LONDON: Usense, the first product developed by Verso Biosense, has successfully completed its first clinical study in partnership with the University of Southampton and National Institute for Health Research.
Usense is a novel tool for better informing healthcare professionals when treating female infertility and was used to continuously monitor the uterine environment in 15 women over a 7-day period.
The device was well tolerated by all participants who received the implant, while the temperature and dissolved oxygen data collected provided a unique insight into a physiological environment that is critical for embryonic development.
This environment has never been continuously monitored before and the unprecedented data was rich in detail, showing both variation between patients and variation over time.
Verso has made an application for regulatory approval for the Usense system with BSI for a UKCA mark and ISO13405 certification, this will shortly be followed by an application for a European CE mark.
Over the last five years Verso and the University of Southampton have filed eight patents across multiple territories to protect the system, implant and underlying technology.
Verso will now be looking to enter into formal commercial agreements with fertility clinics and clinicians within the UK and Europe to begin commercialisation of Usense.
Professor Ying Cheong, Professor of Reproductive Medicine at the University of Southampton commented: “The results are extremely encouraging. The device has been well received by patients, data has recorded successfully and there were low levels of discomfort. Overall we are very pleased and are moving towards being able to improve fertility care considerably.”
“This wireless implant could revolutionise fertility care and treatment across the NHS and internationally and improve the chance of conceiving for many women.”
Joseph Cefai, Head of Product Development at Verso Biosense commented: “Fertility treatment has improved over the last decade as our ability to generate healthy viable embryos for implantation has improved. But problems persist for some women, specifically above the age of 35, in achieving a healthy pregnancy. The uterine environment is still considered to be poorly understood and the incidence of unexplained infertility and recurrent implantation failure remains stubbornly high. Our product is aimed at providing a tool set that clinicians can use to better understand the unique, ever changing and very individual environment into which these precious embryos are being returned.”
Charles Dickson, Chairman of Barkby Group, commented: “The success of this study is extremely good news for Barkby Group and its shareholders, Usense has the potential to become a ‘blood pressure monitor’ for infertility and become a commonly used medical tool used by fertility professionals globally.”
