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23 November 2015 Company Announcements Office Australian Securities Exchange Journal of Medical Virology publishes study demonstrating trophon® EPR as the only high level disinfection system for ultrasound probes proven to kill high-risk, human papillomavirus (HPV) A study published by the Journal of Medical Virology1 demonstrates that the trophon® EPR is the only high level disinfection system proven to kill natural, infectious, high-risk cancer causing strains of human papillomavirus (HPV). The study sets trophon EPR apart from all other high level disinfectants commonly used on ultrasound probes. High-risk HPV accounts for 5% of all cancers worldwide, is responsible for almost all cases of cervical cancer and is a leading cause of oral, throat, anal and genital cancers. A number of published studies have already demonstrated there is a real risk of cross contamination between patients examined with ultrasound probes. The studies showed up to 7% of probes remained contaminated with HPV despite the use of probe covers and routine disinfection.3,4 HPV is also a very stable virus and is able to remain infectious on fomites and surfaces for days.5 Testing of natural, infectious “real” HPV has not previously been possible due to the difficulties of growing enough of the natural, infectious virus for research. This situation changed recently when researchers from Penn State College of Medicine and Brigham Young University in the United States developed a method to grow HPV. “We were the first ever to grow papillomavirus in culture,” said Craig Meyers, Distinguished Professor of Microbiology and Immunology, Penn State College of Medicine. “In our original study we chose, specifically, glutaraldehyde and ortho-phthalaldehyde (OPA) to test because these are disinfectants that hospitals believe are sterilants that kill everything, including papillomavirus.” This original study, which was published in 2014, showed both glutaraldehyde and OPA completely failed to inactivate natural, infectious, high-risk HPV16 – even after 24 hours of contact time.2 The most recent study used a stringent method in line with FDA requirements for virucidal testing, retesting OPA and also testing the trophon EPR device against HPV16 and HPV18, the major cancer-causing types of HPV. The results showed that the trophon EPR was the only disinfectant to completely inactivate HPV. “Our first study showed that commonly used disinfectants are not effective, while this latest study found that trophon EPR was completely effective. The concern is that these other liquid chemical disinfectants are commonly used in medical and healthcare facilities. Where this is happening, HPV is not being killed, posing a risk for transmission” said Professor Meyers. Nanosonics Limited ABN 11 095 076 896 14 Mars Road, Lane Cove NSW 2066 Australia Tel: +61 2 8063 1600 Fax: +61 2 8063 1600 Email: [email protected] w: www.nanosonics.com.au The study concluded that healthcare professionals should carefully consider these results when selecting appropriate disinfection methods and that a review of disinfection standards with respect to high level disinfection may be warranted. “This clinically significant study clearly demonstrates the unique effectiveness of trophon EPR in inactivating high-risk, cancer-causing HPV,” said Michael Kavanagh, Nanosonics Chief Executive Officer and President. “The trophon technology is unique in that it uses a proprietary disinfectant containing a high concentration of hydrogen peroxide that is sonically activated to form a sub-micron particle mist. This mist generates a high number of free radicals with superoxidative properties that destroy the virus. This is a very different approach to the traditional method of soaking probes in toxic liquid chemicals or manually wiping them for a few minutes with a pre-impregnated wipe. “We were confident our technology would be effective against this dangerous virus but until we had tested against the actual virus we were not in a position to make such a claim. “Publication of the study is very timely given the current increased scrutiny of disinfection practices. An alert issued in the US by the Centers for Disease Control and the FDA in September stipulates that reusable medical devices, such as ultrasound probes, must be properly maintained, cleaned and disinfected/sterilized and urged healthcare facilities to immediately review current reprocessing practices to protect patients. “This is just one of a number of studies in our ongoing clinical studies program which has also carried out independent laboratory testing to demonstrate the effectiveness of trophon technology against a wide range of organisms including HIV and chlamydia. This important work supports our objective of establishing trophon EPR as the new standard of care for the high level disinfection of ultrasound probes.” More about HPV According to the Centers for Disease Control and Prevention (CDC) in the US, HPV is the most commonly diagnosed sexually transmitted infection with around 79 million Americans currently infected and about 14 million new genital infections occurring each year. HPV accounts for 5% of cancers worldwide with high-risk types responsible for 99.7% of cervical cancer cases and is strongly linked to anal, vaginal, vulvar and penile cancers. For more information, visit www.hpvdisinfection.com. Link to Study: http://onlinelibrary.wiley.com/doi/10.1002/jmv.24421/abstract Michael Kavanagh CEO / President For more information please contact: Michael Kavanagh, CEO / President or McGregor Grant, CFO, on (02) 8063 1600 Kyahn Williamson, Investor / Media Relations, Buchan Consulting on (03) 9866 4722 About Nanosonics Nanosonics Limited is developing a portfolio of decontamination products designed to reduce the spread of infection. The Company owns intellectual property relating to a unique disinfection and sterilisation technology which can be suited to a variety of markets. Initial market applications are designed for the reprocessing of reusable medical instruments. The Company’s first product is designed to disinfect Ultrasound Transducers. In parallel with the commercialisation of this product, Nanosonics is also developing other medical applications and exploring opportunities for its proprietary technology in other industries. For more information about Nanosonics please visit www.nanosonics.com.au References 1. 2. 3. 4. 5. Ryndock E, Robison R, Meyers C. 2015. Susceptibility of HPV16 and 18 to high level disinfectants indicated for semi-critical ultrasound probes. J Med Virol. In Press. Meyers J, et al. 2014. Susceptibility of high-risk human papillomavirus type 16 to clinical disinfectants. J Antimicrob Chemother 69(6):1546-1550. Casalegno JS, et al. 2012. High risk HPV contamination of endocavity vaginal ultrasound probes: an underestimated route of nosocomial infection? PLoS One 7(10):e48137. M'Zali F, et al. 2014. Persistence of Microbial Contamination on Transvaginal Ultrasound Probes despite Low-Level Disinfection Procedure. PLoS One 9(4):e93368. Ryndock EJ, Meyers C. 2014. A risk for non-sexual transmission of human papillomavirus? Expert Rev Anti Infect Ther 12(10):11651170. MM0188-EN-MR V01