KERICURE INC. — Department of Defense SBIR Phase II: DHA201-D001

Description

The work effort in this Sequential Phase II supports the DHA objective of managing large surface area burn wounds in austere and prolonged field care (PFC) environments. KeriCure Medical’s spray on wound dressing technology, to be marketed under the brand name Field Shield, has been optimized to support combat casualty care’s efforts to improve management of large numbers of burn casualties at point of injury, enabling prolonged casualty care, and long-distance en route care to support wound healing prior to reaching fixed care. The work effort completed under the current SBIR contract advanced the technology from TRL 5 to TRL 7 to date. The proposed work in this Sequential Phase II is intended to advance this technology further, with the ultimate goal of reaching TRL 8/9 for the 510(k) medical device, supporting commercialization and adoption within the military market. The Field Shield Wound Dressing (FSWD) products have established scientific data supporting their effectiveness in managing large surface area burn wounds, as well as their antimicrobial efficacy against multidrug-resistant bacteria, fungi and biofilms, in multiple in vitro, ex vivo, in vivo, and preclinical studies. To date, the FSWD products have completed all studies regarding biocompatibility, safety and effectiveness necessary for FDA 510(k) clearance. The lightweight, ruggedized spray barrier is intended to manage combat wounds, including large burn wounds, in Roles 1 through 4 care. The studies proposed in this effort will establish the ease of use of FSWD in management of multiple large burn wounds, as well as the ability of FSWD to promote wound healing, mitigate infection development, and minimize or eliminate the number and severity of surgical interventions required to achieve wound healing for both thermal and cold induced burn wounds. The ability to provide advance wound care for thermal and atypical burns in prolonged field care is a critical capability gap that Field Shield is positioned to fill with its all-in-one style wound dressing suitable for point-of-injury, en route, and fixed care management of multiple burn wounds. The proposed studies represent the healthcare needs of military Service members, Veterans, beneficiaries and civilians as acute wounds, especially burn wounds, are universal to all populations and can affect any age, gender and ethnicity. The specific aims of this continuation effort will provide critical information on the ability of the FSWD products to advance operational performance and medical readiness for Warfighters, investigating both full thickness thermal burns as well as minimally investigated cold induced burns (frost bite). The studies outlined within the work effort, specifically the in vivo full thickness burn studies and end user evaluations in prolonged field care scenarios, will provide a direct understanding on the utility and efficacy of FSWD in treating both civilian and combat-related burn injuries.