Pursuing USDA Approval – Targets Early 2016 for Commercialization
of PURE Control® as Direct Food Contact Food Safety Solution
SAN DIEGO–(BUSINESS WIRE)–PURE Bioscience, Inc. (OTCQB:
PURE), creator of the patented silver dihydrogen
antimicrobial, today announced that the FDA has completed its review of
the safety and efficacy of the proposed use of silver dihydrogen citrate
(SDC) as a raw poultry processing aid and declared PURE Bioscience’s
food contact notification (FCN) to be effective as of December 18, 2015.
Dramatic SDC test results show consistent reductions in pathogen levels
— including the potential to reduce Salmonella on raw poultry to
below detection levels. A breakthrough technology, SDC is a non-toxic
food safety solution (safe for both people and the environment) –
delivering superior efficacy when compared with other processing aids
used in the market today.
USDA Approval Process Proceeding
The final step in the
regulatory approval process for commercialization of SDC-based PURE
Control® in poultry processing is to obtain USDA approval. With receipt
of the FDA’s approval, PURE is engaged in the review and approval
process with the Food Safety and Inspection Service of the USDA. This
process will involve plant trials under the authorization of the USDA.
The Company is working with partner processors and laboratories, has
developed protocols, and is designing the equipment necessary for the
The USDA trials are expected to take 45-60 days and following completion
and USDA review, PURE expects the USDA to issue a “Letter of No
Objection” and list SDC as an approved poultry processing aid in
Attachment 1, of the FSIS Directive 7120.1, Safe and Suitable
Ingredients Used in the Production of Meat, Poultry and Egg Products.
By early calendar Q2 2016, PURE anticipates having both of the necessary
regulatory approvals to begin commercializing PURE Control as a poultry
processing aid to reduce Salmonella and other pathogens to
prevent foodborne illness.
R. Lambert, CEO of PURE said, “Attaining FDA approval as a direct
food contact processing aid for poultry is a truly important and
catalytic milestone for PURE. It marks the first FDA approval for our
powerful SDC antimicrobial technology – and brings us just one step away
(USDA approval) from bringing PURE Control to the US poultry processing
market as a much needed, effective and non-toxic food safety solution.
“Each year, one in six Americans is sickened by foodborne illness,
according to the CDC. We believe that PURE Control will be an important
breakthrough to help make food safer for consumers, beginning with raw
poultry processors, as they combat prevalent contaminants that have
persisted through processing, including Salmonella and Campylobacter,”
Poultry Processing – $350+ Million Annual US Market Opportunity
In the US, poultry processing aids and interventions represents a
$350+ million annual market. The average US poultry processing plant
spends $1+ million annually in processing aids and intervention
chemistries. PURE Control will be marketed to replace the toxic
chemicals presently used during online reprocessing as well as in
other intervention steps. The Company believes it can capture a
significant share of this market based on PURE Control’s proven
superior efficacy and lower toxicity compared to interventions
currently in use.
EPA approved PURE Hard Surface® disinfectant (applied on surfaces that
come into contact with food but not directly on the food itself) has
already been adopted for use on equipment and plant surfaces at a
growing number of poultry processing plants. PURE will leverage this
especially relevant foothold for its direct food contact initiative
with PURE Control.
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 and its Form 10-Q for the
first quarter ended October 31, 2015 and filed with the SEC on the date
of this press release. 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.
PURE Bioscience, Inc.
Hank Lambert, CEO
+ MacInnis, Inc.
Terri MacInnis, VP of IR
Tom Hemingway, 714-978-4425