About TOMI Environmental Solutions

TOMI Environmental Solutions, Inc. (TOMI) is a global bacteria decontamination and infectious disease control company. The company is providing environmental solutions for indoor air and surface decontamination through the manufacturing, sales, service and licensing of the company's SteraMist brand of products, including SteraMist BIT, a low percentage (7.8%) hydrogen peroxide-based fog or mist that uses Binary Ionization Technology (BIT). The company's solution and process are environmentally friendly as the only by-product from its decontamination process is oxygen and humidity. The company's solution is organic and is listed in Canada as a sustainably a green product with no carbon footprint. The company's 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). The company's 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 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. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the company is required to register with the EPA and certain state regulatory authorities as a seller of disinfectants. In June 2015, SteraMist BIT was registered with the EPA as a hospital-healthcare disinfectant and general broad-spectrum surface disinfectant for use as a misting/fogging agent. SteraMist BIT holds EPA registrations (# 90150-2) for mold control, and air and surface remediation (# 90150-1). In February 2016, the company expanded its label with the EPA to include Clostridium difficile Spores and MRSA, as well as the influenza (Avian) virus h1n1, which has better positioned the company to penetrate all industries, including the biodefense and healthcare industry. In August 2017, the company's EPA label was further expanded to include efficacy against Salmonella and Norovirus. As of January 27, 2017, the company's technology is one of 53 of the EPA's Registered Antimicrobial Products Effective against Clostridium difficile Spores, as published on the EPA's K List. Further, in December 2017, SteraMist was included in the EPA's list G (Norovirus), L (Ebola) and M (Avian Flu). In March 2020, its EPA label was further amended to include Emerging Viral Pathogens claims, thus meeting the criteria against Enveloped viruses and Large Non-enveloped viruses and included on List N (Emerging Viral Pathogens, including SARS-CoV-2). In 2021, the EPA granted SteraMist BIT 0.35% hydrogen peroxide - EPA registration number 90150-3. 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 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. The company maintains this registration in all fifty (50) states, Washington DC, Canada, and approximately forty (40) other countries receive its product. Products and Services SteraPak SteraPak is the company's most affordable and portable SteraMist system yet. The all-in-one SteraPak places the SteraMist technology onto the technicians back, delivering premium disinfection utilizing a rechargeable battery and cordless operation. The SteraPak is sold with a case of BIT Solution of eight (8) 32-ounce bottles. The single applicator Pak enables disinfection of all surfaces, including high touch, sensitive equipment, and electronics. An application time of only five seconds per square foot with no wet contact time allows for safe re-entering of the space within minutes after application. SteraMist Surface Unit The company's SteraMist Surface Unit is a fully portable, handheld, point and spray disinfection/decontamination system intended to provide quick turnover of any affected space. The single applicator unit enables disinfection of all surfaces, including high touch, sensitive equipment, and electronics. An application time of only five seconds per square foot with no wet contact time allows for safe re-entering of the space within minutes after application. The company's SteraMist Surface Unit is lightweight, easy to transport and capable of achieving reliable disinfection/decontamination results, as it is easily incorporated into existing cleaning procedures and protocols. The SteraMist Surface Unit does not require heating, ventilation, or air conditioning systems to be shut down. Further, its touchless application (no wipe, no rinse) reduces risk of cross-contamination between treated surfaces. SteraMist Environment System The company's SteraMist Environment System is a transportable, remotely controlled system that provides complete room disinfection/decontamination of a sealed space up to 103.8 m3 (3,663 ft3) in just under 45 minutes (application and dwell time). Individually, each remote applicator can be used to treat a space of approximately 34.6 m3 (1,221 ft3). Injection times are based on individual room size and number of applicators. Multiple systems can be used simultaneously to accommodate larger or multiple spaces with fast application and minimal down time. The company's hybrid technology applicators can be used in both manual and/or fogging modes. The company's SteraMist Environment System features additional programmable and printable features in PDF format. Other key features include lot # of BIT™ Solution, location identifier, injection/dwell/aeration times, and error notifications. These features are required for many Life Science facilities. The SteraMist Total Disinfection Cart The Total Disinfection Cart was designed with input of public healthcare facilities EVS (Environmental Service) teams using the company's equipment for the SHIELD study that TOMI was participating in. The cart houses the company's Surface Unit, a portable H2O2 monitor, carbon air scrubber, respiratory protection system with positive pressure air flow, storage hooks, and a sign notifying the room is being treated. Included with the Cart is a custom ICU 55-minute terminal cleaning protocol. SteraMist Select Surface Unit The company's Select Unit was designed to meet the needs of its customers who have smaller enclosures that require decontamination. This unit is lightweight and easy to transport with the added ability to function between a lower flow operation and standard operation, such as the SteraMist Surface Unit. The user can adjust air flow, pump fluid flow, set the programmable timer for automatic runs, modify spray/dwell times and the number of treatment cycles along with being equipped with start and stop buttons. It is ideal for the decontamination of Biosafety cabinets, Laminar flow cabinets, Isolators, and other small and medium size laboratory and research equipment. Stainless Steel 90 Degree Applicator TOMI's standard applicator was converted to a 90 degree and manufactured using 316 stainless steel, the ideal applicator to accompany the Select Surface Unit, affording many 90-degree build-in opportunities. This applicator is purchased with a flange for ease of installation either permanently or semi-permanently. iHP Plasma Decontamination Chamber The company's patented cold plasma technology can be integrated with a chamber or cage washer by leading manufacturers. Examples are BetterBuilt, Allentown, and Coy Lab. The company's custom generator/chamber is built into a stainless-steel single door panel and is permanently mounted next to the chamber or washer, while a SteraMist Applicator or 90 Degree Applicator is permanently or semi-permanently mounted in the enclosure. This SteraMist product line includes but is not limited to an internally mounted air compressor, regulator for air pressure adjustment, E-stop button, lever power switch, data logging functions, and multiple dry contract outputs determined by the needs of the customer. SteraMist Custom Engineered System (CES) The SteraMist permanent installation is perfect for any room that requires routine automated decontamination. The CES is an automated system that is installed and plumbed utilizing the facilities' existing HVAC system. This involves permanently installing SteraMist applicators within the designated space to achieve maximum results. The generator and Programmable Logic Control (PLC) are housed in a National Electrical Manufacturers Association (NEMA) enclosure in a central remote location. The entire system can be developed for multiple rooms and various specifications, controlled remotely through the NEMA interface. The status of the decontamination cycle is monitored with indicators and can be integrated into a Supervisory Control and Data Acquisition (SCADA) monitoring board. The system is available with a scale to measure the use of BIT Solution for a customer's ease of reordering the company's consumable and comes in a variety of drum sizes. In addition, this product includes a new upgrade of 90-degree rotating applicators providing even faster equal dispersion of the iHP fog. iHP Corporate Service Decontamination TOMI offers full room, equipment, facility, and emergency disinfection and decontamination services by certified SteraMist technicians. Single and routine services are provided to TOMI customers to coincide with maintenance, mandatory facility shutdowns, or to control a specific threat. SteraMist technicians provide an efficient 4-step facility disinfection decontamination: site review, protocol generation, deployment and service, and post-treatment reporting. Industries and Market Segments The company's SteraMist products are designed to address a wide spectrum of industries using iHP. The company's operations consist of five main divisions based on its target industries: Hospital-HealthCare, Life Sciences, TOMI Service Network (TSN), Food Safety, and Commercial. The company continues to offer its customers a wide range of innovative mobile products designed to be easily incorporated into their existing disinfection and decontamination procedures and protocols. The company's newly released SteraPak, among other product lines will allow it to progress further into market share, specifically for its Life Science, Hospital-HealthCare, TSN, and Commercial divisions. Additionally, the company offers integrated facility equipment installations known as Custom Engineered Systems (CES), routine and 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 the company's customers worldwide regardless of industry requiring or requesting SteraMist disinfection decontamination. Life Sciences 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. 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. Hospital-Healthcare The SteraMist line of products, specifically the SteraMist Surface Unit and SteraMist Total Disinfection Cart, are the company's main solutions to aid its Hospital-HealthCare customers in providing 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. The company's customers that have successfully adopted its technology in Hospital-Healthcare facilities, have recurring revenue and reorder rates of its BIT Solution. TOMI provides protocol development and implementation of SteraMist as it is critical in the healthcare setting, including pandemic preparedness. Gila River is one of TOMI's largest Healthcare customers owning a total of fourteen (14) Surface Units and eight (8) SteraPak's. Food Safety SteraMist aerosolizing cold plasma technology is an effective decontaminant in the food safety industry. 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. TOMI continues to work with premium companies in testing and validating SteraMist technology in the Food Safety and seed industries. In 2022, the company made progress in enhancing brand awareness in the food safety industry by promoting and marketing this division. TOMI has, in cooperation with the USDA, demonstrated that its technology offers a consistent, quick, and effective alternative to the traditional, decade's old chemical disinfection process. TOMI Service Network The TOMI Service Network (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. Commercial The company's 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 company's customers are purchasing its products in all of its divisions to provide quick disinfection throughout various sites in their facilities. Manufacturing The company outsources the manufacturing and blending of its SteraMist line of equipment and BIT Solution. The company's SteraMist equipment is manufactured by ISO9001 registered companies with multiple facilities in Pennsylvania, New York, New Jersey, North Carolina, California, and Australia. The company's solution is blended by an EPA approved blender; its blend includes one (1) sole active ingredient, and 7.8% Hydrogen Peroxide. Intellectual Property As part of the company's intellectual property protection strategy, it has registered its BIT solution with the EPA, all fifty (50) states in the United States, and multiple countries worldwide. The company has received or is in the process of receiving Conformite Europeene (CE) marks in the European Economic Area (EEA) and are approved by Underwriters Laboratory (UL). The company's 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. The company continue to pursue further claims to additional capabilities in on-going United States and worldwide patent applications. The company has obtained two related United States utility patents giving it protection of its technology until the year 2038. The company has obtained utility patents for its 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. The company has 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. The company has been awarded a design patent on its surface-mounted applicator device in the United States, China, Japan, Taiwan, and Korea. The company has filed and have been granted or have pending acceptance on thirty-two (32) separate design patents for its: 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. The company is also pursuing IP protection for further applications of its 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. The company's products are sold around the world under various brand names and trademarks. The company considers its brand names and trademarks to be valuable in the marketing of its products. As of today (December 31, 2022), the company has over two hundred trademarks, (word and/or logo) registered or pending across the globe. TOMI registers marks in eight (8) classes of specification of goods and services: Class 1 for Chemicals for Treating Hazardous Waste, Class 5 for Disinfectants, All-Purpose for Hard Surfaces and for Treating Mold, Class 7 for Handheld Power Operated Spraying Machines, Class 11 for Sterilizers for Medical Use and Air Purification, Class 35 for Business Consultation and Management Services, Class 37 for General Disinfecting Services, Class 40 for Chemical Decontamination and Manufacturing Services, and Class 41 for Providing Education Training and information related to biological and bacterial decontamination services. Marketing and Distribution The company continues 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 it continues 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 the company's suite of products. The company sells its products domestically through its internal sales force, as well as independent sales and manufacturing representatives. Internationally, the company's products are sold through exclusive and non-exclusive sales representatives and distributors. Competition The company's competitors include companies that market other hydrogen peroxide-based products, such as Steris Corporation (Steris); Bioquell, Inc. (Bioquell) owned by Ecolab, Inc. (Ecolab); and The Clorox Company (Clorox), various ultraviolet companies and quad ammonia-chemical companies. Research and Development The company's research and development expenses for the year ended December 31, 2022, were approximately $352,000. Government Regulation The company's business is subject to various degrees of governmental regulation in the countries in which it operates. In the United States, the Environmental Protection Agency (EPA), the United States Food and Drug Administration (the FDA), and other governmental authorities regulate the development, manufacture, sale, and distribution of the company's products and services. History TOMI Environmental Solutions, Inc., a Florida corporation, was incorporated in 1979.