Pursuing USDA Approval – Targets Early 2016 for Commercialization of PURE Control® as Direct Food Contact Food Safety Solution
SAN DIEGO (Dec. 18, 2015) - PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that the FDA has completed its review of the safety and efficacy of the proposed use of silver dihydrogen citrate (SDC) as a raw poultry processing aid and declared PURE Bioscience’s food contact notification (FCN) to be effective as of December 18, 2015.
Dramatic SDC test results show consistent reductions in pathogen levels -- including the potential to reduce Salmonella on raw poultry to below detection levels. A breakthrough technology, SDC is a non-toxic food safety solution (safe for both people and the environment) – delivering superior efficacy when compared with other processing aids used in the market today.
USDA Approval Process Proceeding
The final step in the regulatory approval process for commercialization of SDC-based PURE Control® in poultry processing is to obtain USDA approval. With receipt of the FDA’s approval, PURE is engaged in the review and approval process with the Food Safety and Inspection Service of the USDA. This process will involve plant trials under the authorization of the USDA. The Company is working with partner processors and laboratories, has developed protocols, and is designing the equipment necessary for the trials.
The USDA trials are expected to take 45-60 days and following completion and USDA review, PURE expects the USDA to issue a “Letter of No Objection” and list SDC as an approved poultry processing aid in Attachment 1, of the FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products.
By early calendar Q2 2016, PURE anticipates having both of the necessary regulatory approvals to begin commercializing PURE Control as a poultry processing aid to reduce Salmonella and other pathogens to prevent foodborne illness.
Hank R. Lambert, CEO of PURE said, “Attaining FDA approval as a direct food contact processing aid for poultry is a truly important and catalytic milestone for PURE. It marks the first FDA approval for our powerful SDC antimicrobial technology – and brings us just one step away (USDA approval) from bringing PURE Control to the US poultry processing market as a much needed, effective and non-toxic food safety solution.
“Each year, one in six Americans is sickened by foodborne illness, according to the CDC. We believe that PURE Control will be an important breakthrough to help make food safer for consumers, beginning with raw poultry processors, as they combat prevalent contaminants that have persisted through processing, including Salmonella and Campylobacter,” concluded Lambert.
Poultry Processing - $350+ Million Annual US Market Opportunity
In the US, poultry processing aids and interventions represents a $350+ million annual market. The average US poultry processing plant spends $1+ million annually in processing aids and intervention chemistries. PURE Control will be marketed to replace the toxic chemicals presently used during online reprocessing as well as in other intervention steps. The Company believes it can capture a significant share of this market based on PURE Control’s proven superior efficacy and lower toxicity compared to interventions currently in use.
EPA approved PURE Hard Surface® disinfectant (applied on surfaces that come into contact with food but not directly on the food itself) has already been adopted for use on equipment and plant surfaces at a growing number of poultry processing plants. PURE will leverage this especially relevant foothold for its direct food contact initiative with PURE Control.
About PURE Bioscience, Inc.
PURE Bioscience, Inc. is focused on developing and commercializing our proprietary antimicrobial products primarily in the food safety arena -- providing solutions to the health and environmental challenges of pathogen and hygienic control. Our technology platform is based on patented stabilized ionic silver, and our initial products contain silver dihydrogen citrate, or SDC. SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers 24-hour residual protection and formulates well with other compounds. As a platform technology, SDC is distinguished from existing products in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s failure to implement or otherwise achieve the benefits of its proposed business initiatives and plans; acceptance of the Company's current and future products and services in the marketplace, including acceptance of the Company’s PURE Hard Surface disinfectant by SUBWAY® franchisees; and the ability to convert successful evaluations into customer orders; the ability of the Company to develop effective new products and receive required regulatory approvals for such products, including the required data and regulatory approvals required to use its SDC-based technology as a direct food contact processing aid in raw poultry, produce and raw meat processing; competitive factors; dependence upon third-party vendors, including to manufacture its products; and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission (the SEC), including its Form 10-K for the fiscal year ended July 31, 2015 and filed with the SEC on October 28, 2015 and its Form 10-Q for the first quarter ended October 31, 2015 and filed with the SEC on the date of this press release. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Hank Lambert, CEO
PURE Bioscience, Inc.
Terri MacInnis, Director of IR
Bibicoff + MacInnis, Inc.
Redwood Investment Group