(Released 30 September 2015) Four novel products to treat severe thermal burns will be developed and acquired under contracts with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The products are intended to enhance the available treatment options for disaster response and are being designed to find uses in routine clinical burn care.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will leverage authority granted under the Project BioShield Act of 2004 to purchase one of the products currently available commercially and fund late-stage development and procurement of the other three. These products will be added to the Strategic National Stockpile (SNS) or managed by vendors to help protect people from burn injuries resulting from radiological and nuclear threats.
The detonation of an improvised nuclear device would produce intense heat, resulting in many patients with severe burns. The treatments for such burns require complex procedures including surgical skin grafting that is resource-intensive and technically demanding. With only 127 burn centers nationwide, a mass casualty incident of this scale could easily overwhelm the nation’s burn care infrastructure.
“To protect health and save lives from the impacts of multiple types of disasters, we have to address critical challenges in burn care,” explained BARDA Director Robin Robinson, Ph.D. “These products are intended to offer greater options and help create a continuum of care in a mass casualty incident; together they have the potential to eliminate resource-intensive steps, shorten hospital stays and improve patient outcomes.”
The first product, Silverlon, could improve care for burn patients before they reach the hospital and can receive a surgical treatment for their burn injuries.
Silverlon, manufactured by Argentum of Geneva, Illinois, is a long-acting silver-impregnated nylon bandage available commercially and used widely to cover acute wounds and first- and second-degree thermal burns. The silver helps control bacterial growth within the dressing. This product is being purchased through an interagency agreement with the Defense Logistics Agency at the Department of Defense, which has an existing purchasing arrangement with Argentum. The five-year contract is valued at $20 million, and the product will be delivered over the term of the contract.
The other three products are being developed to address challenges in burn care treatment. BARDA will fund pivotal clinical studies necessary for the companies to submit applications for approval from the U.S. Food and Drug Administration. While this late-stage product development takes place, BARDA will begin procuring the products for the SNS. Wide-scale use of the products could be permitted by FDA in a disaster response under an Emergency Use Authorization.
Each of these three contracts have options for funding additional studies as deemed necessary by the FDA and to make additional purchases to enhance national preparedness.
Under a five-year, $40.4 million contract, MediWound of Israel will develop NexoBrid, a topical gel made of pineapple-based enzymes and designed to dissolve the damaged or dead skin tissue to create a clean wound-bed for skin grafting. If successful, NexoBrid could eliminate the need to surgically remove damaged or dead tissue, a technically-demanding and time-intensive step in burn care, and may decrease the required amount of skin grafting which could speed recovery. This contract has a total value up to $112.8 million.
Stratatech Corporation of Madison, Wisconsin will advance its development of a novel cell-based skin substitute made from living human cells called StrataGraft under a five-year, $59.9 million contract as part of an effort by BARDA. If successful StrataGraft could reduce the need to remove healthy donor-skin from the person’s own body to graft over the burned skin, instead offering an off-the-shelf alternative to using animal or cadaver skin for skin grafts. This contract has a total value up to $246.7 million.
In addition, under a five-year, $16.9 million contract, Avita Medical Americas, LLC of Northridge, California will advance the development of a device called ReCell, which produces a topical spray derived from a small sample of the patient’s own skin. This topical spray may enhance skin growth, allowing burn surgeons to use smaller skin donor grafts, and stretch grafts over a larger burn wound. This contract has a total value up to $79.5 million.
With today’s agreements, using Project BioShield authorities, BARDA has supported the development and procurement of 16 medical countermeasures – vaccines, drugs, and other medical products needed for emergencies – since 2004, including products needed to treat some of the health impacts of ionizing radiation, as well as drugs or products to treat illness from anthrax, smallpox, and botulism.
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. 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.
Within ASPR, BARDA 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.
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.