Shares in Analytica have jumped almost 40 per cent after the medical device designer won approval from the US regulator to sell its e-health treatment system to help women control incontinence.
Stress urinary incontinence affects one in three women worldwide.
It is mostly caused by trauma to the pelvic floor muscles as a result of pregnancy, childbirth and menopause.
Analytica said on Thursday that the US Food and Drug Administration (FDA) had approved its PeriCoach system, which comprises a device, web portal and a smartphone app.
The device evaluates activity in pelvic floor muscles, then transmits the information to a smartphone app and loads it to “PeriCloud” where physicians can monitor the patient’s progress via a web portal.
This enables physicians to remotely determine if a woman is performing her pelvic floor exercises and if these are improving her condition.
“(FDA) clearance allows us to supply the PeriCoach in the world’s biggest medical device market, and we can now pursue distribution agreements and enact our early adopter programme,” Analytica chief executive Geoff Daly said.
“Combined with our CE marking (European approval) we now have the regulatory foundation to sell the PeriCoach globally.”
Analytica expects to launch PeriCoach in Europe and the US in 2015.
The company said the US market for incontinence pads is worth about $5 billion a year.
Shares in Analytica were 0.7 cents, or 38.89 per cent, higher at 2.5 cents on Thursday.