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Based on clinical studies at Imperial College that radiofrequency energy can seal blood vessels, EMcision Limited was formed. The Company specialises in the research, development and marketing of medical and surgical devices that use RF energy to treat/palliate cancers in organs and tissues. The first product from the Company, the Habib™ 4X, has revolutionised the technique of liver surgery and has generated more than $48 million in sales worldwide. The second most successful product, the Habib™ EndoHPB, generated $1 million in revenue in 2012.
Dr Dickinson (Bioengineering) collaborated with Professor Habib (Surgery) to develop novel methods for removing or starving tumours. Resection (removing part of an organ) is theoretically an ideal method for treating liver cancer as the liver can regenerate, but it causes extensive blood loss. The Bioengineering team developed a bipolar electrode system that employs RF current to coagulate a track in the liver; the track can then be cut without bleeding. Prototypes were successfully tested in pre-clinical and clinical trials. 20,000 single-use devices (value: US$40M) have been sold under licence by AngioDynamics, with an estimated saving of >800 lives. Complications, intensive care, blood transfusions, and hospital stay have also been dramatically reduced. Dickinson developed further bipolar devices for maintaining the patency of ducts during pancreatic and biliary cancers, for ablating liver tumours and for blocking tumour blood supply. Sold by Imperial spin-out Emcision, these are also in current clinical use.
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the developed world with a prevalence of 20-25% in the general population. Until Newcastle validated its new diagnostic, the only accurate way to determine the severity of NAFLD was by liver biopsy, an expensive and invasive procedure which is associated with morbidity and occasional mortality. Studies lead by Professor Day in Newcastle have established a non-invasive fibrosis scoring system, the NAFLD Fibrosis Score (NFS), which is capable of accurately differentiating patients with and without fibrosis. The NFS has now been incorporated into two international guidelines, allows biopsy to be avoided in up to 75% of patients and could save the NHS nearly £2m annually.
University of Bristol researchers at the Bristol Heart Institute (BHI) have pioneered the development and clinical take-up of the novel technique of off-pump coronary artery bypass (OPCAB) surgery. Over ten clinical trials and several large cohort analyses have assessed the impact of this technique on elective and high-risk patients. The results have shown that it is as safe as the conventional coronary artery bypass grafting (CABG) technique that uses a cardiopulmonary bypass pump and cardioplegic arrest. Most importantly, however, OPCAB significantly reduces the risk of post-operative complications, and reduces morbidity and mortality. It also uses less hospital resources, reducing time in intensive care and length of hospital stay. In 2011 (the last year for which data are available), 20% of CABG operations in the UK were carried out with the OPCAB technique and it has had significant take-up overseas (for example, 18% of CABG operations in the US and 21% in the EU in 2010). NICE has recommended the safety and efficacy of OPCAB surgery.
This case relates to preclinical research which profoundly aided the successful licensing of trabectidin, a novel anticancer drug. The discovery described here has a beneficial impact on the survival of certain cancer patients and on the income of the major Spanish biotech company Pharmamar SA, which owns and markets trabectidin. Early preclinical and clinical studies of this agent showed that it exerts severe liver toxicity, a side effect which jeopardised its further clinical evaluation. The Leicester group led by Prof Andreas Gescher (AG) investigated the mechanisms by which the drug engages this deleterious effect with funds from Pharmamar. The preclinical work showed eventually that pretreatment of rats with the glucocorticoid steroid drug dexamethasone profoundly counteracts trabectidin-mediated hepatotoxicity. Crucially, this combination did not adversely affect the antitumour activity of trabectidin.
Subsequent clinical evaluation of the combination demonstrated dramatically reduced liver toxicity in patients compared to those who received trabectidin alone. Since 2007 trabectidin has been administered routinely in combination with dexamethasone in the treatment of sarcomas and metastatic ovarian cancer. [text removed for publication] Revenues for Pharmamar from the sale of trabectidin in 2011 were ~81M Euros.
Questions about the benign or malignant nature of liver tumours are common and pressing since they determine how the patient is managed. Benign masses are frequently encountered; they usually do not require intervention but are easily mistaken for malignancies with conventional imaging methods. Work at Imperial College demonstrated that microbubble contrast agents have the special property of lingering in both normal liver tissue and in benign solid masses, whereas malignancies do not retain microbubble. The discovery of this property at Imperial has led to their use worldwide as a diagnostic tool. In 2012 NICE recommended their use as being cost-effective for this use.
Research to address the detection of weak structured signals from within highly variable cluttered imagery, originally for vehicle tracking, is being used to identify textural variations in organ tissue. The technology has been spun out into a company, TexRAD Ltd, using the methodology as a means of detecting tissue abnormalities, typically cancer, assessing response to treatment, and predicting patients' chances of survival. The detection process is being assessed through clinical research use in the UK, Europe and the USA. Regulatory approval for mainstream clinical use is being prepared.
Postoperative local recurrence affects 20-30% of patients with rectal cancer. Between 1993 and 2013, University of Leeds researchers identified the importance of pathology studies to show a disease-free margin around the excised tumour and how to predict this margin routinely and accurately using simple histopathology and preoperative MRI.
We also used photography in the pathological assessment of the quality of surgery and were instrumental in the adoption of modern techniques by professional organisations around the world.
Following adoption of our techniques in England and Scotland, local recurrence has halved with 10% better survival and cost savings of £60 million. Our methods have also become the gold standard in the treatment of rectal cancer patients around the world.
Impact: Health and welfare; policy and guidelines. Anderson and colleagues demonstrated that cryopreservation of ovarian tissue could be used for preservation of fertility following cancer therapy. This step-change has been incorporated into guideline documents internationally and has been adopted into clinical practice world-wide.
Significance: Ovarian tissue has been preserved from many hundreds of women; this is now translating into a growing number of babies born worldwide (currently 24 in nine countries).
Beneficiaries: Women at risk of fertility loss including pre-pubertal girls newly diagnosed with cancer; clinicians; the NHS and healthcare delivery organisations.
Attribution: The underpinning research was performed entirely at UoE.
Reach: Worldwide: UK, Europe, US, Australia.
Collaboration between Imperial College Departments of Mechanical Engineering and Surgery led to the development of active constraint robot solutions which augment surgeon skills so that joint replacement components are implanted accurately and successfully. This led to the founding of Acrobot to develop innovative surgical technologies. Acrobot was acquired by Stanmore Implants Worldwide in 2010. An orthopaedic stereotaxic instrument, based on Imperial research, obtained US Food and Drug Administration (FDA) clearance in 2013. This has led to Mako-Surgical purchasing Stanmore Implants Acrobot technology in April 2013.