SBIR-STTR Award

Approximately 40% of combat wounds become infected that can lead to substantial morbidity and mortality. The patient is often given broad-spectrum antimicrobial treatment, prior to identification of the pathogen, or the antimicrobial susceptibility profiles, contributing to antimicrobial resistance. Delivery of a targeted, real-time wearable device to monitor wound infection on the battlefield and beyond would increase the survival rate of the warfighter, reduce suffering, enable effective use of antimicrobials, and treatment costs alike. The turnaround time for gold standard culture-based testing and molecular methods takes several days and is not feasible for routine monitoring of patient progress. There is currently no FDA-approved, deployable device for real-time and early detection of wound infections and pathogen identification suitable for both the field environments and hospital settings that are telemedicine-capable. Nanobiofab proposes a Real-time Agnostic Patch for Infection Detection (RAPID) using a small, lightweight, noninvasive, AI-powered wearable intelligent Nose (called the “RAPID-iNoseTM”). This patch integrates a wireless high-sensitive nanosensor array and artificial intelligence (AI) algorithms for in situ, continuous sensing of complex microbial volatile organic compounds (mVOCs) released by pathogens. The device allows for rapid data collection (within 1 min), and identification and differentiation of wound pathogens (Gram+ or Gram – bacteria and tentatively fungi) for use throughout the continuum of care in the field, home, and clinical settings including transportation. The RAPID-iNose’s small footprint enables integration into wound dressings systems, hypothermia bags, or transport chambers with on-demand wirelessly tracking and monitoring of infection development and progression to optimize resources. Data can be shared with medical professionals in real-time to realize more accurate and appropriate treatment. Importantly, the ability to discern the less common fungal wound infection from those of bacterial infections would enable monitoring of fungal infections and enable correct treatment. Phase I feasibility studies will empower RAPID-iNose design and development of proof-of-concept prototypes and establish reasonable qualitative infection signal detection of pathogens and identify a pre-clinical animal model for use in Phase II. Phase I-II transition will permit prototype miniaturization. Phase II will allow for the execution of the advanced prototype development of the RAPID-iNose, evaluate the device for pathogen detection in vitro and in vivo, and Q-submission for meeting and feedback from the FDA CDRH-regulated device.

US military personnel are subject to injuries caused by traumatic insults, such as explosions, gunshot wounds, and vehicle accidents. These types of injuries increase the chances of developing infections while waiting for transfer and after admission to medical care facilities. Treating infections due to combat-related wounds requires a high level of medical resources and is less successful compared to civilian wounds, often leading to extended hospital stays and substantial morbidity and mortality. The current practice is to provide broad-spectrum antimicrobial treatment before identification of the pathogen or antimicrobial susceptibility profile, which may also lead to antimicrobial resistance. The majority of these infections have been identified as bacterial, though combat-related fungal wound infections have been found to be an important cause of loss of limb, morbidity, and mortality for military personnel that face traumatic wounds, generally due to blast injuries. Nanobiofab proposes a Real-time Agnostic Patch for Infection Detection (RAPID) device, which utilizes a patented nanosensor array and artificial intelligence algorithms that is telemedicine capable for real-time and rapid detection and following of wound infections and pathogen identification suitable for both the field environment and hospital setting alike. Nanobiofab has developed the RAPID-iNose wearable device, which integrates a wireless high-sensitive nanosensor array and AI algorithms for in situ, continuous sensing of complex microbial volatile organic compounds (mVOCs) released by pathogens. The device can identify and differentiate wound pathogens (Gram+ or Gram– bacteria and tentatively fungi) and provide continuous noninvasive diagnostic capability at any site of injury, enabling the monitoring of infections in real-time for suitable treatment. The RAPID-iNose is small, lightweight, and integrates into wound dressing systems, hypothermia bags, or transport chambers with wirelessly tracking and monitoring of infection development and progression to optimize resources. Data can be shared with medical professionals in real-time to realize more accurate and appropriate treatment. This device will enable the detection of infections in the early stages, allow clinicians to identify pathogens quickly and easily, and reduce treatment costs. In SBIR Phase II, Nanobiofab will refine the alpha version prototype, validate its performance and specifications for pathogen detection in vitro and in vivo, and develop a commercialization plan. These milestones will build upon the successful completion of SBIR Phase I, which resulted in the development of a functional prototype validated on the pig skin tissue model.