To prepare for radiological and nuclear emergencies, the U.S. Department of Health and Human Services (HHS) announced in October 2018 it will work with Argentum Medical, LLC to repurpose its commercial Silverlon® technology for radiation injuries of the skin.
As a pioneer of silver technology, the privately held company has been awarded a three-year, $8.4 million contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract will look at the potential use of its Silverlon technology for use for low-grade and severe skin radiation injuries after a radiation emergency.
Under a separate contract with BARDA, Argentum Medical is nearing completion of studies required to apply for FDA clearance of Silverlon for skin burns caused by sulfur mustard chemical weapon exposure.
“Silverlon antimicrobial technology has been battle field-tested by the U.S. Military in the most austere environments for over a decade. The stringent evaluation process of the HHS further supports Silverlon’s clinically-proven efficacy, safety and multidisciplinary value,” said Raul Brizuela, president and CEO of Argentum Medical. “Radiation injuries of the skin can be life-threatening and require reliable, sustained and versatile antimicrobial protection. It’s an honor to extend our Silverlon technology to support the critical work of the HHS to advance America’s preparedness for radiological and nuclear emergencies.”
Silverlon’s Military Heritage
Developed for combat injuries, Silverlon antimicrobial technology is now used by every branch of the U.S. Military. As the evidence-based antimicrobial dressing available, Silverlon products contain 50 to 100 times more metallic silver ions than other silver-impregnated dressings.
Studies have shown Silverlon to be highly effective in hostile and austere military environments. The U.S. Army uses Silverlon wound-care technology extensively in the management of burn and blast injuries.
Silverlon is incorporated into numerous deployed Medical Tactical Combat Casualty Care kits and is also supplied in bulk to Combat and Support Hospitals and Tactical Forward Surgical Teams. It is also included in burn care protocols in the Joint Theater Trauma System Clinical Practice Guideline.
Silverlon burn products and protocols are extensively used by the US Army and by US Air Force Critical Care Air Transport (CCAT) teams and are taught at the US Air Force School of Aerospace Medicine Critical Care Air Transport Basic Course.
Beyond the military, Silverlon dressings are used today by surgeons and other healthcare professionals around the world on surgical wounds, in negative pressure wound therapy, on chronic wounds, burns, skin grafts, and IV and catheter-related wounds.
Argentum Medical continues to explore new applications and markets for its Silverlon® technology in keeping with its corporate mission to improve clinical outcomes. For more about Silverlon, visit http://www.silverlon.com
More information about the new partnership in the attached news release below.
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News Release
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HHS Press Office: (202) 690-6343
Twitter: @HHSMedia
HHS seeks to repurpose burn dressings for radiation emergencies
(Washington DC, Oct 2, 2018) — To prepare for radiological and nuclear emergencies, the U.S. Department of Health and Human Services (HHS) will work with Argentum Medical, LLC of Geneva, Illinois, to repurpose its commercial product Silverlon for radiation injuries of the skin.
Silverlon is a product that has been cleared by the U.S. Food and Drug Administration as a burn and wound trauma dressing. This contract will look at the potential use of Silverlon for use for low-grade and severe skin radiation injuries after a radiation emergency.
The development work will be done under a three-year, $8.4 million contract between Argentum and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).
“One danger of radiation exposure that many people do not think about is damage to the skin, which can range from mild to potentially life threatening,” said BARDA Director Rick Bright, Ph.D. “As we work to strengthen our nation’s security against radiological weapons, repurposing commercially available products has many advantages.”
Commercially available products that are familiar to medical providers and patients will potentially increase their willingness to use the products. The products also may be readily available in hospitals, ambulances, and other health care facilities, making them quickly accessible during a mass-casualty incident. This availability reduces the need for government stockpiles which minimizes the cost to taxpayers.
While the severity of radiological and nuclear weapon-related skin injury varies, the low-grade skin injury caused by such is similar to a skin injury called radiation dermatitis (RD) that can be seen as a side effect of radiation therapy. Because of this similarity, FDA provided guidance on a streamlined methodology to apply for clearance of the product.
With FDA guidance, a two-pronged approach was developed. A 510(k)-pathway appropriate for a radiation-injury indication covering the symptoms of erythema, such as skin redness and irritation, and dry desquamation, where the skin appears broken or cracked, is the first approach. The second approach requires animal studies to demonstrate mitigation of more severe radiation injuries typically not seen in RD cases.
Under a separate contract with BARDA, Argentum is nearing completion of studies required to apply for FDA clearance of Silverlon for skin burns caused by sulfur mustard chemical weapon exposure.
BARDA continues to seek products to prevent, treat or manage injuries caused by chemical, biological, radiological or nuclear agents in a mass casualty emergency. Proposals are accepted through Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
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