SAN DIEGO, CA (Nov. 10, 2015) - PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that it has received an Acknowledgement Letter from the US Food and Drug Administration (FDA) for its Food Contact Notification (FCN) for Silver Dihydrogen Citrate (SDC) as a spray or dip on processed fruits and vegetables stating that its submission is complete and setting an effective date of January 2016.
Targets Commercialization of PURE Control® for Calendar Q1 2016
PURE is prepared to begin commercialization of PURE Control in calendar Q1 2016 as a food safety solution for a broad range of processed vegetables and fruits that are most frequently associated with pathogen contamination. In its regulatory filing, PURE demonstrated materially significant reductions in Salmonella, Listeria and E. coli in processed fresh produce, as compared with current processing chemicals.
Given the immediate market need and the proven superior efficacy of SDC, the Company believes it can quickly achieve meaningful market penetration among fruit and vegetable processors.
Produce is the leading source of foodborne illness in the US.
The Centers for Disease Control and Prevention (CDC) has identified leafy greens as the primary source of foodborne illness.
There have been recent, highly visible, incidents of foodborne illness outbreaks linked to leafy greens that trace back to both restaurants and processors.
PURE is proactively engaged in both “push” and “pull” sales and marketing initiatives with produce processors, retailers, and distributors to prime demand for PURE Control. Among these are some of the very largest vegetable and fruit processors, grocery and restaurant chains.
Also, PURE is already working with a number of major produce and fruit processors who are using its SDC-based PURE® Hard Surface disinfectant for environmental sanitation. It is expected that these users, like the poultry processors already using PURE Hard Surface, will be early adopters of PURE Control. PURE looks forward to playing a significant role in dramatically reducing the pathogen risk that persists through produce processing.
Hank R. Lambert, CEO of PURE said, “Receiving the FDA’s Acknowledgement Letter is an important step forward in our path toward regulatory approval, and we continue to target making the powerful SDC food safety solution available to the produce processing market in the first calendar quarter of 2016. The timing is especially significant given the recent foodborne illness outbreaks in the news tied to fresh processed produce.
“With this produce processing Acknowledgement Letter following on the heels of our October receipt of the raw poultry processing Acknowledgement Letter, we are now “full speed ahead” in preparing for a calendar Q1 sales launch of PURE Control into both of these lucrative markets. The raw poultry market opportunity is estimated to be in excess of $350 million and the processed produce opportunity is estimated to exceed $300 million. It is our long term goal to capture a significant share, at least 10%, of those markets,” concluded Lambert.
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. 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