Just when all looked lost for a group of parent hopefuls in India, a groundbreaking piece of Australian medical technology developed by Memphasys has turned their dreams of the pitter-patter of tiny feet into reality.
It has been revealed today in a heartwarming development, that after the Sydney-based company’s reproductive biotechnology Felix system led to a baby boy being born in a hospital in India in April, another 10 families have now welcomed healthy little ones into the world.
Felix’s sperm quality enhancement and separation technology made the births possible, helping to solve an increasingly common and particularly intractable global reproductive problem. All of the Indian families who are now enjoying precious time with their new bundles of joy had been struggling with issues surrounding high levels of sperm damage in the prospective fathers and had all been through at least one failed IVF cycle.
Memphasys chief executive officer Alison Coutts said: “This is a landmark moment that validates the Felix device’s ability to provide an effective solution to achieve healthy live births in an extremely challenging patient population. The device clearly fills an important unmet need in IVF.”
The company says 31 couples were enrolled in a study utilising Felix at its Indian partner’s Coimbatore Women’s Hospital Centre (CWHC) in Tamil Nadu. The study resulted in 40 frozen embryo transfers, with a clinical pregnancy rate of 47.5 per cent. The pregnancies resulted in the 11 live births, equating to a live birth rate of 27.5 per cent.
Most significantly, the result is comparable with the current Australia and New Zealand live birth benchmark of 31.3 per cent across all patients who undertake IVF from frozen embryo transfers.
The results of the study were presented on September 9 at the 12th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2023) in Adelaide by Dr Ramaya Jayram from Coimbatore Women’s Hospital Centre. Dr Jayram is the clinician responsible for the study titled, “First Recorded Normal Live Birth after ICSI with Electrophoretically Isolated Spermatozoa Using the Felix™ System”.
Dr Jayram said the use of Felix enabled the patients to undertake the gentle treatment without needing to resort to invasive procedures such as surgical sperm retrieval.
Memphasys says its Felix technology is ideal for men who suffer from high sperm DNA fragmentation, which is strongly correlated with male infertility. It has been used predominantly by CWHC for men suffering from the condition in a bid to improve pregnancy outcomes.
Results to date demonstrate the positive impact of Felix sperm selection in a particularly challenging patient cohort. All the couples now playing happy families included men with high levels of sperm DNA fragmentation averaging 34 per cent. It is understood 20 per cent is considered a high level.
The company’s initial activities were focussed on proprietary electrophoresis and polymer membrane technology – the two key scientific bases underlying Felix – to enable the separation of high-quality sperm from semen. It was developed in conjunction with emeritus laureate Professor John Aitken and his staff at the Priority Research Centre for Reproductive Science at the University of Newcastle in Australia.
Electrophoresis is a laboratory technique used to separate DNA, RNA or protein molecules based on their size and electrical charge. An electric current is used to move the molecules through a gel or another matrix.
The technology is embodied in Felix, which is a patented, automated single-use cartridge that gently separates high-quality sperm from a semen sample in just six minutes for use in human IVF procedures.
In April, Memphasys revealed its first commercial sale of 30 sterile single-use Felix cartridges and a console to the Kobe assisted reproductive therapy (ART) clinic in Japan. The clinic placed the order based on the strong endorsement of the system in two papers published by leading global IVF clinics.
Japan represents one of the top five addressable markets globally for Felix, with a potential market opportunity exceeding $100 million.
While Memphasys’ system is available for sale in Japan, the company says it has elected to initially work with private clinics that only treat self-funded patients, following last year’s introduction of a new IVF reimbursement regime. Management adds that India represents another of the top five addressable markets globally for its system, estimating that the potential market opportunity exceeds $50 million.
Globally, overall human fertility is believed to be decreasing, with about one in every six couples experiencing fertility issues and male infertility affecting about 50 per cent of men. Sperm dysfunction is known as the single most common cause of infertility due to decreasing sperm counts, sperm DNA damage and oxidative stress.
While there is a desperate need to identify or reduce the effects of oxidative stress and DNA damage, little progress has been made in sperm processing for assisted reproductive therapy in over 40 years.
But with 11 cots now filled with healthy happiness in India, it seems the sky and beyond could now be the new reproductive limit.
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By Doug Bright
