What changed in this filing

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Item 1. Business

2023-03-16 compared with 2022-03-29 · 107 added, 65 removed, 176 unchanged (49% of the section changed)

TOMI Environmental Solutions, Inc.

(“TOMI”, “we” and “our”) is a global bacteria decontamination and infectious disease control company, providing environmental solutions for indoor surface decontamination through the manufacturing, sales, service and licensing of our SteraMist® brand of products, including SteraMist® BIT™, a low percentage (7.8%) hydrogen peroxide-based fog or mist that uses Binary Ionization Technology (BIT™).

Our solution and process are environmentally friendly because the only by-product from our decontamination process is oxygen and humidity.

Our solution is organically listed in the United States and Canada as a sustainable green product with no or very little carbon footprint.

Most of our competitors in the disinfection space leave significant byproducts and are corrosive.

SteraMist is noncorrosive and does not damage equipment or facilities.

(“TOMI”, “we” and “our”) is a global bacteria decontamination and infectious disease control company, providing environmental solutions for indoor air and surface decontamination through the manufacturing, sales, service and licensing of our SteraMist® brand of products, including SteraMist® BIT™, a low percentage (7.8%) hydrogen peroxide-based fog or mist that uses Binary Ionization Technology (“BIT™”).

Our solution and process are environmentally friendly as the only by-product from our decontamination process is oxygen and humidity.

Our solution is organic and is listed in Canada as a sustainably a green product with no carbon footprint.

Most of our competitors in the disinfection space leave significant by-products and are corrosive.

SteraMist is not corrosive, and it does not damage equipment or facilities.

Our SteraMist® is a patented technology that produces ionized Hydrogen Peroxide (“iHP™”) using cold plasma science created under a grant by the United States Defense Advanced Research Projects Agency (“DARPA”).

Our EPA registered BIT™ Solution is composed of a low concentration of hydrogen peroxide converted to iHP™ after passing the trade secret blended solution including its sole active ingredient of 7.8% hydrogen peroxide through an atmospheric cold plasma arc.

Our Environmental Protection Agency (“EPA”) registered BIT™ Solution is composed of a low concentration of hydrogen peroxide converted to iHP™ after passing the trade secret blended solution including its sole active ingredient of 7.8% hydrogen peroxide through an atmospheric cold plasma arc.

The newly formed iHP™ fog and mist consists of submicron’s to 3-micron radical particles that are carried throughout the treatment area in a fog or mist moving with the same velocity and characteristics of a gas.

This allows the ionized hydrogen peroxide fog or mist to affect all surfaces and air space throughout the targeted treatment area, over, above and beyond the ability of manual cleaning and many other disinfection decontamination processes.

Proprietary ingredients accelerate mist and fog dispersion by reducing evaporation time and treatment duration.

This allows the ionized hydrogen peroxide fog or mist to affect all surfaces and air space throughout the targeted treatment area, over, above and beyond the ability of a manual cleaning processes.

iHP™ damages pathogenic organisms through the oxidation of proteins, carbohydrates, and lipids.

SteraMist® no-touch disinfection and or decontamination treat areas mechanically, causing cellular disruptions and/or dysfunctions resulting in a 6-log (99.9999%) and greater kill or inactivation of all pathogens in the treatment area.

Our DARPA-originated technology kills on contact with no residue.

This is a science that the world needs to follow.

This simple and effective process-takes 7.8 % hydrogen peroxide and under pressure pushes the liquid through a nozzle in which the stream is met by an atmospheric cold plasma arc which converts the hydrogen peroxide into a plasma created hydroxyl radical with 6-log and greater kill.

This is a duplication of what occurs in atmospheric chemistry and the only by-product is oxygen and humidity.

The world needs to thank, Titan Defense, DARPA and of course nature for the science behind our technology!

Under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), we are required to register with the EPA and certain state regulatory authorities as a seller of disinfectants.

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In 2021, the EPA granted SteraMist® BIT™ 0.35% hydrogen peroxide – EPA registration number 90150-3.

SteraMist® BIT™ brings to the world a mechanical and automated method of cleaning using innovative technology and EPA registered Hospital-HealthCare disinfectant, which improves and upgrades existing disinfecting and cleaning protocols that mitigates the risk of liability in a facility with transmission of resistant infectious pathogens.

We maintain this registration in all fifty (50) states, Washington DC, Canada, and registration and or importation rights in approximately thirty-five (35) other countries as of March 28,2022.

On June 2, 2022, SteraMist was included on the EPA’s List Q for the use of its BIT solution to help fight the spread of rare or novel viruses such as Monkeypox virus, SARS-CoV-2 and its variants that causes COVID-19.

SteraMist® BIT™ brings to the world a mechanical and automated method of cleaning using a game-changing technology and EPA registered Hospital-HealthCare disinfectant providing an upgrade to existing disinfecting and cleaning protocols while limiting liability in a facility when it comes to resistant infectious pathogens.

We maintain this registration in all fifty (50) states, Washington DC, Canada, and approximately forty (40) other countries receive our product.

Our Technology

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Although our technology was developed to combat the hardest to kill pathogens and neutralize the most difficult chemical agents, our products and services have been used by our customers who are fighting at the front lines of combating the COVID-19 pandemic, especially from early 2020 to 2021.

As the COVID-19 pandemic gradually subsides, our customers continued to utilize our products as cleaning protocols have been changed due the impact of the COVID-19 pandemic.

As the COVID-19 pandemic gradually subsided, our customers continue to use our products in new general cleaning protocols due to the impact of the COVID-19 pandemic.

Our technology passed a sanctioned test showing six-log reduction against Geobacillus stearothermophilus .

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Industries & Market Segments

Our product offerings help our customers create a healthier world by providing them a significant opportunity to help reduce the spread of Community Associated Infections (“CAI’s”) and Healthcare-Acquired Infections (“HAI’s”) and the most lethal of pathogens including our recent SARS CoV-2 pandemic and future pandemics.

SteraMist ® and TOMI’s related service platforms are currently being used in a broad spectrum of industries and have the ability to fit into any cleaning protocol.

We have categorized these industries into five (5) divisions:

Our 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:

Hospital-HealthCare, Life Sciences, TOMI Service Network (“TSN”), Food Safety, and Commercial.

Hospital-HealthCare.

SteraMist ® solutions aid our Hospital-HealthCare customers in providing the quality of care and safety they provide to their patients by disinfecting patient and operating rooms, pharmacies, ambulances, and emergency environments in a hospital or healthcare facility.

Our team of technicians and representatives train, write treatment protocols, maintain and troubleshoot capital equipment throughout the world for our Hospital-HealthCare customers.

We continue to penetrate the hospital-healthcare market segment, and under the United States Patient Protection and Affordable Care Act’s (also known as the Affordable Care Act or ACA) Hospital Readmissions Reduction Program, hospitals that have high rates of infections and HAIs are facing significant financial penalties.

Our SteraMist ® BIT ™ technology has proven to reduce the transference spread of infections leading to an overall reduction in the number of patients being infected as a result of the historic poor manual cleaning of these patient rooms, infectious disease rooms and operatory suites, with a corresponding return on investment to the hospital of up to 20-to-1 in the first year.

We continue to offer our customers a wide range of innovative mobile products designed to be easily incorporated into their existing disinfection and decontamination procedures and protocols.

Our newly released SteraPak, among other product lines will allow us to progress further into market share, specifically for our Life Science, Hospital-HealthCare, TSN, and Commercial divisions.

Additionally, we offer integrated facility equipment installations known as Custom Engineered Systems (“CES”), routine & emergency iHP Corporate Service, essential training packages, validations and qualifications, and onsite performance maintenance requests.

Each of these are structured to address the unique disinfection and decontamination needs of our customers worldwide regardless of industry requiring or requesting SteraMist ® disinfection decontamination.

A brief overview of the target industries is presented below:

Life Sciences

Our SteraMist ® line of products is a decontamination solution in this industry, specifically pharmaceutical (compounding and manufacturing), vivariums, research universities, BSLs (biological safety labs) 1, 2, 3 and 4 level, BSC’s (biological safety chambers), isolators, cage washers, and cleanrooms.

With proper implementation of SteraMist ® , all facilities can reduce the risk of infectious as well as potentially infectious agents and/or materials, which facilities such as these handle on a routine basis.

There are many requirements and restrictions on the type of decontamination agents our Life Sciences customers may use to prevent these risks and remediate adverse incidents.

In light of these regulations, our rapid deployment of our effective iHP ™ aerosolized mist is the solution to lower risks, reduce damage to expensive laboratory equipment and furniture, eliminate other labor intense procedures, and perform decontamination clean-up in these spaces quickly, less caustically, requiring no wipe and with no residue.

By using iHP technology these most important facilities are able to perform more experiments a year due to the effective quick treatment that iHP offers.

Our team of technicians and representatives train, maintain, and troubleshoot capital equipment globally for our Life Sciences customers.

Further, our iHP ™ Corporate Service decontamination team provides routine and emergency treatment.

TOMI’s iHP ™ service team performs commissioning and decommissioning of facilities equipment or full complete space decontamination for new and existing customers.

The TOMI Service Network .

The TSN, has allowed us to enhance our corporate service division by creating a multi-nation-wide network composed of existing, full-service specialists.

These professional servicing specialists (TSN partners) focus their businesses in the commercial and residential space.

Our team of customer experience managers and our training department maintains and troubleshoots capital equipment for these individuals with the goal of implementing servicing procedures and protocols throughout the United States and Canada for our TSN partners.

Members are provided access to 24/7 support in marketing their iHP service divisions and landing webpage connected to our website.

We are technically advancing and streamlining engagement for the TOMI Service Network (TSN) by providing a user-friendly membership portal – The SteraMist | TSN Portal.

This membership portal will host all marketing and informational material, ability to share member information to easily collaborate with other members, forums to interact and discuss topics and further develop knowledge on disinfection, podcast link, news alerts about new products and promotions, and direct to an order link.

This portal will be available for desktop as well as a mobile app located on Apple App Store and Google Play.

This portal will also be available for SteraMist Representatives, domestic and international, with amended permissions for ease of access to all SteraMist sales materials.

Our TSN network includes professional first responders that specialize within the mold remediation, hurricane and tornado response and other mitigation fields, biohazard and forensic specialists, and janitorial businesses.

Food Safety Industry.

The SteraMist ® Environment System, CES, the SteraMist ® Select Surface Unit (Plus), SteraBox, 90 Degree Applicator and our iHP ™ Corporate Service Division, are designed to be tailored to provide a complete solution to address the regulatory inspections of disinfecting/decontaminating and Installation Qualification (IQ)-Operational Qualification (OQ)–Performance Qualification (PQ) validation processes within the life sciences industry.

Long term, ongoing projects and validations continue to be a focus and lead to proposals and interest for our CES permanent decontamination room.

As these are longer lead-time sales and manufactured upon order that can take months to design, procure, assemble, and implement, we expect installations to have material impact to our results in 2023 and 2024.

TOMI’s iHP service department continues to grow with new and existing customers in several divisions.

In the life science sector, TOMI’s iHP service department has kept its relationships with large pharmaceuticals (Pfizer/ThermoFisher) as well as adding several smaller life science companies (ForDoz/Lonza) to a regular decontamination schedule.

In addition to these productions’ facilities, TOMI has treated four BSL-3 research laboratories in all parts of the country within the last two months (UNM/UNC/Bioqual/Scripps).

The food safety department steadily gains traction as several plant/produce companies have expressed interest as new and emerging bacteria, toxins, and fungi hamper production.

Finally, the commercial division is a stable source of revenue for TOMI and its service network as many public facilities are feeling the effects of Hurricane Ian.

For 2023 and beyond, TOMI expects growth in SteraMist CES bids and the manufacturing and implementation of these fully automated decontamination systems.

The installed CES will also result in increased solution sales for Life Sciences as the CES’s are used at regular intervals.

The first CES system was completed in 2016 for Dana Farber Cancer Institute, as Dana Farber was designing a new vivarium and had the opportunity to integrate several new technologies to advance overall efficiency, quality, and design.

One such technology was the use of our iHP decontamination.

TOMI’s CES is an automated system that can be fully integrated into any company’s infrastructure, enabling decontamination, without burdening manual use and with the collaboration of current premier customers and partners, TOMI has further perfected the system.

The CES eliminates issues such as human error, guarantees accuracy that is unmatched by competitors, and decreases a client’s labor cost and downtime, and in a short time the CES may make up a majority of TOMI’s revenue.

Since its launch, SteraMist’s CES has become a leading solution to growing customer demands.

Hospital-Healthcare

The SteraMist ® line of products, specifically the SteraMist ® Surface Unit and SteraMist ® Total Disinfection Cart, are our main solutions to aid our Hospital-HealthCare customers in providing high quality of safety to their patients and personnel by disinfecting operating rooms, pharmacies, ambulances, and emergency environments throughout a healthcare facility.

TOMI’s latest product, the SteraPak ® , further assists healthcare communities with an easy-to-use, cordless disinfection solution, creating a more mobile solution.

Our customers that have successfully adopted our technology in Hospital-Healthcare facilities, have recurring revenue and reorder rates of our BIT ™ Solution.

We plan to continue to expand our marketing, advertising and educational campaigns targeted at the Hospital-Healthcare marketing to grow our customer base and increase adoption of our SteraMist ® line of products.

Our team of technicians and representatives train, maintain, and service capital equipment throughout the world for our Hospital-HealthCare customers.

As our Training and Implementation department expands, we expect continued growth and purchases in our Hospital-HealthCare division.

TOMI provides protocol development and implementation of SteraMist ® as it is critical in the healthcare setting, including pandemic preparedness.

TOMI anticipates expansion of current HealthCare customers to follow the model of Gila River Health Care.

Gila River is one of TOMI’s largest Healthcare customers owning a total of fourteen (14) Surface Units and eight (8) SteraPak’s.

The Gila River Indian Community (GRIC) is an Indian reservation in Arizona that is made up of seven (7) districts and is home to the Akimel O’oodham (Pima) and the Pee-Posh (Maricopa) tribes.

Gila River Health Care, a premier Native American healthcare system, provides high quality patient care, delivering a wide variety of medical services such as general surgery, dental, and emergency medicine, as well as associated health services such as pharmacy and laboratory operations, skilled nursing, rehabilitation, and medical transport.

New challenges to food safety will continue to emerge, largely because of changes in our food production, food supply, storage complexities, transportation delays, including more imported foods.

Changes in the environment leads to food contamination, new and emergent bacteria, toxins, and antimicrobial resistance.

Food Safety presents an opportunity for significant growth for TOMI with continued product research and compliance testing.

The food safety industry in North America is under closer scrutiny with the implementation and enforcement of new and established guidelines.

SteraMist ® aerosolizing cold plasma technology is an effective decontaminant in the food safety industry.

According to the CDC, 80 million people per year in the United States contract, and 5,000 people die from, food poisoning or other food-related illnesses.

Current food safety cleaning techniques involve time intensive processes, which can reduce food manufacturers’ profit.

Our iHP ™ degrades into only harmless water (humidity) and oxygen.

We have applied for approval from the United States Food and Drug Administration (the “FDA”) and the United States Department of Agriculture (the “USDA”), when approved we anticipate that our solution can be applied directly to all foods.

Currently we use SteraMist ® on food packing, processing and storage equipment as SteraMist ® is safe for use on electronics and kitchenware, along with high touch surfaces where most pathogens are found (such as phones, computers and kitchen appliances).

We believe that SteraMist ® could be useful for decontamination at all phases of food production, from the farm, slaughterhouse, packaging and canning facilities, food storage locations to the transportation of food and to the restaurants and grocery stores.

TOMI commercial division addresses the viral pathogens threat to everyday operations.

We bring powerful disinfection and decontamination to a wide array of industries with computability in endless use sites, from large-scale land, sea, and air transportation to county and state emergency facilities to retail and educational facilities.

Our commercial customers have the goal to keep employees and first responders healthy while maintaining operations and our latest product launch the SteraPak ® has received well recognized feedback in these markets.

Homeland defense and border protection is a subspecialty of our commercial division .

Our SteraMist ® line of products will give governmental bodies an added tool in their arsenal to mitigate the risk of a weaponized biological and chemical attack.

In addition, SteraMist ® mitigates the spread of emerging pandemic viruses, including strains of Ebola, MERS, MLAV (filovirus), and influenza virus subtypes like h1n1, h5n1, h7n9 and h10n8.

Our SteraMist ® line of products assists border patrol agents in controlling the spread of infectious disease introduced by foreign individuals by decontaminating interview rooms, containment rooms, holding cells and quarantine areas after a potential infected carrier’s condition either improves or the carrier dies.

SteraMist can assist in compliance with the newly established Food Safety Modernization Act guidelines set in place by the FDA, as well as the Safe Food for Canadians Act and Safe Food for Canadians Regulations in Canada.

Today’s Geopolitical aspects of farming and ranching has created an extra layer of concern for the protection of our global limited food supply including food transportation.

TOMI continues to work with premium companies in testing and validating SteraMist ® technology in the Food Safety and seed industries.

In 2022, we made progress in enhancing brand awareness in the food safety industry by promoting and marketing this division.

We are receiving an increase in inquiries within the Food Safety division directly from these efforts.

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

Unsafe food containing harmful bacteria, viruses, parasites, or chemical substances causes more than 200 diseases, ranging from diarrhea to cancers.

It also creates a vicious cycle of disease and malnutrition, particularly affecting infants, young children, elderly and the sick.

With the global population explosion, severe worldwide avian flu pandemics resulting in the unnecessary culling of bird flocks, unusually high accidents resulting in the destruction of over 30 storages, packing and processing food plants, in the U.S.

alone, we anticipate an increase in the demand for a mechanical way to disinfect our food supply.

TOMI has, in cooperation with the USDA, demonstrated that our technology offers a consistent, quick, and effective alternative to the traditional, decade’s old chemical disinfection process.

SteraMist will deliver more consistent and quicker results in all areas of our food supply–From Farm to Market, Processing to Packaging, and Storage to Delivery.

We are currently pursuing all these avenues.

Continued testing and market demand coupled with our new BIT™ 0.35% hydrogen peroxide label will make pursuing these opportunities successful.

In addition, our solution and process are environmentally friendly in that the by-product of SteraMist is only oxygen and water in the form of humidity.

We have our solution listed on OMRI and labeled as organic.

Most disinfectants leave residue on equipment, furniture, objects, and foods.

SteraMist does not leave any chemical residue on any surface.

We have a very low carbon footprint, if any, just oxygen and humidity.

SteraMist is the perfect product for the global current issues in food safety.

We are told we consume too much food, we produced too little food, and our farming screws up the environment, SteraMist is ready to assist in the defense of our food industry for whatever their needs are.

TOMI Service Network

The TOMI Service Network, or TSN, is an expansive network consisting of professionals throughout North America 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 TOMI Service Network (“TSN”) division is addressing the cleaning protocols that have changed permanently due to the COVID-19 pandemic, and our network is expected to play a significant role in facilitating and maintaining these protocols throughout the United States and Canada.

The urgency for emergency disinfection services is starting to pick up due to employees returning to work and the increasing number of contagious variants becoming more of a world concern.

Our education and support of such services that TOMI personnel provide to our members creates an advantage by maintaining strong business relationships while they service thousands of SteraMist ® customers, and the world returns to the new normal which will always focus on emerging pathogens.

Our SteraPak ® release is an important factor for this market that we will increase the new member onboarding.

Current members are showing interest in purchasing the SteraPak ® to expand their current SteraMist ® offerings.

Our Commercial division includes but is not limited to use sites such as aviation, airports, police and fire, prisons, manufacturing companies, automobile, military, cruise ships, shipping ports, preschool education, primary and secondary schools, colleges including dormitories, all modes of public and private transportation, regulatory consulting agencies, retail, housing and recreation, and of course emergency preparedness for counties and cities to use SteraMist ® throughout their community.

The Surface unit and SteraPak ® is a popular product for this division because customers are looking for a more cost-effective solution compared to the current disinfectants on the market.

As quick and mobile disinfection solution is preferred in this industry, we believe that our surface unit along with the SteraPak ® will generate customer interest and create sales opportunities.

Currently our customers are purchasing our products in all of our divisions to provide quick disinfection throughout various sites in their facilities.

INFORMATION WITH RESPECT TO OUR BUSINESS IN GENERAL

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We outsource the manufacturing and blending of our SteraMist ® line of equipment and BIT ™ Solution.

Our SteraMist ® equipment is manufactured by three (3) ISO9001 registered companies with multiple facilities in Pennsylvania, New York, New Jersey, North Carolina, California, and Australia.

Our SteraMist ® equipment is manufactured by ISO9001 registered companies with multiple facilities in Pennsylvania, New York, New Jersey, North Carolina, California, and Australia.

Our solution is blended by an EPA approved blender;

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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 Environmental Protection Agency (“EPA”), all fifty (50) states in the United States, and multiple countries worldwide.

As part of our intellectual property protection strategy, we have registered our BIT ™ solution with the EPA, all fifty (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 twenty (20) Utility Patent applications worldwide for both method and system claims on SteraMist ® BIT ™ , either published or undergoing prosecution.

In 2021, we were granted utility patents in Korea, Canada, Mexico, Taiwan, Israel, and Australia for our SteraMist BIT.

In the recent past, we have obtained two related United States utility patents giving us protection of our technology until the year 2038, and we are pursuing further claims to additional capabilities in on-going United States and worldwide patent applications.

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

Our portfolio includes more than twenty (20) Utility Patent applications worldwide which expire at various dates through the year 2042 for both method and system claims on SteraMist® BIT™, either published or undergoing prosecution.

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

We have obtained two 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, and, currently pending, in Europe and Singapore, 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, and Singapore.

We have been awarded a design patent on our surface-mounted applicator device in the United States, China, Japan, Taiwan, and Korea.

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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 at multiple jurisdictions, such as food decontamination.

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

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.

The fact that iHP and our BIT platform can be incorporated in a new or existing buildings to create an “immune building” should assist in further lab applications of SteraMist in the biosecurity industry in the future

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

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We intend to continue to expand and support research and development on other decontamination and remediation solutions and to form more business alliances with strategic partners.

We continue to perform decontamination services within cleanrooms, bio-safety labs, tissue and blood labs, pharmaceutical labs, vivariums and research universities and we continue to secure additional license agreements with major remediation, construction, forensic clean-up and bio-safety servicing companies.

We continue to perform decontamination services within cleanrooms, bio-safety labs including BSL-3 and BSL-4 labs, tissue and blood labs, pharmaceutical labs, vivariums and research universities and we continue to secure additional license agreements with major remediation, construction, forensic clean-up and bio-safety servicing companies.

Both of these strategies assist in the brand awareness and use of our suite of products.

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The TOMI sales team is already working with Critical Scientific who within months has a large opportunity with the Australian Government agency responsible for scientific research.

In December of 2021, TOMI launched the SteraMist Amazon Store.

The digital storefront expands our sales channels, increases TOMI brand awareness and optimizes and streamlines the buying process for our customers.

The decontamination and environmental infectious disease control industry is intensely competitive and highly regulated.

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For example, the sprayer may not be spraying enough of the chemical to kill the virus or the bacteria, in addition to a lot of these harsh chemicals and sprayers are destroying materials and equipment over time, creating a more costly product in the long run.

Our low percentage of hydrogen peroxide serves as a competitive advantage with respect to transporting our product by air.

Our major hydrogen peroxide competitors have to transport their chemicals by rail, road or sea as the Department of Transportation (DOT) will not allow a product that contains greater than 8% hydrogen peroxide to be transported by air.

Our patented SteraMist technology can treat almost 4,000 cubic feet in 45 minutes with a contact time of only 15 minutes or spray surfaces 5 seconds per square foot with no wet contact time.

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Government regulations include detailed inspection of, and controls over, research and development, product approvals and manufacturing, marketing and promotion, sampling, distribution, record-keeping, storage, and disposal practices.

We believe that we are currently compliant in all material respects with applicable regulatory requirements.

SteraMist with 7.8% Hydrogen peroxide is not subject to stringent government regulations that usually apply to the transporting chemicals We believe that we are currently compliant in all material respects with applicable regulatory requirements.

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

As of March 14, 2022, we have twenty-four (24) full-time executive, operational and administrative employees working within the United States.

As of March 7, 2023, we have thirty (30) 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.

We consider our relationship with the employees to be good.

Available Information

We make available free of charge on or through our corporate website, https://tomimist.com/, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements, and all amendments to those filings as soon as reasonably practicable after such material is electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”).

Information contained on our website is not incorporated by reference unless specifically stated therein.

In addition, the SEC maintains a website that contains reports, proxy statements, and other information about issuers, such as TOMI, who file electronically with the SEC.

The address of the website is www.sec.gov.

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