FDA Approved PURE Control is a Non-Toxic Intervention to Dramatically Reduce Salmonella
SAN DIEGO (April 7, 2016) – PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced the Company has received a permission letter from the USDA’s Food Safety and Inspection Service (FSIS) granting approval to conduct an in-plant poultry processing trial of SDC-based PURE Control® antimicrobial.
A non-toxic intervention to dramatically reduce pathogens including Salmonella, PURE Control will be spray applied to whole chicken carcasses during Online Reprocessing and Offline Reprocessing. For the trial, PURE Control will replace the current processing aid currently being used by the plant.
PURE Control maximizes microbial control and is highly effective against Salmonella, Listeria, E. coli and many other pathogens. During extensive laboratory testing, and in simulated plant conditions, application of PURE Control to raw poultry carcasses during processing has demonstrated the potential to reduce Salmonella to below detection levels. The plant trial is anticipated to confirm a meaningful reduction in pathogens in commercial application. This addresses the top priority of the USDA in its Salmonella Action Plan, to reduce the presence of Salmonella in poultry sold to consumers by 50% from current levels. Presently approximately 28% of raw poultry sold to consumers contains Salmonella.
In-Plant Poultry Processing Trial
The two phase trial will start within the next two weeks and will last 4-6 weeks.
During the two weeks prior to the initiation of the trial, PURE engineering will install the proprietary mixing and delivery equipment for application of PURE Control.
The trial will be conducted following the protocol proposed by PURE and approved by the USDA-FSIS, and will be monitored by FSIS Inspection Personnel in the plant.
During the trial, samples will be randomly pulled and tested for microbial efficacy and residues. The processed poultry will be released into commerce and sold to consumers.
In Phase II of the trial, additional post chill poultry parts will be evaluated using a dip after the completion of Phase I.
Commercialization into $350 Million US Market
Assuming a successful plant trial, PURE anticipates that the USDA-FSIS will issue a “Letter of No Objection,” stating that PURE Control is approved for use in poultry processing 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.
PURE will begin commercializing immediately upon receipt of the letter. It is anticipated that the trial plant processor will become the first customer of PURE Control for poultry processing.
Hank R. Lambert, CEO, said that, “We have been engaged in discussions with major poultry processors in anticipation of approval - and interest is strong in our solution to help processors protect customers and their brand. Within three to five years, we expect to achieve poultry processing aid sales representing a meaningful share of the $350 million US market. Simultaneously, we have already begun commercializing PURE Control in the $300 million US fresh produce processing aid market where we also anticipate generating significant market share.”
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 it mitigates bacterial resistance. 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 the Company’s estimate of the available market opportunity and its ability to obtain a significant percentage of the market on a timely basis, or at all; 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 by the USDA to use PURE Control as a direct food contact processing aid in raw poultry; 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, its Form 10-Q for the first quarter ended October 31, 2015 and its Form 10-Q for the second quarter ended January 31, 2016. 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 Terri MacInnis, VP of IR Tom Hemingway
PURE Bioscience, Inc. Bibicoff + MacInnis, Inc. Redwood Investment Group
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