Analytica close to US, EU filings for PeriCoach

Analytica (ASX:ALT) expects to be able to lodge CE Mark and US FDA applications for PeriCoach, a system for treating urinary incontinence in women, shortly after the end of April.

PeriCoach is currently undergoing electrical safety testing based on the IEC 60601 standard, Analytica said in a product development update, and expects to receive the test report at the end of April.

Once the company has the report, the company plans to file for European approval, and then subsequently lodge a 510(k) medical device application with the US FDA.

Analytica has already received reports that the PeriCoach system complies with ISO 10993, a standard covering biological evaluation of medical devices. Silicone used in the system was tested for cytotoxicity, sensitisation, irritation and systemic toxicity issues, and passed all biocompatibility tests.

The company has meanwhile successfully completed three of four stages of a product usability trial. The final stage will involve a trial of the device in 60 volunteers.

Analytica said it is on track to commence manufacturing in late May. The company has assembled a marketing team to promote the product in Australia and is also engaging marketing specialists for the US and European markets in preparation for launches in the regions.

The company has also recruited Australian pelvic floor health experts for a clinical advisory board, which is helping to plan an extensive clinical trial to help demonstrate the effectiveness of the system.

The PeriCoach system is designed to strengthen the pelvic floor muscles in women with urinary incontinence. It consists of a medical device, web portal and smartphone, to allow physicians to remotely monitor a patient’s progress. The system has already been approved in Australia.

Analytica (ASX:ALT) shares were trading unchanged at $0.028 as of around 1 pm on Tuesday