Australian-based reproductive biotechnology company, Memphasys Limited (ASX: MEM), is pleased to report 10 new live, healthy births in India from using the Felix System. This brings total live births to date using the Felix System in India to 11.
High sperm DNA fragmentation is commonly associated with poor pregnancy outcomes. The Felix System has unequivocally demonstrated that it can effectively deal with high sperm DNA fragmentation levels.
MEM’s Indian KOL (Key Opinion Leader) partner, Coimbatore Womens Hospital Centre, has predominantly utilised the Felix System for males suffering from high sperm DNA fragmentation to achieve positive pregnancy outcomes.
At the Coimbatore Womens Hospital Centre, 33 couples were enrolled in a study which utilised the Felix System. The study resulted in forty frozen embryo transfers, with a clinical pregnancy rate of 47.5%. From these pregnancies there was a total of 11 live births, equating to a live birth rate of 27.5%. The first live birth of a healthy baby boy from a patient with an extremely high DNA fragmentation level was publicly reported earlier this year. Notably, the overall live birth result is comparable with the current Australia and NZ benchmark of 31.3% live birth rate across all patients undertaking IVF from frozen embryo transfers.
The distinguishing feature of the study is that the outcome was achieved in a demanding patient demographic, where patients had undergone at least one previously unsuccessful IVF cycle and all males had high levels of sperm DNA fragmentation (average of 34%).
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 a gentle treatment without needing to resort to invasive procedures such as surgical sperm retrieval.
MEM has temporarily suspended sales of Felix System in India following changes introduced on 9 August 2022 by the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO), which oversees the regulation of all medical devices sold in India including human assisted reproduction clinical processes.
MEM has already acted to address these changes by submitting a voluntary product registration with CDSCO as an initial strategy to sell non-commercial quantities in India. MEM is also seeking regulatory advice on importing the Felix System into India for special test purposes until it achieves in-country (TGA) registration which would enable unrestricted importation of the device.
Felix is the premium, automated device comprising a console with single-use cartridges for sperm preparation in human IVF procedures. The device gently separates sperm from a semen sample in six minutes, using electrophoresis and size exclusion membranes without causing damage to sperm DNA. Felix is MEM’s first commercial product.