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Major Scientific Report Cites Favorable Analysis of SteraMist ionized Hydrogen Peroxide Technology in the Sterilization of N95 Respirators and Other PPE

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TOMI Environmental Solutions announced that its SteraMist iHP technology effectively sterilizes N95 masks, retaining filtration up to ten cycles, as shown in a study by the Greater Boston Pandemic Fabrication Team.

This technology addresses PPE shortages during the COVID-19 pandemic, making it a potential solution for busy medical centers. The study suggests that up to 7,200 masks could be sterilized daily, and TOMI is hopeful for FDA's Emergency Use Authorization.

Positive
  • SteraMist retains filtration efficiency of N95 masks after ten sterilization cycles.
  • Potential to sterilize 4,800-7,200 masks daily could alleviate PPE shortages.
  • SteraMist demonstrated to be twice as effective as similar alternatives.
Negative
  • No current Emergency Use Authorization (EUA) from the FDA despite ongoing evaluations.
  • Results indicated that N95 masks sterilized with SteraMist technology retained filtration up to ten cycles

FREDERICK, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”, “the Company”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination, utilizing its premier Binary Ionization Technology (BIT) platform through its SteraMist products - a hydrogen peroxide-based mist and fog composed of ionized Hydrogen Peroxide (iHP) announces that SteraMist has recently been featured in a study investigating PPE sterilization in a sealed environment chamber using biological indicator assemblies.

The COVID-19 pandemic has led to widespread shortages in personal protective equipment (PPE) for clinicians and first responders. Shortages in filtering facepiece respirators (FFR’s) such as the N95 mask which are certified to filter 95% of airborne particles are particularly problematic because these normally single use items are a main stream of infection control.

In a recent study conducted by the Greater Boston Pandemic Fabrication Team (PanFab), Harvard-MIT Center for Regulatory Science, Harvard Medical School at the Dana Farber Cancer Institute (DFCI) lab in conjunction with MIT and ICS labs, a commercial laboratory accredited to perform testing by the National Institute for Occupational Safety and Health (NIOSH), SteraMist ionized Hydrogen Peroxide (iHP™) was applied directly to masks and filtering facepiece respirators to gauge retention of filtration ability after application. Five N95 masks from three separate manufacturers were included in the study, and their ability to form an airtight seal and filter aerosolized particles were observed after SteraMist application. Results indicated that N95 masks sterilized with SteraMist technology retained filtration up to ten cycles – the largest number tested to date. The study concluded that these results make for an “effective approach for a busy medical center”.

The study states that four distinct hydrogen peroxide-based technologies have been commercialized, with three having been given Emergency Use Authorization (EUA) from the FDA despite limited peer-reviewed data: Steris (Vaporized Hydrogen Peroxide, 30-35% liquid H2O2), Advanced Sterilization Products’ Sterrad (Hydrogen Peroxide Gas Plasma, 58-60% H2O2), and Bioquell (Hydrogen Peroxide Vapor, 30-35% liquid H2O2). SteraMist’s iHP has the most recent and complete data portfolio to date including meeting recent National Institute for Occupational Safety and Health standards.

The study also stated, “. . . our results support the use of iHP as a PPE sterilant when delivered using a SteraMist-equipped environment chamber. At this rate, assuming idealized staffing and logistics, roughly 4800–7200 masks could be sterilized for use per day given a typical 100-minute sterilization cycle. These numbers could be increased with the addition of an overnight workforce” (Cramer, Plana, Yang, et al.)

Dr. Halden Shane, TOMI CEO, commented: “As communities continue to face the pandemic, TOMI is committed to spending the time and resources required to provide transparency around the efficacy of our solution by bringing SteraMist to healthcare and research settings around the globe. This innovative use of SteraMist to disinfect masks will help ease the ongoing burden on facilities to keep a readily-available stock of PPE to help protect first responders, hospital and medical staff, patients, and visitors. Notably, this study demonstrated that the use of SteraMist in PPE sterilization proved to be twice as effective as using other similarly formulated alternatives. Since May of 2020, the FDA has been evaluating our technology, and we are hopeful that the positive results of this study will encourage this federal agency to issue the Emergency Use Authorization (EUA) that will allow our safe and effective technology to be widely distributed. SteraMist technology has been tested and proven effective against the most difficult to kill bacterial spores, including the successful kill of SARS CoV-2 virus, as recently reported from the University of Virginia. We’re pleased to have been included in this N95 and PPE study and look forward to continuing to do our part to help keep healthcare workers safe during the current pandemic and beyond.”

The article can be read in full at: https://www.nature.com/articles/s41598-021-81365-7 (Published online January 21, 2021)

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world® 

TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of ionized Hydrogen Peroxide (iHP). Represented by the SteraMist® brand of products, iHP produces a germ-killing aerosol that works like a visual non-caustic gas.

TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.

TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.

For additional information, please visit http://www.tomimist.com/ or contact us at info@tomimist.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Certain written and oral statements made by us may constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). Forward-looking statements are identified by such words and phrases as “we expect,” “expected to,” “estimates,” “estimated,” “current outlook,” “we look forward to,” “would equate to,” “projects,” “projections,” “projected to be,” “anticipates,” “anticipated,” “we believe,” “could be,” and other similar phrases. All statements addressing operating performance, events, or developments that we expect or anticipate will occur in the future, including statements relating to revenue growth, earnings, earnings-per-share growth, or similar projections, are forward-looking statements within the meaning of the Reform Act. They are forward-looking, and they should be evaluated in light of important risk factors that could cause our actual results to differ materially from our anticipated results. The information provided in this document is based upon the facts and circumstances known at this time. We undertake no obligation to update these forward-looking statements after the date of this release.

INVESTOR RELATIONS CONTACT

John Nesbett/Jennifer Belodeau
IMS Investor Relations
jnesbett@imsinvestorrelations.com 


FAQ

What are the results of the SteraMist technology study?

The study showed that N95 masks sterilized with SteraMist retained filtration efficiency after ten cycles.

How many masks can be sterilized using SteraMist technology?

The study suggests that up to 4,800–7,200 masks could be sterilized per day.

Is SteraMist technology awaiting FDA approval?

Yes, TOMI is hopeful for Emergency Use Authorization from the FDA for its SteraMist technology.

What is the significance of the recent SteraMist study?

It highlights SteraMist's effectiveness in PPE sterilization during the COVID-19 pandemic.

Who conducted the study on SteraMist’s effectiveness?

The study was conducted by the Greater Boston Pandemic Fabrication Team in collaboration with Harvard and MIT.

TOMI Environmental Solutions, Inc.

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