The First Clinical Study for our Device
In May 2021, we received approval from Medicines Health products Regulatory Agency ('MHRA') for the initiation of the first clinical study for our groundbreaking uterine sensing device and biosensing data platform.
Verso's first-in-class product monitors three key parameters in the uterine environment – oxygen, temperature and pH – for an extended period of time.
These parameters are fundamental in embryo development and are tightly controlled in embryo culture for in vitro fertilisation (IVF). Our product and data platform continuously captures critical in-vivo, biosensing data to provide actionable insights for clinicians and patients on the IVF journey with the overarching aim of facilitating optimisation and personalisation of fertility treatment.
The study, which is supported by the UK NIHR's i4i Programme in a joint project with the University of Southampton, aims to demonstrate the effective and safe use of this novel, wireless powered, uterine monitoring device in women of reproductive age.
The study will test the Verso biosensing device in 20 women continuously over a seven-day period and is being conducted at the Princess Anne Hospital in Southampton.
The successful conclusion of this study will enable Verso to apply for a CE mark on its first product and we expect this to be granted in 2022.