Tomi Environmental Solutions, Inc. (Tomz): Análise de Pestle [Jan-2025 Atualizado]

Na paisagem em rápida evolução da desinfecção ambiental, a Tomi Environmental Solutions, Inc. (Tomz) fica na vanguarda de tecnologias transformadoras que estão reformulando como abordamos o controle e a higienização de infecções. Desde tecnologias de ponta UV e peróxido de hidrogênio a sistemas inovadores automatizados, essa análise abrangente de pilotes revela o complexo ecossistema de desafios e oportunidades que definem o posicionamento estratégico de Tomz em um mundo pós-panorâmico, onde a saúde pública, a inovação tecnológica e a sustentabilidade ambiental convergentes com a URSECEDENTENTE urgência.

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores Políticos

Aumento dos regulamentos federais e estaduais, apoiando tecnologias de desinfecção

A Agência de Proteção Ambiental dos EUA (EPA) registrou 84 tecnologias de desinfecção a partir de 2023, com estruturas regulatórias específicas que apoiam soluções avançadas de higienização.

Agência regulatória	Número de aprovações de tecnologia de desinfecção	Ano
EPA	84	2023
Tecnologias recomendadas do CDC	36	2023

Contratos do governo e subsídios para soluções de higienização relacionadas ao CoVID-19

O financiamento federal de tecnologia de desinfecção relacionado ao CoVID-19 atingiu US $ 247 milhões em 2023, com alocações específicas para soluções avançadas de higienização.

• Departamento de Saúde e Serviços Humanos CoVID-19 Tecnologia Subsídios: US $ 127 milhões
• Investimentos de tecnologia de desperdício em nível estadual: US $ 92 milhões
• Financiamento da Tecnologia de Desinfecção de Emergência Federal: US $ 28 milhões

Potenciais tensões geopolíticas que afetam a expansão do mercado internacional

Restrições comerciais globais e limitações de transferência de tecnologia afetam os mercados internacionais de tecnologia de desinfecção.

Região	Restrições de importação de tecnologia	Desafios de acesso ao mercado
Ásia-Pacífico	37% aumentou o escrutínio regulatório	Moderado
União Europeia	24% de requisitos de conformidade	Baixo

Prioridades emergentes de políticas de saúde pública Apoiando tecnologias avançadas de desinfecção

Estruturas de política de saúde pública priorizam cada vez mais tecnologias avançadas de desinfecção em vários setores.

• Padrões de desinfecção obrigatórios para desinfecção: 68% dos estados implementaram novos regulamentos
• Requisitos de Santização da Instituição Educacional: 42 Estados atualizados Diretrizes
• Protocolos de desinfecção de transporte público: US $ 56 milhões em financiamento federal alocado

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores econômicos

A demanda contínua do mercado de serviços de saúde e instalações médicas por controle de infecção

O tamanho do mercado global de desinfecções hospitalares foi avaliado em US $ 4,2 bilhões em 2022 e deve atingir US $ 7,8 bilhões até 2030, com um CAGR de 8,5%.

Segmento de mercado	2022 Valor	2030 Valor projetado
Mercado de desinfecção hospitalar	US $ 4,2 bilhões	US $ 7,8 bilhões

Potenciais desafios econômicos de flutuação de gastos com saúde

Os gastos com saúde nos EUA atingiram US $ 4,5 trilhões em 2022, representando 17,3% do PIB. Os gastos com saúde global que se espera que cresçam 5,4% ao ano até 2024.

Métrica	2022 Valor	Taxa de crescimento
Gastos com saúde nos EUA	US $ 4,5 trilhões	5,4% anualmente

Mercado em crescimento para soluções de desinfecção comercial e comercial

O mercado de desinfecções comerciais estimou em US $ 3,6 bilhões em 2023, com crescimento projetado para US $ 5,9 bilhões até 2028.

Segmento de mercado	2023 valor	2028 Valor projetado
Mercado de desinfecções comerciais	US $ 3,6 bilhões	US $ 5,9 bilhões

Investimento em tecnologias emergentes de prevenção de doenças infecciosas

O mercado global de diagnóstico de doenças infecciosas se projetou para atingir US $ 89,8 bilhões até 2027, com um CAGR de 5,8%.

Segmento de mercado	2022 Valor	2027 Valor projetado	Cagr
Diagnóstico de doenças infecciosas	US $ 63,5 bilhões	US $ 89,8 bilhões	5.8%

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores sociais

Consciência pública aumentada sobre o controle de infecção pós-pós-panorâmica

De acordo com uma pesquisa de 2023 Gallup, 78% dos americanos permanecem preocupados com a transmissão de doenças infecciosas em espaços públicos. O mercado global de controle de infecções foi avaliado em US $ 20,3 bilhões em 2022 e deve atingir US $ 34,5 bilhões até 2027.

Ano	Nível de preocupação pública	Valor de mercado de controle de infecção
2022	72%	US $ 20,3 bilhões
2023	78%	US $ 26,7 bilhões
2024 (projetado)	82%	US $ 30,5 bilhões

Ênfase corporativa nos protocolos de segurança e saúde no local de trabalho

A Administração de Segurança e Saúde Ocupacional (OSHA) informou que 75% das empresas têm protocolos de higienização no local de trabalho desde 2020. O mercado de bem -estar corporativo deve atingir US $ 93,4 bilhões até 2025.

Setor corporativo	Protocolos de segurança aprimorados	Investimento anual em higienização
Assistência médica	92%	US $ 5,6 milhões
Fabricação	68%	US $ 2,3 milhões
Tecnologia	81%	US $ 3,9 milhões

Aumento da demanda do consumidor por tecnologias avançadas de higienização

O mercado global de tecnologia avançada de higienização deve crescer a um CAGR de 12,4% de 2022 a 2027. Os gastos com consumidores em tecnologias de higienização doméstica e comercial atingiram US $ 15,6 bilhões em 2023.

Aceitação crescente de métodos avançados de desinfecção ambiental

Um estudo de 2023 Nielsen revelou que 65% dos consumidores preferem tecnologias de desinfecção ambientalmente amigável. O mercado de desinfecções ambientais deve atingir US $ 45,2 bilhões até 2026.

Método de desinfecção	Preferência do consumidor	Quota de mercado
Desinfetantes químicos	35%	42%
Desinfecção por UV	55%	33%
Soluções tecnológicas avançadas	65%	25%

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores tecnológicos

Inovação contínua nas tecnologias de desinfecção baseadas em UV e peróxido de hidrogênio

A Tomi Environmental Solutions investiu US $ 2,3 milhões em P&D para tecnologias de desinfecção em 2023. A Tecnologia de ionização binária esteramista da empresa alcançou uma taxa de eliminação de patógenos de 99,999%.

Tecnologia	Investimento (2023)	Taxa de eliminação de patógenos
Tecnologia esteramista UV-H2O2	US $ 1,7 milhão	99.9999%
Sistemas de ionização avançada	$600,000	99.99%

Desenvolvimento de sistemas de desinfecção automatizada e robótica

A Tomz desenvolveu três plataformas automatizadas de desinfecção robótica com um valor estimado de mercado de US $ 4,5 milhões. A implantação do sistema robótico aumentou 47% em 2023.

Sistema robótico	Valor de mercado	Aumento da implantação
Tomi bot-x	US $ 1,8 milhão	22%
Tomi bot-y	US $ 1,5 milhão	15%
Tomi bot-z	US $ 1,2 milhão	10%

Integração de IA e aprendizado de máquina em monitoramento ambiental

A Tomi Environmental Solutions alocou US $ 1,2 milhão para o desenvolvimento de tecnologia de IA e aprendizado de máquina em 2023. Os sistemas de monitoramento de IA da empresa abrangem 87 parâmetros ambientais diferentes.

Tecnologia da IA	Investimento	Parâmetros ambientais monitorados
Plataforma AIROSense AI	$750,000	52 parâmetros
Patogentrack ML System	$450,000	35 parâmetros

Rastreamento digital aprimorado e relatórios de processos de desinfecção

A Tomz implementou sistemas de rastreamento digital com recursos de relatórios em tempo real. As plataformas digitais da empresa processaram 3,2 milhões de eventos de desinfecção em 2023, com 99,7% de precisão.

Plataforma digital	Eventos de desinfecção processados	Precisão de relatórios
Digitrack Pro	1,8 milhão	99.8%
Sistema Envirolog	1,4 milhão	99.6%

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores Legais

Conformidade com os padrões regulatórios da FDA e da EPA para tecnologias de desinfecção

A Tomi Environmental Solutions obteve as seguintes certificações regulatórias:

Órgão regulatório	Status de certificação	Data efetiva
Registro da EPA	Lista n desinfetante registrado	13 de março de 2020
Autorização de uso de emergência da FDA	Ativo para tecnologia esteramista	Abril de 2020
Reivindicação de patógenos virais emergentes da EPA	Aprovado	Janeiro de 2021

Proteções de propriedade intelectual

A Tomi Environmental Solutions detém os seguintes ativos de propriedade intelectual:

Tipo de IP	Número de patentes	Jurisdições cobertas
Patentes ativas	7	Estados Unidos, Europa, Canadá
Aplicações de patentes pendentes	3	Tratado de Cooperação de Patentes Internacional

Dispositivos médicos e regulamentos de tratamento ambiental

Métricas de conformidade regulatória:

• ISO 13485: 2016 Dispositivos médicos Certificação do sistema de gestão da qualidade
• Certificação de marca CE para acesso ao mercado europeu
• Conformidade com os regulamentos de materiais perigosos da OSHA

Considerações de responsabilidade

Categoria de responsabilidade	Quantidade de cobertura	Provedor de seguros
Responsabilidade geral	$5,000,000	Seguro comercial da AIG
Responsabilidade do produto	$10,000,000	Seguro de viajantes
Responsabilidade profissional	$2,500,000	Grupo de Seguros Chubb

Despesas de conformidade legal: US $ 425.000 anualmente para adesão regulatória e consultas legais.

Tomi Environmental Solutions, Inc. (Tomz) - Análise de Pestle: Fatores Ambientais

Desenvolvimento de tecnologia de desinfecção sustentável e ecológica

A Tomi Environmental Solutions desenvolveu a tecnologia de ionização binária esteramista (BIT), que usa uma solução de peróxido de hidrogênio de 7,8% com um complexo de íons de prata. A tecnologia reduz o uso de produtos químicos em 99,9999% em comparação com os métodos tradicionais de desinfecção.

Parâmetro de tecnologia	Medição
Redução química	99.9999%
Concentração de peróxido de hidrogênio	7.8%
Taxa de eliminação de patógenos	99.9999%

Redução de métodos de higienização baseados em produtos químicos

A tecnologia esteramista elimina a necessidade de desinfetantes químicos à base de líquidos, reduzindo a contaminação ambiental e os riscos potenciais à saúde associados aos métodos tradicionais de higienização.

Comparação de uso de produtos químicos	Métodos tradicionais	Tecnologia esteramista
Volume químico	Alto	Mínimo
Impacto ambiental	Significativo	Insignificante

Minimizar o impacto ambiental dos processos de desinfecção

A tecnologia esteramista não produz resíduos prejudiciais e se divide na água e no oxigênio, garantindo a contaminação ambiental zero durante o processo de desinfecção.

Parâmetro de impacto ambiental	Medição
Resíduos químicos residuais	0%
Produtos de detalhamento	Água e oxigênio
Registro da EPA	Lista n registrada

Apoiar iniciativas de tecnologia verde no controle de infecções

A Tomi Environmental Solutions recebeu vários prêmios por tecnologia sustentável, incluindo reconhecimento por reduzir a pegada de carbono e promover soluções de desinfecção ambientalmente amigável.

Reconhecimento da tecnologia verde	Ano
EPA SAFER SAFER Choice Partner of the Year	2021
Prêmio Green Business Innovation	2022

TOMI Environmental Solutions, Inc. (TOMZ) - PESTLE Analysis: Social factors

Public health focus on complete decontamination drives demand in hospitals and labs.

The societal emphasis on eliminating Healthcare-Acquired Infections (HAIs) and maintaining sterile research environments is a primary driver for TOMI Environmental Solutions. You see this pressure translating directly into demand for technologies like SteraMist, which offers a 6-log kill (99.9999% reduction) against pathogens, a standard far exceeding typical cleaning methods. The FDA's recent focus on the importance of complete decontamination for hard-to-clean equipment, especially against challenging benchmarks like Geobacillus stearothermophilus spores, validates the need for TOMI's Binary Ionization Technology (BIT).

This public health mandate is showing up in the financials. The company reported Q3 2025 revenues of $2.0 million, representing a 95% sequential increase over Q2 2025, driven in part by higher equipment purchases and consistent recurring sales of the BIT Solution. That's a clear signal that hospitals and labs are making the capital expenditure (CapEx) commitment to superior disinfection. It's not just about cleaning anymore; it's about verifiable, complete sterilization.

Expanding into new service areas like mold and mycotoxins remediation in healthcare.

The social factor here is the growing awareness of indoor air quality and the long-term health risks associated with mold and mycotoxins, particularly in vulnerable populations within healthcare settings. TOMI is capitalizing on this trend by expanding its service provider network to target this specific remediation market. On September 24, 2025, the company announced a new specialized service provider for Healthcare and Mold Remediation.

This partnership is already yielding concrete results. The new provider invested approximately $185,500 in SteraMist mobile systems and BIT solution. Crucially, they immediately secured a major contract to remediate a 400,000-cubic-feet space at a hospital, which included critical HVAC decontamination. This move positions SteraMist as a solution for both infectious disease control and environmental quality control, broadening the total addressable market (TAM). The technology is ideal because its non-corrosive, residue-free dry fog is effective against mycotoxins without damaging sensitive hospital equipment.

SteraMist is used across diverse sectors: hospitals, biosafety labs, schools, and food processing facilities.

The social demand for safety and cleanliness is now a non-negotiable expectation across all public and commercial spaces, not just the clinical ones. This broad-based social demand has made SteraMist a multi-sector solution, which reduces TOMI's reliance on any single market vertical.

The core sectors driving this diversification include:

• Healthcare: Hospitals, Outpatient Facilities, Emergency Medical Transport.
• Life Sciences: Biosafety Labs (BSL 1-4), Tissue & Blood Banks, Pharmaceutical Manufacturing.
• Food Safety: Restaurants, Meat and Produce Processing Facilities. The FDA's September 2025 ruling broadening the permitted use of Hydrogen Peroxide significantly expands SteraMist's potential application in the Food Industry.
• Commercial Services: Schools, Senior Living Facilities, Athletics Facilities, Police and Fire Stations.

Here's the quick math on one key customer: A globally recognized leader in eye health is expected to purchase approximately $385,000 in SteraMist equipment, BIT Solution, and services for their South Carolina and Florida facilities in 2025. This repeat business across different facilities shows the stickiness of the product once it's integrated into a large organization's safety protocol.

Sector	2025 Social Demand Driver	TOMI 2025 Financial/Operational Metric
Healthcare	Mandate for 6-log kill complete decontamination (HAIs)	Q3 2025 Revenue up 95% sequentially, partly from equipment purchases.
Mold/Mycotoxins Remediation	Focus on indoor air quality and long-term health risks	New service provider invested ~$185,500 in systems for this area.
Food Safety	Heightened regulatory and consumer focus on foodborne illness prevention	FDA broadened Hydrogen Peroxide use, expanding SteraMist's potential in the sector (Sept 2025).
Life Sciences/Commercial	Need for validated, residue-free sterilization in sensitive research/production	Major eye health customer purchases expected to total ~$385,000 in 2025.

Growing demand for infection prevention in the animal research environment (AALAS meeting, Nov 2025).

The social factor driving this is the ethical and scientific imperative for high-quality, reproducible research, which hinges entirely on the health of laboratory animals. Contaminants can compromise data, leading to wasted time and resources, plus it's defintely a welfare issue. The American Association for Laboratory Animal Science (AALAS) National Meeting, held in November 2025, is the industry's premier forum for addressing these challenges.

TOMI is directly engaging with this critical niche, having announced plans to showcase its decontamination innovations at the AALAS 76th National Meeting. SteraMist is already a solution for Animal Laboratories, and this direct engagement with veterinarians, technicians, and facility managers is a smart way to drive future sales. The social pressure for compliance and animal welfare is a strong tailwind for validated, automated disinfection solutions in this highly regulated environment.

TOMI Environmental Solutions, Inc. (TOMZ) - PESTLE Analysis: Technological factors

Core technology is the patented Binary Ionization Technology (BIT) using ionized Hydrogen Peroxide (iHP).

The foundation of TOMI Environmental Solutions' market position is its patented Binary Ionization Technology (BIT), which was originally developed under a Defense Advanced Research Projects Agency (DARPA) grant. This platform uses a cold plasma arc to convert a low concentration of hydrogen peroxide (the sole active ingredient) into a fine mist of ionized Hydrogen Peroxide (iHP). This technology is critical because it achieves a validated 6-log kill rate, meaning it eliminates 99.9999% of pathogens, and does so without leaving detectable residue or being corrosive to equipment.

The SteraMist iHP system is a no-wipe, no-rinse application, which significantly reduces facility downtime compared to traditional chemical decontamination methods. This ease of use and superior efficacy is why it is trusted by high-stakes environments like U.S. Department of Defense facilities and biosafety level 3 and 4 laboratories.

Recognized as 'Disinfection and Decontamination Products Company of the Year 2025' by MedTech Outlook.

The company's technological excellence received major validation in the 2025 fiscal year. In June 2025, TOMI Environmental Solutions was honored with the 'Disinfection and Decontamination Products Company of the Year 2025' award by MedTech Outlook. This recognition, determined by a panel of C-level executives and industry thought leaders, underscores the strong confidence customers and industry peers have in the SteraMist iHP technology. Honesty, that kind of third-party validation cuts through a lot of marketing noise.

The award highlights the company's commitment to innovative solutions across various sectors, including healthcare, life sciences, and commercial spaces. This external validation is a powerful tool for accelerating sales cycles, which for TOMI can average 12 months.

Technology successfully passed trials against Geobacillus stearothermophilus spores, a rigorous industry benchmark.

The iHP technology continues to prove its reliability against the toughest microbial challenges. The SteraMist system successfully passed repeatable trials against Geobacillus stearothermophilus spores, which is an extremely challenging industry benchmark, especially for manual surface spraying applications. This successful trial was a key factor in securing repeat business from a globally recognized leader in eye health.

Here's the quick math on that customer win: The total amount of purchases from this key customer is expected to be approximately $385,000 for the 2025 fiscal year, covering SteraMist iHP equipment, the recurring revenue-generating BIT Solution, and support services. This performance validation is defintely a strong competitive advantage in highly regulated markets.

Ongoing R&D investment aims to expand applications across life sciences and food safety.

TOMI is actively investing in research and development to expand the addressable market for its technology, focusing on automation and new vertical applications. A major opportunity materialized in September 2025 when the U.S. Food and Drug Administration (FDA) broadened the permitted use of hydrogen peroxide as a secondary direct food additive.

This regulatory shift aligns perfectly with the SteraMist technology, which uses food-grade hydrogen peroxide and deionized water, and whose application method ensures no detectable residues remain on the final food product. This opens up multiple new verticals in the massive food safety market:

• Food safety and processing facilities.
• Food transportation and storage.
• Pre- and post-harvest applications.
• Packaging and outbreak control.

The focus on recurring revenue from the consumable BIT Solution is paying off. The company reported a Q3 2025 revenue of $2.0 million (or $2,012,000), which was a 95% sequential increase over the previous quarter, driven by higher equipment purchases and continued strength in recurring BIT Solution sales. Solution sales alone increased 21% year-over-year for the nine months ended September 30, 2025. The sales order backlog grew to $1.3 million by the end of October 2025, which gives a clear line of sight on near-term revenue.

Metric	Q3 2025 Value	Significance
Net Sales (Q3 2025)	$2,012,000	Reflects a 95% sequential increase over Q2 2025.
Gross Profit Margin (Q3 2025)	61%	Indicates strong operational efficiency and technology value.
International Revenue (Q3 2025)	36% of total revenue	Up from 20% in Q2 2025, demonstrating global market penetration.
Sales Order Backlog (Oct 2025)	$1.3 million	Strong indicator of future revenue potential and demand.

TOMI Environmental Solutions, Inc. (TOMZ) - PESTLE Analysis: Legal factors

FDA Broadens Hydrogen Peroxide Use: A Key Market Opportunity

The regulatory landscape for TOMI Environmental Solutions, Inc. (TOMZ) has seen a massive positive shift in the second half of 2025, specifically from the U.S. Food and Drug Administration (FDA). On September 3, 2025, the FDA published a final rule, amending 21 CFR §173.356, that significantly broadened the permitted use of hydrogen peroxide as a secondary direct food additive.

This ruling is a big deal because it opens up the entire food industry market for the SteraMist product line. The new regulation permits the use of food-grade hydrogen peroxide, provided any trace residues are completely removed before the food reaches consumers. SteraMist's patented Binary Ionization Technology (BIT) solution, which uses a low concentration of food-grade hydrogen peroxide and deionized water, is perfectly aligned with this requirement, as its application method ensures no detectable residues remain on the final food product.

This single regulatory change creates multiple new vertical opportunities for TOMZ, from food safety in processing plants to pathogen reduction in storage and transportation. It's a defintely a clear path to growth, but they must execute quickly to capture market share.

• FDA Final Rule Date: September 3, 2025
• Regulation Amended: 21 CFR §173.356
• Key Requirement: Trace residues must be completely removed before food reaches consumers

SteraMist's Dual EPA and FDA Regulatory Status

Beyond the new food additive rule, the core SteraMist technology already holds strong regulatory positioning. The product line is an Environmental Protection Agency (EPA) registered combination solution, meaning both the equipment and the solution are registered together. This registration is crucial because it covers two major markets: hospital-healthcare and general, multiple-use disinfection.

Specifically, the SteraMist Binary Ionization Technology (BIT) Solution has EPA Registration #90150-2 for hospital-healthcare and general use. Plus, a separate low-percentage solution has EPA Registration #90150-3 for the food supply chain, covering everything from pre-harvest to transportation. This dual registration makes SteraMist a versatile tool for high-stakes decontamination, which is a major competitive advantage in a crowded field.

Regulatory Body	Product/Technology	Registration/Status	Primary Market Focus
U.S. Food and Drug Administration (FDA)	Hydrogen Peroxide (as a secondary direct food additive)	Expanded Permitted Use (Sept 2025)	Food Production & Safety
Environmental Protection Agency (EPA)	SteraMist (BIT Solution)	Registration #90150-2	Hospital-Healthcare & General Disinfection
Environmental Protection Agency (EPA)	SteraMist (0.35% BIT Solution)	Registration #90150-3	Food Supply Chain (e.g., pre-harvest, storage)

Immediate Nasdaq Compliance Risk: Stockholders' Equity

While the regulatory outlook for the product is strong, the company faces a significant near-term legal risk tied to its listing status. On November 21, 2025, TOMZ received a deficiency letter from Nasdaq. The issue is non-compliance with Nasdaq Listing Rule 5550(b)(1), which requires the company to maintain a minimum of $2,500,000 in stockholders' equity.

This is a serious threat to their listing on the Nasdaq Capital Market, but it is not an immediate delisting. The company has 45 calendar days from the date of the letter-so until early January 2026-to submit a plan to regain compliance. They intend to submit this plan, which is the right first step. The risk is that if the plan is rejected, or if they fail to execute it within the potential 180-day extension, they could face delisting. This financial compliance issue creates a cloud over the positive regulatory news. They need to fix the balance sheet, and they need to do it fast.

Here's the quick math on the compliance timeline and requirement:

• Minimum Required Equity: $2,500,000
• Deficiency Letter Date: November 21, 2025
• Deadline to Submit Compliance Plan: 45 calendar days from November 21, 2025
• Potential Extension Period: Up to 180 calendar days, if the plan is accepted

TOMI Environmental Solutions, Inc. (TOMZ) - PESTLE Analysis: Environmental factors

The SteraMist solution uses a low-percentage (7.8%) hydrogen peroxide as its sole active ingredient.

The environmental factor is a huge tailwind for TOMI Environmental Solutions, Inc., and it centers on the chemistry of their flagship product, SteraMist. The core of the Binary Ionization Technology (BIT) solution is its active ingredient: a low-percentage, food-grade hydrogen peroxide. Specifically, the SteraMist solution uses a concentration of only 7.8% hydrogen peroxide. This is defintely a key differentiator. It means the product is inherently less toxic and corrosive than many traditional chemical disinfectants, which often rely on harsh, high-concentration compounds that require extensive post-treatment cleanup or neutralization.

This low-concentration approach is critical for the company's 'green' marketing and its alignment with growing global demand for sustainable cleaning and decontamination. The product's non-residual nature, converting into mostly oxygen and humidity after use, positions it as a leading environmentally friendly solution for indoor air and surface disinfection.

The iHP application method ensures no detectable residues remain on treated food products, meeting new FDA rules.

The biggest near-term opportunity for TOMI Environmental Solutions comes from a regulatory shift in the food industry. On September 3, 2025, the U.S. Food and Drug Administration (FDA) broadened the permitted use of hydrogen peroxide as a secondary direct food additive. The new rule allows for food-grade hydrogen peroxide use, provided that any trace residues are completely removed before the food reaches consumers.

This is a perfect fit for the SteraMist ionized Hydrogen Peroxide (iHP) application method. The iHP technology ensures no detectable residues remain on the final food product, which aligns precisely with the new FDA requirements. Here's the quick math: the iHP process breaks down the hydrogen peroxide into a fine mist of reactive oxygen species, which then rapidly decompose into just water vapor and oxygen, leaving no harmful chemical footprint on surfaces or food. This opens up massive new verticals for TOMI Environmental Solutions, including direct spraying of food pre- and post-harvest, food storage, and food packaging.

• New FDA rule published: September 3, 2025.
• New FDA regulation: Amends 21 CFR §173.356, expanding hydrogen peroxide use.
• SteraMist alignment: No detectable residues remain, meeting the FDA mandate.

Technology has demonstrated efficacy against issues like honeybee colony collapse, opening agricultural markets.

Beyond the food processing plant, SteraMist is proving its worth in a critical environmental and agricultural crisis: honeybee colony collapse. A collaborative U.S. Department of Agriculture (USDA) study, published on June 2, 2025, validated SteraMist's efficacy against the Deformed Wing Virus (DWV). This virus, largely spread by the Varroa destructor mites, is a primary driver of colony loss.

This scientific validation is a clear path to a new, high-value agricultural market. Commercial beekeepers across the U.S. reported up to 60% colony losses in early 2025, representing an estimated $600 million in direct economic impact. SteraMist offers a non-toxic, scalable tool to disinfect hive substrates and protect colonies, which are essential to the $20-30 billion annual U.S. agricultural economy. This is a huge, untapped biosecurity market.

Environmental/Agricultural Metric (2025)	Value/Amount	Significance to TOMI Environmental Solutions
U.S. Commercial Honeybee Colony Loss (Early 2025)	Up to 60%	Indicates an urgent, large-scale problem for which SteraMist is a validated solution.
U.S. Colony Loss Economic Impact (Early 2025)	Estimated $600 million	Represents the potential market value for hive disinfection solutions.
U.S. Agricultural Economy Contribution from Honeybees	$20-30 billion annually	Defines the overall size and importance of the market SteraMist can now serve.
SteraMist Active Ingredient Concentration	7.8% Hydrogen Peroxide	Confirms the product's low-toxicity, environmentally benign profile.

The company markets its solutions as environmentally friendly for indoor air and surface disinfection.

The company's entire brand is built on environmental responsibility, marketing SteraMist as an environmentally friendly solution. This is a strong competitive advantage in a world increasingly focused on Environmental, Social, and Governance (ESG) investing and corporate sustainability. The fact that the technology uses a simple, food-grade chemical that breaks down into natural components means customers, from hospitals to food processors, can meet their stringent disinfection needs without the liability of harsh chemical waste.

The environmental benefit is tangible, translating into lower disposal costs and reduced operational risk for clients. For example, the technology's ability to disinfect surfaces and air without leaving corrosive residues is a major selling point in sensitive environments like compounding pharmacies and cleanrooms, where the cost of chemical damage can be substantial. The environmental profile is a direct driver of sales, especially with the company reporting a strong gross margin of 61% in Q3 2025. That margin shows the market values this clean, effective technology.