Memphasys Limited has achieved its first material revenues following CE Mark approval for its Felix™ System, activating multi-year contracts across Europe, the Middle East, and Asia. The company is now transitioning from regulatory preparation to global commercial rollout with a focus on recurring revenues.
- First material revenues of approximately $102,000 invoiced in December quarter
- CE Mark approval secured, enabling sales across Europe and CE-recognised regions
- Multi-year contracts signed with Centro Fertilità Assistita (Italy) and International Technical Legacy (Middle East)
- New supply agreement entered in India, expanding access to 200+ IVF clinics
- Annual operating costs cut by ~39%, leadership restructure completed
Regulatory Breakthrough Unlocks Commercial Potential
Memphasys Limited marked a pivotal moment in its commercial journey during the December 2025 quarter by securing CE Mark approval for its Felix™ System. This regulatory milestone opens the door for commercial sales across the European Economic Area and other jurisdictions recognising the CE Mark, effectively transitioning the company from a development and regulatory phase into active global commercial execution.
The CE Mark approval not only validates the Felix™ System’s compliance with stringent EU Medical Device Regulations but also activates previously signed multi-year contracts, enabling Memphasys to begin invoicing customers and generating recurring revenues.
First Revenues and Multi-Year Contracts Signal Market Acceptance
For the first time, Memphasys reported material invoiced revenues of approximately $102,000 during the quarter, supported by contracted minimum revenues of around $1.5 million over multiple years. Key commercial agreements include a five-year supply deal with Centro Fertilità Assistita (CFA Italia), one of Italy’s largest private fertility groups, valued at approximately A$925,000. CFA Italia placed initial cartridge orders ahead of contractual triggers, demonstrating early demand.
In the Middle East, the company’s direct sales efforts bore fruit with International Technical Legacy (ITL) placing initial and repeat orders for Felix™ cartridges under a five-year exclusive agreement valued at about $390,000. This traction was further supported by active engagement at the Middle East Fertility Society Conference and direct clinic interactions in Qatar and the UAE.
Memphasys also made its first commercial inroads into India by signing a supply agreement with Andro Diagnostics, granting access to a network of over 200 IVF clinics. This positions the company well for rapid market activation pending regulatory approval expected mid-2026. In Japan, repeat orders from a leading private fertility network underscore growing clinical adoption.
Operational Efficiency and Leadership Changes
Alongside commercial progress, Memphasys has undertaken significant cost restructuring, reducing annual operating expenses by approximately 39%. This cost discipline aims to free capital for manufacturing scale-up and regulatory acceleration. The company also completed a leadership restructure aligned with its direct selling strategy, including the departure of CEO Dr David Ali and the appointment of A/Prof Hassan Bakos to lead clinical engagement and sales growth.
Financially, Memphasys raised $1.1 million through equity placements during the quarter to support its commercial rollout and manufacturing readiness. However, cash runway remains tight, with available funding covering less than half a quarter at current burn rates, though one-off restructuring costs are expected to ease in coming periods.
Looking Ahead, Scaling Revenues and Expanding Markets
With CE Mark approval secured and initial revenues flowing, Memphasys is poised to scale its commercial operations across Europe, the Middle East, India, and Japan. The company’s focus remains on embedding its Felix™ System within IVF clinics through a recurring consumable-driven revenue model and disciplined capital deployment. Progress on regulatory approvals in India and Australia will be critical to unlocking further growth opportunities.
Memphasys’ December quarter results mark a clear inflection point, transitioning from preparation to execution. The coming quarters will be telling as the company seeks to convert contracted revenues into sustained cash flow and broaden its global footprint.
Bottom Line?
Memphasys has crossed a crucial commercial threshold, but execution risks and cash constraints will test its momentum in 2026.
Questions in the middle?
- How quickly can Memphasys scale recurring revenues beyond initial contract minima?
- What is the timeline and likelihood for regulatory approvals in India and Australia?
- How will the leadership changes impact commercial execution and investor confidence?