Fiscal Year 2025 Multi-Topic Request for Project Proposals

Purpose

This solicitation, issued by MTEC, represents a 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 materiel (e.g., medical devices, drugs, and biologics). Military relevance is a key feature of this RPP.

Scope of Work

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.

Minimum Requirements for Submission of an Enhanced White Paper

Enhanced White Papers submitted in response to this RPP shall meet the following minimum requirements:

Demonstrate Military Relevance: Proposed projects shall focus on providing medical solutions to support readiness and care in future battlefield scenarios.

Fit the Prototype Definition: Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. The definition of a “prototype” is as follows: (A) a prototype project addresses a proof of concept, model, (B) reverse engineering to address obsolescence, (C) pilot, novel application of commercial technologies for defense purposes, (D) agile development activity, (E) creation, design, development, demonstration of technical or operational utility, or (F) combinations of the foregoing. A process, including a business process, may be the subject of a prototype project.

Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): The minimum acceptable KRL/TRL at the time of submission of the Enhanced White Paper is at least KRL/TRL 3 for most of the focus areas listed herein. Offerors have achieved KRL/TRL 3 if:

• Knowledge Products: Offeror has validated hypotheses that suggest applications (e.g., prediction for prognosis, screening for diagnosis, or treatment for prevention).
• Pharmaceutical (Drugs): Offeror has demonstrated initial proof-of-concept for candidate drug constructs in a limited number of in vitro and in vivo research models.
• Pharmaceutical (Biologics, Vaccines): Offeror has demonstrated initial proof-of concept for biologic/vaccine constructs in a limited number of in vitro and in vivo research models.
• Medical Devices: Offeror has demonstrated initial proof-of-concept for device candidates in a limited number of laboratory models (may include animal studies).
• Medical Information Management (IM)/Information Technology (IT) & Medical Informatics: Medical Informatics data and knowledge representation schema are modeled.

Offerors should note that all topics within Focus Areas 1 (Combat Casualty Care), as well as Focus Areas 3.10 and 3.13, require a minimum TRL/KRL of 4.

Represent New Submissions to MTEC: Focus on proposed solutions that have not been submitted to MTEC under previous RPPs within the past 2 years, including the 22-02-MPAI and 23-06-USAMRDC-MultiTopic. The Government is already aware of concepts submitted in response to previous MTEC solicitations including the 21-06-MPAI and 22-02-MPAI; therefore, such projects are not allowed to be resubmitted here. This RPP is intended only for submission of new projects to MTEC or substantially revised or modified proposals in accordance with previous Government feedback, not identical resubmissions.

Offerors should note that some Focus Area topics specify different minimum TRL for solutions to be considered for funding. See Addendum 1 for a reference checklist to assist in assessing the TRL of the proposed project.

Align to a Specified Focus Area: Enhanced White Papers shall align to a single Focus Area specified in Section 3.3 of this RPP. Failure to align to a single Focus Area of Interest may result in an “Unacceptable” rating and render the proposal ineligible for award.

Note: Failure to meet any or all of these minimum requirements may result in an overall “Unacceptable” rating of the Enhanced White Paper with minimum or no additional feedback provided.

Focus Areas of Interest

To meet the intent of this RPP, each Enhanced White Paper shall specifically address only one Focus Area 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 may not be considered for funding. Additionally, proposals that fail to include all required documentation as listed in Section 4.2 of this RPP may not be considered for funding. See Addendum 6 that identifies the documents that are required and/or encouraged for each Focus Area.

Focus Area 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 minimum required solution characteristics:

• Must be able to conformto 3-dimensional wound shape (i.e., not a bandage).
• Must be self-absorbing or removable through wound irrigation.
• Must be effective against at least one, but preferably multiple, high priority pathogens: Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus.

Focus Area 2 - Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound Infection

This focus area of interest seeks the development of drug/biological treatments for sepsis, including host-based therapeutics.

Focus Area 3 - Antivirals for the Prevention and/or Treatment of Endemic and Emerging Infectious Diseases (Non-biothreat Pathogens)

This focus area of interest seeks the 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:

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

Focus Area 4 - Prevention of Endemic Diarrheal Diseases

This focus area of interest seeks the development of immunoprophylactics for endemic viral diarrheal diseases, with a focus on norovirus.

Focus Area 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):

• Decipher the intricate relationship between combat polytrauma, infections, and sepsis for data-driven clinical practice guideline revisions and field medicine.
• Modernize the effectiveness of acute traumatic wound management. Proposed projects shall 1) assess the effectiveness of the Acute Traumatic Wound Management guidelines, and 2) optimize these guidelines to enhance the standard of care for traumatic wound infections 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.
• 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 6 – Musculoskeletal Injury

Musculoskeletal injuries are the number one threat to Warfighter readiness, resulting in approximately 2.4 million medical visits and 25 million limited duty days. In the training environment, musculoskeletal injury accounts for up to 80% of causes for a Service Member being medically non-deployable, significantly impacting overall combat lethality. In the deployed environment, non-battle injuries account for 30% of all medical evacuations, and more than 85% of Service Members medically evacuated for musculoskeletal injury do not return to theater. Prior musculoskeletal injury is one the biggest predictors of future musculoskeletal injury and approximately half of Service Members can expect to sustain a new musculoskeletal injury each year.

The intent of this Musculoskeletal Injury Focus Area is to find solutions of high relevance to, and focused on, the Warfighter that have the potential to be applied closer to the operational environment. For the purposes of this funding opportunity, musculoskeletal injury care encompasses multiple domains including musculoskeletal injury risk identification and mitigation; initial interventions that improve survivability and maximize ability to stay in the fight pending evacuation to definitive care; and optimization of post-musculoskeletal injury outcomes.

Focus Area 7 – Quick Sterilant for Stainless Steel Medical Instruments

Future battlefield scenarios may require a chemical sterilant that can sterilize quickly, safely, and without power. In particular, there is a need to sterilize surgical, medical, or laboratory tools within ten (10) minutes using non-toxic chemicals and non-hazardous disposal methods. Solutions to this focus area are intended to provide sterilization capability to medical roles and teams that lack or have limited access to electrical power, indoor plumbing, and transportation.

Focus Area 8 - Sensory Systems

The Defense Health Agency (DHA) Sensory Systems Program focuses on military related injury or illness to sensory systems including research to characterize basic mechanisms and to advance assessment, diagnosis, monitoring, and treatment.

The Sensory Systems Program is organized into modalities of Auditory, Ocular, and Pain to encompass multiple distinct components of sensory medical science and technology (S&T) research. The program is intended to inform and describe DoD medical capabilities focused on injury or illness to sensory systems, including research to characterize basic mechanisms and to advance assessment, diagnosis, monitoring, and treatment.

Focus Area 9 – Intracranial Pressure Monitor

Intracranial pressure (ICP) is a physiologic parameter that is indicative of proper brain health. Traumatic events to the head and brain can cause ICP to elevate, which can rapidly become lifethreatening. Current standards of care for measuring and monitoring ICP are invasive and require penetrating the skull with a monitoring device, a surgical procedure typically performed by a neurosurgeon. Invasive surgical procedures introduce additional risks to casualties, which are exacerbated by austere field conditions and limited access to neurosurgical providers in combat operations. A capability to non-invasively and accurately measure and monitor ICP far-forward in the battlefield will inform the need for casualty evacuation (CASEVAC) and improve management of casualties over prolonged operations and where evacuation is not readily available/accessible.

Focus Area 10 – Precision Nutrition Development

Optimal nutrition is crucial for warfighters as it directly impacts their physical and cognitive performance, which is essential in high-stakes, demanding environments. Proper nutrition provides the energy and nutrients needed for physical endurance, helping warfighters maintain strength, stamina, and resilience during sustained training and/or combat operations. A balanced, well-timed diet supports muscle function, aiding in injury recovery, and helping to sustain performance under extreme conditions. It also fuels cognitive functions like decisionmaking, focus, and reaction time, ensuring that warfighters can remain sharp and effective in stressful, high-pressure situations.

Focus Area 11 – Vector-based Surveillance

United States military personnel live and work globally, sometimes in austere environments. This global presence increases the likelihood of exposure to emerging infectious diseases. Most emerging infectious diseases are zoonotic (transmited from animals to humans), and disease transmission to humans is often facilitated by arthropod vectors. Effective medical countermeasures do not exist for many of these emerging infectious diseases, limiting the ability to prevent illness and control the transmission of disease. Microbial genomic surveillance using next generation sequencing is a tool that can be used to track pathogens as they evolve and spread, generating data necessary to mitigate the threat of large-scale outbreaks in immunologically naïve populations. Microbial genomic surveillance in global “hotspots” suspected of harboring emerging pathogens requires an established capability to rapidly process and data.

Additional Points of Consideration

• Industry Partners: Proposed projects are encouraged to include relevant industry partners, especially considering that the eventual goal is to transition products to industry for U.S. Federal Drug Administration (FDA) approval and/or commercialization.
• Cost Share: It is anticipated that the Government funds would provide incentive for industry funding to join the project. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.