Regulatory and Commercial Roadmap

Felix™ System

Memphasys is progressing a robust global regulatory and commercialisation strategy for the Felix™ System, aimed at bringing this novel sperm separation technology to market across key jurisdictions.

Clinical Evidence and Submissions

Memphasys has completed a clinical trial of the Felix™ System. Positive trial data, supported by an extensive literature review, will form the basis for submissions to major regulatory bodies including:

  • CE Mark – European Union,
  • Therapeutic Goods Administration (TGA) – Australia, and 
  • Central Drugs Standard Control Organisation (CDSCO) – India.

Preparation of the technical documentation for CE Mark submission is underway, with registration targeted for FY2025. This will be followed by TGA and CDSCO registrations. 

China Regulatory Pathway

Following a successful licencing agreement with our current partners in China licensing activities will commence. It is expected that our partners will be able to assist to expedite registration and commercialisation. This is targeted for FY2025.

Commercial Launch Timeline

  • End of FY2025 – Commercial launch in Europe
  • Beginning of FY2026 – Commercial launch in Australia and India
  • Beginning of FY2026 – Commercial launch in China 
  • Beginning of FY2026 – Commencement of offshore manufacturing

United States Regulatory Outlook

Memphasys has completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the Felix™ System. Based on initial feedback, the device is likely to be classified as a novel Class II device requiring a de novo submission. The U.S. regulatory strategy continues to evolve in parallel with progress in other jurisdictions. The regulatory strategy in the US will move forward with commercial partnerships in place.

Strategic Partnerships

In parallel with regulatory activities, strategic partnership discussions are underway to support regional distribution and commercial scaling.

RoXsta™ System

RoXsta™ Regulatory Overview

RoXsta™, Memphasys’ rapid oxidative stress assessment system, is currently in the development phase and progressing through key international regulatory pathways:

  • European Union: Intended to be classified as a Class B In Vitro Diagnostic (IVD) device under the EU In Vitro Diagnostic Regulation (IVDR).
  • Australia: The RoXsta™ System may be classified as a Class 2 IVD medical device.
  • India: Anticipated to fall under Class B or Class C IVD category, regulated by CDSCO, depending on final classification criteria for oxidative stress diagnostic tools.
  • China: Expected to be regulated as a Class II medical device under the National Medical Products Administration (NMPA) framework, subject to local clinical validation and registration requirements.
  • United States: Planned to be classified as a Class II IVD device.

Memphasys is committed to advancing RoXsta™ through these global regulatory pathways, with the goal of providing multiple industries with a streamlined, accurate tool for oxidative stress assessment.