Analytica's PeriCoach, a smartphone-connected Kegel exercise coach for women, has received a second FDA 510(k) clearance, one that allows it to be sold over-the-counter. Its previous clearance, from March of last year, was for prescription use only.
“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," CEO Geoff Daly said in a statement. "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. This will help to raise awareness amongst physical therapists and health care professionals, who remain an important channel.”
Analytica is an Australian company and the device, which is also called a pelvic floor exerciser, was already available over the counter in Australia and the UK. It's cleared to be marketed to eliminate bladder leakage, or Stress Urinary Incontinence, a condition the company says affects one in three women.
When inserted, the PeriCoach device will detect the strength of each muscle contraction and record each exercise session. The data from the device is sent via Bluetooth to a companion app, which analyzes the exercise data and offers the user a picture of how well she is doing her exercises over time. The app will also send exercise reminders and can send results to a clinician or pelvic health specialist.
There's two reasons it makes sense to make the device available over-the-counter. One is that urinary incontinence can be embarrassing to discuss, even with a doctor, so potentially more women will treat it if they can do so without needing to have that conversation and secure a prescription.
"Our research has identified that 58 percent of women don't want to talk to their clinician about their UI," Daly told MobiHealthNews in an email. "They cite 'embarrassment' and many just think it's part of getting older and being a mum. It's a private matter. Retail could include drug stores and other retail outlets, but the majority want online with the anonymity that goes with it. Without OTC they require a prescription, which adds a barrier to purchase."
Another possible reason is that Kegel exercisers also have a lot of uses beyond urinary incontinence, and having the device available over the counter will make it available to women without that condition. For instance, another company, London-based Chiaro, markets its smartphone-connected Kegel exerciser via claims that the device improves core, back, and abdominal strength. And on its own website, Analytica mentions that "strong Kegel muscles can also enhance sexual experience for women at any age".
The Pericoach system, which includes the device, the app, and a 12-month subscription to a data management system, costs $299. Analytica sees regulatory clearances as a market differentiator that enhance confidence in its products.
"Our regulatory clearances provide assurance to customers and clinicians that the product has been designed, developed, tested and manufactured to internationally recognised medical device standards," Daly said.