PURE Bioscience Receives USDA Permission Letter and FDA FCN Acknowledgement Letter

SAN DIEGO--()--PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented non-toxic silver dihydrogen citrate (SDC) antimicrobial, announced that the Company has received two required key regulatory notifications on the Company's path to commercialize PURE Control® as a superior raw poultry processing aid into the +$350m US market.

FDA FCN Acknowledgement Letter

PURE received an Acknowledgement Letter from the US Food and Drug Administration (FDA) stating that the FDA had completed its review of the safety and efficacy of the proposed use of SDC in concentrations up to 160 PPM as a raw poultry processing aid, and setting an effective date of May 18, 2017.

  • Upon receipt of the FDA’s Acknowledgement Letter, PURE filed for inclusion of SDC in concentrations up to 160 PPM in the Food Safety and Inspection Service (FSIS) directive 7120.1 (“Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products”) for use in pre-OLR (online reprocessing) and post chill processing of fresh poultry.
    • Once the 7120.1 listing is published, PURE can commercialize PURE Control up to 160 PPM for all non-OLR poultry processing applications.

USDA In-Plant Poultry Processing Trial

  • PURE also received a permission letter from the USDA’s Food Safety and Inspection Service (FSIS) granting approval to conduct an in-plant poultry processing trial of SDC-based PURE Control antimicrobial. The USDA’s Permission Letter enables PURE to conduct trials where PURE Control will be spray applied to whole chicken carcasses during Online Reprocessing (OLR).
  • The trial should start within the next three weeks and is expected to be completed by the end of calendar Q2 (June).
  • The trial will be conducted following the protocol proposed by PURE and approved by the USDA-FSIS, and will be monitored by FSIS Inspection Personnel in the plant.
  • Assuming a successful plant trial, and that no additional trials are required by USDA, PURE anticipates that the USDA-FSIS will issue a “Letter of No Objection,” stating that PURE Control is approved for use in OLR applications (typically within four weeks) and list SDC as an approved poultry processing aid in Attachment 1 of the FSIS Directive 7120.1.

Upon receipt of the “Letter of No Objection,” PURE can immediately commercialize PURE Control for OLR applications.

Superior Benefits of PURE Control

FDA approved PURE Control antimicrobial is applied directly onto raw poultry carcasses, parts and organs as a spray or dip during processing to eliminate pathogens causing foodborne illness, including Salmonella. PURE knows of no other equally effective, lowest-toxicity solution to eliminate Salmonella in poultry processing – and believes PURE Control is the breakthrough solution the poultry industry needs. SDC is distinguished by the fact that it is non-toxic and more effective. Currently used poultry processing intervention chemistries, most notably Peracetic acid (or PAA), are highly toxic, irritants to users, negatively impact the environment, and are corrosive to equipment.

Poultry Sales Cycle

With positive test results and final regulatory approvals in hand, PURE expects the sales cycle for poultry processors to be faster than what the Company has experienced in sales of FDA approved PURE Control to fresh produce processors for several reasons:

  • Poultry processors will use PURE Control to replace currently used toxic interventions. Produce processors use it as an incremental step and cost.
  • The product has proven superior to currently used chemistries in eliminating Salmonella and Campylobacter. As evidenced by recent FSIS data, interventions in use today are not getting the job done.
  • Poultry processors are under growing scrutiny and pressure to meet new government standards and PURE Control can enable processors to achieve those goals.
  • Where current toxic interventions can have a negative impact on product yield (cauterizing fat), in testing PURE Control has shown a neutral to positive processing yield impact.

A number of leading poultry processors are existing customers using the Company’s first product, PURE® Hard Surface disinfectant, and therefore are already aware of and receiving the superior benefits of SDC. These processors are using PURE Hard Surface for environmental, plant and equipment surface disinfection as a replacement for less effective and toxic legacy products.

Hank R. Lambert, CEO of PURE, said, “The receipt of these two critical regulatory notifications allows us to initiate the final steps toward commercializing PURE Control as a raw poultry processing aid - our second large and important US market for the product.

Last month we received our first PURE Control order from a fresh produce industry leader. That catalytic milestone both validated SDC’s superior efficacy and established PURE Control as a viable weapon in the war against foodborne illness. Once we complete the in-plant poultry trial for OLR applications and obtain USDA approval, we look forward to achieving meaningful market penetration in US processing aids markets for both poultry and produce.”

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.

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 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, the timing of customer testing and orders, customers continuing to place product orders as expected and to expand their use of the Company’s products throughout their operations; the ability of the Company to develop effective new products and receive required regulatory approvals for such products, including the required data from plant trials and final 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 and its Form 10-Q for the second quarter ended January 31, 2017. 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.

Contacts

PURE Bioscience, Inc.
Hank Lambert, CEO
619-596-8600 ext.103
hlambert@purebio.com
or
Bibicoff + MacInnis, Inc.
Terri MacInnis, VP of IR
818-379-8500
terri@bibimac.com
or
Redwood Investment Group
Tom Hemingway, 714-978-4425
tomh@redwoodfin.com

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Release Summary

PURE Bioscience Receives USDA Permission Letter and FDA FCN Acknowledgement Letter - two required key regulatory notifications on the path to commercialize PURE Control® antimicrobial.

PURE Bioscience, Inc.