Analytica (ASX:ALT) has started patient recruitment for a clinical trial for its PeriCoach pelvic floor muscle training system for treatment of urinary incontinence and female sexual dysfunction.
While the trials are not required for registration or sales clearance, they will provide the company with a foundation for market differentiation, clinician confidence and efficacy information for reimbursement studies.
100 patients will be recruited at 4 Australian sites over the coming months, with each patient monitored over 20 weeks.
The PeriCoach System is a personalised device, web portal and smartphone app that provides real-time biofeedback for pelvic floor muscle exercises.
Weak pelvic floor muscles can contribute to bladder leakage and sexual dysfunction.
Pelvic floor muscle exercises are recommended by the prestigious American College of Physicians as first-line non-pharmacological treatment for urinary incontinence.
The PeriCoach system provides real-time biofeedback to enhance the performance and effectiveness of performing the exercises.
The patented technology is a result of five years research and testing to international standards.
Usability trials and the expanding collection of testimonials lends further support for the effectiveness of the PeriCoach.
The PeriCoach system has achieved registration as a medical device with the TGA (Australia), CE-marking for Europe, and FDA clearance in the U.S.
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