What changed in this filing

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Item 1. Business

2025-04-14 compared with 2024-04-01 · 77 added, 56 removed, 288 unchanged (32% of the section changed)

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SteraMist’s innovative methodology, inspired from atmospheric chemistry, not only guarantees effectiveness but also maintains a commitment to environmental sustainability by ensuring the only by-product from the process is oxygen and humidity, a complete package of benefits unmatched in its industry.

We owe our success to the collaborative efforts of Titan Defense and DARPA who uncovered a superior technology that mimics nature’s cleansing mechanism, bringing this natural phenomenon indoors providing a competitive edge that exceeds the capabilities of our competition in the healthcare disinfection, life sciences decontamination, and food safety sanitization markets.

We attribute our success to the collaborative efforts of Titan Defense and DARPA who uncovered a superior technology that mimics nature’s cleansing mechanism, bringing this natural phenomenon indoors and providing us with a competitive edge in the healthcare disinfection, life sciences decontamination, and food safety sanitization markets.

We believe that we possess the best technologies in the world in the disinfection and decontamination space.

The needs of the pharmaceutical and vivarium space, as well as experiences with global pandemics and other heath related emergencies, such as the COVID-19 pandemics, has provided us with the opportunity and expertise to implement a clear strategy to develop and manufacture additional products to enhance and improve our portfolio.

In addition, we continue to market and commercialize our BIT technology as an industry standard in disinfection and decontamination globally, which we believe will lead to increased market share, profitability, and capability strength.

Our products are an environmentally friendly solution, and our processes address the concerns of sustainability.

Customers are requesting and discussing the positive results of our product and the environmentally friendly results compared to the caustic and environmentally unfriendly results of many other disinfectants.

SteraMist has established a successful track record in fighting pandemics and outbreaks and implementing SteraMist for emergency preparedness is vital.

The COVID-19 pandemic took the world by surprise, and history has shown that other pandemics and viruses are likely to follow.

Using a proven and trusted disinfectant for emergency outbreaks and daily for preventative maintenance, such as SteraMist, can alleviate the threat of infections from spreading and could stop a possible outbreak.

The Science Behind the Technology

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By harnessing the power of atmospheric chemistry, our process converts 7.8% hydrogen peroxide into a plasma-generated hydroxyl radical, achieving a 6-log and greater kill of pathogens leaving only oxygen and humidity as by-products.

It’s a simple yet effective solution that sets a new standard for global cleaning disinfection decontamination practices.

It is a simple yet effective solution that sets a new standard for global cleaning disinfection decontamination practices.

BIT technology was initially developed in response to weaponized anthrax spore attacks, and detailed testing performed by DARPA demonstrated the success of the technology in neutralizing chemical warfare agents.

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In 2021, SteraMist BIT 0.35% hydrogen peroxide received its EPA registration (#90150-3), and on June 2, 2022, SteraMist was added to its seventh EPA’s List, List Q for combating rare or novel viruses like Monkeypox virus and SARS-CoV-2 variants causing COVID-19.

TOMI continuous to build its portfolio of feasibility studies with renowned and trusted partners.

TOMI continues to build its portfolio of feasibility studies with renowned and trusted partners.

In 2023, the U.S.

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Our comprehensive solutions encompass a range of capital equipment and services, from mobile sprayers and foggers to fully automated installed systems, alongside routine and emergency deployment, qualification, and validation procedures.

We also operate across diverse sectors such as Life Sciences, Hospital-Healthcare, Food Safety, and everyday buildings visited by people, and provide the option for routine and emergency treatment through our service provider membership, the TOMI Service Network (“TSN”).

Our revenue is derived from a variety of industry groups.

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At TOMI, we are dedicated to modernizing operational efficiencies across diverse industries, including life sciences, hospital-healthcare, food safety, hospitality, and emergency service sectors.

By integrating SteraMist iHP technology into facilities now, we not only mitigate existing risks but also strengthen defenses against future challenges the world may face.

By integrating SteraMist iHP technology into facilities proactively, we not only mitigate existing risks but also strengthen defenses against future challenges the world may face.

Establishing a culture of safety and hygiene through routine cleaning disinfection protocols employers instill confidence among their patients, researchers, employees, students, emergency responders - showcasing a commitment to the well-being of everyone.

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We now provide a wide array of products and services customized to meet the unique operational needs of our global clientele, providing a customizable approach to our customers and elevating their overall performance.

In 2023, TOMI expanded its network of international distributors and partnered for the first time with distributors domestically.

Our distribution network spans across the Life Sciences, Hospital-Healthcare, Food Safety, and Commercial industries.

This effort along with maintaining our key current Independent Manufacturing Representatives is aimed to enhance revenue and increase brand awareness.

Moving forward, we anticipate substantial benefits from these distributor groups, paving the way for growth and success in the years ahead.

We tackle critical global challenges, delivering real results that reflect our dedication to making a positive impact on employees, customers, investors, and the communities we serve.

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Today, our impressive roster of clients includes Tower Health, Novant Health, Pfizer, Merck, Fresenius Kabi, DKI, First Onsite, Fleet, Nestle Purina, Simplot, Perdue, and various government agencies such as the National Institutes of Health (“NIH”) and United States Department of Agriculture (“USDA”).

The Company is equipped for when these esteemed organizations prioritize expanding their use of SteraMist iHP.

As an example, the Department of Homeland Security’s Science and Technology Directorate budget overview for FY 2025 has budgeted for 16 of TOMI’s Environment units for the decommissioning of Plum Island’s labs.

Not only does this signify significant growth for our Company, but it aligns with our corporate mission:

The Company is equipped for when these esteemed organizations prioritize expanding their use of SteraMist iHP and aligns with our corporate mission:

Innovating for a Safer World .

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SteraMist products are designed to address a wide spectrum of industries using iHP.

Our operations consist of five main divisions based on our current target industries:

Life Sciences, Hospital-HealthCare, TSN, Food Safety, and Commercial.

Our operations consist of four main divisions based on our current target industries:

Life Sciences, Hospital-HealthCare, Food Safety, and Commercial.

Launched in sequential order as listed to either strategically address the needs and/or ensure compliance with the specific regulations governing each industry segment.

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According to the World Health Organization, HAIs affect millions of patients globally each year, leading to prolonged hospital stays, increased healthcare costs, and deaths.

In 2024, it’s estimated that approximately 7-10% of patients admitted to healthcare facilities worldwide will acquire at least one HAI during their stay.

Approximately 7-10% of patients admitted to healthcare facilities worldwide will acquire at least one HAI during their stay.

This translates to millions of cases annually, with significant economic burdens and human costs.

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Additionally, investing in targeted marketing campaigns and educational initiatives to raise awareness about the benefits of automated disinfection processes can help overcome resistance to change and accelerate market penetration.

TOMI Service Network (“TSN”)

TSN is an expansive network consisting of professionals who are exclusively licensed and trained to use the SteraMist products.

With the purchase of SteraMist and joining TSN, TOMI trains and services a wide array of professional remediation companies in the use of SteraMist throughout the TSN division.

TSN allows for increased accessibility and brand awareness of iHP services to facilities in need of local routine and emergency disinfection and decontamination.

The TSN addressed many cleaning protocols that changed permanently due to the COVID-19 pandemic, and our network plays a significant role in facilitating and maintaining these protocols.

COVID-19 highlighted the limitations of reactive approaches to cleanliness and hygiene.

Recognizing this, TOMI is now championing a proactive approach to disinfection.

While the pandemic may have initially spurred reactive measures, we are advocating for a shift towards proactive, ongoing disinfection protocols.

Through consistent and persistent efforts, we are slowly but steadily changing minds across all industries that individuals interact with in their daily lives.

By emphasizing the importance of maintaining clean and safe environments as a preemptive measure providing long-term benefits of proactive disinfection in ensuring the health and well-being of their employees, customers, and communities, rather than merely reacting to immediate threats, we are promoting a culture of preventive healthcare via our TSN.

Every day there are news articles around the world pertaining to the contamination of food supply.

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Therefore, adherence to sanitation practices is paramount in the food industry to mitigate risks and maintain food safety standards.

In 2023, we made significant strides in boosting brand awareness within the food safety industry through targeted promotion and marketing initiatives.

Leveraging a similar strategy to what proved successful in the Life Sciences sector;

we focused on building a customer base through referrals and feasibility studies, gradually expanding our reach.

By fostering relationships with key supporters of our technology and remaining patient in our approach, we have finally laid a foundation.

In 2024, we expect to continue to expand and grow our presence in this critical market segment.

In line with adopting a proactive approach through our TOMI Service Network, it’s imperative for the entire commercial world to follow suit.

We have made significant strides in boosting brand awareness within the food safety industry through targeted promotion and marketing initiatives.

Leveraging a similar strategy to what proved successful in the Life Sciences sector, we focused on building a customer base through referrals and feasibility studies, gradually expanding our reach.

By fostering relationships with key supporters of our technology and remaining patient in our approach, we have finally laid a foundation and expect to continue to expand and grow our presence in this critical market segment.

In line with adopting a proactive approach through our service providers, it’s imperative for the entire commercial world to follow suit.

Proactive disinfection practices not only ensure the health and safety of employees, customers, and visitors but also safeguard business continuity and reputation.

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Additionally, TOMI will continue to offer protocol development and implementation services for SteraMist iHP, recognizing its critical role in various settings, particularly in pandemic preparedness scenarios.

New Program Offering:

SteraMist Pro Certified (SPC)

TOMI partners with an expansive network consisting of professionals who are exclusively licensed and trained to use the SteraMist products.

TOMI trains and services a wide array of professional remediation companies in the use of SteraMist.

TOMI is now championing a proactive approach to disinfection.

The 2020 pandemic may have initially spurred reactive measures, we are advocating for a shift towards proactive, ongoing disinfection protocols.

Through consistent and persistent efforts, we are slowly but steadily changing minds across all industries that individuals interact with in their daily lives.

To do this more widely, we launched the SteraMist Pro Certified (SPC) program, signifies a significant step towards industry excellence.

Our aim is to establish a standard that reflects a commitment to continuous improvement, adherence to evolving disinfection and biohazard response norms, and dedication to setting benchmarks in the field.

Central to our mission is ensuring that the SPC program resonates with consumers by placing their needs at the forefront, portraying the certification as user-centric rather than SteraMist-centric.

This approach is crucial in garnering recognition and legitimacy for the certification.

In optimizing our communication, offerings, and requirements, we are prioritizing the categorization of Certification participants:

Individuals, Sole Proprietors/Small Businesses, Franchises, and Internal/Departments.

This classification will enable us to tailor our approach and support to meet the specific needs and challenges faced by each group.

As we move forward, the SteraMist Pro Certified (SPC) program will encompass a comprehensive set of criteria to ensure industry-leading standards.

This includes:

SteraMist equipment ownership:

Demonstrating a commitment to utilizing SteraMist technology for effective disinfection.

Public health commitment:

Upholding a dedication to safeguarding public health through rigorous disinfection practices.

Training excellence:

Ensuring thorough and ongoing training for personnel involved in disinfection procedures.

Employee awareness and training:

Fostering a culture of awareness and competence among staff regarding disinfection protocols.

Equipment maintenance assurance:

Guaranteeing the proper maintenance and upkeep of SteraMist equipment to optimize performance.

Internal self-audit program:

Implementing regular self-assessment processes to monitor and improve disinfection practices.

Customer feedback innovation:

Embracing customer feedback to drive innovation and enhance service delivery.

Continuous improvement documentation:

Documenting efforts to continuously enhance disinfection practices and procedures.

Environmental sustainability commitment:

Incorporating environmentally sustainable practices into disinfection operations.

Emergency response plan with risk assessment:

Developing comprehensive plans and risk assessments to effectively respond to emergencies.

The SPC program seeks to ensure certified entities are equipped to deliver disinfection decontamination while prioritizing public health, safety, and environmental sustainability.

The environmental infectious disease control industry or disinfection, decontamination, and sanitization arena is intensely competitive and highly regulated.

Competition is intense in all five of our divisions and includes many large and small competitors.

Competition is intense in all four of our divisions and includes many large and small competitors.

SteraMist iHP Provides a 99.9999% or six-log kill and above kill (i.e., the statistical destruction of all microorganisms and their spores) on all challenged pathogens, on multiple surfaces including Bacillus atrophaeus spores, Bacillus subtilis spores and Geobacillus stearothermophilus spores naked or dressed the last spore is considered a gold standard for validation of sterilization versus household/industrial cleaners that offer a 99.9% (sanitizing) or three-log kill to 99.99% (disinfection) or four-log kill.

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The NV+ is sold with a case of BIT Solution of four-gallon bottles or a case of two 10-liter bottles.

SteraMist Custom Engineered System

SteraMist Custom Engineered System (CES)

The SteraMist Customer Engineered System (“CES”) permanent installation is perfect for any room that requires routine automated decontamination.

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As these relationships continue to grow, we are confident that the groundwork laid in 2023 will soon yield tangible results, driving further adoption and utilization of SteraMist solutions worldwide.

SteraMist Hybrid

The SteraMist Hybrid, a combination of innovation, seamlessly integrating our CES's elegant permanently installed stainless-steel applicators with the generator of the ENV.

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This innovative system provides a cost-effective alternative while ensuring compliance with industry standards.

SteraMist Integrated System

The SteraMist Integrated System (“SIS”) lineup marks a significant advancement, following the SteraMist Select and SteraMist Plasma decontamination chamber products.

We’ve consolidated the capabilities of these predecessors into three new offerings, providing versatile options to meet the diverse needs of our customers, both in terms of product functionality and accessibility.

The SIS-Stand Alone or SIS-SA, replacing the SteraMist Select, and the SIS-Pharm are now available for integrated enclosure decontamination.

The SIS-SA will be stocked in inventory and showcased alongside our NV+ at InterPhex in April 2024.

SteraMist Integrated System (SIS)

The SteraMist Integrated System (“SIS”) lineup marks a significant advancement providing versatile options to meet the diverse needs of our customers, both in terms of product functionality and accessibility.

The SIS-Stand Alone or SIS-SA and the SIS-Pharm are now available for integrated enclosure decontamination.

The SIS-SA will be stocked in inventory and applicators are sold separately.

Conversely, the SIS-Pharm is made-to-order, delivering tailored solutions for specific customer requirements in enclosure decontamination, like our CES.

Both offerings are crafted to streamline products while catering to individual customer needs.

Furthermore, we’re collaborating with manufacturers of enclosure decontamination products to develop the SIS-MFG, formerly known as the Plasma decontamination chamber.

Our custom generator enclosure is shipped unassembled for integration by Original Equipment Manufacturer or OEMs, providing the flexibility to mount and fully integrate iHP control panel components and applicators into OEM enclosure.

The SIS-MFG is an iHP enclosure integrated by Original Equipment Manufacturer or OEMs, providing the flexibility to mount and fully integrate iHP control panel components and applicators into OEM enclosure.

This design ensures that the generator remains out of sight while providing customers an easier method of purchasing iHP as their decontamination solution in a turnkey product.

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Initially, systems were provided by outsourced consultants with the assistances of certified TOMI personnel, but now TOMI offers an all-inclusive package directly, providing an additional source of revenue.

In the latter half of 2024, we plan to expand this department, offering IOQ/PQ services to both current and prospective customers, further solidifying our commitment to delivering comprehensive solutions and exceptional service.

In 2024, we significantly expanded our support services for customers, offering a comprehensive range of options.

From basic training to full validation packages, we are committed to keeping all services in-house, creating an additional revenue stream.

Customers can choose from one or multiple service packages, totaling ten distinct offerings, to accompany their capital equipment purchases.

INFORMATION WITH RESPECT TO OUR BUSINESS IN GENERAL

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Intellectual Property

Our success depends in part upon our ability to obtain and maintain proprietary protection for our products and technologies.

We protect our technology and products by, among other means, obtaining United States and foreign patents.

In addition, the process of obtaining and protecting patents can be long and expensive.

We also rely upon trade secrets, technical know-how, and continuing technological innovation to develop and maintain our competitive position.

As part of our intellectual property protection strategy, we have registered our BIT™ solution with the EPA, all 50 states in the United States, and multiple countries worldwide.

We have received or are in the process of receiving Conformité Européene (“CE”) marks in the European Economic Area (“EEA”) and are approved by Underwriters Laboratory (“UL”).

Our portfolio includes more than 25 Utility or Design Patents worldwide which expire at various dates through the year 2038 for both method and system claims on SteraMist® BIT™, as well as design of devices.

We continue to pursue further claims to additional capabilities in on-going United States and worldwide patent applications.

We have obtained three related United States utility patents, giving us protection of our technology until the year 2038.

We have obtained utility patents for our technologies in diverse countries such as Brazil, Japan, Korea, Israel, Australia, Taiwan, Canada, Mexico, Europe, Singapore, New Zealand, and, currently pending, in the UK, and continue to pursue protections all over the world.

We have submitted utility patent applications in multiple countries, including Europe, China, Brazil, Korea and Australia for further additional applications of SteraMist BIT, and a related application has already been determined novel and inventive in Taiwan, Japan, Israel, New Zealand, Australia and Singapore.

We have obtained five related United States utility patents, giving us protection of our technology until the year 2038.

We have most recently obtained patent protection for our backpack decontamination units and mobile carts in the United States.

We have obtained utility patents for our technologies in diverse countries such as Brazil, Japan, Korea, Israel, Australia, Taiwan, Canada, Mexico, Singapore, New Zealand, Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Slovenia, Sweden and in the UK, and continue to pursue protections all over the world, including China and Europe.

We have submitted utility patent applications in multiple jurisdictions and countries, including Europe, China, Brazil, Korea and Australia for further additional applications of SteraMist BIT, and a related application has already been determined novel and inventive in Taiwan, Japan, Israel, New Zealand, Australia and Singapore.

We have recently filed new patent pending applications on novel uses and enhancements of our technology in the United States.

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Decontamination Chamber(s), Decontamination Applicator, Decontamination Cart, Applicator, and Surface Mounted Applicator 90-Degree Device.

These patents are published around the world, including but not limited to United States, China, Hong Kong, Europe, United Kingdom, Singapore, Taiwan, Vietnam, Canada, South Korea, and Japan.

We are also pursuing IP protection for further applications of our SteraMist BIT in diverse fields in multiple jurisdictions, such as food decontamination and, in installed systems for the application of iHP for the protection of buildings post outbreak or after a biological attack.

These patents are published around the world, including but not limited to the United States, China, Hong Kong, Europe, United Kingdom, Singapore, Taiwan, Vietnam, Canada, South Korea, and Japan.

We are also pursuing IP protection for further applications of our SteraMist BIT in diverse fields in multiple jurisdictions, such as food decontamination in the US and, in installed systems for the application of iHP for the protection of buildings post outbreak or after a biological attack in the US, China, Europe and Japan.

With worldwide attention on the etiology of SARs CoV2 coming from a lab leak, attention on the prevention and control of a leak or mishap should be on the mind of all the biological labs managers around the world.

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Our current patents with claims to systems already serve to provide protection for our technology in this area and our on-going pending applications will further enhance the scope of our intellectual property.

Initial positive search reports for our filed improvement applicator designs in cell biology may be followed by national stage applications in many countries.

Our products are sold around the world under various brand names and trademarks.

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Internationally, our products are sold through exclusive and non-exclusive sales representatives and distributors.

During 2023, we focused on expanding our network of distributors and sale representative and business development initiatives.

We brought on and onboarded 9 distributors and 11 sales representatives, which has expanded our presence domestically and on an international basis.

Research & Development

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To date, every registration for our technology we have applied for has been accepted.

As of March 7, 2024, we have 26 full-time executive, operational and administrative employees working within the United States.

As of April 10, 2025, we have 20 full-time executive, operational and administrative employees working within the United States.

Most of our sales are conducted by global exclusive distribution agreements or domestically by our internal sales team or independent manufacturing representatives.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business