AeroClean Receives FDA Clearance For Pūrgo™ Medical Grade Air Hygiene Technology

Rhea-AI Summary

AeroClean Technologies (Nasdaq: AERC) has received FDA 510(k) clearance for its Pūrgo™ air purification technology, classifying it as a Class II Medical Device. This clearance validates the device's capability to eliminate 99.99% of harmful airborne microorganisms, including bacteria and viruses like COVID-19. The patented SteriDuct™ technology combines hospital-grade HEPA filtration with UV irradiation, ensuring enhanced indoor air quality. AeroClean aims to supply this technology to healthcare facilities, businesses, and government agencies as part of their mission to promote a healthier environment.

Positive

• FDA clearance validates Pūrgo™ as a Class II Medical Device, enhancing credibility.
• Technology proven to eliminate 99.99% of harmful airborne microorganisms, addressing public health concerns.
• Utilizes patented SteriDuct™ technology, offering a competitive edge in air purification solutions.

Negative

• None.

FDA Clearance Provided After Review Of Patented Germicidal UV-C LED Air Purification Technology Proven Effective At Eliminating Harmful Airborne Microorganisms

PALM BEACH GARDENS, Fla., June 06, 2022 (GLOBE NEWSWIRE) -- AeroClean Technologies (“AeroClean” or the “Company”) (Nasdaq: AERC), a leading air hygiene technology company and producer of patented UV-C LED technology inside its innovative air purification Pūrgo™ device, today announced that the U.S. Food and Drug Administration (FDA) has granted AeroClean’s Pūrgo technology 510(k) clearance, classifying it as a Class II Medical Device. The clearance was provided after a thorough review of the patented Pūrgo device, which utilizes patented germicidal UV-C LED air purification technology and is proven to eliminate 99.99% of harmful airborne microorganisms, including bacteria, fungi and viruses, like COVID-19. As experts in Indoor Air Quality (IAQ), AeroClean provides healthcare facilities, businesses, hospitality venues and government agencies with the highest medical grade air purification and air sanitization technology.

“We are proud to have been granted FDA clearance for AeroClean’s Pūrgo™ device and thank the administration for their in-depth review of our patented air hygiene technology,” said Jason DiBona, CEO of AeroClean. “As experts in indoor air quality, we aim to provide healthcare facilities, businesses, hospitality venues and government agencies with the highest medical-grade air purification and air sanitization technology. FDA clearance of our Pūrgo™ system, which is powered by our patented SteriDuct™ technology, represents a major step forward in significantly improving air quality where people meet, work and live.”

Pūrgo™ has been rigorously tested in a variety of laboratory test chambers and multiple real world indoor spaces. The patented technology uses hospital-grade HEPA filtration as well as optimized germicidal UV irradiation to provide supplemental, localized air cleaning and enhanced ventilation so businesses and organizations can cost-effectively comply in real-time with recent federal guidelines supporting healthy building initiatives and cleaner, safer indoor air.

Developed by medical professionals and aerospace engineers, the FDA-cleared Pūrgo™ solution goes beyond basic filtration, which has been the standard for indoor air purification for decades. Traditional air filtration systems only capture larger particles such as dust and pet hair and offer limited intermittent cleaning of indoor air, potentially increasing the exposure to fine particulate and harmful bioaerosols.

AeroClean is committed to help businesses and organizations improve IAQ for a healthier and safer world, so work, play, and life keeps going. For more information about AeroClean technology and Pūrgo™ solutions, visit: www.AeroClean.com.

About AeroClean Technologies:
AeroClean is a pathogen elimination technology company on a mission to keep work, play and life going—with continuous air hygiene products called, Pūrgo™ (pure-go). We create solutions for hospitals, offices, and many shared spaces as well as elevators, transportation and more. Pūrgo™ products feature SteriDuct™, a proprietary technology developed by our best-in-class aerospace engineers, medical scientists and innovators. Powered by SteriDuct™, our solutions are medical grade, eradicating 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 Contact
Drew Tybus
Drew@OakPR.com

Investor Relations Contact
Ryan Tyler
Chief Financial Officer, AeroClean
RTyler@AeroClean.com

or:
Brian Pinkston
MATTIO Communications
aeroclean@mattio.com

FAQ

What is AeroClean Technologies' stock symbol?

AeroClean Technologies' stock symbol is AERC.

What recent FDA action did AeroClean Technologies receive?

AeroClean Technologies received FDA 510(k) clearance for its Pūrgo™ air purification technology.

What does the Pūrgo™ device do?

The Pūrgo™ device eliminates 99.99% of harmful airborne microorganisms, including viruses and bacteria.

What technology powers the Pūrgo™ device?

The Pūrgo™ device is powered by patented SteriDuct™ technology.

What markets is AeroClean targeting with its technology?

AeroClean targets healthcare facilities, businesses, hospitality venues, and government agencies.