AeroClean Technologies Inc. announced that, the U.S. Food and Drug Administration has granted AeroClean 510k clearanc to update its Purgo air purifier's indications for use to include the elimination of SARS-CoV-2, the RNA virus that causes COVID-19. The FDA has reviewed the laboratory performance data and confirmed the applicability of Purgo to remove SARS-CoV-2 from the air in indoor environments. The clearance adds SARS-CoV-2 to the list of microorganisms already cleared.

As part of AeroClean's ongoing commitment to improve Indoor Air Quality for a healthier and safer world, the Company has commenced additional efficacy testing on viruses that are known threats to health such as influenza and respiratory syncytial virus. AeroClean's Purgo air purifier is classified as a Class II Medical Device and utilizes clinical-grade HEPA filtration and germicidal UV-C LED air sanitization technology, proven to eliminate 99.99% of harmful airborne microorganisms, including bacteria, fungi, and viruses. As previously announced, independent laboratory testing has proven Purgo™ is effective at reducing the viral concentration of the SARS-CoV-2 the virus that causes COVID-19.

Testing was completed on the Omicron variant which the CDC identifies as one of the most dominant variants currently circulating in the United States. The independent testing conditions simulated real world environments, with room sized chambers. The independent testing was conducted by Innovative Bioanalysis laboratories to test the efficacy of the AeroClean Purgo™ units against SARS-CoV-2, the Omicron variant, during a 60-minute test run.

The AeroClean Purgo™ unit demonstrated a significant and quantifiable reduction in the recoverable active Omicron variant of SARS-CoV-2 in indoor air space, as shown by a 94.17% gross reduction after 30 minutes, and a 99.998% gross reduction in the highly transmissible airborne virus after 60 minutes in a room-sized chamber.