Silverlon is elevated by FDA clearance as a vital device in managing radiation-induced skin injuries, making it an invaluable resource in disaster preparedness and patient care.

GENEVA, Ill., Oct. 3, 2024 /PRNewswire-PRWeb/ -- Bravida Medical (formerly known as Argentum Medical) – a leader in infection prevention and wound care solutions – proudly announces its newest 510(k) clearance from the U.S. Food and Drug Administration (FDA). Silverlon®, a silver-plated burn and wound care dressing, is now indicated for managing acute cutaneous radiation injuries (CRIs), including moist desquamation, without full-thickness skin ulceration or necrosis.

This FDA 510(k) clearance marks a significant milestone for Bravida Medical, reinforcing Silverlon's position as a critical solution in routine and emergency medical care.

Bravida Medical's partnership with the Biomedical Advanced Research and Development Authority (BARDA)—part of the Health and Human Services Administration for Strategic Preparedness and Response—began in 2013 with the award of a contract (number HHSO100201300019C) for pilot studies to develop protocols and animal models for repurposing Silverlon dressings for mass casualty applications.

In 2015, BARDA provided additional funding for Bravida Medical to perform the studies required for the FDA 510(k) clearance for mustard-induced vesicant injuries. Silverlon received the first-ever 510(k) clearance for managing mustard-induced vesicant injuries in 2019. This clearance provided the U.S. government with a medical countermeasure in its longstanding effort to defend the country against the potential use of chemical weapons, specifically sulfur mustard, which can cause severe injuries to the skin, eyes, and respiratory tract.

BARDA invested again in Bravida Medical in 2018 with funding for human clinical trials and animal studies to evaluate the benefits of radiation injuries. Leveraging research and data collected from 2013 to 2021, Bravida Medical earned FDA Breakthrough Device Designation for Silverlon burn dressings in 2021. The momentum continued in 2022 when Silverlon secured its second 510(k) clearance for radiation dermatitis and CRIs through dry desquamation, making it the first medical device in the United States to achieve such clearance. Bravida Medical achieved a third clearance in July 2024 for managing radiation dermatitis and acute CRIs, including moist desquamation – a more severe injury than dry desquamation.

With the first and second contract (number HHSO1002018000022C) awarded, BARDA has invested over $30 million in Bravida Medical. These indications positively impact cancer patients undergoing radiation therapy and the greater population in the event chemical warfare breaks out. The public-private partnership has not only made the world safer but also improved cancer patients' quality of life.

"This new 510(k) clearance is a tremendous accomplishment for Bravida Medical and represents years of dedicated effort and collaboration," said Raul Brizuela, CEO of Bravida Medical. "Silverlon is further established as a vital device in managing radiation-induced skin juries, making it an invaluable resource in disaster preparedness and patient care. Bravida has essentially won the 'triple crown' of mass casualty indications."

As a result of this collaboration with BARDA, Silverlon is one of the most studied anti-microbial dressings on the market today (click here to view all studies conducted on Bravida Medical products). In addition, the partnership has strengthened Silverlon's commercialization and sustainability worldwide.

Silverlon's advanced silver-plated technology offers broad-spectrum antimicrobial protection, creating an optimal environment for managing radiation-induced injuries. Developed originally for the U.S. military, Silverlon dressings are used extensively to manage burn and blast injuries in combat zones. Their ability to conform to the body and maintain prolonged contact has been proven essential in both military and civilian settings.

To read BARDA's announcement on this achievement, click here.