PURE Bioscience receives EPA registration of expanded efficacy claims for SDC-based disinfectant

November 7, 2007 — SAN DIEGO, CA — PURE Bioscience today announced it has received EPA registration of expanded bacterial and viral efficacy claims for its silver dihydrogen citrate (SDC)-based disinfectant (Axen30(TM)). The amended label now includes kill claims against eight new organisms, including Avian Influenza A (bird flu), Human Corona virus (SARS surrogate), Feline Calicivirus (norovirus), rotavirus, Campylobacter jejuni, and Acinetobacter baumannii as well as two additional strains of MRSA: community-associated MRSA (CA-MRSA) and community-associated PVL positive MRSA (PVL MRSA).

Powerful Weapon against resistant bacteria
Regarding the expanded bacterial claims, Michael L. Krall, president and CEO of PURE Bioscience, states, “PURE Bioscience has long recognized the importance of controlling organisms responsible for nosocomial infections, particularly those that have become resistant to antibiotics. Our SDC-based disinfectant already carried a two-minute claim for methicillin-resistant Staphylococcus aureus (MRSA). It now carries claims against two additional resistant strains of staph, community-associated MRSA (CA-MRSA) and community-associated PVL positive MRSA (CA-MRSA, PVL positive), eliminating both organisms in just two minutes.”

Also added to the expanded label are two-minute kill claims on Campylobacter jejuni, one of the leading causative agents for human gastroenteritis worldwide, and Acinetobacter baumannii, an opportunistic nosocomial pathogen responsible for serious infections among soldiers wounded in Iraq and Afghanistan.

Timely new viral efficacy claims
Expanded viral efficacy claims for PURE’s SDC-based disinfectant include a three-minute kill against Human Corona virus and rotavirus and a ten-minute kill against norovirus and Avian Influenza A. The Human Corona virus infects the gastrointestinal tract and the upper respiratory tract. The most notable of the Human Corona viruses is the SARS-CoV strain, which causes SARS (severe acute respiratory syndrome). Rotavirus is the most frequent cause of severe diarrhea among children and leads to the hospitalization of approximately 55,000 children in the Untied States each year. Noroviruses cause gastroenteritis, more commonly referred to as “stomach flu.” Norovirus is highly contagious and spreads rapidly throughout closed environments.

Avian Influenza A viruses cause Avian influenza, often referred to as “bird flu.” Bird flu is a naturally occurring infection primarily in birds; however, infections with these viruses can occur in humans.

Krall also comments on the new viral claims, “The standard viral kill time for disinfectants is 10 minutes, and our prior viral tests were performed to meet that standard. Based on the most recent three-minute viral test results against Human Corona virus and rotavirus, we intend to begin retesting the other viruses and expect this SDC-based disinfectant to demonstrate quicker kill times. Following successful testing, we plan to submit the updated information to the EPA for registration.

Krall concludes, “Earlier this year, we identified significant and growing needs in the marketplace. In February we initiated independent third-party laboratory testing to establish the data for these new claims, and the EPA label amendment was filed immediately upon completion of the battery of tests. With the recent issuance of the EPA’s registration of our expanded claims, we feel we are now well positioned to provide an even more comprehensive solution to help combat very serious worldwide health challenges.”

SDC is an electrolytically generated source of stabilized ionic silver. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, low toxicity, and the inability of bacteria to form a resistance to it. The first new disinfectant active to be registered by the EPA in more than 30 years, SDC-based products are antiviral, antifungal, and antibacterial, including a 30-second kill and 24-hour residual protection against standard indicator bacteria and a two-minute kill claim on MRSA (methicillin-resistant Staphylococcus aureus), CA-MRSA, PVL-MRSA, and VRE (vancomycin-resistant Enterococcus faecium). Moreover, SDC-based disinfectants are odorless, colorless, non-corrosive, non-flammable, and compatible with other disinfecting and cleaning chemicals.

Private label SDC-based hard surface disinfectant products are currently available through a number of PURE’s distributors and are ideal for use not only as a household disinfectant but also in hospitals, schools, prisons, and other closed population environments.

About PURE Bioscience
PURE Bioscience (PURE) develops and markets technology-based bioscience products that provide solutions to numerous global health challenges. PURE’s proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today’s global trend toward industry and consumer use of “green” products while providing competitive advantages in efficacy and safety. Patented silver dihydrogen citrate (SDC) is an electrolytically generated source of stabilized ionic silver. SDC is colorless, odorless, tasteless, non-toxic, non-caustic, and formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity, and the inability of bacteria to form a resistance to it. SDC also offers 24-hour residual protection against standard indicator bacteria. PURE Bioscience, headquartered in El Cajon, CA (San Diego metropolitan area), was incorporated in 1992. Additional information about PURE Bioscience is available at www.purebio.com.


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