Highlights

  • Memphasys achieved Vietnamese registration for the Felix System in August 2026, completing the regulatory milestone on schedule.
  • Registration triggered TMSC Vietnam's first commercial order for 600 Felix cartridges under a two-year A$530,000 exclusive agreement.
  • Including 100 cartridges previously delivered, total Felix cartridges delivered or ordered for Vietnam now stand at 700.
  • TMSC Vietnam has reported the first successful pregnancy following use of Felix by a client clinic, although the company cautioned that an individual outcome does not establish results for other patients.

Memphasys Limited (ASX:MEM) has achieved regulatory registration for its Felix System in Vietnam, clearing the way for full commercial sales and triggering the first 600-cartridge order under its distribution agreement with TMSC Vietnam. The two-year agreement has a contracted value of A$530,000, with Year 1 commitments of A$205,000 and Year 2 commitments of A$325,000. Memphasys shares were trading at $0.0060, unchanged at 11:48 am on 20 August 2026.

Vietnam Registration Completes Regulatory Milestone

The Vietnamese registration was achieved during August 2026, in line with the timetable previously communicated by Memphasys. The milestone allows the Felix System to transition from market preparation and clinical testing into commercial sales.

TMSC Vietnam had previously received 100 Felix cartridges and three consoles to support in-market testing, product introduction and clinical preparation. The new 600-cartridge order brings the total number of cartridges delivered or ordered for Vietnam to 700.

The commercial order forms part of TMSC Vietnam's contracted purchasing commitments under the exclusive two-year commercialisation agreement signed on 1 June 2026.

Commercial Rollout Moves Forward

Memphasys and TMSC Vietnam are now moving towards broader market introduction across Vietnamese fertility clinics. Under the commercial model, Memphasys is responsible for supporting product education, clinical positioning and market development, while TMSC Vietnam contributes local regulatory expertise, reproductive-health experience and relationships within the healthcare system.

The agreement provides for quarterly cartridge purchase volumes to increase as clinical adoption develops. This structure gives Memphasys a pathway towards recurring consumable sales as Felix systems are introduced into additional clinics.

TMSC Vietnam has already begun introducing Felix to fertility clinics. The distributor has also reported the first successful pregnancy following use of the system by a client clinic in Vietnam. Memphasys has noted that this individual clinical outcome should not be interpreted as establishing or predicting outcomes for other patients.

Opportunity in Vietnam's Fertility Market

Vietnam represents an important assisted reproductive technology market in South-East Asia, with the company pointing to increasing healthcare investment, Demand for fertility services and expanding fertility infrastructure.

TMSC Vietnam is based in Hanoi and operates across areas including reproductive health, diagnostics, digital health and medical-device distribution. Its experience in male fertility and relationships with healthcare providers are expected to support the Felix rollout.

The immediate focus for Memphasys is converting early clinic engagement into broader adoption and recurring cartridge demand rather than relying solely on initial system placements.

Felix Commercialisation Strategy

Felix is designed to isolate viable sperm cells for use in human assisted reproduction. Memphasys describes the technology as combining electrophoresis with size-exclusion membranes to provide a standardised sperm-selection process.

The company's commercial strategy centres on contracted and recurring sales through direct and distribution channels. The Vietnam agreement represents one step in that strategy, with cartridge purchases providing a recurring component alongside the Felix systems themselves.

With regulatory registration now completed, the company can proceed with commercial Supply under the existing agreement rather than remaining in a preparatory market-entry phase.

Conclusion

Memphasys has completed the Vietnamese regulatory milestone for Felix and triggered a 600-cartridge commercial order from TMSC Vietnam, taking total cartridges delivered or ordered in the market to 700. The A$530,000 two-year agreement provides a defined commercial framework, while the first reported pregnancy following use of Felix represents an early clinical milestone that does not by itself establish broader treatment outcomes. The next stage will depend on clinic adoption, recurring cartridge demand and the company's ability to expand commercial use of the technology in Vietnam.