FDA Approves Co.’s New Medical Grade Air Hygiene Device

June 9, 2022

Source: Streetwise Reports   06/07/2022

Shares of AeroClean Technologies Inc. traded 150% higher after the company reported it received 510k clearance from the U.S. FDA for its Pūrgo™ medical-grade indoor air purification technology that uses UV-C LEDs to eradicate airborne bacteria, fungi, and viruses, including COVID-19.

Covid

Indoor air purification and pathogen eradication technology company AeroClean Technologies Inc. (AERC:NASDAQ), which utilizes proprietary UV-C LED technology to kill airborne bacteria, fungi, and bacteria, yesterday 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 company stated that the approval was granted following a full review of its innovative air purification Pūrgo™ device. The firm mentioned that the Pūrgo device employs patented germicidal UV-C LED air purification technology that can eliminate 99.99% of harmful airborne microorganisms, including viruses such as SARS-CoV-2.

The firm advised that it leverages its expertise in Indoor Air Quality (IAQ) to deliver the highest medical grade air purification and air sanitization technology for hospitals and medical facilities, schools and universities, hospitality venues and hotels and government agencies.

AeroClean Technologies’ CEO Jason DiBona commented, “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…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.”


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The company noted that its Pūrgo™ solutions were created and developed by aerospace engineers and medical professionals. AeroClean stated that its products greatly exceed basic standard air filtration methods that only capture larger particles such as dust and pet hair and do not allow for continuous indoor air cleaning or for elimination of harmful bioaerosols.

The firm noted that its Pūrgo™ solutions use hospital-grade HEPA filtration combined with optimized germicidal UV irradiation to provide enhanced ventilation allowing businesses and organizations to cost-effectively meet federal indoor air safety guidelines.

AeroClean is an interior space air purification and pathogen elimination and eradication tech co. based in Palm Beach Gardens, Fla. The company’s continuous cleaning air hygiene products called, Pūrgo™ (pure-go) are designed for use in medical facilities and hospitals, elevators and shared public spaces and public transportation.

The firm noted that its Pūrgo™ line of medical grade air sanitization products employ the use of a proprietary technology called SteriDuct™ that are capable of destroying and eliminating 99.99% of airborne bacterial, viral and fungal microorganisms. The company claims that it is able to achieve this with the use of safe, solid-state ultraviolet-C light-emitting diode (UV-C LED) emitters that are set to an optimum wavelength to kill nearly 100% of these pathogens.

AeroClean Technologies started the day with a market cap of around $65.9 million with approximately 13.88 million shares outstanding. AERC shares opened 9.5% lower today at $4.30 (-$0.45, -9.47%) from yesterday’s $4.75 closing price and then proceeded to trade over 150% higher. The stock has traded today between $3.85 and $14.23 per share and is currently trading at $12.01 (+$7.26, +152.84%).

 

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