VivoPlex prepares for first clinical feasibility study of wireless uterine sensor
Trial expected to generate key data for approval of device in Europe
Oxford, UK, April 20, 2020 – VivoPlex Group Ltd, which is transforming fertility treatment with precision medicine, has received the UK regulatory approvals required to initiate the 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 is supported by the UK NIHR’s i4i Programme in a joint project with the University of Southampton, from which the company was spun out. 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.
VivoPlex is collaborating with key opinion leaders and other companies in the female reproductive health and fertility field to improve the collective understanding of the uterine environment, helping clinicians optimise and personalise treatments.
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.’
For further information, please contact:
Joanna Smart, CEO
Tel: +44 (0) 2380 111555
Emma Palmer Foster, Communications
Tel: +44 (0) 7880 787185
Notes to editors
VivoPlex Group Ltd
VivoPlex is a transformative precision health technology company focused on human fertility. With a novel approach to monitoring the uterine environment, it is expected to drastically change the dynamics of the fertility treatment sector. Its product is in development as the first insertable wireless device for the measurement of key uterine parameters – oxygen concentration, pH and temperature – in vivo. Better understanding of these levels in humans in real time and over the long term should enable improvement of the success rate of fertility treatment, currently 25-30%. Around 12% of women wishing to have a child experience subfertility, and the IVF market is growing at a CAGR of 11% (Allied Market Research 2017), driven by factors such as rising age at which women are having children and increasing disposable income globally.
The VivoPlex product comprises an insertable monitor no bigger than an intra-uterine device (IUD or coil) plus a wearable in the form of washable, discreet briefs which provides wireless power to the device and transmits data to proprietary software for use by the fertility specialist. It has generated positive results in early studies, and has potential in a range of other applications such as livestock monitoring and animal welfare. The company, which brings together a multidisciplinary team of clinical fertility experts and world-class biosensor and digital technology engineers with experienced corporate and business development executives, was established in 2015 as a spin-out from the University of Southampton. For more information please visit www.vivoplex.com.
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