SensiBile

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Up to 30% of people who receive a liver transplant will develop biliary complications, which have a significant impact on patient morbidity, healthcare resources and, in the worst-case scenario, necessitate a second transplant that incurs even higher post-operative costs. There are currently no pre-operative tests for surgeons to define the quality of a liver or to predict the likelihood of post-transplant biliary complications, but Sensibile is poised to change that.

Addressing an unmet need 

Liver disease in the UK is on the rise, with the only curative treatment for end-stage disease being liver transplantation, a major procedure both physically and financially, that is often thwarted by biliary complications.

SensiBile is a University of Edinburgh-born project that is set to revolutionise liver transplant prognoses by defining the quality of donor organs prior to transplantation. Led by Dr Sofia Ferreira Gonzalez, Postdoctoral Research Fellow in the Centre for Regenerative Medicine, SensiBile is comprised of an interdisciplinary team of scientists and surgeons that is committed to improving quality of life for liver transplant recipients, lowering costs for the healthcare system, and easing the workload of transplant surgeons. 

The science 

The team is doing this by developing a diagnostic biomarker to help assess the viability of the biliary compartment and the quality of the donor liver prior to transplantation. By comparing bile from successful and non-successful transplants, SensiBile is defining a biosignature expressed exclusively in livers that will develop biliary complications. The team is developing a point-of-care test that combines this biosignature and electrochemical sensors that will be used during organ procurement. With this simple, non-invasive technology, surgeons will be able to identify high-risk livers ahead of transplantation and make more informed decisions on patient health and wellbeing. Testing donated livers in this way also has the potential to expand the donor pool, improve donor-recipient matching and prevent the development of biliary complications.

Support at every stage

Determined to accelerate her academic research to real-world impact but unsure how best to proceed, Sofia turned to Edinburgh Innovations (EI) for strategic advice and financial support. An initial £5,000 of iTPA seed funding and Entrepreneur-in-Residence mentoring gave Sofia the early support to scope out the project’s feasibility. Recognising the vast potential of the project, EI leveraged its networks to connect Sofia with an industry mentor to help Sofia build collaborations with hospitals and incorporate the valuable input of clinicians into her project development plans. Bespoke support from EI’s Business Development and Enterprise Services teams guided Sofia as she progressed through the Lean Launch market and user research programme to explore the commercial landscape of SensiBile, generated an Invention Disclosure and secured an Innovate iCURE grant to test the feasibility of the biomarkers in a commercial world.

Sofia leaned into the different pockets of expertise across the University and EI, and the idea of bringing SensiBile to life steadily took shape. Access to the cluster of liver expertise at the Centre for Regenerative Medicine and th Centre for Precision Cell Therapy for the Liver, and the support of colleagues and co-founders Professor Stuart Forbes and Hannah Esser, have been particularly instrumental in building SensiBile . 

Other key members of the team include Professor Till Bachmann, Deputy Head of Infection Medicine & Personal Chair of Molecular Diagnostics and Infection at the University of Edinburgh, who is developing SensiBile’s electrochemical biosensor platform along with Senior Research Fellow Holger Schulze. The team also draws on the expertise of scientists and surgeons in Edinburgh, Italy and Austria, as well as the resources and support of the IRR at the University of Edinburgh and Scottish Enterprise.

Next steps

Sofia has remained resolute in her ambition to commercialise her innovation for the benefit of liver transplant patients across the world. The SensiBile team is steadily working towards bringing its biomedical device from bench to bedside. Perfecting the biosignature and finalising the platform will allow the team to test the device on-site at the Innsbruck Medical Hospital, where team member Professor Stefan Schneeberger is based, and where the majority of SensiBile’s samples have come from. After this, hopes are high that the outcome of clinical studies will lead to regulatory approval.