Memphasys Signs 1,800-Cartridge Indian Supply Agreement Under Go-Direct Model

Memphasys Advances Indian Market Presence

Memphasys Limited (ASX – MEM), an Australian reproductive biotechnology company, has taken a significant step forward in expanding its commercial footprint in India by signing a non-exclusive supply agreement with Andro Diagnostics, a subsidiary of the Andrology Center Coimbatore. This deal marks the first under Memphasys’ new global go-direct commercial strategy, which aims to accelerate product adoption by working directly with key clinical partners rather than relying solely on distributors.

The agreement commits Andro Diagnostics to a minimum purchase of 1,800 Felix™ cartridges in the first year following regulatory approvals, with deliveries scheduled quarterly. Year two sees this commitment increase by at least 50% to 2,700 cartridges, reflecting confidence in the product’s growing demand. The Felix™ System, a patented sperm separation technology, has already demonstrated clinical success in India, including multiple live births, underscoring its potential impact on assisted reproductive technologies.

Regulatory Milestones and Market Opportunity

The activation of this supply agreement hinges on obtaining the CE Mark and Indian CDSCO approvals, with the CE Mark submission progressing well and an outcome anticipated by early 2026. The regulatory landscape in India shifted in 2022 when the Felix™ System was reclassified as a medical device, temporarily halting sales. This new agreement signals a re-entry into the market with a robust commercial framework designed to capture the rapidly expanding IVF sector.

India’s IVF market, valued at approximately USD 1.06 billion in 2023, is forecast to grow at a compound annual growth rate of nearly 8%, reaching USD 1.82 billion by 2030. With around 300,000 IVF cycles performed annually and male-factor infertility accounting for roughly half of these cases, the Felix™ System’s ability to provide faster, high-integrity sperm selection positions it well to meet increasing clinical demand, especially as more clinics adopt ICSI-based procedures.

Strategic Implications and Future Outlook

Memphasys’ CEO, Dr David Ali, highlighted that this agreement transforms years of clinical collaboration into a structured commercial partnership, delivering near-term revenue growth potential. The dedicated Felix™ team established by Andro Diagnostics will actively promote and support adoption across a network of over 200 IVF clinics, providing a substantial platform for scaling sales.

Beyond India, Memphasys is advancing regulatory and commercial efforts in other key markets including Japan, New Zealand, and the Middle East. The company’s disciplined execution of its commercialisation roadmap aims to secure recurring cartridge demand and improve manufacturing efficiencies, targeting gross margins below A$40 per cartridge. This positions Memphasys for a potential step-change in revenue generation during the 2026 financial year.

As the company awaits regulatory approvals, the market will be watching closely to see how quickly Felix™ can regain and expand its presence in India’s burgeoning fertility sector, and how this momentum might translate into broader global growth.