Vietnamese registration triggers first 600-cartridge commercial order
Memphasys (ASX: MEM) has achieved Vietnamese registration for its Felix™ System in August 2026, completing the regulatory milestone in line with the timetable previously advised to the market.
The clearance triggers TMSC Vietnam’s first commercial order of 600 Felix™ cartridges under a two-year A$530,000 exclusive commercialisation agreement. Combined with 100 cartridges already delivered for in-market testing, total cartridges delivered or ordered for Vietnam now reaches 700.
In an early signal of clinical traction, TMSC Vietnam has reported the first successful pregnancy following use of Felix™ by a client clinic in Vietnam. With registration secured, full commercial sales can now commence in one of South-East Asia’s fastest-growing assisted reproductive technology (ART) markets.
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What the registration unlocks commercially
The regulatory milestone allows full commercial sales of Felix™ to commence in Vietnam, marking the transition from pre-launch clinical preparation to full commercial supply. It represents the point at which the contracted agreement moves from preparation into active product distribution.
Memphasys entered into the two-year exclusive commercialisation agreement with TMSC Viet Nam Medical Technology Company Limited on 1 June 2026 for the sale and distribution of the Felix™ System in Vietnam. The 600-cartridge order forms part of the contracted purchase commitments under that agreement.
The Vietnam commercialisation agreement, signed on 1 June 2026, established the contractual framework now moving into active product distribution, with quarterly cartridge volumes structured to grow as clinic adoption builds across the two-year term.
The table below summarises the key contracted terms and delivery figures disclosed by the Company.
| Metric | Detail |
|---|---|
| Total contract value | A$530,000 |
| Year 1 value | A$205,000 |
| Year 2 value | A$325,000 |
| First commercial order | 600 cartridges |
| Previously delivered | 100 cartridges + 3 consoles |
| Total cartridges delivered/ordered | 700 |
Contracted quarterly cartridge volumes are structured to increase as clinical adoption develops, pointing to a recurring revenue profile as clinic uptake builds across the two-year term.
Company commentary
The achievement of registration on schedule, commencement of the first 600-cartridge commercial order and first reported pregnancy following use of Felix™ demonstrate tangible progress against the Vietnam market-entry plan outlined in June 2026.
Early clinical traction: first pregnancy reported
TMSC Vietnam has advised Memphasys that its early engagement with fertility clinics over the past 3 weeks has resulted in the first successful pregnancy reported following use of Felix™ by a client clinic in Vietnam.
The Company has been careful to frame this outcome appropriately. As Memphasys noted, an individual clinical outcome does not establish or predict outcomes for other patients.
Even with that caveat, the early result is described as an encouraging milestone as TMSC Vietnam moves from market preparation into broader commercial introduction.
How Felix™ works and why it matters
Felix™ is a patented bio separation technology that isolates the most viable sperm cells for use in human assisted reproduction. It is designed to improve the quality of sperm selected for fertility procedures.
The system combines electrophoresis and size-exclusion membranes to deliver a fast, gentle and standardised sperm selection process.
According to Memphasys, Felix™ replaces traditional centrifugation, a spinning process that can cause cellular stress and DNA damage. The Company positions the system as a repeatable alternative for clinicians.
Felix pivotal study results presented at FSANZ 2026 in August showed a statistically significant improvement in Embryo Utilisation Rate over density gradient centrifugation (58.8% vs 49.1%) and 100% clinician preference across 103 couples at 10 Monash IVF Group centres, providing the clinical evidence base underpinning commercial adoption in new markets.
For investors, the commercial logic sits in the consumables. The consumables create a recurring revenue model that scales as clinic adoption grows.
Why Vietnam matters for the investment case
Vietnam is positioned as an important ART market in South-East Asia, supported by increasing healthcare investment, rising demand for fertility services and expanding fertility infrastructure across Hanoi and Ho Chi Minh City.
The Company’s partner, TMSC Vietnam, is a Hanoi-based medical technology company with an established focus on reproductive health, diagnostics, digital health tools and medical-device distribution. Its experience in male fertility and existing healthcare relationships underpin its role in the national rollout.
Under the commercial model, responsibilities are split between the two parties:
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Memphasys works alongside TMSC Vietnam on product education, clinical positioning and market development.
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TMSC Vietnam leverages its local regulatory expertise, reproductive-health experience and relationships across the Vietnamese healthcare system to build clinic adoption.
This structure aligns with the Company’s broader strategy of building contracted and recurring sales through direct and distribution-led channels.
Outlook and next steps
With registration now complete, Memphasys and TMSC Vietnam plan to focus on converting early clinic engagement into broader adoption and recurring cartridge sales. The Company will continue to support training, product education and selected clinic engagement as the commercial rollout progresses.
Registration achieved on schedule, the first 600-cartridge commercial order commenced, and the first pregnancy reported following Felix™ use together demonstrate tangible progress against the Vietnam market-entry plan outlined in June 2026, marking the transition from market preparation into full commercial supply across the two-year agreement structure disclosed to the market.
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