FDA clears PeriCoach to go over the counter

Brisbane-based company Analytica (ASX:ALT) has been granted FDA clearance for its PeriCoach medical device, previously available in the US by prescription only, to be sold over the counter. The PeriCoach assists women to exercise their pelvic floor muscles in order to reduce or eliminate stress urinary incontinence, a condition that affects one in three women.

Urinary incontinence (UI) affects approximately 25 million women in the United States. The National Association for Continence reported that women wait up to six years before talking with a clinician about their UI, as they are too embarrassed to discuss the issue or believe it is a normal condition. Meanwhile, the US market for incontinence pads is worth $5 billion a year, despite the fact that these products only address the symptom of leaking and not the underlying cause of the condition.

The American College of Physicians recommends pelvic floor exercises, or Kegels, as the first line treatment option for conservative management of UI, as they have been proven to be effective if performed consistently and properly. According to Dr Leslie Rickey of the Yale School of Medicine, the FDA clearance for PeriCoach means that “home training just got a lot more convenient”.

“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,” added Analytica CEO Geoff Daly. “This will help to raise awareness amongst physical therapists and healthcare professionals, who remain an important channel.”

The over-the-counter regulatory clearance is in line with the regulatory clearances Analytica has already achieved in Australia and the UK.

Analytica (ASX:ALT) shares were trading 16.67% higher at $0.007 as of around 12 noon on Wednesday.