Mobius Medical is delighted to be the appointed Contract Research Organisation (CRO) conducting the clinical trial of the Memphasys FelixTM System. Memphasys Limited is an award-winning biotechnology company specializing in bio-separations and reproductive biotechnology for commercial applications.
The aim of this clinical trial will be to statistically prove the Felix™ System is not inferior to either of the current commercial sperm separation techniques, Density Gradient Centrifugation (DGC) and Swim-up, which are used to prepare sperm for Intracytoplasmic Sperm Injection (ICSI), a common In Vitro Fertilisation (IVF) procedure.
Memphasys’ Executive Chair, Alison Coutts said, “We are excited to be undertaking this clinical study with Monash IVF and Mobius. Monash IVF has been a key collaborator in the development of the Felix™ System. The technical team has provided invaluable assistance with design optimisation and subsequent testing of the Felix™ System. Mobius is a well-credentialed CRO with special expertise in medical devices”.
Alison further said, “The study is an important milestone on the path to securing regulatory approval in Australia and, subsequently, in key markets such as the USA. We have already sold a Felix™ System to a Chinese KOL site for research purposes and this trial should accelerate interest in further research sales in the future. It will also supplement the current commercialisation of the Felix™ System in markets with lower regulatory hurdles where sales can occur now, such as Japan, India, Canada, New Zealand”.
The study will be conducted at four Monash IVF sites located in Melbourne and Sydney, Australia. The company expects the first patient to be enrolled in March 2022 and completed December 2022. Finally, they are hoping to market the product 12 months after regulatory approval. To learn more about Memphasys and the Felix™ system visit: http://www.memphasys.com.au/.