Highlights
- Felix™ System approved by the Therapeutic Goods Administration (TGA) and included on the Australian Register of Therapeutic Goods (ARTG)
- Approval granted approximately two months ahead of previously guided timeframe
- TGA registration enables immediate commercial sale and clinical deployment of Felix™ across Australia
- Following CE Mark approval in Europe and existing compliance in selected international markets, TGA approval establishes Australia as a major high-regulatory commercial market for Felix™
- Early approval accelerates activation of advanced commercial discussions and revenue generation
Memphasys Limited (ASX: MEM) (“Memphasys” or “the Company”) is pleased to announce that the Felix™ System has received approval from the Australian Therapeutic Goods Administration (TGA) and has been successfully included on the Australian Register of Therapeutic Goods (ARTG).
Importantly, TGA approval has been granted approximately two months ahead of the Company’s previously guided time-frame, representing a material acceleration of Memphasys’ Australian commercial rollout.
Ahead-of-Schedule Approval Reflects Execution Momentum
The Company had previously guided the market to expect Australian regulatory clearance by April 2026. Receipt of approval in February 2026 materially de-risks the near-term commercial pathway, compresses time to market and brings forward revenue-generating activity.
Early approval reflects the strength of the Company’s regulatory, manufacturing and quality systems, and underscores Memphasys’ ability to execute to plan - and ahead of schedule.
Following CE Mark approval in Europe and existing compliance in selected international markets, TGA approval establishes Australia as a significant high-regulatory commercial market for Felix™.
Lindley Edwards, Chair of Memphasys, commented:
“Securing TGA approval for Felix™ approximately two months ahead of our stated timeline is a strong validation of the quality of the technology, the robustness of our regulatory strategy and the discipline of our execution.
Just as importantly, this approval allows us to accelerate commercial activity in Australia, bringing forward engagement with IVF clinics and converting advanced discussions into revenue-generating outcomes sooner than anticipated.”
What Early TGA Approval Means for Commercialisation
With ARTG inclusion now secured, Memphasys is immediately authorised to:
- market and sell the Felix™ System in Australia,
- deploy Felix™ consoles into IVF laboratories,
- supply Felix™ cartridges on a recurring per-procedure basis, and
- transition from pre-commercial readiness into active market deployment.
Australia represents a strategically important initial market, with more than 60,000 fresh IVF cycles performed annually where Felix™ has a direct clinical application. Early regulatory clearance positions Memphasys to capitalise on these opportunities earlier than expected.
Acceleration of Advanced Commercial Discussions
Memphasys has been engaged in advanced commercial discussions with Australian stakeholders, including IVF clinics and potential distribution partners, in parallel with the regulatory process. The earlier-than-expected approval enables these discussions to move immediately into execution and deployment phases.
The Company’s Australian commercial strategy is focused on building an installed base of Felix™ systems and establishing scalable, recurring cartridge revenue streams linked to IVF procedure volumes.
Global Commercial Momentum Continues
The Australian approval follows the Company’s CE Mark certification1 and complements ongoing regulatory and commercial progress across multiple jurisdictions, including markets where Felix™ has already been compliant and in use.
Outlook
With Australian regulatory approval now secured earlier than anticipated, Memphasys is entering a phase of accelerated commercial execution. The Company will continue to update shareholders as Australian commercial agreements are finalised and as further regulatory and commercial milestones are achieved internationally.
About us:
About Memphasys
Memphasys Limited (ASX: MEM) is an Australian-based reproductive biotechnology company commercialising the Felix™ System, a patented bio separation technology that isolates the most viable sperm cells for human assisted reproduction.
By combining electrophoresis and size-exclusion membranes, Felix™ delivers a fast, gentle and standardised sperm selection process that enhances sperm quality and reduces laboratory time. The system replaces traditional centrifugation, which can cause cellular stress and DNA damage, offering clinicians a superior, repeatable alternative.
Memphasys’ commercial strategy focuses on building contracted sales through direct and distribution-led channels, scaling production to improve margins, and establishing Felix™ as a new global standard in sperm preparation for ART procedures.
Website: www.memphasys.com
The Felix™ System is a registered trademark of Memphasys Limited. All rights reserved.
Contact details:
David Tasker
Managing Director
Chapter One Advisors
Tel: +61 433 112 936
E: [email protected]