PURE Bioscience, Inc. focuses on developing and commercializing proprietary antimicrobial products that provide solutions to the health and environmental challenges of pathogen and hygienic control.
The company's technology platform is based on patented stabilized ionic silver, and its initial products contain silver dihydrogen citrate (SDC). SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers residual protection and formulates well with other compounds.
The company offers PUR...
PURE Bioscience, Inc. focuses on developing and commercializing proprietary antimicrobial products that provide solutions to the health and environmental challenges of pathogen and hygienic control.
The company's technology platform is based on patented stabilized ionic silver, and its initial products contain silver dihydrogen citrate (SDC). SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers residual protection and formulates well with other compounds.
The company offers PURE Hard Surface as a food contact surface sanitizer and disinfectant to restaurant chains, food processors and food transportation companies. The company also offers PURE Control as a direct food contact processing aid. In addition to the company's direct sales efforts with PURE Hard Surface and PURE Control, it markets and sells its SDC-based products indirectly through third-party distributors supporting various industries.
Strategy
The key elements of the company's strategy include expanding sales and distribution for its products into the food industry with a focus on a dual track of food safety market opportunities; commercializing its EPA (the U.S. Environmental Protection Agency) registered PURE Hard Surface disinfectant and sanitizer for use in foodservice operations, food manufacturing and food transportation; commercializing the U.S. Food and Drug Administration (FDA) approved PURE Control as a direct food contact processing aid for fresh produce; commercializing FDA approved PURE Control as a food processing and intervention aid for food processors treating raw poultry in pre and post on-line reprocessing; continuing to grow and establish new strategic alliances to maximize the commercial potential of its technology platform; continuing to partner with third parties who are seeking, or intend to seek, approvals to market SDC-based products in markets outside the U.S.; developing additional proprietary products and applications; and protecting and enhancing its intellectual property.
In addition to the company's products addressing food safety, it intends to leverage its technology platform through licensing and distribution collaborations to develop new products and enter into new markets.
Products
In addition to PURE Hard Surface and PURE Control, the company manufactures and sells SDC-based products for end use, products preserved with SDC, and SDC as a raw material ingredient for manufacturing use. The company's products are as follows:
PURE Hard Surface Disinfectant and Sanitizer (Ready to Use)
PURE Hard Surface is the company's SDC-based, patented and EPA-registered, ready-to-use hard surface disinfectant and food contact surface sanitizer. PURE Hard Surface combines high efficacy and low toxicity with bacterial and viral kill times in as few as 30-seconds and 24-hour residual protection. The product kills resistant pathogens, such as Methicillin-resistant Staphylococcus aureus (MRSA) and Carbapenem-resistant Klebsiella pneumoniae (NDM-1), and effectively eliminates dangerous fungi and viruses, including HIV, Hepatitis B, Hepatitis C, Norovirus, Influenza A, Avian Influenza and H1N1. It also eradicates hazardous food pathogens, such as E. coli, Salmonella, Campylobacter and Listeria. PURE Hard Surface delivers broad-spectrum efficacy yet remains classified as least-toxic by the EPA. The active ingredient, SDC, has been designated as Generally Recognized as Safe (GRAS) for use on food processing equipment, machinery and utensils.
PURE Control
The company has the necessary regulatory approvals from the FDA to offer PURE Control as a direct food contact processing aid for fresh produce and raw poultry. The company also has regulatory approvals from the USDA for certain methods of application of PURE Control on poultry. Additionally, subject to the results of the company's focused in-plant validation efforts for its approved produce and poultry solutions, the company intends to seek approval to utilize PURE Control as a direct food contact processing aid for raw meats, including beef and pork.
Poultry Processing Aid: In 2017, the company received the required approvals from the FDA stating that its food contact notification for SDC as a raw poultry processing aid is complete. The company received a No Objection Letter from the USDA's Food Safety and Inspection Service (FSIS) granting approval for the higher concentrations of SDC-based PURE Control to be used as a spray or dip applied to poultry carcasses, parts and organs in pre-OLR (on-line reprocessing) and post chill processing of fresh poultry.
Produce Processing Aid: In 2016, the company received the required approvals from the FDA stating that its FCN for SDC as a spray or dip on processed fruits and vegetables is complete.
Other Processing Aids under Development: Subject to the results of the company's focused in-plant validation efforts for the company's approved produce and poultry solutions, it intends to seek approval to utilize PURE Control as a direct food contact processing aid for raw meats, including beef and pork. In addition, the company may identify other food processing opportunities for SDC.
Additional SDC-Based Products
In addition to PURE Hard Surface and PURE Control, the company manufactures and sells SDC-based products for end use, products preserved with SDC and SDC as a raw material ingredient for manufacturing use. These products include PURE Complete Solutions, including PURE Multi-Purpose and Floor Cleaner Concentrate and PURE Multi-Purpose Hi-Foam Cleaner Concentrate; Axen30; Axenohl; and SILVERION.
PURE Complete Solution
The company's PURE Complete Solution includes PURE Hard Surface and concentrated cleaning products that were launched as companion products to PURE Hard Surface. The PURE Complete Solution offers a comprehensive, user-friendly cleaning, disinfecting and sanitizing product line to end-users including its targeted foodservice, food manufacturing and food processing customers. The company can also target this product line to hospital and medical care facilities, janitorial service providers and the distributors that supply them.
PURE Multi-Purpose and Floor Cleaner Concentrate (End-User Dilutable)
PURE Multi-Purpose Cleaner is an environmentally responsible cleaning product that is protected by SDC. SDC ensures the quality and safety of PURE Multi-Purpose and Floor Cleaner without human or environmental exposure to toxic chemical preservatives. PURE Multi-Purpose and Floor Cleaner is non-toxic and non-flammable and contains no EDTA, phosphates, ammonia or bleach, as well as no VOCs or NPEs. This efficient cleaner provides professional strength cleaning in a concentrate formula that yields a 1:96 - 1:256 use dilution that is safe for use on all resilient surfaces, including floors, glass and food contact surfaces.
PURE Multi-Purpose Hi-Foam Cleaner Concentrate (End-User Dilutable)
PURE Multi-Purpose Hi-Foam Cleaner is an environmentally responsible, professional strength high foam forming cleaning product that is protected by SDC. SDC ensures the quality and safety of PURE Multi-Purpose Hi-Foam Cleaner without human or environmental exposure to toxic chemical preservatives. PURE Multi-Purpose Hi-Foam Cleaner is non-toxic and non-flammable and contains no EDTA, phosphates, ammonia or bleach, as well as no VOCs or NPEs. PURE Multi-Purpose Hi-Foam Cleaner provides high foam cleaning in a concentrate formula that yields a 1:50 use dilution that is safe for use on stainless steel equipment, resilient floors, walls and painted surfaces.
Axen 30 (Ready-to-Use)
Axen30 is the company's patented and EPA-registered hard surface disinfectant and is a predecessor ready-to-use product to PURE Hard Surface. Axen30 is sold on a limited basis by distributors under their respective private labels.
Axenohl (Raw Material Ingredient)
Axenohl is the company's patented and EPA-registered SDC-based antimicrobial formulation for use as a raw material ingredient in the manufacturing of EPA-registered products. Axenohl is a colorless, odorless and stable solution that provides fast acting efficacy against bacteria, viruses and fungi manufactured into consumer and commercial disinfecting and sanitizing products. Axenohl is currently sold on a limited basis to distributors who manufacture their own respective end-use products.
SILVERION (Raw Material Ingredient)
SILVERION is the company's patented SDC-based antimicrobial formulation for use as a raw material ingredient in the manufacturing of personal care products. It can be used as either an active ingredient or a preservative. SILVERION is a colorless, odorless and stable solution that provides ionic silver in a water-soluble form. It provides fast acting efficacy at low concentrations against a broad-spectrum of bacteria, viruses, yeast and molds. SILVERION is sold domestically and outside of the United States in various personal care products.
EPA Registrations
The company sells its EPA-regulated products under three EPA registrations, including SDC3A, its hard surface disinfectant and food contact surface sanitizer; Axen30, the company's hard surface disinfectant; and Axenohl, its antimicrobial formulation for use as a raw material in the manufacturing of EPA-registered products.
PURE Hard Surface SDC3A Registration
The EPA registration for SDC3A, marketed as PURE Hard Surface, the company's disinfectant and food contact surface sanitizer.
Toxicity Categories
The EPA categorizes the toxicity of antimicrobial products from Category I to Category IV. SDC3A is a Category IV product for which no signal words are required.
Axen30 Registration
Axen30 is a hard surface disinfectant and is a predecessor product to SDC3A. It offers similar broad-spectrum efficacy but longer kill times. Axen30 is not approved for use on food contact surfaces. Axen30 is sold on a limited basis by distributors under their respective private labels.
Axenohl Registration
Axenohl is sold to distributors who manufacture their own respective end-use products.
Manufacturing
The company has a five-year manufacturing supply agreement with Intercon Chemical Company (ICC) with a three-year renewal term option, or the Manufacturing Supply Agreement, pursuant to which the company granted ICC the right to be the non-exclusive manufacturer for all its SDC-based products. The agreement consists of manufacturing, packaging, and distribution of PURE's SDC-based products.
Intellectual Property
The company has applied for the U.S. and foreign patent protection for its SDC technology. The company owns twelve U.S. issued patents. Approximately thirty patents have been issued outside of the U.S., and it owns approximately four patents pending around the world. The expiration dates for its twelve U.S. issued patents begin in 2018 and end in 2030. In 2013, the company decided to abandon pending and issued patents in non-strategic international territories. The company intends to focus its future patent prosecution and defense efforts primarily to North America, Europe, Asia and Mexico.
Further, the company owns the registered trademarks or pending trademark applications for PURE Bioscience, Powered by SDC Ag+, PURE, Axenohl, Axen, SILVERION, and PURE Control. In addition, the company has applications for other trademarks pending around the world, which may or may not be granted. The company previously allowed the marks Kinderguard, Cruise Control, Staphacide, Nutripure, Elderguard, and Critterguard to go abandoned, as they were no longer in line with its food safety business strategy.
Research and Development
For the year ended July 31, 2023, the company's research and development expense were $297,000.
Government Regulations
The company manufactures and sells in the U.S. certain disinfecting products that kill or reduce microorganisms (bacteria, viruses, and fungi). The manufacture, labeling, handling and use of these products are regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The company sells three products registered by the EPA under FIFRA, certain of which are approved for use on food contact surfaces and others of which are approved for use on non-food contact hard surfaces.
In international markets, the company sells its products under active registrations held by it, or by its distributors. The company holds a registration from Health Canada for its disinfectant product. Other third-party distributors hold registrations in China and are actively pursuing registrations for the company's disinfectant products in various Asian markets.
History
The company was incorporated in the state of California in 1992. It was formerly known as Innovative Medical Services and changed its name to Pure Bioscience in 2003. The company was reincorporated in the state of Delaware under the name PURE Bioscience, Inc. in 2011.
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