Five burn treatments will be developed to improve the nations ability to respond to a chemical, radiological or nuclear incident, according to the Department of Health and Human Services, which has invested $40 million in the project.
The Biomedical Advanced Research and Development Authority, an HHS division within the Office of the Assistant Secretary for Preparedness and Response, maintains a development program for thermal burn medical countermeasures. Medical countermeasures are drugs, vaccines and medical products needed in disaster medical care. BARDA conducted three years of market research and outreach to burn clinicians and responders before adding the five new projects to the program.
The detonation of an improvised nuclear device would produce intense heat, potentially resulting in severe burns that can cover large portions of a patients body. Injuries to the skin also can be caused by exposure to high levels of radiation. An incident involving a chemical agent such as sulfur mustard, known as mustard gas, also could cause severe burns.
With only 127 burn centers nationwide, a mass casualty incident could overwhelm the nations burn care infrastructure, prompting the need for technologies to ease the treatment bottleneck. To address this gap in a sustainable way, BARDA seeks to develop drugs and medical products that both support disaster response and enhance daily emergency medical care.
BARDA focuses on repurposing products already approved by the Food and Drug Administration or pursues disaster response and daily medial uses for a new product in parallel. This strategy also improves the long-term availability of medical countermeasures for burn disasters by relying on products established in the commercial market.
One of the projects is a novel cell-based skin substitute called StrataGraft that is designed to treat severe thermal burns. Stratatech Corp. of Madison, Wisc., will develop the product.
Severe burns typically require specialized treatment, including surgery to remove any damaged or dead tissue. The resulting wound bed often requires coverage with skin grafts, from a cadaver or the patients own body. StrataGraft provides an off-the-shelf skin replacement made from cells. Separate from the BARDA contract, the company will pursue developing this technology to treat other skin conditions, such as diabetic foot ulcers.
Novan Therapeutics of Durham, N.C., will develop NOAH Ointment, which uses Novans proprietary technology for controlled release of nitric oxide, a cell-signaling molecule with known therapeutic effects, into the wound bed. Nitric oxide may promote recovery of the burn wound by preventing injury progression and facilitating the growth of new tissue. Separate from the BARDA contract, Novan is developing the technology to treat other acute and chronic skin conditions.
Argentum Medical of Geneva, Ill., will conduct studies of its Silverlon wound dressing for use on burns caused by exposure to radiation or sulfur mustard. Silverlon is a silver-plated nylon bandage that already is widely used to aid the healing of acute wounds and thermal burns. When moist, the bandage releases silver, a broad-spectrum antimicrobial agent, into the wound to prevent infection. Silverlon can be used on burn wounds for up to seven days to reduce the medical care needed to change dressings, a potential bottleneck for mass casualty care.
Arteriocyte Medical Systems Inc. of Cleveland will develop its Bio-Bandage, which can accelerate the recovery of burn wounds when used in combination with existing burn treatments. Bio-Bandage is a gel-based dressing derived from the patients blood plasma on-site using Arteriocytes Magellan System, a medical device approved by the FDA to accelerate healing in hip-bone and breastbone injuries and in cosmetic surgery.
Spectral MD Inc. of Dallas will develop the DeepView imaging system, which provides a non-invasive method of differentiating between dead and live skin, thus aiding surgeons in preparing wound beds for skin grafting. This technology could increase the success of skin grafting, preserve scarce graft products, shorten hospital stays and increase the number of surgeons who could respond to a mass casualty incident despite not having extensive skin grafting experience.
BARDA is seeking additional proposals for products that could be used to treat illnesses and injuries caused by disasters. Visit www.medicalcountermeasures.gov or the Federal Business Opportunities (www.fbo.gov) for the latest opportunities.