional trial capabilities and subsequent conduct of studies related to care of the war wounded in Ukraine.

Areas of interest include, but are not limited to wound infection/management, tourniquet use, hemorrhage and resuscitation, evacuation, traumatic brain injury, rehabilitation and traumatic stress. Of particular interest is the impact of time delays between wounding and initial care as well as throughout the care continuum. Trauma registry development and data analysis is an additional priority.

o FA 1.12.2 – Evaluation of Casualty Care Technologies in Ukraine: This focus area of interest aims to evaluate, optimize, and/or validate casualty care technologies for use in the forward operational environment. Examples of proposed studies could focus on the evaluation of utility, ease of use, compatibility with the forward operating environment, and clinical outcomes. The project deliverable could also include recommendations for technology improvements to optimize use in the forward operating environment. Priority will be given to proposed casualty care technologies that are (not listed in order of importance):

o currently in development by the U.S. DoD;

o have obtained regulatory clearance/approval from a European body and interested in pursuing approval via the U.S. FDA; or o have obtained regulatory clearance/approval by the U.S. FDA but need funding for validation studies in a forward operational environment.

FOCUS AREA 2 – MILITARY INFECTIOUS DISEASES: This technology area focuses on vaccines, drugs, vector detection assays, and novel therapeutics to treat multidrug‐resistant organisms in combat wound infections, as well as vector control measures for insect vectors that transmit naturally occurring endemic diseases with demonstrated or potential capability to decrease military operational effectiveness. This area specifically focuses on solutions for prolonged care scenarios, where wound infection poses a significant threat to operational readiness and effectiveness, as well as solutions enhancing medical readiness in response to infectious diseases encountered by Service members during deployment that can significantly impact performance. The following are focus areas of interest (not listed in order of importance):

o FA 2.1 ‐ Prophylactic to Prevent Infection in Battlefield Wounds from Complex Traumatic Penetrating Injuries in a Far‐Forward, Austere Environment: This focus area of interest seeks the development of materiel solutions that have the following required solution characteristics:

o Must be able to conform to 3‐dimensional wound shape (i.e., not a bandage) o Must be self‐absorbing or removable through wound irrigation o Must be effective against at least one, but preferably multiple, high priority pathogens:

Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus o NOTE: Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

In addition, it is strongly preferred that proposed solutions provide the following desired solution characteristics:

o Integration of novel antibiotic drug classes against Gram‐negative pathogens o Single solution with ability to provide antibiotics, pain analgesics, and/or hemostasis compounds

At the time of proposal submission, it is strongly preferred that Offerors also include the following in their enhanced white papers:

o Toxicity data (if required by FDA) o Regulatory strategy with documented FDA engagement (including minutes from pre‐ submission meetings) o FA 2.2 ‐ Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound

Infection: Development of drug / biological treatments for sepsis, including host‐based therapeutics.

o Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

o Toxicity data (if required by FDA) are preferred o FA 2.3 ‐ Antivirals for the Prevention and/or Treatment of Endemic and Emerging Infectious Diseases (Non‐biothreat Pathogens): Development of broadly acting antivirals (small molecules, innovative antibody approaches, repurposed antivirals) that can be administered via oral (PO), intramuscular (IM), transdermal (TD) or subcutaneous (SC) routes (Intravenous (IV) not preferred) that are effective against pathogens relevant to the military:

o Two or more pathogens from the Bunyavirales order (e.g., Lassa virus, Crimean Congo Hemorrhagic Fever virus, Severe Fever with Thrombocytopenia Syndrome virus) o The Flaviviridae family with Dengue virus as the primary target (against all four serotypes) and all other flaviviruses as secondary targets

NOTES:

o Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

o Inclusion of toxicity data (if required by FDA) are preferred.

o Regulatory strategy with documented FDA engagement (including minutes from pre‐ submission meetings) is strongly preferred o FA 2.4 ‐ Prevention of Endemic Diarrheal Diseases: Development of immunoprophylactics for endemic viral diarrheal diseases, with a focus on norovirus.

NOTES:

o Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

o Inclusion of toxicity data (if required by FDA) are preferred.

o FA 2.5 ‐ Knowledge Product Solutions for the Prevention of Infection in Traumatic Penetrating Wounds: Solutions are expected to optimize clinical practice guidelines for at least one of the following (not listed in order of importance):

o FA 2.5.1 ‐ Decipher the intricate relationship between combat polytrauma, infections and sepsis for data‐driven clinical practice guideline revisions and field medicine.

o FA 2.5.2 – Modernize the effectiveness of acute traumatic wound management. Proposed projects shall 1) assess the effectiveness of the Acute Traumatic Wound Management guidelines3 and 2) optimize these guidelines to enhance the standard of care for traumatic wound infectious found in operational environments. It is encouraged that proposed projects have access to study populations and data already collected from human subjects that support the goals of this program and the ability to interpret these data. The project shall deliver translatable processes, knowledge and technology (i.e., training, clinical practice guidelines for assessment and interventions, and clinical trial endpoints) to optimize and inform care for traumatic wound infections found in operational environments.

o FA 2.5.3 ‐ Leverage polytrauma of infection preclinical models to evaluate emerging solutions and therapeutics that target infections of traumatic penetrating wounds, identifying refinements needed for solution maturation.

FOCUS AREA 3 – MILITARY OPERATIONAL MEDICINE: This technology area aims to maximize health, readiness, and performance by countering stressors and preventing physical and psychological injuries during training and operations. The following are focus areas of interest (not listed in order of importance):

o FA 3.1 ‐ Individual Occupational and Environmental Exposure Monitoring: The development and refinement of a health assurance platform integration with environmental and physiological sensor technologies for individual occupational and environmental exposure monitoring. Required capabilities include the integration and testing of specialized volatile organic compound and fine particulate matter sensing capabilities; algorithms for environmental hazard monitoring and physiological effects; development of a suite of modules enabling remote monitoring of bio‐fluids for examination of biomarkers and exposure levels; and operational validation of the above capabilities in at least one or more military‐relevant environments.

o FA 3.2 ‐ Advanced Research Using Multi‐enclave AI Analytics of Biomedical Readiness for Formation‐ centric Military Performance: Required capabilities include the ability to perform AI analytics on biomedical readiness data, to include the synthesis of medical readiness and training readiness collected at point of need and transferred as required, across multiple network enclaves with differential security / firewall permissions. Demonstration of analytic and/or data movement capability required in military‐relevant environments with military formation‐centric focus, either garrison / training or deployed or both.

3 https://jts.health.mil/assets/docs/cpgs/Wound_Management_PFC_24_Jul_2017_ID62.pdf o FA 3.3 ‐ Understanding Tinnitus: Mitigating tinnitus will sustain Soldier lethality in multi‐domain operations. Tinnitus can have severe effects on battlefield situational awareness and diminish the effectiveness on Soldier readiness. Depending on severity, tinnitus can impact effective communication within military maneuver units and/or airborne air support craft. Tinnitus and hearing loss are the top two disabilities for all Veterans awarded compensation for service‐connected disabilities. The underlying cause of tinnitus is not known, and there is no objective test for tinnitus.

The overall objective of this focus area of interest is to advance effective strategies to prevent, test, manage and treat for this condition. Enhanced white papers will be expected to propose studies that assess the physiological effects of service‐related neurosensory traumatic injury on the onset and progression of tinnitus. Prototype solutions may address the impact of tinnitus by optimizing the restoration and rehabilitation processes of hearing following service‐related neurosensory traumatic injury. Proposals may also aim to provide recommendations and/or propose mitigation strategies to improve or refine the development of or existing prototypes used in relation to tinnitus.

o FA 3.4 ‐ Leverage Medical Health Data for Neurosensory Injury Prevention and Treatment Strategies: Leveraging medical health data has become a DoD‐wide focus. Neurosensory injuries such as optical trauma, hearing loss and vestibular dysfunction, are prevalent among military personnel due to the nature of their duties. By leveraging medical health information, comprehensive information about the occurrence, patterns, and outcomes of these injuries could be gathered. This data enables researchers and healthcare providers to identify risk factors, develop preventive measures, and design targeted treatment strategies for military exposure induced neurosensory injuries. It also facilitates the monitoring and evaluation of interventions, leading to evidence‐based practices and can improve both the short‐term and long‐term outcomes for the neurosensory injury in the military context. This focus area of interest seeks data‐driven insights and recommendations to enhance prevention strategies and inform treatment protocols, and may potentially lead to the follow‐on work related to improved prevention, management and treatments of neurosensory injuries. Proposed work may include the following activities:

o Collect and analyze medical health data from service members to identify patterns, associations, and governing forces related to neurosensory injuries to inform prevention and treatment strategies.

o Incorporate military hazardous exposure data, such as noise exposure levels, duration, and specific environments, in conjunction with medical health data to discover hidden correlations and risk factors that could inform prevention and treatment strategies.

o Utilize advanced data analytics and machine learning techniques to identify and develop predictive indicators, potential intervention strategies, and personalized risk assessments for neurosensory injuries.

o FA 3.5 – Hearing Protection Communication: Hearing protection devices (HPDs) are essential safety equipment for military personnel, who are routinely exposed to high‐intensity sounds that can permanently damage hearing. However, HPDs also impair situational awareness and communication.

Warfighters are acutely aware of such side‐effects and their impact on performance in key operational tasks, contributing to disuse in the same operational settings where injurious high‐intensity sounds are common. The subsequent loss of hearing results in an immediate degradation of operational capability, impeded communications, and significant disability payments after service completion.

Advancements in HPD technologies are necessary to mitigate the negative perceptual side effects of HPDs.

This Focus Area of Interest is concerned with the evaluation and enhancement of HPDs in simulated operational environments (e.g., 3‐dimemntional multi‐source sound fields). Proposed solutions may generate knowledge products to inform and/or refine HPD prototypes currently in use or under development. Offerors are encouraged to align proposals to the short‐, mid‐, or long‐term goals of this effort:

o FA 3.5.1 – Short‐Term Goal: Evaluate the performance of HPD technology under military operationally relevant conditions to determine deviations from laboratory measurements.

o FA 3.5.2 – Mid‐Term Goal: Develop and incorporate advanced acoustic technologies to mitigate adverse perceptual side‐effects of HPDs.

o FA 3.5.3 – Long‐Term Goal: Evaluate the effects of HPD technology on enhanced human performance during key operational and military‐relevant tasks and optimize HPD technology for the military environment as needed.

o FA 3.6 ‐ Brain Computer Interface (BCI) Translations: Advancements in BCI for vision restoration have the potential to benefit military service members who may have acquired vision loss due to military traumatic injuries, improving their quality of life and the ability to return to duties. BCI prototypes that are within scope must stimulate part of the visual pathway, such as the retina, optic nerve, and visual cortices, to generate visual perceptions. This effort is looking to fund a human study or clinical trial focused on using BCIs, specifically visual neural prostheses, to offer a more direct approach to restore vision. Offerors with an approved Investigational Device Exemption by the U.S. FDA are strongly encouraged for this focus area.

o FA 3.7 ‐ Temporary Cornea Repair (TCR): Ocular injuries are a major cause of battlefield casualty and permanent disability and represent a threat to operational readiness and a socioeconomic burden.

Closure of these injuries requires surgical intervention by an ophthalmologic surgeon and most often must occur within 24 hours to preserve any amount of residual vision, with the time to primary surgical repair strongly correlated with final visual acuity. Delays in initiation of pre‐operative treatment in animal models of eye injury have been shown to have a negative impact on physiological values associated with injury severity, and case studies indicate that delays in pharmacological treatment for endophthalmitis correlate with worse outcomes, suggesting that acute care in the emergency setting has the potential to improve outcomes. Currently DoD is lacking solutions to address this military requirement for ocular injuries in the battlefield. Proposed solutions must address at least one of the following requirements:

o A near‐term solution that could repurpose an FDA‐approved surgical aid‐indicated solution already shown to improve wound healing efficacy in clinical trials. This should be an expanded indication without the need for a full New Drug Application to the FDA and the full scope of clinical trials, suggesting the potential for a near‐term solution meeting all research requirements.

o To develop a medium‐term solution that would likely to require funding of advancement in cGMP‐capable manufacturing of the prototype and FDA device approval. Such a solution is likely a medium‐term solution requiring an estimated minimum of 3 years of effort with consistent funding and real property investment in manufacturing capability.

o To develop a far‐term solution with FDA approval eye stabilization device for Role of Care 1 as a result of the improved safety profile in animal studies and apparent therapeutic effects.

It would be expected that no aspect of this potential solution has reached any stage of clinical testing in humans, and this approach also requires the development of a new FDA‐approved eye shield device.

o FA 3.8 ‐ Psychological Health, including Psychological Disorders Treatment: Mature and integrate a scalable, digital health suite of tools that extends options for monitoring and care management of adjustment disorders to behavioral health officers (BHOs), offers self‐care for Service members with adjustment disorders in garrison settings who may have limited access to clinical providers, and offers providers and leaders a more upstream evaluation and monitoring of risk‐related events/problems and symptoms in members within their units. Of interest is a military‐centric digital e‐health platform, provider dashboard, and individual app all with military‐specific content to mitigate adjustment disorders, and also capabilities for monitoring high frequency events and person‐level risk factors for adjustment‐related difficulties and offering evidence‐based treatment/interventions for one or more of the conditions/issues commonly co‐occurring with adjustment disorders (e.g., insomnia, distress) which could be self‐administered where appropriate. Requirements for submissions are as follows:

o The proposed digital platform must have proven (tested) capabilities for secure and asynchronous connectivity, for use in remote and/or austere environments with Active‐Duty Service Members (ADSM) o Offeror must provide established supporting data on their platform's feasibility and acceptability in ADSM and military provider populations o Must use psychometrically‐sound measures o Must align to be compatible with existing DoD Behavioral Health tools used by BHOs (e.g., the

BH Pulse).

o Offeror must have a verifiable plan for access to an ADSM population to conduct the research to further test this platform and content for effectiveness of the interventions and BH monitoring capabilities.

o Teaming is strongly encouraged, especially with DoD research laboratories who have expertise in these content areas. Datasets regarding existing DoD Behavioral Health tools in use (e.g., BH Pulse) may be available for sharing/leveraging upon award.

o Must provide a letter of support from a U.S. military commanding officer stating Offeror’s access to and participation by ADSM population. Proposals without appropriate letters of support may be withdrawn.

o FA 3.9 ‐ Objective Behavioral Health Assessment and Monitoring: Non‐invasive assessment and monitoring of behavioral health‐related conditions and symptoms (e.g., depression, post‐traumatic stress disorder (PTSD), acute stress reactions, acute stress disorder, pain, somatic symptoms) using analysis of paralinguistic features from audio recordings acquired immediately after a potentially traumatic event (e.g., car accident, assault), and the following weeks of recovery. The desired use case for this prototype would be identifying if behavioral health symptoms are improving or declining, and/or using predicting changes in symptoms from one timepoint to the next.

o Proposals utilizing AI/ML approaches should be substantiated by demonstrating expertise in this field.

o Offeror must provide a description of the supporting preliminary data demonstrating a TRL 3 which will be used to refine analyses of paralinguistic markers.

o Use of publicly available paralinguistic analysis packages are acceptable and encouraged o FA 3.10 ‐ Effective, Scalable Treatments for Full Remission: Evaluate and refine scalable treatments or treatment regimens that maximize full remission of PTSD or Adjustment Disorders symptoms in ADSM populations, to maintain medical readiness.

o Must provide preliminary treatment/intervention data from clinical trials that can inform refinement strategies and hypotheses.

o Minimum of KRL 4 is required for submission of an Enhanced White Paper to this focus area of interest, such as already having completed pilot intervention trial.

o Proposals for new (initial pilot) treatment clinical trials will not be considered.

o Therapies for co‐occurring PTSD and Alcohol Use Disorder will not be considered for this RPP, as this topic area is resourced by a separate Program.

o Given the shortage of behavioral health clinicians in the U.S., the preferred treatments are those which are more scalable, such as portable neuromodulation, stellate ganglion block, or other non‐psychotherapy treatments. Scalability includes considerations for the required personnel resources (i.e., avoid treatments that solely rely on psychologists and other highly trained and experienced behavioral health personnel to administer in a 1:1 regimen), individuals' logistical barriers to care, highly specialized or lengthy provider training, unit cost per person, etc.

o Must provide a letter of support from a U.S. military commanding officer stating Offeror’s access to and participation by ADSM population. Proposals without appropriate letters of support may be withdrawn.

o FA 3.11 ‐ Postventions for Suicide: Development of theory‐based military‐specific postventions for suicide, particularly after discharge from in‐patient treatment for suicide ideations or attempt (e.g., reintegrating Service Members back into their unit/installation), after a suicide exposure, or during the transition phase from active duty to Veteran status. Postvention solutions may include but are not limited to crisis response plan components, military peer/buddy resources, lethal means safety interventions, or other evidence‐based interventions for postvention support. Proposed solutions should be intended for use by non‐clinical personnel (e.g., military leaders, peers, family, unit prevention staff, or chaplains) and should be developed with the intention to transition into military installations.

Populations of interest for this Focus Areas include:

o Active Duty Service Members o National Guard or Reserves o Military Service Academy Service Members, and/or Reserve Officers' Training Corps

Populations NOT of interest include:

o Veterans o Personnel in retired military status

Solutions NOT of interest include:

o Passive sensing, or "wearables" o Artificial intelligence technology‐based algorithms for monitoring or predicting harmful behaviors o Technology solutions that are intended as clinical decision support tools o Mobile applications or platforms that have not already been integrated in the DoD o Any technological product that requires FDA approval and is not currently FDA approved o FA 3.12 ‐ Cross‐Cutting Prevention: This Focus Area of interest seeks theory‐based research to support program, training, or intervention development, efficacy/effectiveness testing, and implementation of military primary prevention approaches that have cross‐cutting impacts on multiple harmful behaviors, including suicide, sexual assault/violence and harassment, ostracism, domestic abuse, and alcohol and substance misuse. Solutions for this focus area of interest are intended to be comprehensive prevention approaches that address multiple ecological levels (e.g., individual, unit, installation, leadership), to promote healthy behaviors and reduce risk factors for harmful behaviors. Solutions should be designed with the intention to transition into military installations.

Populations of interest for these Focus Areas include:

o Active Duty Service Members o National Guard or Reserves o Military Service Academy Service Members, and/or Reserve Officers' Training Corps

Populations NOT of interest include:

o Veterans o Personnel in retired military status

Solutions NOT of interest include:

o Passive sensing, or "wearables" o Artificial intelligence technology‐based algorithms for monitoring or predicting harmful behaviors o Technology solutions that are intended as clinical decision support tools o Mobile applications or platforms that have not already been integrated in the DoD o Any technological product that requires FDA approval and is not currently FDA approved o FA 3.13 ‐ Warfighter Fitness to include Musculoskeletal Injury Prevention and Treatment: Proposed solutions must be at a minimum TRL 4 (clinical studies preferred) and should relate to at least one of the following areas (not listed in order of importance):

o Validated musculoskeletal injury risk screening and assessment tools to identify individual and unit‐level musculoskeletal injury risk and performance decrements.

o Advancement of imaging devices or objective assessment tools that can accurately distinguish bone, muscle, tendon and/or ligament injury and recovery.

o Biologic or drug therapy that can speed recovery of minor tendon/ligament injuries in an operational environment for rapid return to duty. Animal studies are not permitted.

o Solutions to design AND develop AND implement training programs for Warfighter health and fitness.

o FA 3.14 ‐ Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass

(HSM): Operationally‐relevant helmet and helmet‐borne system (or HSM) guidance to minimize performance decrement is needed for dismounted Soldier populations. Using biomechanical / physiologic, operational performance, and user feedback data obtained human subject volunteers, HSM guidance will be generated to provide thresholds on HSM properties (mass and longitudinal CM offset) to material developers and health hazard assessors specifically for dismounted Soldier populations. Offerors are encouraged to address the following in their proposals:

o Leverage computational models to assess the biomechanical response of the human spine during dismounted operations.

o Use physiologic, biomechanical, and kinematic data collected during DoD human subject field‐ and lab‐based testing as inputs into newly developed or existing musculoskeletal models to assess spinal response to HSM.

o Perform static and dynamic optimizations of cervical spine movements associated with dismounted maneuvers and techniques with vary HSM conditions.

o Conduct analyses to estimate metrics such as ligament strain, intervertebral stresses, joint angles, joint forces and moments, and muscle forces under different HSM conditions.

The metrics will assist in the extrapolation of both operational performance decrement and potentially injurious effects resulting from HSM exposures. The Offeror’s ability to associate these model‐predicted outputs with the reported spinal pain symptomology and other applicable medical outcomes or health effects that have been associated with HSM exposures such as neck pain/discomfort, neck muscle activation, and neck fatigue will support the development of guidance and thresholds to minimize HSM‐related operational and biomechanical performance decrement.

o FA 3.15 ‐ Biomechanical Tolerance of the Human Head to High‐Rate Localized Blunt Impacts: Injury criteria for high‐rate blunt impacts to the head, such as those resulting from ballistic‐induced behind helmet blunt trauma, are required to develop injury ‐based performance criteria for DoD personal protective equipment (PPE). The purpose is to have medically based criteria for future development and evaluation of next generation PPE. There is also a need to develop medically‐based performance requirements for helmets in order to protect against the whole spectrum of head/brain injuries occurring in military operational environments. Offerors are encouraged to address the following in their proposals:

o Leverage existing published literature, and previous DoD‐funded projects investigating head injuries caused by blunt impacts at loading rates ranging from sports‐related impacts and motor vehicle accidents to behind‐armor blunt impacts resulting from defeated ballistic projectiles.

o Leverage existing and emerging clinical data and emerging field data on head injuries being collected by the DoD, law enforcement community, industry, and academia.

o Develop and conduct, in cooperation with DoD laboratories, innovative medical research to characterize physiological response (e.g., head injury, traumatic brain injury), and head impact parameters under military‐relevant exposures, using mechanical, cadaveric, or animal surrogates.

o Collaborate with DoD laboratories, industry, and academia to leverage existing computational models of the head, brain, and torso to support, and potentially expand, the experimental studies mentioned above.

o Correlate physiological response to impact parameters to develop and deliver injury risk thresholds or probability risk curves for head injuries related to high rate localized blunt impacts.

o Collaborate with DoD laboratories with complementary capabilities to leverage DoD research expertise and to ensure operational relevance of the proposed research.

FOCUS AREA 4 – U.S. AIR FORCE SCHOOL OF AEROSPACE MEDICINE: The Air Force Aerospace and Operational Medicine Enterprise (AOME) seeks to maximize Airman performance and readiness, as well as the development of mitigation measures for physical and psychological stressors, illness and injuries during Airman training and operations by executing studies and analyses. The Studies and Analysis Portfolio general focus areas can be broadly categorized into the following areas of interest: Aerospace Medicine and Physiology, Public Health and Preventative Medicine, Occupational Medicine and Bioenvironmental Engineering, and En Route Care and Expeditionary Medicine. The following focus areas of interest are based on urgent and near‐term needs and issues identified within the Air Force (AF) population. Proposals must be appropriate for one‐year (12 month), short term investigations to address focus areas of interest listed below (not listed in order of importance):

o FA 4.1 ‐ Musculoskeletal Injury Prevention and Treatment for Aircrew and Maintainers: Neck and back pain is a known occupational hazard for the high‐performance aircraft community. The government seeks solutions, including tools to prevent, reduce, screen and diagnose musculoskeletal condition as well as alternative/integrative medicine approaches, for prevention or treatment of musculoskeletal injuries. Proposed solutions shall focus on providing reliable measurements to determine platform‐specific neck/back dysfunction and improvements due to embedded care.

o FA 4.2 ‐ Aerospace Physiology: Solutions relating to the physiologic assessment in high altitude

Fighters/Trainers. Solutions should relate to at least one of the following areas (not listed in order of importance):

o Assessments of the physiologic response to exposures and stressors from the fighter/trainer environment; can cover any of the following: including effects of fluctuating pressure, high O2, air quality, breathing resistance, thermal burden, dehydration, rest/sleep (physical fatigue), cognitive fatigue, Aircrew Flight Equipment (AFE) integration (how AFE impacts in‐ flight physiology, and how AFE components interact with each other to impact physiology and aircrew performance), and combined stressors on performance and decision making in ground‐based testing and operational environments, including the analysis of potential countermeasures to optimize pilot performance and eliminate sources of risk.

o Solutions to sustain Aircrew performance in extreme environments.

o Conduct a comprehensive technology assessment of the current military health system simulators that can monitor and track physiologic responses from training student pilots.

o There is a strong demand for wearables that are cross compatible across multiple systems to collect physiologic data, that are reliable and validated in the operational environment.

Offerors are to conduct a comprehensive technology assessment of commercial off the shelf products, including their suitability for use in the operational environment and their validated measurement capabilities, to help aid aircrew and decision makers on what can be flown in the aircraft and what can be accurately collected from those sensors.

o FA 4.3 ‐ Carcinogens (source NDAA 2021 Sec 750): Proposed projects are expected to relate to at least one of the following areas (not listed in order of importance):

o Development and evaluation of prototypes that can identify carcinogenic toxins or hazardous materials associated with military flight operations from shipboard or land bases or facilities.

o Development and evaluation of prototypes that can identify exposures to ionizing radiation and nonionizing radiation from which airmen could have received increased radiation amounts.

o Establishment of guidelines for carcinogen exposure as it relates to demographics for each airman to include duty stations, duties and aircraft flow.

o Establishment of guidelines that outline the duties and potential exposures of airmen that are associated with higher incidence of cancer.

o Development and evaluation of screening tools and/or methods that relate to carcinogen exposure to airmen.

o FA 4.4 ‐ Precision Medicine and Medical Standards: Development of solutions relating to at least one of the following areas (not listed in order of importance):

o Surveillance of conditions, indications, clinical practice guideline adherence, and outcomes to support cost benefit analyses for AF population.

o Genomics for mishap investigations (gene expression, subtracting human and molecular autopsy).

o Studies providing data to support evidence‐based aerospace medicine standards.

o Psychological Performance and Mental Health (solutions should relate to at least one of the following areas; not listed in order of importance):

o Mental health and psychological disorders amongst airmen and potential influence on readiness and retention.

o Neurocognitive diversity; cognitive testing and correlates with mental health and other outcomes.

o Assessment of the feasibility of integrating the use of personality data and wearable technology to facilitate adjustment…