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TOMI Secures Critical Ireland Market Approval, Strengthening SteraMist's Position Across the European Union

(Very Positive)
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TOMI Environmental Solutions (NASDAQ:TOMZ) reported that its Binary Ionization Technology BIT Solution has received formal approval in Ireland under the European Union’s Biocidal Products Regulation (BPR). This extends SteraMist authorizations to Ireland plus 10 other European markets including Austria, Italy, the Netherlands, Belgium, Denmark, Germany, Hungary, Spain, Great Britain and Northern Ireland.

The BPR approvals cover BIT Solution for both SteraMist room fogging and surface spraying equipment, for professional indoor use against bacteria, yeasts and mycobacteria across medical, healthcare, industrial, commercial, hospitality, institutional and tertiary sectors. According to TOMI, Ireland is a major life sciences and pharmaceutical hub where many of its existing and prospective contamination-control customers already operate.

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Positive

  • BIT Solution BPR approval in Ireland adds to 10 existing European markets
  • Authorization covers SteraMist room fogging and surface spraying equipment
  • Professional indoor use approval for multiple sectors and microbial targets
  • Access to major life sciences hub with 90+ pharmaceutical companies

Negative

  • None.

Market Context

The August 3 EPA registration was followed by TOMZ's 8.75% 24-hour gain, offering a regulatory prece...
Analysis

The August 3 EPA registration was followed by TOMZ's 8.75% 24-hour gain, offering a regulatory precedent for this Ireland authorization. TOMI's active S-3 shelf permits up to $50,000,000, but is marked not effective, adding financing context.

Key Figures

Ireland approval: August 17, 2026 Other European markets: 10 markets Pharmaceutical exporter ranking: 3rd-largest +2 more
5 metrics
Ireland approval August 17, 2026 EU Biocidal Products Regulation authorization
Other European markets 10 markets In addition to Ireland
Pharmaceutical exporter ranking 3rd-largest Ireland global pharmaceutical exporter ranking
Pharmaceutical companies More than 90 Companies located in Ireland
Top global pharmaceutical companies 9 of the top 10 Global pharmaceutical companies located in Ireland

Historical Context

5 past events · Latest: Aug 14 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 14 Earnings report Positive -6.4% Revenue growth and narrowed losses preceded a 6.42% 24-hour decline.
Aug 10 Earnings date notice Neutral -5.0% Conference-call scheduling preceded a 4.95% decline without reported financial results.
Aug 04 Critical-mineral assay Positive +10.9% Rare-earth assay disclosure preceded a 10.92% gain in TOMZ shares.
Aug 03 EPA registration Positive +8.8% Unconditional EPA registration preceded an 8.75% gain in TOMZ shares.
Jul 29 Guidance update Positive -7.9% Revenue guidance reaffirmation and pipeline disclosure preceded a 7.88% decline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Across the five recent events, positive announcements produced two aligned gains and three divergences, including a 6.42% decline after the latest earnings release.

Key Terms

biocidal products regulation, mutual recognition, mycobacteria
3 terms
biocidal products regulation regulatory
"EU Biocidal Products Regulation (BPR) Mutual Recognition Extends SteraMist Authorization"
A legal framework that sets rules for approving, labeling, placing on the market, and using chemical or biological products intended to kill or control harmful organisms (for example disinfectants, insecticides and rodent control products). It matters to investors because it determines which products can be sold, what tests and paperwork companies must complete, and the timelines and costs for market access—similar to food-safety or drug-approval rules but for pest- and germ-control products.
mutual recognition regulatory
"EU Biocidal Products Regulation (BPR) Mutual Recognition Extends SteraMist Authorization"
Mutual recognition is an agreement where two or more jurisdictions, regulators or organizations accept each other’s approvals, standards or decisions so a product, service or legal status approved in one place can be used in the other without repeating the full approval process. For investors, this speeds market access, lowers regulatory costs and reduces uncertainty—similar to two countries agreeing to honor each other’s driver’s licenses so people can drive without taking another test.
mycobacteria medical
"The product is approved for professional indoor use, addressing bacteria, yeasts, and mycobacteria"
A group of related bacteria that includes both disease-causing species and harmless environmental types; they are like a family of cousins that share similar biology. They matter to investors because some species cause serious human and animal infections, drive demand for diagnostics, vaccines and antibiotics, influence regulatory review and public-health spending, and can affect the commercial prospects of companies in biotech, pharmaceuticals, medical devices and laboratory testing.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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EU Biocidal Products Regulation (BPR) Mutual Recognition Extends SteraMist Authorization to a Rapidly Growing Key Life Sciences Market

FREDERICK, Md., Aug. 17, 2026 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global leader in disinfection and decontamination solutions, announced today that its Binary Ionization Technology has received formal approval in Ireland under the European Union's Biocidal Products Regulation (BPR), extending the Company's growing footprint of authorizations across the European Union.

BIT Solution is now approved in Ireland in addition to 10 other European markets including: Austria, Italy, the Netherlands, Belgium, Denmark, Germany, Hungary, Spain, Great Britain and Northern Ireland.   The EU authorizations cover BIT Solution for both SteraMist room fogging and surface spraying equipment. The product is approved for professional indoor use, addressing bacteria, yeasts, and mycobacteria serving the medical, healthcare, industrial, commercial, hospitality, institutional, and tertiary sectors.

“Ireland's approval reinforces SteraMist's position in a market that is home to some of the world's most demanding contamination-control and decontamination standards,” said Dr. Halden Shane, CEO of TOMI Environmental Solutions. “As the region's life sciences and healthcare sectors continue to raise the bar on validated, documented efficacy, we believe iHP technology is well positioned to meet that demand and expand its footprint across the market.”

Ireland Life Sciences Addressable Market

Ireland represents one of Europe's most concentrated life sciences and pharmaceutical manufacturing hubs and is also where one of TOMI's established decontamination and sterilization competitors is headquartered. Securing authorization in this market positions SteraMist and iHP technology alongside long-established players in a region where regulatory scrutiny and validation standards are among the most demanding in the world. According to IDA Ireland, Ireland ranks as the world's third-largest pharmaceutical exporter and is home to more than 90 pharmaceutical companies, including nine of the world's top 10 global pharmaceutical companies (Source: IDA Ireland).

TOMI continues to see growing interest in SteraMist iHP decontamination from organizations expanding their contamination-control programs internationally, as customers increasingly look to standardize decontamination protocols across multi-country operations. Many of TOMI's existing pharmaceutical and life sciences customers already maintain operations in Ireland, with rising interest from U.S.-based customers evaluating international expansion of their contamination-control programs, including into European markets such as Ireland.

About 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 https://www.steramist.com or contact us at info@tomimist.com.

Forward-Looking Statements

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 TOMI’s products and services to serve the international sector. 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, our ability to acquire new customers and expands sales; 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, 2025 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/Zach Nevas

IMS Investor Relations  

tomi@imsinvestorrelations.com  


FAQ

What did TOMI Environmental Solutions (NASDAQ:TOMZ) announce about SteraMist in Ireland on August 17, 2026?

TOMI announced that its BIT Solution for SteraMist received formal approval in Ireland under the EU Biocidal Products Regulation. According to TOMI, this extends existing authorizations and supports use in professional indoor decontamination across multiple sectors in a key European life sciences market.

What does the new Ireland BPR approval mean for TOMI’s SteraMist BIT Solution (TOMZ)?

The Ireland BPR approval allows SteraMist BIT Solution for professional indoor use in Ireland, covering room fogging and surface spraying. According to TOMI, this places its iHP technology alongside established competitors in a highly regulated, contamination‑control focused life sciences and pharmaceutical hub.

In how many European markets is TOMI’s BIT Solution for SteraMist now approved?

BIT Solution is now approved in Ireland and 10 other European markets, totaling 11. According to TOMI, these include Austria, Italy, the Netherlands, Belgium, Denmark, Germany, Hungary, Spain, Great Britain and Northern Ireland under the EU Biocidal Products Regulation framework.

Which sectors can use TOMI’s SteraMist BIT Solution in Ireland under the BPR approval?

The approval allows professional indoor use in medical, healthcare, industrial, commercial, hospitality, institutional and tertiary sectors. According to TOMI, BIT Solution is authorized for SteraMist room fogging and surface spraying to address bacteria, yeasts and mycobacteria in these environments.

How important is Ireland’s life sciences market for TOMI Environmental Solutions (TOMZ)?

Ireland is described as one of Europe’s most concentrated life sciences and pharmaceutical hubs. According to TOMI, it hosts 90+ pharmaceutical companies and is the world’s third‑largest pharmaceutical exporter, making Ireland an attractive market for SteraMist contamination‑control deployments.

Does TOMI already have customers with operations in Ireland for its SteraMist iHP technology?

TOMI reports that many existing pharmaceutical and life sciences customers already maintain operations in Ireland. According to TOMI, there is rising interest from organizations standardizing contamination‑control protocols across multi‑country operations, including potential expansion into European markets such as Ireland.