TOMI Environmental Solutions, Inc. (TOMZ): Análisis PESTLE [Actualizado en Ene-2025]

En el panorama en rápida evolución de la desinfección ambiental, Tomi Environmental Solutions, Inc. (TOMZ) se encuentra a la vanguardia de las tecnologías transformadoras que remodelan la forma en que abordamos el control y la desinfección de la infección. Desde tecnologías de peróxido de rayos UV e hidrógeno de vanguardia hasta sistemas automatizados innovadores, este análisis integral de mano de mortero revela el complejo ecosistema de desafíos y oportunidades que definen el posicionamiento estratégico de Tomz en un mundo post-pandémico donde la salud pública, la innovación tecnológica y la sostenibilidad ambiental convergen con sin acreditación sin acreditación. urgencia.

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores políticos

Aumento de las regulaciones federales y estatales que respaldan las tecnologías de desinfección

La Agencia de Protección Ambiental de EE. UU. (EPA) registró 84 tecnologías de desinfección a partir de 2023, con marcos regulatorios específicos que respaldan soluciones de desinfección avanzada.

Agencia reguladora	Número de aprobaciones de tecnología de desinfección	Año
EPA	84	2023
Tecnologías recomendadas por los CDC	36	2023

Contratos gubernamentales y subvenciones para soluciones de desinfección relacionadas con Covid-19

La financiación de la tecnología de desinfección relacionada con Federal Covid-19 alcanzó los $ 247 millones en 2023, con asignaciones específicas para soluciones avanzadas de desinfección.

• Departamento de Salud y Servicios Humanos COVID-19 Subvenciones de tecnología: $ 127 millones
• Inversiones de tecnología de desinfección a nivel estatal: $ 92 millones
• Financiación de tecnología de desinfección de preparación para emergencias federales: $ 28 millones

Tensiones geopolíticas potenciales que afectan la expansión del mercado internacional

Restricciones comerciales globales y limitaciones de transferencia de tecnología impactan los mercados de tecnología de desinfección internacional.

Región	Restricciones de importación de tecnología	Desafíos de acceso al mercado
Asia-Pacífico	37% aumentó el escrutinio regulatorio	Moderado
unión Europea	Requisitos de cumplimiento del 24%	Bajo

Prioridades de política de salud pública emergentes que apoyan tecnologías de desinfección avanzadas

Los marcos de política de salud pública priorizan cada vez más las tecnologías de desinfección avanzadas en múltiples sectores.

• Normas de desinfección obligatoria del centro de salud: el 68% de los estados implementó nuevas regulaciones
• Requisitos de desinfección de la institución educativa: 42 estados pautas actualizadas
• Protocolos de desinfección del transporte público: $ 56 millones en fondos federales asignados

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores económicos

Demanda continua del mercado de la salud y las instalaciones médicas de control de infecciones

El tamaño del mercado global de desinfección hospitalaria se valoró en $ 4.2 mil millones en 2022 y se proyecta que alcanzará los $ 7.8 mil millones para 2030, con una tasa compuesta anual de 8.5%.

Segmento de mercado	Valor 2022	2030 Valor proyectado
Mercado de desinfección del hospital	$ 4.2 mil millones	$ 7.8 mil millones

Desafíos económicos potenciales del gasto en salud fluctuante

El gasto en salud de los Estados Unidos alcanzó los $ 4.5 billones en 2022, lo que representa el 17.3% del PIB. Se espera que el gasto de atención médica global crezca al 5,4% anual hasta 2024.

Métrico	Valor 2022	Índice de crecimiento
Gasto de atención médica de EE. UU.	$ 4.5 billones	5.4% anual

Mercado creciente para soluciones de desinfección comercial e industrial

El mercado de desinfección comercial estimado en $ 3.6 mil millones en 2023, con un crecimiento proyectado a $ 5.9 mil millones para 2028.

Segmento de mercado	Valor 2023	2028 Valor proyectado
Mercado de desinfección comercial	$ 3.6 mil millones	$ 5.9 mil millones

Inversión en tecnologías emergentes de prevención de enfermedades infecciosas

El mercado global de diagnóstico de enfermedades infecciosas proyectó que alcanzará los $ 89.8 mil millones para 2027, con una tasa compuesta anual del 5.8%.

Segmento de mercado	Valor 2022	2027 Valor proyectado	Tocón
Diagnóstico de enfermedades infecciosas	$ 63.5 mil millones	$ 89.8 mil millones	5.8%

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores sociales

Conciencia pública aumentada del control de infecciones después de la pandemia

Según una encuesta de 2023 Gallup, el 78% de los estadounidenses permanecen preocupados por la transmisión de enfermedades infecciosas en espacios públicos. El mercado global de control de infecciones se valoró en $ 20.3 mil millones en 2022 y se proyecta que alcanzará los $ 34.5 mil millones para 2027.

Año	Nivel de preocupación pública	Valor de mercado de control de infección
2022	72%	$ 20.3 mil millones
2023	78%	$ 26.7 mil millones
2024 (proyectado)	82%	$ 30.5 mil millones

Énfasis corporativo en los protocolos de seguridad y salud en el lugar de trabajo

La Administración de Seguridad y Salud Ocupacional (OSHA) informó que el 75% de las empresas han mejorado los protocolos de desinfección en el lugar de trabajo desde 2020. Se espera que el mercado de bienestar corporativo alcance los $ 93.4 mil millones para 2025.

Sector corporativo	Protocolos de seguridad mejorados	Inversión anual en desinfectación
Cuidado de la salud	92%	$ 5.6 millones
Fabricación	68%	$ 2.3 millones
Tecnología	81%	$ 3.9 millones

Aumento de la demanda del consumidor de tecnologías avanzadas de desinfección

Se espera que el mercado global de tecnología de desinfección avanzada crezca a una tasa compuesta anual del 12.4% de 2022 a 2027. El gasto del consumidor en tecnologías de desinfección en el hogar y comerciales alcanzó los $ 15.6 mil millones en 2023.

Creciente aceptación de métodos avanzados de desinfección ambiental

Un estudio de 2023 Nielsen reveló que el 65% de los consumidores prefieren tecnologías de desinfección amigables con el medio ambiente. Se proyecta que el mercado de desinfección ambiental alcanzará los $ 45.2 mil millones para 2026.

Método de desinfección	Preferencia del consumidor	Cuota de mercado
Desinfectantes químicos	35%	42%
Desinfección UV	55%	33%
Soluciones tecnológicas avanzadas	65%	25%

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores tecnológicos

Innovación continua en tecnologías de desinfección a base de peróxido UV e hidrógeno

Tomi Environmental Solutions ha invertido $ 2.3 millones en I + D para tecnologías de desinfección en 2023.

Tecnología	Inversión (2023)	Tasa de eliminación de patógenos
Tecnología Steramist UV-H2O2	$ 1.7 millones	99.9999%
Sistemas de ionización avanzados	$600,000	99.99%

Desarrollo de sistemas de desinfección automatizados y robóticos

Tomz ha desarrollado 3 plataformas de desinfección robótica automatizadas con un valor de mercado estimado de $ 4.5 millones. El despliegue del sistema robótico aumentó en un 47% en 2023.

Sistema robótico	Valor comercial	Aumento de despliegue
Tomi Bot-X	$ 1.8 millones	22%
Tomi Bot-y	$ 1.5 millones	15%
Tomi Bot-Z	$ 1.2 millones	10%

Integración de IA y aprendizaje automático en el monitoreo ambiental

Tomi Environmental Solutions asignó $ 1.2 millones para el desarrollo de tecnología de IA y aprendizaje automático en 2023. Los sistemas de monitoreo de IA de la compañía cubren 87 parámetros ambientales diferentes.

Tecnología de IA	Inversión	Parámetros ambientales monitoreados
Plataforma de IA Envirosense	$750,000	52 parámetros
Sistema PathogentRack ML	$450,000	35 parámetros

Seguimiento digital mejorado e informes de procesos de desinfección

Tomz implementó sistemas de seguimiento digital con capacidades de informes en tiempo real. Las plataformas digitales de la compañía procesaron 3.2 millones de eventos de desinfección en 2023, con una precisión del 99.7%.

Plataforma digital	Eventos de desinfección procesados	Precisión de informes
Digitrack Pro	1.8 millones	99.8%
Sistema de envirólogos	1.4 millones	99.6%

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores legales

Cumplimiento de las normas regulatorias de la FDA y la EPA para las tecnologías de desinfección

Tomi Environmental Solutions ha obtenido las siguientes certificaciones regulatorias:

Cuerpo regulador	Estado de certificación	Fecha de vigencia
Registro de la EPA	Lista n desinfectante registrado	13 de marzo de 2020
Autorización de uso de emergencia de la FDA	Activo para la tecnología esteramista	Abril de 2020
Reclamo de patógenos virales emergentes de la EPA	Aprobado	Enero de 2021

Protección de propiedad intelectual

Tomi Environmental Solutions posee los siguientes activos de propiedad intelectual:

Tipo de IP	Número de patentes	Jurisdicciones cubiertas
Patentes activas	7	Estados Unidos, Europa, Canadá
Aplicaciones de patentes pendientes	3	Tratado de cooperación de patentes internacionales

Regulaciones de dispositivos médicos y tratamiento ambiental

Métricas de cumplimiento regulatorio:

• ISO 13485: Certificación del sistema de gestión de calidad de dispositivos médicos 2016
• Certificación CE Mark para el acceso al mercado europeo
• Cumplimiento de las regulaciones de materiales peligrosos de OSHA

Consideraciones de responsabilidad

Categoría de responsabilidad	Cantidad de cobertura	Proveedor de seguros
Responsabilidad general	$5,000,000	Seguro comercial AIG
Responsabilidad del producto	$10,000,000	Seguro de viajero
Responsabilidad profesional	$2,500,000	Grupo de seguros de Chubb

Gasto de cumplimiento legal: $ 425,000 anuales para adherencia regulatoria y consultas legales.

Tomi Environmental Solutions, Inc. (Tomz) - Análisis de mortero: factores ambientales

Desarrollo de tecnología de desinfección sostenible y ecológica

Tomi Environmental Solutions ha desarrollado la tecnología de ionización binaria esteramista (BIT), que utiliza una solución de peróxido de hidrógeno al 7,8% con un complejo de iones de plata. La tecnología reduce el uso químico en un 99.9999% en comparación con los métodos de desinfección tradicionales.

Parámetro tecnológico	Medición
Reducción química	99.9999%
Concentración de peróxido de hidrógeno	7.8%
Tasa de eliminación de patógenos	99.9999%

Reducción de métodos de desinfección basados ​​en productos químicos

La tecnología esteramista elimina la necesidad de desinfectantes químicos basados ​​en líquidos, reduciendo la contaminación ambiental y los riesgos potenciales para la salud asociados con los métodos tradicionales de desinfección.

Comparación de uso químico	Métodos tradicionales	Tecnología esteramista
Volumen químico	Alto	Mínimo
Impacto ambiental	Significativo	Despreciable

Minimizar el impacto ambiental de los procesos de desinfección

La tecnología esteramista no produce residuos dañinos y se descompone en agua y oxígeno, lo que garantiza cero contaminación ambiental durante el proceso de desinfección.

Parámetro de impacto ambiental	Medición
Residuos químicos residuales	0%
Productos de desglose	Agua y oxígeno
Registro de la EPA	Lista n registrada

Apoyo a las iniciativas de tecnología verde en el control de infecciones

Tomi Environmental Solutions ha recibido múltiples premios por tecnología sostenible, incluido el reconocimiento para reducir la huella de carbono y promover soluciones de desinfección amigables con el medio ambiente.

Reconocimiento de tecnología verde	Año
EPA Safer Choice Partner of the Year	2021
Premio de Innovación de Negocios Verdes	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.