VivoPlex Group Ltd, which is aiming to help women boost their fertility, has received UK regulatory approval to begin a first clinical feasibility study of its wireless battery-free uterine sensor system.
The study is expected to generate key clinical data to support European approval (CE marking) for the company’s first product, which is part of a range of reproductive health biosensors it is developing. The approval for the study is an important milestone for the company in the path towards commercialisation of its intra-uterine sensing system.
The study aims to demonstrate the safe and effective use of the uterine sensor device in women of reproductive age, and the feasibility of conducting future clinical trials. The study will test the sensor in 20 women.
VivoPlex’s technology can monitor, for the first time ever, three influential parameters in the uterine environment – temperature, pH and oxygen level – for the optimisation of fertility and female reproductive health. These parameters are deemed crucial in embryo development and are tightly controlled within the incubators used in in vitro fertilisation (IVF) laboratories.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given a notice of no objection to the study, and the Research Ethics Committee at the study centre in Southampton has given a favourable opinion, enabling VivoPlex to complete preparations for the study. In line with other medical device and pharmaceutical companies, the study will start as soon as practicably possible after clinical capacity becomes available post the COVID-19 pandemic.
Joanna Smart, CEO of VivoPlex, said ‘We are delighted that we can proceed with our planned clinical feasibility study. This marks the transition of VivoPlex to a clinical-stage company and represents a significant milestone on the road to near-term commercial launches. The field of female reproductive health needs better tools to support evidence-based clinical decisions and we at VivoPlex are excited to have developed a technology that can provide valuable insights to clinicians.’