Ann: TGA clearnance to assist treatment of Pelvic Organ Prolapse, page-2

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" 2 May 2018 - Brisbane, Australia – Analytica Ltd (ASX: ALT). Analytica is pleased to announce that it
has received Australian Therapeutic Goods Administration clearance for the expanded clinical indication for
the PeriCoach System to assist in the conservative treatment of Pelvic Organ Prolapse (POP). PeriCoach is
now the only smartphone pelvic floor muscle rehabilitation system indicated for women to target resolution
of symptoms for mild to moderate POP, urinary incontinence and sexual wellness.
Pelvic organ prolapse is a very common and serious condition. Data suggests that 50% of women that have
given birth have some degree of POP and half of women over 50 complain of prolapse symptoms. Estimates
state women have a lifetime risk of up to 12% of undergoing a surgical intervention, with a re-operation
rate of nearly 20%. Each surgical intervention in the US is estimated to cost between USD$10,000-
USD$20,000. As the population continues to age and awareness of the condition grows, it is projected that
the number of women with POP will increase up to 46%.
The PeriCoach system with its patent protected force sensing technology assists women to properly perform
pelvic floor exercises. Pelvic floor muscle exercises have been demonstrated to be an effective tool in
treating women with mild to moderate POP symptoms. In a 2015 case study, Analytica demonstrated that
when the PeriCoach was used in coordination with a pelvic floor physiotherapist, symptoms of POP were
reduced, quality of life improvements were reported, and the requirement of an assistive inserted pessary
was no longer needed.
Dr Michael Monsour, Analytica Chairman said “In the US alone, as many as 60 Million women experience
POP, urinary incontinence and sexual wellness concerns. As the population ages, more women are at risk for
surgery, leaving room for complications and a large burden on healthcare systems. Expanding the indication
of PeriCoach to support women experiencing the very serious condition of POP further demonstrates our
commitment to providing clinicians with a comprehensive tool to support early interventions.”
“This clearance from the TGA is significant in that the PeriCoach system is indicated for the most common
conditions stemming from a weak pelvic floor: urinary incontinence, sexual wellness, and pelvic organ
prolapse. No other system on the market has this capability. This additional capability adds substantial
value and progresses the sale of the company and PeriCoach system to a multinational”.