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ASP Gets FDA Nod On Mask Sterilizations

Irvine-based Advanced Sterilization Products (ASP) already had plans to ramp up operations in Irvine this year, following its sale to a $20-billion valued industrial technology conglomerate in 2019 and recent moves to expand its base in and around the Spectrum area of the city.

Then came the coronavirus, and ASP, a maker of sterilization and disinfection products for healthcare uses, saw its products generate national headlines as a potential solution to a lack of medical-grade masks for doctors and nurses.

ASP, which employs some 700 people with the bulk at its home base in Irvine, last week received Food and Drug Administration approval under its Emergency Use Authorization (EUA) to use its sterilization systems to decontaminate N95 respirator masks.

The system, called Sterrad, uses vaporized hydrogen peroxide gas to clean products.

The FDA said ASP has installed 9,930 Sterrad systems in 6,300 hospitals across the U.S.

The machines in total have the capability to sterilize per day about 4 million N95s, masks that provide more effective respiratory protections to their users than typical surgical masks.

It takes between about 24 minutes to 55 minutes for the disinfecting process to take place, depending on the model of the product.

In the ideal cases, “you want to get [the masks] back to the original users,” after the disinfecting process, ASP President Dominic Ivankovich said.

“As you can expect, when somebody wears a mask it becomes a bit form-fitted to their face.”

By using ASP’s products, the company thinks it can at least triple the lifespan of the hard-to-find N95 masks.

Markets Lacking Products

ASP thinks its products can help more than just hospital workers during the pandemic, according to Ivankovich.

“It’s not just healthcare professionals that are exposed to the limitations of the supply chains around personal protective equipment—it’s a lot of markets as well,” Ivankovich told the Business Journal last Tuesday, a day after getting the FDA nod.

“Our goal is to make sure we get the equipment to the places where it can make the most difference.”

The government agency echoes the sentiment.

“We need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators,” FDA Commissioner Dr. Stephen Hahn said in a statement.

ASP’s products are the second type of decontamination process recently approved by the FDA.

The first approved decontamination process adopted by Duke University is called the Battelle CCDA Critical Care Decontamination System. However, the Battelle machines have a much smaller daily capacity than Sterrad with only 80,000 masks decontaminated per day.

Depending on model type, the cost of the Sterrad system can run $130,000 or so, with annual maintenance costs in the $19,000 range, according to a 2017 report in the American Journal of Infection Control.

$800M Business

ASP was previously a unit of Johnson & Johnson (NYSE: JNJ). In April 2019, it sold the Irvine unit to Everett, Wash.-based Fortive Corp. (NYSE: FTV) for about $2.8 billion; it’s now part of Fortive’s professional instrumentation division, which in 2019 did about $4.4 billion in revenue.

ASP’s Ivankovich was previously with Fortive, which was spun off from Danaher Corp. in 2016.

ASP as a stand-alone unit of J&J reported 2018 net revenue of about $800 million. In addition to the terminal sterilization products like Sterrad, it also makes larger sterilization units for endoscopic-related devices, as well as an array of product monitoring offerings.

Fortive officials said in early February that ASP’s recent growth percentage was in the “low single digits.”

The effects on the pandemic on ASP’s business volume since then haven’t been disclosed.

James Lico, president and chief executive of Fortive, last week cited ASP as a business making an impact during the crisis, noting that “across the company, our teams are acting with great energy and speed to apply our technology.”

Broadcom Space

ASP has already been preparing for more work out of Irvine, where its operations are based at a pair of buildings long used by J&J sitting alongside the Santa Ana (5) Freeway, across from the Spectrum shopping center.

It recently inked a lease to expand its local base, taking over part of a floor at Broadcom’s campus at the Five Point Gateway campus.

The roughly 30,000-square-foot sublease pushes ASP’s area footprint to nearly 150,000 square feet, according to brokerage data. It’s the first reported sublease of Broadcom space at the Great Park Neighborhoods since the chipmaker moved into its new Irvine digs a couple years ago.

ASP is currently advertising 15 open positions in Irvine on its website, in an assortment of engineering, science and marketing jobs.

Ivankovich said the company is likely to be cautious in hiring, until he is able to determine the state of the world.

For now, the company is in full operation, although many in Irvine are working remotely.

“We actually have a mixed model right now,” he said. “We have some people working from home if their jobs allow. Of course, we have people on the manufacturing line [and] some of engineer and test labs where some of that work can only be done locally.”

“These are people who have made the reduction of hospital acquired infection their life’s work.” 

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