Advanced Dermal Regeneration Substitutes for Treatment of Severe Burns and Complex Traumatic Injuries

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, through the Biomedical Advanced Research and Development Authority (BARDA), is conducting a sources sought notice for advanced dermal regeneration substitutes capable of treating large-area skin loss from thermal burns or traumatic injuries in mass casualty incidents, with responses due by August 28, 2026. This is a pre-solicitation notice for information purposes only and will not result in a contract award; BARDA intends to use responses to establish vendor source files and assess the current state of commercially available or near-commercial technologies.

Respondents must submit separate technical and business representations not exceeding 10 single-sided pages in 12-point Times New Roman font to Yifan.Yang@hhs.gov by 4:00 PM ET on August 28, 2026. Technical representations must address 12 qualifying criteria including vascularized neodermis formation, host tissue integration, infection control and barrier function, ambient temperature storage with 2–5 year shelf life, US domestic manufacturing without human or animal donor tissue dependence, usability in austere environments, clinical maturity with human clinical data preferred, product composition (fully synthetic, biosynthetic, or acellular/cellular), applicability across adult and pediatric populations, rapid deployment capabilities, and supporting documentation. Business representations must cover company mission, manufacturing and supply chain capability, current market list price with future projections, and strategies to increase market penetration in the burn and trauma injury market. Unmarked information will be presumed to have unlimited rights; respondents must clearly mark proprietary, trade-secret, or confidential materials.