Pure Bioscience receives key Calif. product registration

Dec. 16, 2004
Pure Bioscience's silver dihydrogen citrate-based hard surface disinfectant has been registered by the California Department of Pesticide Regulation. Axen30 hard surface disinfectant is also registered by the U.S. Environmental Protection Agency (EPA) and each of the 49 other states...

SAN DIEGO, Dec. 16, 2004 (BUSINESS WIRE) -- Pure Bioscience's silver dihydrogen citrate-based hard surface disinfectant has been registered by the California Department of Pesticide Regulation. Axen30 hard surface disinfectant is also registered by the U.S. Environmental Protection Agency (EPA) and each of the 49 other states.

Michael L. Krall, president and CEO of Pure Bioscience, stated, "Those in the industry know that obtaining California EPA registration can be as difficult if not more difficult than obtaining US EPA registration. The long-awaited California registration clears the way for many large retailers and distributors to sell Axen30 nation-wide under their private labels."

Axen30 is derived from Pure Bioscience's flagship technology: a patented, aqueous antimicrobial called silver dihydrogen citrate (SDC). SDC is an electrolytically generated source of stabilized ionic silver that can serve as the basis for a broad range of products in diverse markets. Colorless, odorless, tasteless and non-caustic, SDC formulates well with other compounds. Pure produces and markets pre-formulated, ready-to-use product, as well as varying strengths of SDC concentrate as an additive or raw material for inclusion in other companies' products.

Pure is marketing Axen30 as a ready-to-use disinfectant to industry leading companies and distributors for commercial and consumer applications. For instance, the company recently formed a strategic alliance with Clean Control Corp. to accelerate sales of its SDC-based disinfection technology. When asked about the Axen30 California registration, Stephen Davison, Clean Control's founder and president, added, "The California registration has been the missing piece of the puzzle, and we are excited to be able to aggressively move this phenomenal product into our retail and industrial customers." Clean Control Corporation manufactures and distributes more than 50 cleaning products in multiple market segments including household and retail, commercial, institutional and industrial, wholesale, private labeling and automotive. The product line includes the internationally recognized OdoBan multi-purpose deodorizer and disinfectant.

Pure also has Environmental Protection Agency (EPA) registration for its 2400-parts per million (ppm) technical grade SDC concentrate (trade name Axenohl) as well as for its Axen and Axen30 hard surface disinfectant products.

Powerful disinfectant
Axen30 is distinguished from many of the leading commercial and consumer products because of its superior efficacy combined with its lower toxicity ratings. For example, leading brand household spray disinfectants declare a 10-minute disinfection time against three widespread disease-causing bacteria: Staph, Pseudomonas and Salmonella (Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 15442 and Salmonella choleraesuis ATCC 10708), whereas Axen30 claims a 30-second disinfection time on these same organisms -- 20 times faster than the claims made by the leading competitor. Additional claims for Axen30 include a remarkable 24-hour residual kill on standard indicator bacteria, two-minute kill time on some resistant strains of bacteria, 10-minute kill time on fungi, 30 second kill time on HIV Type I and 10-minute kill time on other viruses.

Lowest toxicity
Based on the EPA toxicity categorization of antimicrobial products ranging from Category I (high toxicity) down to Category IV, Axen30 is a Category IV antimicrobial for which precautionary labeling statements are normally not required. This compares with Category II warning statements for most leading brands of antimicrobial products.
In addition to use in commercial, industrial and consumer applications including restaurants, homes and medical facilities, federal and state approved use claims for Axen30 disinfectant also feature children's toys, toy boxes, play tables and activity centers, jungle gyms, playpens, child car seats, strollers and diaper changing tables. The inclusion of such sensitive use sites emphasizes the "least-toxic" characteristics of Axen30 while expanding its versatility in the professional and consumer disinfection markets. The new claims open potential key market opportunities for Pure as its distributors position to penetrate the childcare segment which includes daycare centers, preschools, schools, gymnasiums and children's activity centers.

Large potential
Pure's silver dihydrogen citrate technology also shows promise as a broad-spectrum antimicrobial for use in human and veterinary healthcare products. The company has chosen to pursue approvals through the U.S. Food and Drug Administration (FDA) by partnering with Therapeutics, Incorporated, which has assumed responsibility for funding and managing the testing and regulatory process for potential FDA regulated silver dihydrogen citrate-based products. Therapeutics, Incorporated is focusing on development of silver dihydrogen citrate-based products for the treatment of bacterial, viral and fungal mediated diseases and conditions, beginning with women's health products and acne treatment products. Therapeutics, Incorporated expects its development work will result in multiple Investigational New Drug (IND) filings with the USFDA.

About Clean Control Corp.
Founded in 1980, Clean Control Corp. (www.cleancontrol.com) of Warner Robins, Ga., is a premier manufacturer of high quality cleaning products for household, institutional and commercial use. Clean Control's flagship product, OdoBan, is sold worldwide for use in kitchens, bathrooms and other household areas to eliminate unpleasant odors while leaving a fresh scent. The triple action formula cleans, disinfects and deodorizes. Clean Control has expanded its product line to include more than 50 products specifically formulated for institutional/industrial, household, automotive and RV use to make everyday cleaning easier. Clean Control's top customers include Sysco Corp.; The Home Depot Supply, a division of The Home Depot Inc.; Mohawk Industries; Sam's Club, a division of Wal-Mart Stores Inc.; and BJ's Wholesale Club.

About Pure Bioscience
Pure Bioscience develops and markets technology-based products in the bioscience and water treatment sectors to provide non-toxic solutions to global health challenges. Its proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate antimicrobials and TriglycylborideTM pesticides, represent innovative advances in diverse markets. It's also a U.S. leader in pharmaceutical water purification with its Fillmaster equipment, and the Company has expanded into residential water treatment with its Nutripure water filtration systems. Pure Bioscience is based in El Cajon, Calif. Incorporated in 1992, it was formerly named Innovative Medical Services.

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