Targeting Q1 2016 for Commercialization
SAN DIEGO, CA (Sept. 17, 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) stating that its Food Contact Notification (FCN) for Silver Dihydrogen Citrate (SDC) as a raw poultry processing aid is complete and setting an effective date of December 2015.
Initiates USDA Approval Process:
The next step in the regulatory approval process is to obtain USDA approval. With its receipt of the FDA’s Acknowledgement Letter, PURE is now eligible to initiate this next step. Accordingly, after its receipt of the Acknowledgement Letter from the FDA, PURE immediately submitted its FCN to the Food Safety and Inspection Service of the USDA to commence the USDA review and approval process. As part of the USDA process, PURE is preparing to conduct in-plant process validation and optimization trials with the authorization of the USDA. At the completion of the trials , PURE expects the USDA to issue a “Letter of No Objection” and list SDC as an approved on line reprocessing poultry processing aid in Attachment 1, table 1 of the FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products.
Hank R. Lambert, CEO of PURE said, “We continue to target making the powerful SDC food safety solution available to the poultry processing market in the first quarter of 2016. We were pleased to receive the FDA’s Acknowledgement Letter, which has enabled us to immediately commence the USDA review and approval process. We intend to initiate the necessary USDA plant trials well in advance of the FDA’s effective date for the FCN. Being able to start the USDA notification process now means that the December 2015 FDA effective date for the FCN in no way changes our go-to-market strategy or timing.”
In August 2015, PURE received a request from the FDA for additional information to support its FCN, to which PURE responded promptly. The Acknowledgement Letter confirms that PURE has satisfied the FDA’s request for additional information, and as a result, the FDA set the effective date for the FCN at 120 days (December 2015) after PURE’s August submission. The additional information was not related to the safety of SDC, but was focused on the environmental assessment provided based on the intended use. The approval of the FCN will be based on the Safety Assessment submitted by PURE, which the FDA has acknowledged without further question.
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.
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 on a timely basis, or at all, 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.
Hank Lambert, CEO
PURE Bioscience, Inc.
Terri MacInnis, Director of IR
Bibicoff + MacInnis, Inc.
Redwood Investment Group