SOURCE: PURE Bioscience, Inc

PURE Bioscience, Inc

October 09, 2014 08:36 ET

PURE Submits Food Contact Notification to FDA for SDC Antimicrobial Use in Produce Processing

Data Suggests Processors Incorporating SDC Can Improve Pathogen Reduction Results 100-Fold With Only One Step

SAN DIEGO, CA--(Marketwired - Oct 9, 2014) - PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that it has submitted a Food Contact Notification (FCN) to the U.S. Food and Drug Administration (FDA) for Silver Dihydrogen Citrate (SDC) as a produce processing aid, expanding the use for SDC as a direct food contact substance. Test results demonstrate significant log reductions in Salmonella, Listeria and E. coli O157:H7 when applied to leafy greens.

Meaningful SDC Produce Test Results
Testing performed at Kansas State University, under the direction of Dr. James Marsden, evaluated the efficacy of SDC against Salmonella, Listeria and E. coli O157:H7 on iceberg lettuce, spinach and cilantro. These leafy greens were chosen for evaluation because they are challenging to effectively treat during processing.

  • SDC achieved average reductions up to 2.36 log10 CFU/cm2 when applied alone as a spray and up to 3.10 log10 CFU/cm2 when combined with chlorine wash, simulating current processing steps;
  • Sensory evaluations of produce treated with SDC indicated no difference in color, appearance or odor to untreated controls; and
  • SDC had no effect on the nutritional composition of the produce.

Currently, processors target achieving only a 1 log10 CFU/cm2 reduction per intervention treatment. Data suggests that by incorporating SDC, processors can improve their results 100-fold with only one step. This represents a significant advantage to processors as well as improvement to the safety of processed produce going to the consumer.

Produce - Leading Source of Foodborne Illness in the US
The Centers for Disease Control and Prevention (CDC) estimates that produce was responsible for 46% of foodborne illnesses and 23% of foodborne illness-related deaths in the US between 1998 and 2008. Leafy greens were identified as the primary source of foodborne illnesses.

Hank R. Lambert, CEO of PURE said, "The produce industry takes food safety seriously, and understands the importance and challenges in reducing contamination on fresh produce. Armed with the validation of this impressive test data, we believe SDC offers the industry a practical and effective solution to reduce the food safety threat presented by processed raw produce. This breakthrough for SDC can open what we estimate to be a new market opportunity in excess of $200 million in the US for PURE."

PURE recently completed a financing which provides the Company with sufficient working capital to support its operations for more than 12 months, excluding incremental revenue from its food safety commercialization efforts to accelerate commercialization of SDC as a food safety solution to prevent foodborne illness:

  • PURE now has two FCN's filed with the FDA (for processing poultry and for processing produce) and has begun testing SDC on meats (beef and pork).
    • The Company expects to file an FCN for processing beef and pork in early calendar 2015;
  • PURE is reinforcing existing sales and marketing capabilities for SDC as a hard surface disinfectant into QSRs (quick service restaurants) and food manufacturers/processors.

FDA Approval Process
The FDA's FCN Program ensures the safety of Food Contact Substances (FCS) used in food processing and packaging.

  • The FCN review period is 120 days from filing, after which, if there are no concerns from the FDA, the FCN automatically becomes effective.
  • An FCN is considered to be proprietary as it applies only to the specific product and manufacturer or supplier identified in the FCN.
  • Subject to receipt of FDA approval, PURE expects to begin commercialization of SDC in calendar Q1 2015 for use in produce processing.

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.

Forward-looking Statements
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 cash position and liquidity requirements, 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, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission, including our annual report on Form 10-K filed October 24, 2013. 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.

Contact Information

  • Contacts:
    Tom Hemingway
    Redwood Investment Group
    714-978-4425
    Email Contact

    Terri MacInnis
    VP of IR
    Bibicoff + MacInnis, Inc.
    818-379-8500
    Email Contact

    Company Contact:
    Peter C. Wulff
    CFO & COO
    PURE Bioscience, Inc.
    619-596-8600 ext.111
    Email Contact