Proposed EPA Restrictions To Limit Ethylene Oxide Exposure Expands Market Opportunity for TOMI Environmental Solutions

Rhea-AI Summary

TOMI Environmental Solutions (NASDAQ: TOMZ) has commented on the EPA's proposed restrictions to limit Ethylene Oxide (EtO) emissions by 80%. This decision could disrupt the sterilization market for approximately 20 billion medical devices sterilized annually with EtO, potentially creating a significant demand for alternatives like TOMI's patented Binary Ionization Technology (BIT™). SteraMist, TOMI's product, offers superior disinfection with a decontamination efficacy of 99.9999%, using only hydrogen peroxide. Unlike EtO, it emits no carcinogenic byproducts and can sterilize equipment without causing temperature damage. TOMI aims to aid the healthcare industry in transitioning to safer practices while addressing the growing concerns about EtO exposure, which has been linked to an increased cancer risk.

Positive

• Potential increase in demand for TOMI's BIT™ technology due to EPA's proposed restrictions on Ethylene Oxide.
• SteraMist's decontamination efficacy of 99.9999%, providing a superior alternative to EtO.
• Non-toxic and non-corrosive characteristics of SteraMist, appealing to healthcare providers seeking safer sterilization methods.

Negative

• None.

- Approximately 20 billion medical devices are sterilized per year with Ethylene Oxide and restricting its usage could create a significant market void that may be filled with alternative decontamination processes such as TOMI’s patented Binary Ionization Technology ® (BIT™) Technology -

FREDERICK, Md., April 26, 2023 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today commented on the Environmental Protection Agency’s (EPA) recent proposed restrictions to limit Ethylene Oxide (EtO) exposure. The announced proposals can be found here. Approximately 20 billion medical devices are sterilized per year with EtO, and restricting its usage could create a significant market void that may be filled with alternative sterilization processes such as TOMI’s patented Binary Ionization Technology ® (BIT™) Technology.

The EPA is proposing to cut Ethylene Oxide (EtO) emissions by 80% through the implementation of more stringent air emissions standards at 86 commercial sterilizer locations in the United States. Ethylene Oxide exposure has been linked to an increased risk of cancer, with the EPA’s own analysis reporting an additional cancer risk between 1 in 36 and 1 in 10 for those who work with the chemical.

EtO, a chemical disinfectant for pharmaceuticals and medical equipment, can sterilize medical products such as catheters, personal protective equipment, and pharmaceutical ingredients that would have been otherwise damaged or degraded by other high-temperature or steam sterilizations.

TOMI’s patented Binary Ionization Technology ® (BIT™) solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI’s active ingredient leaves no residue, has decontamination efficacy upwards of 99.9999%, and takes 5 seconds to complete, a significant improvement from older technologies. Unlike other sterilization agents, SteraMist does not emit any carcinogenic byproducts, only oxygen and water. Additionally, SteraMist offers flexible storage and superior versality compared to EtO, which can be highly volatile. SteraMist validates against the gold standard for sterilization Geobacillus stearothermophilus spores. A detailed comparison of iHP™ and EtO can be found by inquiring at www.tomimist.com.

"SteraMist products are non-toxic, non-corrosive, and do not cause temperature damage to medical equipment or devices," said Dr. Halden Shane, CEO of TOMI Environmental Solutions. "It is estimated that approximately 50 percent of medical supplies are sterilized with EtO, making it critical to the U.S. healthcare industry. We will work closely with both established and new partners in the healthcare industry to help ensure a transition to lower EtO emissions is successful, and believe our superior solution provides the perfect alternative given it is faster, more environmentally sustainable and has no carcinogenic risk to site workers and those living close by."

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 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 and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI products are designed to service a broad spectrum of use sites, including, but not limited to, hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments. 

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  

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to potential market opportunities of TOMI products resulting from the EPA announcement, anticipated financial performance and operating results, including expected growth in sales and market demand; anticipated performance of strategic partnerships; anticipated revenue opportunities of CES products; growth strategies of the company; and anticipated distribution capability.

Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors include, but are not limited to, the impact of COVID-19 pandemic on our business and customers; our ability to maintain and manage growth and generate sales, our reliance on a single or a few products for a majority of revenues; the general business and economic conditions; and other risks as described in our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by us with the SEC and other periodic reports we filed with the SEC. The information provided in this document is based upon the facts and circumstances known at this time. Other unknown or unpredictable factors or underlying assumptions subsequently proving to be incorrect could cause actual results to differ materially from those in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:  

John Nesbett/Jennifer Belodeau  

IMS Investor Relations  

tomi@imsinvestorrelations.com  

FAQ

What are the implications of the EPA's proposed restrictions on Ethylene Oxide for TOMZ?

TOMZ could see a significant increase in demand for its sterilization solutions, particularly its Binary Ionization Technology, as the EPA proposes to cut Ethylene Oxide emissions by 80%.

How effective is TOMI's SteraMist technology compared to Ethylene Oxide?

SteraMist has a decontamination efficacy of 99.9999%, making it a more effective and safer alternative to Ethylene Oxide.

What health risks are associated with Ethylene Oxide exposure?

The EPA has linked Ethylene Oxide exposure to an increased cancer risk, estimating an additional risk between 1 in 36 and 1 in 10 for workers.

How does TOMI plan to address the transition away from Ethylene Oxide within the healthcare industry?

TOMI plans to collaborate closely with healthcare partners to facilitate a successful transition to lower Ethylene Oxide emissions using its technology.

What is the market size potential for TOMZ following the EPA's announcement?

With 20 billion medical devices sterilized annually, TOMZ could capitalize on a significant market void created by the restrictions on Ethylene Oxide.