September 27, 2013
HHS pursues new innovative treatments for severe burns
Five burn treatments will be developed to improve the nation’s ability to respond to a chemical, radiological, or nuclear incident. The new treatments represent a nearly $40 million investment by the U.S. Department of Health and Human Services in products that hold promise for disaster response and daily emergency medical care.
HHS’ Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response, maintain a development program for thermal burn medical countermeasure. 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 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 patient’s body. Injuries to the skin can also 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 nation’s burn care infrastructure, prompting the need for technologies that could ease the treatment bottleneck. To address this gap in a sustainable way, BARDA seeks to develop drugs and medical products that support both disaster response and enhance daily emergency medical care.
BARDA focuses on repurposing products already approved by the U.S. 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.
“Developing innovative treatments for severe burns is critical to protecting health and safety for radiation and chemical mass casualty events as well as routine medical care,” said BARDA Director Robin Robinson, Ph.D. “Sustainability of these medical countermeasures for thermal burns is critical for their availability when they are needed most. Our repurposing and multi-purpose strategy facilitates development, ensures availability, and reduces overall costs for thermal burn medical countermeasures.”
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 under a two-year, $9.9 million contract. The contract could be extended for up to a total of five years and $47.2 million. 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 patient’s own body. StrataGraft provides an off-the-shelf skin replacement made from cells. Separate from 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 under a two-year, $7.9 million contract. NOAH Ointment uses Novan’s 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 is already 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. The contract for $7.8 million over two years and could be extended for up to a total of five years and up to $16.5 million.
Arteriocyte Medical Systems Inc. of Cleveland will develop its Bio-Bandage for its ability to accelerate the recovery of burn wounds when used in combination with existing burn treatments. Bio-Bandage is a gel-based dressing derived from the patient’s blood plasma on-site using Arteriocyte’s Magellan System, a medical device approved by the FDA to accelerate healing in hip-bone and breastbone injuries and in cosmetic surgery. The contract is for $11.8 million over two years and could be extended up to a total of five years and $101 million.
Spectral MD Inc. of Dallas will develop the DeepView imaging system under a 15-month, $2.4 million contract. The DeepView imaging system provides a non-invasive method of differentiating between dead and live skin, 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 without extensive skin grafting experience who could respond to a mass casualty incident. The contract could be extended for a total of up to five years and up to $13.1 million.
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.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit www.hhs.gov.
BARDA, an agency within HHS’ Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.