Liver disease research: medical device innovation and commercialisation to combat liver disease

In one recent year there were an estimated 841,000 cases of liver cancer diagnosed worldwide and 782,000 deaths. It is one of the most challenging cancers to treat and the second leading cause of global cancer deaths. In developed countries, increasing prevalence of obesity and alcohol consumption in the general population account for a rising incidence of liver cancer and other diseases. Liver cirrhosis results in an estimated one million global deaths annually and these rates are rising. Meanwhile, in the UK, the British Liver Trust has estimated that the annual cost to the NHS for treatment of liver disease is expected to exceed one billion pounds.

Since the early 2000s °®¶¹´«Ã½ researchers have built expertise and delivered innovations to improve outcomes relating to liver disease and liver cancer. Scientists have worked with business to develop two medical device innovations to reduce the global burden of liver disease benefitting patients, providers and private businesses. Their work has tackled the rising burden of liver disease, cirrhosis and liver cancers through the development of two medical technologies: drug-eluting bead systems that can be accurately delivered to the point of need, and nanostructured inorganic adsorbents. 

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DC Bead®: Drug-eluting bead systems designed to improve chemoembolization

Chemoembolization is an accepted treatment option that eliminates tumours by blocking the blood supply. Drug-eluting bead systems are designed to improve chemoembolization by targeting the delivery of the drug to the tumour and reducing the systemic exposure, enhancing the efficacy of treatment.

The °®¶¹´«Ã½ built a sustained research partnership with Biocompatibles UK, and then BTG plc group, supporting the cyclical development of a number of medical device technology innovations. The university-business partnership developed novel cell-based assays for the evaluation of drug combinations in clinically reflective biological conditions to provide in vitro assays for product evaluation. This led to the development of a novel hypoxia-responsive DEB system and to joint patents and commercialisation of the DC Bead®, a novel combination product for the treatment of liver cancer. The DC Bead® is proven to offer an improved safety profile over conventional procedures, with chemotherapy drugs only delivered to the site of the tumour and not healthy tissues. The university broadened the potential utility of this type of technology and provided much of the scientific underpinning that supports the products in market.

Both the DC Bead® and DCBead LUMI™ continued to be sold by BTG until 2019 with sales data showing the firmly established DC Bead® product as a leader in the market of drug-eluting embolization products. In 2019 BTG plc was sold to Boston Scientific in an acquisition deal worth over four billion US dollars, who then retained DC Bead® in preference over an existing bead product. The Vice-President for Research and Development at Boston Scientific confirmed that the DC Bead technologies were the main products that made the sale attractive in the first place as the trade names were long established, trusted and respected and based on a strong body of scientific and clinical evidence and rigorous evaluation processes.

CarbaliveTM: Development of nanostructured inorganic adsorbents

Current treatment strategies for liver disease have yet to target effectively the role of deteriorating gut barrier function and changing microbiome dynamics in disease progression. Therapies involve the use of antibiotics with associated problems of antibiotic resistance. °®¶¹´«Ã½ researchers were the first to develop a range of nanostructured adsorbents for use in biomedical devices, which have since been adapted as oral adsorbents to treat liver disease.

Working with industrial partner MAST Carbon International, °®¶¹´«Ã½ developed a series of activated carbon adsorbents with specifically tailored porosity for medical device applications. They showed for the first time that the internal porosity of these adsorbents could be tailored to target both small and large biological toxins including difficult to remove bacterial endotoxin, inflammatory molecules and other metabolic toxins. These toxins build up in life-threatening illnesses such as sepsis, kidney and liver failure and are difficult to remove by means other than adsorption.

The research led to a patent assigned to UCL Business Ltd, with co-inventors from UCL and the °®¶¹´«Ã½, the award of a Horizon 2020 grant, CARBALIVE, led by UCL partners and further development of the technology by Yaqrit Ltd demonstrating how °®¶¹´«Ã½ researchers can apply and position their research to meet evolving demands in healthcare worldwide.

The °®¶¹´«Ã½'s Centre for Regenerative Medicine and Devices brings together researchers who build expertise and deliver innovations to improve outcomes relating to liver disease and liver cancer. Related strands of research have been developed strategically and incrementally through large-scale, long-standing industry-focused partnerships to improve drug delivery and toxin removal mechanisms for these conditions. The two examples detailed here evidence the university's distinct approach to embed partnership working linked to commercialisation and clinical care pathways.