AeroClean's Pūrgo™ Air Purifier Receives FDA Clearance for the Elimination of SARS-CoV-2
Additional Testing Being Performed to Confirm Elimination of Influenza and RSV
PALM BEACH GARDENS, Fla., Dec. 07, 2022 (GLOBE NEWSWIRE) -- AeroClean Technologies ("AeroClean" or the "Company") (NASDAQ:AERC), a leading air hygiene technology company, today announced that, the U.S. Food and Drug Administration ("FDA") has granted AeroClean 510k clearance (K223328) to update its Pūrgo™ air purifier's ("Pūrgo™") 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 Pūrgo 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 ("IAQ") 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 (RSV).
"FDA clearance of our Pūrgo™ technology's ability to eliminate SARs-CoV-2 is an incredible milestone and provides the expected expansion of scope that all of our testing has indicated," said Jason DiBona, Chief Executive Officer of AeroClean. "Our team is dedicated to improving indoor air quality through the creation of long-term, health-focused solutions, and this latest indication validates the significant strength of our Pūrgo™ air sanitization device. We are currently completing additional testing to determine the efficacy of Pūrgo's™ ability to remove other airborne microorganisms such as RSV and Influenza. We hope to see the preliminary results shortly."
Mr. DiBona added, "Its widely known that we are experiencing a ‘tripledemic', composed of Influenza, RSV, and SARs-CoV-2, that has swept the United States in recent weeks. With the especially high impact these illnesses have had on the public, and particularly the country's pediatric wards, Pūrgo™ is an essential tool that can be used to help create safer indoor environments."
AeroClean's Pūrgo™ 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 Pūrgo™ 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 Pūrgo™ units against SARS-CoV-2, the Omicron variant, during a 60-minute test run. The AeroClean Pūrgo™ 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.
AeroClean's efficacy test report on the Omicron Variant of SARS-CoV-2 can be available on request by sending an email to [email protected].
For more information about AeroClean technology and Pūrgo™ solutions, visit: www.AeroClean.com.
- Please refer to P-100A IFU document. IFU and previous testing reports are available on request.
About AeroClean Technologies
AeroClean is a pathogen elimination technology company on a mission to keep work, play and life going—by improving indoor air quality. Our air hygiene product, Pūrgo™ (pure-go), is an FDA 510(k) cleared, Class II medical device that provides continuous air filtration, sanitization and supplemental ventilation solutions with technology that can be applied in any indoor space - including in hospitals, offices, and even in elevators. Pūrgo™ products feature SteriDuct™, a proprietary germicidal technology developed by our best-in-class aerospace engineers, medical scientists and innovators that work to eradicate viral, fungal, and bacterial airborne microorganisms. Our purpose is simple: to never stop innovating solutions that keep people healthy and safe, so life never stops. Learn more at aeroclean.com.
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