SAN DIEGO--(BUSINESS WIRE)--PURE Bioscience, Inc. (OTCQB: PURE), creator of the non-toxic, patented silver dihydrogen citrate (SDC) antimicrobial, today announced the Company had received a Preliminary Notification (PNC) authorization letter from the U.S. Food and Drug Administration (FDA) granting permission to conduct in-plant poultry processing trials at higher concentrations of the SDC-based PURE Control® antimicrobial to dramatically reduce Salmonella and Campylobacter.
PURE has submitted the PNC to the USDA seeking permission to promptly begin poultry plant trials using up to 200 PPM of PURE Control.
- SDC is a non-toxic intervention that in testing has demonstrated superior reductions in a wide range of pathogens, including Salmonella and Campylobacter, during poultry processing.
- The pending USDA poultry processing trials (estimated to begin by the end of calendar Q1 ’17 with results reported before the end of calendar Q2 ’17), will evaluate PURE Control applied as a spray to whole chicken carcasses during Online Reprocessing and Offline Reprocessing.
Once approved and commercialized, poultry processors will be able to use PURE Control in place of the highly toxic interventions currently being used.
Pending trial results that are satisfactory to the USDA, and the issuance of a “No Objection” letter, PURE anticipates the final steps to commercialization of PURE Control for poultry processing to include:
- Receipt of an Acknowledgement Letter from the FDA that its FCN (Food Contact Notification) for use of SDC as a raw poultry processing aid at higher concentrations is complete, setting an effective date in May ’17 (the end of the FDA’s statutory 120-day review period).
- With USDA and FDA approvals in hand, PURE can begin to immediately commercialize PURE Control for US poultry processing into this new +$350m annual market.
- It is anticipated that the plant trial processors will be among the first customers for PURE Control for poultry processing.
Hank R. Lambert, CEO, said that, “As soon as we complete the regulatory process to gain approvals for use of SDC throughout poultry processing, we are poised to begin commercialization into this important new market.
“We already have strong interest from major poultry processors in our PURE Control solution to help meet stricter USDA standards for Salmonella control, replace current highly toxic interventions and protect their customers and brand. This interest was reinforced and expanded just last week when PURE exhibited and featured the benefits of PURE Control at IPPE (the world's largest annual poultry and meat production and processing expo attended by more than 30,000 industry leaders and their suppliers).”
Lambert continued, “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 - with first orders expected this calendar quarter.”
Superior Effectiveness of PURE Control
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 upcoming plant trial is anticipated to confirm a meaningful reduction in pathogens in commercial application. PURE Control 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. According to the USDA, presently approximately 28% of raw poultry sold to consumers contains Salmonella.
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 any 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 ability to convert successful evaluations and tests into customer orders and customers continuing to place product orders as expected and to expand their use of the Company’s products; 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 meat processing and to expand its use in OLR poultry 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, 2016, its Form 10-Q for the first quarter ended October 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.