fda grants class II Medical clearance for MEDICAL GUARDIAN

Aerus, committed to providing cutting-edge technologies to create the healthiest indoor environments around the world, announced today that it received Class II Medical Device clearance from the U.S. Food and Drug Administration (FDA) for the Aerus Medical Guardian with ActivePure Technology, the first active air purifier for health care.  

ActivePure is the most powerful surface and airpurification technology ever discovered. It can operate safely in occupied spaces and prevents recontamination in real time. The Aerus Medical Guardian with ActivePure Technology, a free-standing, portable unit intended for use in professional health-care environments, is a 24/7 airborne contaminant reduction solution. The unit is the first of its kind, using NASA-inspired ActivePure Technology to purify the air continuously and actively without the use of ozone. 

The Aerus Medical Guardian with ActivePure Technology works safely 24 hours a day to protect the rooms where it is installed, even when occupied by large numbers of people. The product cleared by the FDA is intended for medical purposes and is used to reduce staphylococcus epidermidis and erwinia herbicola bacteria; MS2 and Phi-X174 viruses; aspergillus niger fungal spores; and bacillus globigii bacterial spores from the air in a temperature-controlled professional health care-environment of 70 to 71 degrees Fahrenheit, 40%-45% RH. 

While the market is saturated with a variety of capturebased air purifiers that rely on a HEPA filter, carbon or UVC light to reduce contaminants, the Aerus Medical Guardian with ActivePure Technology is the only FDA-cleared, real-time, active air-purification unit that quickly and powerfully eliminates airborne contaminants. It also disinfects safely without chemicals and without the need to capture the particles. 

Air purification systems with ActivePure Technology are currently also used in international health systems, including in Brazil, Canada, Italy, Poland, Portugal, Spain and Thailand. 

 “Until now, there has not been a clear gold standard in preventative measures for air purification in health-care settings -- and the Aerus Medical Guardian with ActivePure Technology fills that void,” said Joe Urso, chief executive officer of Aerus. “We believe our breakthrough technology will be a gamechanger in hospitals. Never have hospitals and medical facilities had an active air-purification system that works as quickly to reduce airborne pathogens as does the Aerus Medical Guardian with ActivePure Technology. Our powerful technology and affordable Aerus Medical Guardian unit offers health-care providers and their patients the higher level of protection they deserve.” 

Product Efficacy and Testing The Aerus Medical Guardian with ActivePure Technology demonstrated in independent lab testing that it significantly reduces:  

• MS2 bacteriophage RNA virus
• Phi-X147 bacteriophage DNA virus
• Staphylococcus epidermidis – gram-positive bacteria
• Erwinia herbicola – gram-negative bacteria
• Aspergillus niger fungal mold
• Bacillus globigii bacterial mold 

Aerus Medical Guardian Technology

 The Aerus Medical Guardian with ActivePure Technology provides continuous active surface and air purification through its unique, patented ActivePure Cell. An internal fan draws in air from the room where the unit is located. Air moves into the unit, where negative ions -- created from ion brushes -- charge incoming contaminants so that the oppositely charged carbon-coated HEPA filter media can be more easily entrained from the passing air. As air exits the filter, it passes through the ActivePure Cell, which contains two ultraviolet bulbs and a proprietary metal-based photocatalyst. 

This catalyst, when exposed to the energy from the UV bulbs, creates hydroxyl radicals and super ions, which enter ambient air to oxidize, mineralize and convert organic compounds into nonorganic forms. The released particles, known as ActivePure Molecules, fill the entire air space of the room, rapidly seeking and destroying microscopic pathogens, including RNA viruses, DNA viruses, bacteria, mold and fungi. Whereas, passive technology, also known as capture, air purifiers require pathogens to pass through the device.