The Bio-Z™ Smart Bandage – empowering priority response to pathogen invasion in wounds

Over 30% of burn injured Warfighters experience sepsis due to wound infection in austere environments where evacuation is restrained: sepsis is the leading cause of death.  ParaNano Wound Care, LLC (“ParaNano”) has developed the Bio-Z™ Smart Bandage (“the Bio-Z™”); a simple-to-use burn wound product addressing this challenge. The Bio-Z™ exhibits a visual color-change indicating evolving pathogen invasion in burn lesions. The Bio-Z™ is a 2x2cm membrane that can be paired with absorbent dressings to monitor for rising pathogen load for up to 72 hours.  A glance at the Bio-Z™ visually reveals signs of pathogen invasion without removal of the dressing, and before pathogen load crosses the threshold of infection. The Bio-Z™ enables continuous point-of-care wound monitoring and efficient triage for evacuation without the need for specialized knowledge or equipment. ParaNano has completed feasibility studies in 2022 demonstrating agnostic color-change response to Gram+/- pathogens. Further study confirmed the Bio-Z™ responds to lipase secreted by all ESKAPEE pathogens, and Candida auris and Candida albicans in a detection range of 104CFU/cm2 to 106CFU/cm2 within six (6) hours of exposure. These studies have verified the Bio-Z™ is biocompatible, not cytotoxic, and meets the requirements for FDA registration as a Class I bandage. The Bio-Z™ is advancing towards commercialization in long-term care facilities where wound infections (e.g., in diabetic ulcers) are common among the older (65+) population, particularly in limited-resource areas of the U.S. The overall aim of this Direct to Phase II SBIR project is to refine the Bio-Z™ for use in care of burn injured Warfighters in austere environments. Objective 1: Refine for use with DoD Clinical Practice Guidelines. Objective 2: Conduct pre-clinical trial using in vivo models of an infected/inflamed partial- or full-thickness burn wound. Objective 3: Validate production at scale using Good Manufacturing Practice. Objective 4: Verify efficacy of E-beam sterilization for case-lot, packaged product at scale. Objective 5: Demonstrate consistent performance of the Bio-Z™ Smart Bandage. At the end of Phase II, ParaNano will deliver prototypes for military evaluation that have been successfully refined and evaluated for efficacy, evaluated for safety with respect to biocompatibility, toxicity, and immunogenicity, and with appropriate FDA registration. The Bio-Z™ is accurate, cost-effective, and can be produced at commercial scale.  The Bio-Z™ is single-use, compact, and light weight: a package of 20 weighs under an ounce. The Bio-Z™ requires no special training and is easy to use in mass casualty events by unpracticed first responders, both military and civilian. The innovative Bio-Z™ product will guide priority of evacuation for burn-injured Warfighters, decreasing the time to arrival at a higher level of care, enabling earlier intervention to stop sepsis before it starts and diminish the likelihood of mortality.