One in 15 Indian couples struggle with infertility, with the figure standing at one in six in Australia. IVF then becomes a viable option, with one in 20 Aussie couples opting for the procedure. Even so, with sperm deterioration over time, the IVF process becomes trickier.

That’s where Felix comes in. Developed by Australian reproductive biotechnology company, Memphasys Limited (ASX: MEM), Felix is an automated device, comprising a console and single-use cartridges designed for sperm preparation in human IVF procedures. The device delicately separates sperm from a semen sample in just six minutes, using electrophoresis and size exclusion membranes, all while preserving the integrity of sperm DNA. Felix is Memphasys’ inaugural commercial product, slowly seeing worldwide adoption.

The Company has reported the birth of ten new live, healthy babies in India using the Felix System. This brings total live births to date using the Felix System in India to eleven. 

What’s more, these births come in light of a particularly challenging sperm selection process. All couples treated had experienced at least one failed IVF cycle in the past, and all the male participants had elevated levels of sperm DNA damage, up to 34%.

MEM’s strategic partner in India, the Coimbatore Women’s Hospital Centre, has primarily employed the Felix System to address the issue of high sperm DNA fragmentation in males, with the aim of achieving successful pregnancy outcomes. High levels of sperm DNA fragmentation are typically linked to unfavourable pregnancy results.

At the Coimbatore Women’s Hospital Centre, a study involving the use of Felix included thirty-three couples. This study led to a total of forty frozen embryo transfers, resulting in a clinical pregnancy rate of 47.5%. Out of these pregnancies, there were eleven live births, corresponding to a live birth rate of 27.5%. 

Dr Ramaya Jayram from Coimbatore Womens Hospital Centre, the clinician responsible for the study, said, “The use of the Felix Device enabled the patients to undertake this gentle treatment without needing to resort to invasive procedures such as surgical sperm retrieval.”

Earlier this year, Memphasys reported the birth of the first live healthy baby boy in India from a patient with an exceptionally high level of DNA fragmentation. The overall live birth rate achieved in this study is comparable to the current benchmark in Australia and New Zealand, which stands at 31.3% for live birth rates in all patients undergoing IVF from frozen embryo transfers.

India ranks among the top five global markets with potential for the sperm selection device. However, Memphasys has had to temporarily halt its sales in India due to regulatory changes introduced on August 9, 2022, by the Central Drugs Standard Control Organisation (CDSCO), the regulatory body overseeing all medical devices, including those used in human-assisted reproduction clinical processes.

Memphasys has submitted a voluntary product registration with CDSCO as an initial approach to sell limited quantities of the device in India. Additionally, the Company is actively seeking regulatory guidance to import the Felix System into India for specialised testing purposes until it obtains in-country registration with the Therapeutic Goods Administration (TGA), which would enable unrestricted importation of the device.

In FY23, the Company’s revenue decreased by 43% on FY22 to $15k against a net loss of $3.4 million. It ended the year with $637.8k in cash. Having to temporarily halt its sales in India then comes at unfavourable timing for the Company.

However, it hopes that the new uptake of Felix worldwide—with Japan, which is facing declining birth rates, joining the roster—will help bolster its financials.

The research, titled “Inaugural Successful Live Birth Following ICSI with Spermatozoa Isolated via Electrophoresis Using the Felix™ System”, was delivered by Dr. Jayram during the Asia Pacific Initiative on Reproduction Congress (ASPIRE 2023) in Adelaide on September 9, 2023.