June 18, 2024


Extraordinary care

Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]

Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of care, we would clearly have a unique opportunity for a long time because the sterilization companies have this big equipment sitting in the basement of hospitals and clinics.”

Sterifre CEO Rick Shea [Photo courtesy of Sterifre]

Shea hopes to close a $20 million Series C round by June, which would double the amount already raised by the Kirkland, Washington-based company and fund its commercial activities and manufacturing.

The device uses a 600 ml Aura-D hydrogen peroxide cartridge that lasts about 600 cycles, cleaning between 4,000 and 6,000 devices depending on their size.

That single cartridge replaces about 44 canisters of disposable disinfectant wipes, Sterifre Chief Commercial Officer Mike Goonewardene said, saving storage space, reducing waste and freeing up healthcare staff who are currently wiping or spraying by hand.

The company is selling the system as a monthly subscription that covers the cost of the device, repairs, maintenance, training and consumables such as the Aura-D cartridge and indicator strips that confirm disinfection each cycle.

Such a business model is “very unique for medical devices,” said Shea, who was an executive with Goonewardene at Stericycle before the company went public. “It’s not unique in the medical field, as we’ve been successful using this model in the past.”

Sterifre Chief Commercial Officer Mike Goonewardene [Photo courtesy of Sterifre]

Goonewardene explains the pitch: “We can go to a hospital and say, ‘Let’s determine what your current operating expenditure is for disinfecting these point-of-care devices. That’s going to be the products, some labor, some damage to stuff when you use these chemistries that are available on the market today. Let’s mutually determine what that number is and divide by 12. You just give us that each month [and] for not $1 more, you can have a safer, more environmentally friendly, automated point-of-care system for disinfection. … Give us some opex, no capex — we’re gonna take the risk on the capital — and let’s get busy.”

That risk could prove disastrous for Sterifre if the machines need repair or replacement too frequently, so the company hired expert help for design, development and manufacturing.

The Sterifre Aura disinfection system with its doors open, revealing the Aura-D hydrogen peroxide cartridge. [Photo courtesy of Sterifre]

“We decided when we formed the company that we didn’t want to do engineering internally, we didn’t want to do manufacturing internally,” Shea said. “We wanted to end up being a sales and marketing and customer service company. All those other activities that in my history I’ve always done internally, we contracted out.”

The company hired Cleveland-based Nottingham Spirk for development design and market research to consider whether to pursue sterilization or high-level disinfection — both are FDA regulated — and decided on intermediate-level disinfection, which is regulated by the EPA.

As Sterifre moved through the process leading up to its November 2021 EPA registration, it hired Vancouver, Washington-based Simplexity Product Development to get the product ready for scaled manufacturing. Their task: cut the 60 lb device’s weight in half, quiet the operating noise from around 60 decibels to under 30, and reduce the cost of manufacturing by about 40%, all without changing the system configuration as tested.

Simplexity CEO Dorota Shortell

Simplexity CEO Dorota Shortell [Photo courtesy of Simplexity]

“I don’t know if there’s any part that we didn’t redesign. … This is one of my favorite projects because of this whole full-system approach,” Simplexity CEO Dorota Shortell said. “We are touching every type of system and it’s got fluids, it’s got electronics, it’s got firmware. It’s a perfect project for us and our capabilities. We love it.”

Simplexity also identified St. Paul, Minnesota-based Minnetronix Medical as the best contract manufacturer to build the products, aiming to deliver the first units to customers as soon as late spring or summer.

Pre-sale buyers have already signed up for the devices, Shea said, and three Sterifre salespeople in Boston, New Orleans and Kansas City, Kansas, are demonstrating the devices in the field.

“We’re in a pretty good spot,” he said. “We have a great patent portfolio. The company was started on two initial patents and we’ve expanded that both domestically and internationally. We’ve got regulatory behind us, so it’s really commercial execution now.”

For more design details, dive into this Aura case study on Simplexity’s website.