NonSurgical Debridement   3

Treatment and care for burn injuries is both resource and labor intensive. The national capacity is typically limited and presents a significant limitation to when a sudden surge capacity is required in a burn mass casualty incident (BMCI). A BMCI in a geographic area could overwhelm a regional existing capacity and present to substantial resource constraints. To mitigate this challenge, BARDA has collaboratively worked with the burn care community to identify areas of improvement in the delivery of this care. This collaboration has identified numerous area which BARDA has systematically addressed over the years. The two major areas where enhanced treatment options could provide a meaningful difference are in the initial care and triage of patients, and secondly, in the long-term treatment and recovery steps of burn care. The focus of this RFP is to address the long-term treatment and recovery steps of burn care.

Surgical debridement is the current standard of care for removing dead skin tissue (eschar) from severe burn injuries, the required first step in definitive care. This involves shaving the burn area with bladed instruments and/or use of high-pressure water jets, both of which remove healthy tissue as well as the targeted necrotic tissue. These current debridement methods are labor-intensive, require highly specialized surgical training and resources, and invokes additional risk to the patient due to unavoidable removal of healthy skin. Furthermore, surgical debridement is usually delayed for the first few days after injury to allow for observation and visual assessment of its healing trajectory. This presents additional risks to the patient and potentially prolongs hospital stays. Enzymatic debridement products more selectively remove necrotic burned skin and can be applied in non-surgical settings (e.g. patient bedside) to free up operating room resources, a critical capability for mass casually response. This enables earlier patient care, can reduce resource burden, and potential improves patient outcomes. Such products should be compatible with current procedures to allow easy integration into routine care for ready availability and medical end user familiarity during BCMI's. This Statement of Objective (SOO) focuses on products which enzymatically debride severe burns to reduce the need for surgical resources for definitive burn care.

Based on this background, the objective of this RFP is to support procurement of an FDA-approved enzymatic debridement product and potentially support development of a next generation product for increased preparedness value. This product must be capable of removing necrotic skin from both partial and full thickness thermal burn wounds in pediatric and adult burn patients. The procurement strategy would involve creating a deployable cache of product (Preparedness Inventory) managed by the vendor and in coordination with their commercial (Planned) inventory. This establishes a vendor-managed inventory (VMI) as a collaborative access-maintenance system of product to maintain ready for emergency deployment (also see Section C- Objectives). To prevent product expiry and waste, the vendor will sell older units from the Preparedness Inventory through their commercial sales mechanism and rotate in newer product. BARDA will pay for this maintenance and the right to access/deploy this cache in the event of a national emergency. Funding will also provide BARDA the option to access an additional, pre-negotiated amount of the vendor's commercial (Planned) inventory to also deploy for larger emergencies and/or to increase the size of the Preparedness Inventory for increased preparedness. This system allows for national preparedness and response flexibility while limiting waste of unused product by not creating an inventory too large to be rotated into commercial sales when not needed for response. In addition, is critical the USG invest in next generation debridement products that are more cost effective, sustainable, and capable to addressing national health threat needs. Towards those goals, PBS funding would additionally support the development of a more effective, room temperature stable formulation and explore the potential for its use on blast trauma wounds for additional preparedness capability and return on investment.

See the attachment for more information regarding this opportunity.