AeroClean’s Pūrgo™ Air Purifier Receives FDA Clearance for the Elimination of SARS-CoV-2
08 December 2022 - 12:36AM
GlobeNewswire Inc.
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 info@aeroclean.com.
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
TechnologiesAeroClean 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.
Media ContactDrew Tybusdrew@oakpr.com
Investor Relations ContactsRyan TylerChief
Financial Officer, AeroCleanRTyler@AeroClean.com
Rob KellyMATTIO Communicationsaeroclean@mattio.com
AeroClean Technologies (NASDAQ:AERC)
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