TOMI Environmental Solutions Advances New Product, SteraMist Integration System – Standalone (SIS-SA)

Rhea-AI Summary

TOMI Environmental Solutions (NASDAQ:TOMZ), a global decontamination solutions provider, has announced the successful first installation of its SteraMist Integration System – Standalone (SIS-SA) in the life sciences sector, specifically for the pharmaceutical isolator market. The installation was completed at a leading pharmaceutical CDMO that had previously invested in SteraMist technology.

The company expects to generate over $500,000 in revenue from the new SIS-SA product in fiscal 2025. With the life science sterility testing market projected to reach $3.4 billion by 2031 at a CAGR of 12.4%, TOMI is positioning itself to capitalize on the growing demand for sterile drug manufacturing environments through its innovative Binary Ionization Technology® (BIT™) platform.

Positive

• First successful installation of SIS-SA system in life sciences sector
• Expected revenue of over $500,000 from SIS-SA product in fiscal 2025
• Additional installations scheduled for later this year
• Operating in a growing market expected to reach $3.4B by 2031 with 12.4% CAGR

Negative

• Heavy reliance on a single or few products for majority of revenues
• Significant market and execution risks in new product deployment

Insights

Life Sciences Industry Analyst

TOMI's new SteraMist system targets the growing $3.4B life sciences market with promising initial deployment and revenue potential.

TOMI Environmental Solutions has successfully completed its first installation of the SteraMist Integration System – Standalone (SIS-SA) for a pharmaceutical CDMO, marking a strategic advancement in the company's product lineup. This system represents an evolution of TOMI's iHP (ionized Hydrogen Peroxide) technology, specifically designed to address critical decontamination needs in pharmaceutical isolators.

The timing of this product deployment is particularly noteworthy as it aligns with significant industry trends. The life science sterility testing market is projected to reach $3.4 billion by 2031, growing at a CAGR of 12.4%. This growth is driven by increasing regulatory scrutiny, expanding pharmaceutical production, and heightened focus on contamination control in sterile manufacturing environments.

From a technical perspective, the SIS-SA appears to offer flexible implementation options, as evidenced by its retrofit application in an existing isolator system. This suggests potential for both new installations and upgrades to existing infrastructure, broadening the addressable market. The company's mention of additional scheduled installations indicates early market acceptance and suggests a pipeline of similar projects.

The revenue projection of over $500,000 from the SIS-SA product for fiscal 2025 provides a concrete metric of the near-term financial impact. While modest relative to the overall market size, this represents a foothold in a rapidly growing sector and establishes TOMI's presence in the specialized pharmaceutical manufacturing equipment space.

The strategic significance extends beyond immediate revenue. By establishing relationships with both CDMOs and isolator manufacturers, TOMI is positioning itself within the pharmaceutical manufacturing ecosystem, potentially creating additional integration opportunities as facilities upgrade their contamination control systems to meet evolving regulatory standards.

FREDERICK, Md., July 16, 2025 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced the successful first installation of its new SteraMist Integration System – Standalone (SIS-SA) in the life sciences sector, beginning with pharmaceutical isolator market.

The life science sterility testing market is experiencing significant growth, driven by increased demand for pharmaceutical and biotechnology products, stricter regulatory standards, and advancements in testing methodologies. This growth reflects the critical need to ensure the safety and efficacy of sterile products across the pharmaceutical, medical device, and biopharmaceutical sectors. As life sciences organizations strive to meet stringent regulatory requirements and produce sterile drugs, the role of aseptic isolators becomes increasingly critical.

A leading pharmaceutical drug Contract Development and Manufacturing Organization (CDMO) company first implemented SteraMist iHP technology in 2023. Having previously purchased several Surface Unit handheld direct spray systems, they further invested in the first quarter of this year by acquiring the new SIS-SA, complete with a 90-degree applicator, to retrofit an existing isolator in collaboration with a prominent isolator manufacturing company.

The successful recent installation and validation of this iHP isolator is the first completed deployment of the SIS-SA, part of the SteraMist Integrated Systems (SIS) launched in the second half of last year. TOMI is actively working on additional projects of this type, with installations scheduled for later this year

Dr. Halden Shane, CEO and Chairman of the Board of TOMI Environmental Solutions, Inc., states “The successful installation of our first SIS-SA system marks an important achievement and is a milestone in our strategy to expand our footprint in the life sciences industry. As demand grows for safe, sterile drug manufacturing environments, our SteraMist technology continues to demonstrate its value. With the life science sterility testing market expected to grow to $3.4 billion by 2031 at a CAGR of 12.4%, we believe TOMI is well positioned to meet the evolving needs of life science manufacturers through innovative, scalable solutions like SIS-SA.”

The Company expects to realize in excess of half a million dollars in revenue from the new SIS-SA product in fiscal 2025.

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.steramist.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 anticipated growth in the life science markets and TOMI’s products to serve life science sectors. 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 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, 2024 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/Rosalyn Christian
IMS Investor Relations
tomi@imsinvestorrelations.com

FAQ

What is TOMI's new SteraMist Integration System – Standalone (SIS-SA)?

SIS-SA is TOMI's new disinfection system designed for the pharmaceutical isolator market, utilizing their iHP technology for sterile drug manufacturing environments.

How much revenue does TOMZ expect from the SIS-SA product in 2025?

TOMI Environmental Solutions expects to generate over $500,000 in revenue from the new SIS-SA product in fiscal 2025.

What is the market potential for TOMI's sterility testing solutions?

The life science sterility testing market is expected to grow to $3.4 billion by 2031 with a CAGR of 12.4%, driven by increased demand for pharmaceutical products and stricter regulatory standards.

Who was the first customer to implement TOMI's new SIS-SA system?

A leading pharmaceutical drug Contract Development and Manufacturing Organization (CDMO) that had previously purchased several SteraMist Surface Unit systems was the first to implement the SIS-SA system.

What technology does TOMI's SteraMist system use?

SteraMist uses Binary Ionization Technology® (BIT™), which utilizes a low percentage hydrogen peroxide and patented ionized Hydrogen Peroxide (iHP™) technology for disinfection.