Regulatory Plan

In support of planned regulatory filings in Australia and overseas, Memphasys is conducting a clinical study involving the Felix™ device in collaboration with the Monash IVF Group Ltd (ASX: MVF), an Australian reproductive and fertility services company.

The clinical results, together with a literature review, will be filed in a formal regulatory submission (conformity assessment application) to the Therapeutic Goods Administration (TGA) in Australia. These clinical data will also support Felix™ device registrations in other international jurisdictions.

Memphasys is preparing for a pre-submission meeting with the US Food and Drug Administration (FDA). Initial feedback from specialist regulatory consultants is that as the Felix™ device will be classed as a novel class II device and as there is no predicate device, it is likely to require a de novo submission. Further details on the pre-submission meeting and expected timelines will be reported when they come to hand.