Analytica : USFDA Issues Warning Letters to Vaginal Rejuvenation Laser Manufacturers for Deceptive Treatment Claims

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ANALYTICA LTD - ABN 12 006 464 866

COMPANY ANNOUNCEMENT

USFDA Issues Warning Letters to Vaginal Rejuvenation Laser Manufacturers for Deceptive Treatment Claims

1 August 2018. Analytica would like to direct shareholders to a recent USFDA announcement regarding Vaginal Rejuvenations.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm

'Vaginal rejuvenation' products use lasers to scar the tissue inside the vagina and sellers of these products have made claims about treating conditions including urinary incontinence and sexual function. The FDA Commissioner Scott Gottlieb, M.D said in the announcement that "These products have serious risks and don't have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed."

This concern follows international investigations into other treatments for pelvic floor disorders including the Australian Senate inquiry into mesh implants. Internationally recognised bodies such as the American College of Physicians and American College of Obstetrics and Gynaecology recommend pelvic floor exercise as the first-line treatment for urinary incontinence and other pelvic floor disorders. Other treatments such as pharmaceuticals and surgery should only be considered after pelvic floor exercises have been tried.

Analytica Chairman Dr Michael Monsour says "This comes as no surprise. The pelvic floor consists of a complex set of muscles and if you want to reduce the symptoms of incontinence and pelvic organ prolapse, pelvic floor exercises work. It's not magic - you just need to put in the hard work. The good news is that the PeriCoach is a proven solution. It can ensure pelvic exercises are performed correctly and regularly, and if further treatment is necessary, a woman can share with her clinician a report on her exercise history and conservative treatment programme compliance."

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For more information about the PeriCoach System, visit:www.PeriCoach.com

For more information about Analytica, visitwww.AnalyticaMedical.com

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About Analytica Limited

Analytica's lead product is the PeriCoach® System - an e-health treatment system for women who suffer Stress Urinary Incontinence. This affects 1 in 3 women worldwide and is mostly caused by trauma to the pelvic floor muscles as a result of pregnancy, childbirth and menopause.

PeriCoach comprises a device, web portal and smartphone app. The device evaluates activity in pelvic floor muscles. This information is transmitted to a smartphone app and can be loaded to a cloud database where physicians can monitor patient progress via web portal. This novel system enables physicians to remotely determine if a woman is performing her pelvic floor exercises and if these are improving her condition. Strengthening of the pelvic floor muscles can also potentially improve sexual sensation or satisfaction and orgasm potential in some women.

PeriCoach has regulatory clearance in Australia, and has CE mark and USFDA 510(k) clearance. The product is available for sale from pericoach.com in Australia, New Zealand, UK and Ireland.