The Department of Defense (DOD) is seeking proposals for the development of a diagnostic product aimed at detecting infectious and inflammatory complications in burn wounds, specifically through a non-invasive method that does not require dressing removal. This opportunity, titled "Direct to Phase II Open Topic for Burn Wound Complication Diagnostic Product," focuses on creating a product that can provide visual indicators of pathogens and dysfunctional inflammatory biomarkers, thereby assisting medical and non-medical personnel in resource-limited settings, such as combat or disaster scenarios. The initiative is critical for improving patient outcomes in both military and civilian contexts, particularly in situations where timely evacuation is essential to prevent severe complications from burn injuries. Proposals are due by October 22, 2024, and interested parties can find more information and submit their applications through the DOD SBIR website.

## Description

Infectious and inflammatory complications of burn wounds leading to sepsis, organ failure, or death if left untreated threatens burn casualties in prolonged field care and delayed evacuation settings. In austere settings (ex: combat, wilderness, open ocean, etc.) where medical evacuation is limited for many hours or days, and patients must be prioritized for evacuation to a higher level of care, medical and/or non-medical first responders may have difficulty identifying burn wound complications, particularly when the casualty has minimal other injuries and appears otherwise stable. The unpracticed first responder may fail to recognize an infected or complicated severe burn, placing the patient at high risk of infection, shock, or other major complications, including death. Current clinical practice guidance (CPG) for burn injury under prolonged care involves simple coverage of the burn wound with clean dry gauze.1 Visual assessment and clinical monitoring for infection or dysfunctional inflammation requires dressing removal which is excruciatingly painful and exposes the wound to the outside environment thus increasing the risk of infection. Currently no other method exists for providers to monitor for burn wound complications in a combat environment. Burn wound exudate provides a rich source of biomarkers2, all of which provide a convenient source for rapid detection of pathogens and/or damaging inflammatory proteins3. Pathogens of greatest concern within burn wounds5 include MRSA, VRE, Pseudomonas, Acinetobacter, Candida Albicans, and Aspergillus, and the presence of biomarkers2,3 indicative of dysfunctional immune response include angiogenin, VEGF, IL-6, etc. Limited resources necessitate rationing of medical supplies and decisions regarding which patients should take evacuation priority over others can be difficult. No point-of-care burn wound product currently exists that is capable of informing the provider whether the wound is infected or dysfunctionally inflamed. The development of &ldquo;smart&rdquo; dressings in recent years4 offer promise for other types of wounds, however, burn wound dressings that provide meaningful information about the burn wound microenvironment have yet to be developed. The ability to adequately care for and assess evacuation priority in burn injured service members in a resource-limited environment remains challenging. The need exists to develop a non-invasive, easy-to-use, method of detecting burn wound complications while avoiding unnecessary and painful dressing changes and minimizing the usage of precious medical supplies. A diagnostic burn wound product capable of detecting the presence of pathogens and/or dysfunctional inflammatory biomarkers would assist providers in prioritizing evacuation. This open topic seeks the development of a burn wound product that provides a means for detecting infectious and/or inflammatory complications without the need for dressing removal. Non-exhaustive examples of the envisioned product include, but are not limited to, a color changing dressing, a dressing with a visual +/- indicator, or a paper-based test strip combined with a gauze dressing. The proposed product is expected to have no, or minimal, toxicity and should be easily used by non-medical military personnel in resource limited settings. The proposed product will be impactful in both the military and civilian settings where large numbers of casualties, such as that seen in the 2023 Maui wildfires, must be cared for and triaged while awaiting evacuation.

## Objective

This topic is intended for technology proven ready to move directly into Phase II and is accepting Direct to Phase II proposals only. Development of a simple burn wound product that provides an indicator of evolving immunopathogenesis, immune dysfunction, and/or pathogenic invasion within the burn lesion without removal of the dressing.

## Phase I

This topic is intended for products that are ready to begin at Phase II. As such, the offeror shall provide detail and documentation which demonstrates the accomplishment of a &quot;Phase I-like&quot; effort demonstrating proof-of-concept. This includes, insofar as possible, the scientific and technical merit of an early-stage prototype that is capable of providing a visual indicator of presence of pathogens and/or dysfunctional inflammatory biomarkers. Demonstration of feasibility may include the following:<ul><li> Characterization of the candidate product</li><li> Strong proof-of-concept that the candidate product is capable of identifying pathogens and/or immune markers of concern </li><li> Preliminary data to support the safety and efficacy of the prototype.</li><li> Design specifications for the prototype.</li><li> Statistically significant performance data (if available)</li></ul>Proposals should contain preliminary data (published or unpublished) supporting the rationale for the continued development of the candidate product(s) and data related to the mechanism of action of the proposed product, if known. Describe how the product will be usable in a resource-limited setting by medical and non-medical first responders. 

## Phase II

This phase will focus on refinement and optimization of a prototype that provides a visual indicator of the presence of pathogens and/or dysfunctional inflammatory biomarkers. The desired prototype should be simple enough for medical or non-medical personnel to use in a resource-limited setting with minimal additional training. Offerors should propose products at or above Technology Readiness level (TRL) 3 from initial testing of design concepts and evaluation of a candidate product where study endpoints are defined, and animal models are proposed. The proposal shall describe the planned study design, product development, testing, and validation of the prototype product in a relevant animal model of burn injury. The testing and practical implementation of the prototype product should be relevant to partial- or full-thickness burn wounds. The proposed work may include, but is not limited to, the following:<ul><li> Prototype refinement/maturation progressing towards clinical product</li><li> Preclinical studies (as needed) to support an Investigational Device Exemption (IDE) (or other appropriate FDA) submission</li><li> Preclinical studies under GLP (as needed) to support IDE or other appropriate FDA submission</li><li> Stability and shelf-life studies if needed</li><li> Establishment of Good Manufacturing Practice (GMP) planning for clinical trials and for market release</li></ul>Required Phase II deliverables will include: 1) Successful refinement of a prototype product, 2) Successful evaluation of the efficacy of the product(s) in a relevant in vivo model of an infected/inflamed partial- or full-thickness burn wound, and 3) initial evaluation of the safety of the product with respect to biocompatibility, toxicity, and immunogenicity, and 4) Delivery of no less than 4 prototypes for military evaluation. The investigator shall also describe a detailed strategy for obtaining regulatory/FDA approval as well as the transition plan for the Phase III effort. It is anticipated that by the end of the Phase II effort, the applicant will have engaged with the FDA through a pre-submission meeting with the appropriate FDA office. 

## Phase III: Dual Use Applications

If successful, Phase II work will result in a novel product that detects the presence of infection and/or inflammation through an easily visualized indicator. During Phase III, additional experiments will be performed as necessary to prepare for FDA review of an IDE application (if applicable). Further assessment of functionality of the product and application frequencies (if applicable) may be conducted during Phase III. Expansion of the pathogen or immune marker capabilities should occur during Phase III. In addition, applicants are expected to conduct a pre-submission meeting with the FDA prior to the completion of Phase III. A plan for protection of intellectual property should be created and executed. Efforts should also include initial GMP manufacturing of the product and plans for future scale-up of the product. The small business should have plans to secure funding from non-SBIR government sources such as the Military Burn Research program, the Joint Warfighter Medical Research Program, and/or the private sector to develop or transition the prototypes into a viable product for sale to the military and/or commercial markets. The end-state of the research will be the full development of one or more products consisting of an innovative burn wound product capable of providing visual feedback that alerts the user of bacterial invasion and/or dysfunctional immune response. Military application: The potential product may transition to an Acquisition Program managed by the Service Product Developers for inclusion into the fielded medical system, or be available to Service Medical Treatment Facilities, for the treatment of those who sustain partial- or full-thickness burn wounds. Commercial application: medical and non-medical first responders could utilize this product to aide in determining the existence of evolving complications of a burn wound that would require priority evacuation to mitigate further complication, thus reducing morbidity, mortality and global healthcare costs associated with burn injury.

1729929013588.pdf

The DHA244-DP002 initiative focuses on developing a "smart" burn wound diagnostic product that can non-invasively assess complications without the need for dressing removal, addressing the critical need for effective burn management in resource-limited environments, such as combat settings. Proposals for this Direct to Phase II opportunity must demonstrate proof-of-concept for a prototype capable of indicating the presence of pathogens and dysfunctional immune markers. Successful Phase II efforts aim to refine the prototype for eventual regulatory approval and broader applications within military and civilian contexts, enhancing patient care and minimizing evacuation risks.

Topic

Agency

Program

Topic Link

Additional Information