New Data Demonstrate for the First Time STERRAD(R) NX(TM) System Technology Effective in Prion Inactivation (Only for Use Outside the U.S.)

PARIS -

- Multiple Tests Show Gaseous Hydrogen Peroxide STERRAD(R) Sterilization System Technology Efficiently Inactivates Protein-based Infectious Agents Linked to Fatal Brain Diseases

Advanced Sterilization Products(R) (ASP) announced today newly published data showing that the low-temperature hydrogen peroxide sterilization technology used in the STERRAD(R) NX(TM) Systems is able to inactivate prions, protein-based infectious agents linked to bovine spongiform encephalopathy (BSE, also known as “mad cow disease”) and other fatal brain diseases. Until now, the only approved process for full inactivation of prions, which have an unusually high level of resistance to sterilization methods, was combination of soaking in aggressive chemicals and high-temperature steam (special prion cycle at 134 degrees C, 18 minutes). These key findings were published in the August 2009 issue of Infection Control and Hospital Epidemiology.

Prions, which are protein-based infectious agents, cause neurodegenerative brain diseases characterized by the formation of “holes” in brain tissue. The time between exposure to prions and development of symptoms is usually long, but once the symptoms do appear, brain damage and death often come quickly. Prions are highly resistant to the commonly used procedures for inactivating them, and until recently, only the most severe sterilization processes had been proven effective.

“Since there is no cure at this time, prion diseases can pose a significant threat to the public and to healthcare facilities that attempt to treat individuals with prion-related maladies,” said Dr. Pascal Clayette, SPI-BIO, CEA, Fontenay-aux-Roses, France. “Complicating the challenge of prion inactivation is that the currently recommended procedures are often damaging to the materials used in medical devices.”

“These data are exciting for infection prevention specialists because it is important to have an effective and less damaging sterilization solution, which will enable hospitals and clinics to prevent spread of prions, while at the same time protect valuable surgical equipment from potential damage caused by high-temperature steam sterilization,” said Klaus Roth, SMP GmbH, Tubingen, Germany.

About the Data

ASP selected to involve several independent laboratories in France and Germany. They combined their expertise and used consensual experimental methodology to drive the most comprehensive studies available today on prion inactivation. 61 series of tests (41 in vivo and 20 in vitro) allowed exhaustive evaluation and comparison of disinfection, washing and sterilization procedures. STERRAD(R) NX(TM) Sterilization Systems similar to those routinely used in hospital obtained better results than prion Steam cycle at 134 degrees C, 18 minutes (special optimized steam cycle recommended by World Health Organization for inactivation of prions).

About Prion Diseases

Prion diseases are caused by prions (proteinaceous infectious particle only), which are infectious agents composed entirely of proteins. Prion diseases, or transmissible spongiform encephalopathies (TSEs), are a family of rare, progressive neurodegenerative disorders that affect both humans and animals, and include bovine spongiform encephalopathy (BSE, also known as “mad cow” disease) in cattle and Creutzfeldt-Jakob Disease (CJD) in humans. They can be sporadic, familial or acquired. Unlike conventional diseases, prion diseases exhibit no immune reaction or inflammation; however, they are transmissible via conventional means (e.g., food, blood transfusion, surgery). Diseases caused by prions have long asymptomatic incubation periods and are always fatal.

About STERRAD(R) Sterilization Systems

Engineered using ASP’s breakthrough gas plasma technology, STERRAD(R) Sterilization Systems sterilize instruments and medical devices safely and effectively, without the limitations or risks associated with peracetic acid, steam and ethylene oxide gas systems. With thousands of units in use at hospitals and healthcare facilities around the world, STERRAD(R) Sterilization Systems produce a measurable return on hospital’s sterilization investment by reducing instrument repair costs, offering rapid cycles, reducing instrument inventories and enhancing safety.

About Advanced Sterilization Products (ASP)

Advanced Sterilization Products (ASP), a Division of Ethicon, Inc., a Johnson & Johnson company is a leading developer of innovative instrument sterilization, high level disinfection and cleaning technologies. The company is dedicated to protecting patients, healthcare workers, and the environment with products that focus as much on safety as they do on efficacy and cost-effectiveness. Utilizing advanced instrument processing technologies, these products help customers to promote positive patient outcomes while controlling costs, increasing productivity and enhancing safety. The company is based in Irvine, California.

Source: Advanced Sterilization Products

Catherine Heron of Chandler Chicco Agency, +33(0)1-53-43-92-43 (France), cheron at ccapr.com, for Advanced Sterilization Products; or Katie Sweet of ASP, +1-949-789-3945 (U.S.), ksweet at its.jnj.com