SOURCE: PURE Bioscience, Inc

PURE Bioscience, Inc

September 09, 2015 08:36 ET

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

Reactivates Commercial Path Into Second New Market Segment in Excess of $300 Million

SAN DIEGO, CA--(Marketwired - Sep 9, 2015) -  PURE Bioscience, Inc., (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that it has resubmitted a Food Contact Notification (FCN) to the US 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.

PURE believes its FCN resubmission has adequately addressed the FDA's prior issues regarding the FCN originally submitted in October 2014 and withdrawn without prejudice in January 2015. The Company's resubmission follows the June 2015 resubmission of its FCN for poultry processing and constructive discussions with the FDA regarding results of new SDC testing on produce including lettuce, spinach and spring mix:

  • Demonstrating materially significant reductions in, Salmonella, Listeria and E. coli in produce;
  • While achieving silver residue levels that are approaching non-detectable; and 
  • Below existing FDA guidelines.

The Company's resubmission covers a broad range of processed vegetables and fruits that are most frequently associated with pathogen contamination.

PURE estimates that the US market opportunity for produce processing aids is currently in excess of $300 Million. Given the immediate market need and the proven superior efficacy of SDC against Salmonella, Listeria and E. coli, PURE believes it can achieve significant market penetration following receipt of FDA approval.

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 illness.

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, after which, if there are no concerns from the FDA, the FCN automatically becomes effective. With an effective FCN for produce, PURE can then immediately begin to commercialize SDC as a food safety solution into this new market.

Food Safety Problems - The SDC Solution
US Public Health Statistics track pathogens in the food supply chain -- clearly demonstrating an ever increasing need for more effective, efficient and safer interventions. Processing aids or interventions commonly used in the US food industry today are highly toxic chemistries. In addition, pathogens can become increasingly resistant and render current interventions less efficacious.

PURE believes that SDC is a significant improvement over current processing chemicals and provides numerous important advantages, including:

  •  Does not induce bacterial resistance;
  • More effective in reducing or eliminating pathogens;
  • Easier to handle and dilute;
  • Non-corrosive to processing equipment; and
  • Non-toxic -- does not create noxious fumes.

Hank R. Lambert, CEO of PURE, said, "We feel confident to make the resubmission at this time because we have good reason to believe that our new test results included in our FCN resubmission clearly and adequately address the FDA's earlier concerns.

"Also, we are already working with a number of major produce and fruit processors who are using our SDC-based PURE Hard Surface® disinfectant. We believe our test results will be compelling to the FDA, and we are optimistic that the agency will view these results as a breakthrough in the industry's ability to dramatically reduce the pathogen risk that persists through produce processing -- thus opening an important and significant new market for SDC as a food safety solution," Lambert concluded.

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 http://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, 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 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-Q for the quarterly period ended April 30, 2015 and filed with the SEC on June 15, 2015. 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:
    Hank R. Lambert
    CEO
    PURE Bioscience, Inc.
    619-596-8600 ext.103
    Email Contact

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

    Tom Hemingway
    Redwood Investment Group
    714-978-4425
    Email Contact