Summary
- Medical device company Analytica Limited, on Friday, announced that PeriCoach® demonstrated non-inferiority to in-clinic pelvic floor physical therapy.
- The trial results published in the prestigious Journal of Female Pelvic Medicine & Reconstructive Surgery.
- The trial was designed for evaluating if home biofeedback is non-inferior to standard of care supervised PFPT for treating stress urinary incontinence.
ASX-listed medical device company Analytica Limited’s (ASX:ALT) shares had a strong end to the week after the release of favourable clinical trials results for its PeriCoach® therapy intervention. On 20 November 2020, ALT share price closed at A$0.003, up by an impressive 50%. The Company has a market capitalisation of almost A$7.03 million.
PeriCoach demonstrated non-inferiority to treat Stress Urinary Incontinence (SUI) to traditional supervised pelvic floor physical therapy.
Let us discuss the trial in detail-
About Analytica Limited
Brisbane-headquartered ASX-listed company Analytica Limited is engaged in designing, developing and commercialising Class I and Class II medical devices. The Company’s lead product, PeriCoach® System, is an e-health treatment system for Stress Urinary Incontinence patients.
PeriCoach has received TGA approval in Australia and also has a CE mark and FDA 510(k) clearance. The system has regulatory clearance in Australia for Pelvic Organ Prolapse treatment.
Primary outcome met in PeriCoach trial
On 20 November 2020, the medical devices company announced the publication of results from a clinical trial for PeriCoach from The University of New Mexico in an esteemed Journal of Female Pelvic Medicine & Reconstructive Surgery. The trial results demonstrated PeriCoach non-inferiority to in-clinic pelvic floor physical therapy.
The primary outcome measurement was met, with the biofeedback group using PeriCoach demonstrating non-inferiority to PFPT based on the quality of life score as measured by the International Consultation on Incontinence Questionnaire short form (ICIQ-SF).
PeriCoach trial in brief
The clinical trial was a randomised single-centre study led by principal investigator Dr Lauren de Winter.
The study was designed to assess whether home biofeedback is non-inferior to standard of care supervised pelvic floor physical therapy (PFPT) for treating stress urinary incontinence (SUI) in women who wish for non-surgical therapy.
The trial included 48 participants and compared PeriCoach personal biofeedback device usage with PFPT. It was aimed to support the implementation of personal biofeedback devices to overcome the issues with patient distance as well as the ability to maintain clinician monitoring.
Chairman of Analytica Dr Michael Monsour commented-
Dr Monsour also added that Analytica had the ambitious objective of forming a system to provide a treatment which is at the same level as that of pelvic floor physiotherapy (PFPT). The publication of the study in an esteemed Journal validates that the Company has met its objective.
