GENEVA – As the medical world struggles to track and treat a drug-resistant superbug fungus, a company in Geneva manufactures and sells an anti-microbial dressing that blocks it from causing infection, and kills infection even after it starts.
The superbug is called Candida auris, first identified in 2009, which the Centers for Disease Control and Prevention call "an emerging fungus that presents a serious global health threat."
Silverlon, manufactured by Argentum Medical LLC, at 2571 Kaneville Court, Geneva, is the anti-microbial dressing that kills C. auris within three hours, preventing it from invading a wound, according to the company.
As its name suggests, Silverlon uses silver-plated nylon in its anti-microbial wound dressings, studies show.
St. Charles resident Raul Brizuela is president and CEO of Argentum Medical LLC, the official manufacturer of Silverlon. Brizuela is the founder of Cura Surgical LLC, which partnered with Shore Capital in 2017, a private equity group in Chicago.
“This is a fungus that has caused many challenges in the world of health care,” Brizuela said. “So what we are doing with our anti-microbial technology – and getting antimicrobial technology FDA clearances to help prevent infection – is keeping microbes out of wounds and eradicating them in the (wound) dressing.”
Brizuela said using an anti-microbial dressing like Silverlon aids patients in other ways in that it will avoid infection by protecting the wound and then the patient may not need additional antibiotics.
“It is protecting that wound and helping to prevent an infection,” Brizuela said. “Once infection happens – especially when it comes to this fungus – it is very difficult to control and the mortality rate is extremely high. What our job is, is to provide health care workers with another tool to help them prevent infection from starting in the first place.”
'Its drug resistance is unprecedented'
The danger of C. auris cannot be understated. According to the July 31, 2019 Annals of Internal Medicine, "Its drug resistance is unprecedented among known human-pathogenic yeasts."
The potentially fatal yeast infection has been identified in more than 30 countries, including the U.S., according to the Centers for Disease Control.
CDC spokesman Brian Katzowitz stated in an email that the agency does not have specific numbers on deaths from C. auris.
"But based on information from a limited number of patients, more than one in three patients with invasive C. auris infection die," according to Katzowitz's email. "However, many of these people may have other serious illnesses that increase their risk of death."
Between May 24, 2016 and July 31, 2019, 212 confirmed and four probable clinical cases were identified, according to spokeswoman Melaney Arnold for the Illinois Department of Public Health. Of those, 128 were in Chicago, 76 were in Cook County outside Chicago and 12 were in DuPage, Lake, Kankakee, Will and Winnebago counties, she said.
Director of Disease Prevention for Kane County, Uche Onwuta, said there are no cases in Kane County, but all local hospitals and long-term care facilities know to report it.
“It is emerging and we will deal with it same way we deal with other reportable diseases – investigate and mitigate their transmission and keep community healthy,” Onwuta said.
U.S. military relies on Silverlon
Brizuela said his company sells Silverlon to hospitals and nursing homes all over the world to prevent infection, including Europe, Latin America, the Middle East and Africa.
But the largest market is with the U.S. military since the early 2000s, Brizuela said, where it is used extensively to help control infection for burns and blast burn injuries to soldiers.
“That is where the technology cut its teeth and where we went from zero revenue to millions of dollars when the Iraq war broke out,” Brizuela said.
Military surgeons studied Silverlon because they needed something other than a cream, which melted in the desert heat, leaving then unable to manage wounds, Brizuela said.
The temperature in the desert can be as high as 50 degrees Centigrade, Brizuela said, which translates to122 degrees Fahrenheit.
“The FDA cleared Silverlon for management of infected wounds, so we can be a tool in the process of managing a wound that has become infected,” Brizuela said.
One of the things the company is most proud of when it comes to Silverlon technology, Brizuela said, is its relationship with the Biomedical Advanced Research and Development Agency, or BARDA.
The agency is part of the U.S. Department of Health and Human Services of the Assistant Secretary for Preparedness and Response, according to its website, www.phe.gov.
It was established to protect the nation from chemical, biological, radiological and nuclear threats, as well as pandemic influenza and emerging infectious diseases, according to the website.
“Their mission is to help the U.S. in case of – God forbid – a mass casualty event. One example would be sulfur mustard gas,” Brizuela said.
Conjuring images of World War I where sulfur mustard – also known as mustard gas – was first used, Brizuela said it is essentially a chemical weapon that burns skin.
Mustard gas has been banned as a weapon since 1925. The United Nations accused the Islamic State of using mustard gas in an attack in Syria in 2017.
“We received the first clearance ever by the FDA for management of wounds that were created by vapor (of) sulfur mustard,” Brizuela said.
“That clearance was the culmination of six years of work and millions of dollars of U.S. government invested in Argentum to be able to submit the appropriate data package to the FDA for this clearance,” Brizuela said. “We had to run a very, very difficult gauntlet vetting process to qualify for those research grants.”
In short, the federal government invested research dollars in Argentum to facilitate the FDA clearance for a product to manage wounds in the event of a chemical attack that causes burns.
“Our small Geneva-based company literally made history in the last six weeks,” Brizuela said.
Effective on 1st, 2nd-degree burns
Indeed, according to July 22 press release from the U.S. Department of Health and Human Services, "The U.S. government reached a milestone in its longstanding efforts to defend the country against potential use of chemical weapons: The first U.S. Food and Drug Administration clearance of a product to manage certain blister injuries caused by sulfur mustard, commonly known as mustard gas."
“The ASPR’s (Assistant Secretary for Preparedness and Response) Biomedical Advanced Research and Development Authority (BARDA) provided technical expertise and funding to support the studies necessary to show that the product, Silverlon, is appropriate for use on first- and second-degree skin burns caused by exposure to sulfur mustard,” the release stated.
“Chemical weapons like sulfur mustard cause horrific, painful and life-altering injuries, yet in the 100-year history of sulfur mustard use, no medical countermeasures existed – until now,” BARDA Director Rick Bright, Ph.D., stated in the release. “At BARDA, we are excited to have supported the first cleared product for use on skin injuries caused by sulfur mustard. This clearance exemplifies BARDA’s ongoing commitment to our partners and the nation as we seek out promising technologies and products to improve our nation’s health security and protect Americans.”
Argentum Medical, LLC, has received FDA clearances for multiple indications for Silverlon since 2003 and in that time the wound dressing has been used extensively by the U.S. military to treat burn and blast wounds. Silverlon dressings also are used widely by the healthcare and first responder communities, the release stated.
“Getting the first clearance ever for management of wounds by mustard gas – it’s really a historic accomplishment,” Brizuela said. “All of this goes to validating the efficacy of our product.”