Tomi Environmental Solutions, Inc. (Tomz): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage rapide de la désinfection environnementale en évolution, Tomi Environmental Solutions, Inc. (TOMZ) est à l'avant-garde des technologies transformatrices qui remodèlent la façon dont nous abordons le contrôle et la désinfection des infections. Des technologies UV de pointe des UV et du peroxyde d'hydrogène aux systèmes automatisés innovants, cette analyse complète du pilon révèle l'écosystème complexe de défis et d'opportunités qui définissent le positionnement stratégique de Tomz dans un monde post-pandemique où la santé publique, l'innovation technologique et la durabilité environnementale convergent avec sans précédent urgence.

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs politiques

Augmentation des réglementations fédérales et étatiques soutenant les technologies de désinfection

L'Agence américaine de protection de l'environnement (EPA) a enregistré 84 technologies de désinfection à partir de 2023, avec des cadres réglementaires spécifiques soutenant des solutions de désinfection avancées.

Agence de réglementation	Nombre d'approbations de la technologie de désinfection	Année
EPA	84	2023
Technologies recommandées par CDC	36	2023

Contrats et subventions gouvernementales pour les solutions de désinfection liées à Covid-19

Le financement fédéral de la technologie de désinfection liés à Covid-19 a atteint 247 millions de dollars en 2023, avec des allocations spécifiques pour des solutions de désinfection avancées.

• Département de la santé et des services sociaux Covid-19 GRANTS TECHNOLOGY: 127 millions de dollars
• Investissements technologiques de désinfection au niveau de l'État: 92 millions de dollars
• Financement de la technologie de désinfection de préparation aux urgences fédérales: 28 millions de dollars

Tensions géopolitiques potentielles affectant l'expansion du marché international

Restrictions commerciales mondiales et limitations de transfert de technologie a un impact sur les technologies de la technologie de désinfection internationale.

Région	Restrictions d'importation technologique	Défis d'accès au marché
Asie-Pacifique	37% ont augmenté l'examen réglementaire	Modéré
Union européenne	Exigences de conformité 24%	Faible

Priorités de politique de santé publique émergente soutenant les technologies de désinfection avancées

Les cadres de politique de santé publique priorisent de plus en plus les technologies de désinfection avancées dans plusieurs secteurs.

• Normes de désinfection obligatoires de l'établissement de soins de santé: 68% des États ont mis en œuvre de nouveaux règlements
• Exigences de désinfection des établissements d'enseignement: 42 États Lignes directrices mises à jour
• Protocoles de désinfection des transports publics: 56 millions de dollars en financement fédéral alloué

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs économiques

Demande de marché des soins de santé et des établissements médicaux en cours pour le contrôle des infections

La taille du marché mondial de la désinfection des hôpitaux était évaluée à 4,2 milliards de dollars en 2022 et devrait atteindre 7,8 milliards de dollars d'ici 2030, avec un TCAC de 8,5%.

Segment de marché	Valeur 2022	2030 valeur projetée
Marché de la désinfection à l'hôpital	4,2 milliards de dollars	7,8 milliards de dollars

Défis économiques potentiels de la fluctuation des dépenses de santé

Les dépenses de santé américaines ont atteint 4,5 billions de dollars en 2022, représentant 17,3% du PIB. Les dépenses mondiales de santé qui devraient augmenter à 5,4% par an jusqu'en 2024.

Métrique	Valeur 2022	Taux de croissance
Dépenses de santé aux États-Unis	4,5 billions de dollars	5,4% par an

Marché croissant pour les solutions de désinfection commerciale et industrielle

Marché de désinfection commerciale estimé à 3,6 milliards de dollars en 2023, avec une croissance prévue à 5,9 milliards de dollars d'ici 2028.

Segment de marché	Valeur 2023	2028 Valeur projetée
Marché de désinfection commerciale	3,6 milliards de dollars	5,9 milliards de dollars

Investissement dans les technologies émergentes de prévention des maladies infectieuses

Le marché mondial des diagnostics des maladies infectieuses prévoyait de atteindre 89,8 milliards de dollars d'ici 2027, avec un TCAC de 5,8%.

Segment de marché	Valeur 2022	2027 Valeur projetée	TCAC
Diagnostics des maladies infectieuses	63,5 milliards de dollars	89,8 milliards de dollars	5.8%

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs sociaux

Conscience accrue du public du contrôle des infections post-pandemique

Selon une enquête Gallup en 2023, 78% des Américains restent préoccupés par la transmission des maladies infectieuses dans les espaces publics. Le marché mondial du contrôle des infections était évalué à 20,3 milliards de dollars en 2022 et devrait atteindre 34,5 milliards de dollars d'ici 2027.

Année	Niveau de préoccupation du public	Valeur marchande du contrôle des infections
2022	72%	20,3 milliards de dollars
2023	78%	26,7 milliards de dollars
2024 (projeté)	82%	30,5 milliards de dollars

L'accent mis sur l'entreprise sur les protocoles de sécurité et de santé au travail

L'Administration de la sécurité et de la santé au travail (OSHA) a indiqué que 75% des entreprises ont amélioré les protocoles de désinfection en milieu de travail depuis 2020. Le marché du bien-être des entreprises devrait atteindre 93,4 milliards de dollars d'ici 2025.

Secteur des entreprises	Protocoles de sécurité améliorés	Investissement annuel dans la désinfection
Soins de santé	92%	5,6 millions de dollars
Fabrication	68%	2,3 millions de dollars
Technologie	81%	3,9 millions de dollars

Augmentation de la demande des consommateurs pour les technologies de désinfection avancées

Le marché mondial des technologies de désinfection avancée devrait croître à un TCAC de 12,4% de 2022 à 2027. Les dépenses de consommation pour les technologies de désinfection maison et commerciale ont atteint 15,6 milliards de dollars en 2023.

Acceptation croissante des méthodes avancées de désinfection environnementale

Une étude Nielsen 2023 a révélé que 65% des consommateurs préfèrent les technologies de désinfection respectueuse de l'environnement. Le marché de la désinfection environnementale devrait atteindre 45,2 milliards de dollars d'ici 2026.

Méthode de désinfection	Préférence des consommateurs	Part de marché
Désinfectants chimiques	35%	42%
Désinfection UV	55%	33%
Solutions technologiques avancées	65%	25%

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs technologiques

Innovation continue dans les technologies de désinfection à base de peroxyde UV et d'hydrogène

Tomi Environmental Solutions a investi 2,3 millions de dollars dans la R&D pour les technologies de désinfection en 2023. La technologie d'ionisation binaire stérimiste de la société a atteint un taux d'élimination des agents pathogènes de 99,9999%.

Technologie	Investissement (2023)	Taux d'élimination des agents pathogènes
Technologie stérimiste UV-H2O2	1,7 million de dollars	99.9999%
Systèmes d'ionisation avancés	$600,000	99.99%

Développement de systèmes de désinfection automatisés et robotiques

Tomz a développé 3 plates-formes de désinfection robotiques automatisées d'une valeur marchande estimée à 4,5 millions de dollars. Le déploiement du système robotique a augmenté de 47% en 2023.

Système robotique	Valeur marchande	Augmentation du déploiement
Tomi bot-x	1,8 million de dollars	22%
Tomi bot-y	1,5 million de dollars	15%
Tomi bot-z	1,2 million de dollars	10%

Intégration de l'IA et de l'apprentissage automatique dans la surveillance environnementale

Tomi Environmental Solutions a alloué 1,2 million de dollars au développement de l'IA et de la technologie d'apprentissage automatique en 2023. Les systèmes de surveillance de l'IA de l'entreprise couvrent 87 paramètres environnementaux différents.

Technologie d'IA	Investissement	Paramètres environnementaux surveillés
Plateforme Envirosense AI	$750,000	52 paramètres
Système PathoGentrack ML	$450,000	35 paramètres

Suivi numérique amélioré et rapport des processus de désinfection

Tomz a implémenté les systèmes de suivi numérique avec des capacités de rapport en temps réel. Les plateformes numériques de l'entreprise ont traité 3,2 millions d'événements de désinfection en 2023, avec une précision de 99,7%.

Plate-forme numérique	Événements de désinfection traités	Précision des rapports
Digitrack Pro	1,8 million	99.8%
Système d'environ	1,4 million	99.6%

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs juridiques

Conformité aux normes réglementaires de la FDA et de l'EPA pour les technologies de désinfection

Tomi Environmental Solutions a obtenu les certifications réglementaires suivantes:

Corps réglementaire	Statut de certification	Date d'entrée en vigueur
Enregistrement de l'EPA	Liste n désinfectant enregistré	13 mars 2020
Autorisation d'utilisation d'urgence de la FDA	Actif pour la technologie stérimiste	Avril 2020
EPA émergeant les agents pathogènes viraux	Approuvé	Janvier 2021

Protection de la propriété intellectuelle

Tomi Environmental Solutions détient les actifs de propriété intellectuelle suivants:

Type d'ip	Nombre de brevets	Juridictions couvertes
Brevets actifs	7	États-Unis, Europe, Canada
Demandes de brevet en instance	3	Traité international de coopération en matière de brevets

Règlement sur les dispositifs médicaux et le traitement environnemental

Métriques de la conformité réglementaire:

• ISO 13485: Certification du système de gestion de la qualité des appareils médicaux 2016
• Certification CE Mark pour l'accès au marché européen
• Conformité aux réglementations sur les matières dangereuses de l'OSHA

Considérations de responsabilité

Catégorie de responsabilité	Montant de la couverture	Assureur
Responsabilité générale	$5,000,000	Assurance commerciale AIG
Responsabilité du produit	$10,000,000	Assurance voyageurs
Responsabilité professionnelle	$2,500,000	Groupe d'assurance Chubb

Dépenses de conformité juridique: 425 000 $ par an pour l'adhésion réglementaire et les consultations juridiques.

Tomi Environmental Solutions, Inc. (Tomz) - Analyse du pilon: facteurs environnementaux

Développement de technologie de désinfection durable et respectueux de l'environnement

Tomi Environmental Solutions a développé la technologie d'ionisation binaire stérimiste (BIT), qui utilise une solution de peroxyde d'hydrogène à 7,8% avec un complexe d'ions argentés. La technologie réduit l'utilisation des produits chimiques de 99,9999% par rapport aux méthodes de désinfection traditionnelles.

Paramètre technologique	Mesures
Réduction des produits chimiques	99.9999%
Concentration de peroxyde d'hydrogène	7.8%
Taux d'élimination des agents pathogènes	99.9999%

Réduction des méthodes de désinfection basées sur les produits chimiques

La technologie stérimiste élimine le besoin de désinfectants chimiques à base de liquide, réduisant la contamination environnementale et les risques potentiels pour la santé associés aux méthodes de désinfection traditionnelles.

Comparaison d'utilisation des produits chimiques	Méthodes traditionnelles	Technologie stérimiste
Volume chimique	Haut	Minimal
Impact environnemental	Significatif	Négligeable

Minimiser l'impact environnemental des processus de désinfection

La technologie stérimiste ne produit aucun résidu nocif et se décompose en eau et en oxygène, assurant une contamination environnementale nulle pendant le processus de désinfection.

Paramètre d'impact environnemental	Mesures
Déchets chimiques résiduels	0%
Produits de panne	Eau et oxygène
Enregistrement de l'EPA	Liste n enregistrée

Soutenir les initiatives technologiques vertes dans le contrôle des infections

Tomi Environmental Solutions a reçu plusieurs prix pour les technologies durables, notamment la reconnaissance de la réduction de l'empreinte carbone et de la promotion des solutions de désinfection respectueuse de l'environnement.

Reconnaissance de la technologie verte	Année
EPA SAFER CHOICT PARTENER DE L'ANNÉE	2021
Prix ​​de l'innovation commerciale verte	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.