Analytica medical device gets clearance from American FDA
ASX listed Analytica has received approval from the powerful US Food and Drug Administration or “FDA” to sell their unique “PeriCoach” incontinence medical device without the need for a prescription in the USA.
The PeriCoach is a proprietary medical device developed by Analytica to assist women to exercise their pelvic floor muscles in order to reduce or eliminate urinary incontinence. According to the company, 25 million women in the United States are afflicted with urinary incontinence.
The PeriCoach can now be sold over the counter in the USA potentially busting the American market wide open for the company.
According to Analytica, the National Association for Continence reported that women wait up to six years before talking with a clinician about their urinary incontinence as they are too embarrassed to discuss the issue or alternatively they believe it to be a normal condition.
Analytica say the US market for incontinence pads is worth around $5 billion a year and whilst diapers and pads are a common option for women, they only address the symptom of leaking and not the underlying cause of the condition.
The American College of Physicians recommends pelvic floor exercises as the first line treatment option for conservative management of urinary incontinence as they have been proven to be effective if performed consistently and properly.
Many women however are not aware if their pelvic floor exercises are being carried out effectively and that’s where the PeriCoach steps in to send a signal to the user that their pelvic exercises are being done correctly or not.
“Women can use pelvic floor exercises or “Kegels” to reduce or eliminate urinary incontinence symptoms, and with PeriCoach now available over the counter, home training just got a lot more convenient,” said Leslie Rickey, MPH, MD, Associate Professor of Urology and of Obstetrics, Gynaecology and Reproductive Sciences and Fellowship Director of Female Pelvic Medicine and Reconstructive Surgery, Yale School of Medicine.
“It is critical that women put their trust in new technology for pelvic floor muscle training that has been medically tested and FDA-cleared, as these products have an internal component and are designed to treat a real medical condition.” said Dr Rickey.
Analytica CEO, Geoff Daly said “This is a terrific achievement for Analytica which opens up a significant market opportunity within the United States and also positions us attractively for a potential licensing partner. Achieving OTC clearance in such a short time means the device is more easily accessible by women in the US who will no longer need a referral from their health professional to purchase the product. “
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