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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.
Impact: UoE-developed techniques to determine liver volume and define, pre-operation, the minimum liver remnant required have transformed the viability and success of liver surgery and stimulated commercial development of imaging software/hardware.
Significance: Precise functional liver volume measurement prior to surgery is now the standard of care and, for example, renders 85% of patients previously deemed irresectable to be resectable with a perioperative mortality of 2-4%.
Beneficiaries: Patients with liver cancer; the NHS and healthcare delivery organisations; imaging software/hardware companies.
Attribution: Pivotal studies were led by Wigmore and Garden at UoE.
Reach: Worldwide; technique recommended in guidelines in Europe, N America, Asia, Australasia; deployed in the management of 3600 patients per annum in the UK alone; the use of open-source software increases accessibility in developing world.
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.
Microsulis Medical Ltd was founded in 1997 by the University of Bath to commercialise Professor Nigel Cronin's invention of a device for microwave endometrial ablation (MEA) for use in treating excessive menstrual bleeding (menorrhagia). This minimally invasive therapy has a success rate exceeding 80% and remarkably short treatment and recuperation times. It has been used to treat over 20,000 patients worldwide since 2008. In Feb 2011 Microsulis sold the rights to its MEA device for $3m to a US company in order to concentrate on another application of Cronin's microwave technology, namely microwave tissue ablation (MTA) for use in treating cancer. Microsulis MTA systems are in place in over 100 hospitals worldwide and have been used in over 5000 treatments of tumours of the liver, lung, kidney and bone, including otherwise inoperable cases. In Feb 2013, the company was bought by AngioDynamics (a major international provider of healthcare devices) for $15m. This acquisition is expected to provide a major boost to both the reach of the life-saving MTA technology and global sales. Currently Microsulis employ around 20 people at their base near Portsmouth, producing and developing their MTA devices. Their sales revenue since 2008 totals over £11m.
A low-cost, efficient, blood cell salvage technology (HemoSep) has resulted from research carried out at Strathclyde between 2008 and 2013. The novel technology has been patented and licensed to Brightwake Ltd., who manufacture the device in the UK and market it through a global distribution network. HemoSep has now been used in clinical centres across Europe, North America, and South Africa since its commercial launch in late 2012. The use of the device has been shown to reduce the need for donor blood transfusions in open-heart surgical patients by at least 1 unit (450 ml) with an associated reduction in transfusion related complications such as heightened inflammatory response and bleeding. The reduction in blood transfusions associated with the use of HemoSep has a considerable cost benefit to healthcare providers (in North America blood costs up to $1600 per unit). In addition, commercialisation of HemoSep has led to the creation of new manufacturing, marketing and sales jobs in the UK and overseas.
The Boutelle team has developed a biosensor that uses rapid-sampling microdialysis (rsMD) to detect ischaemia (restricted blood supply to tissue) during surgery and intensive care. The rsMD biosensor is implanted into tissue at risk and provides a real-time readout of chemical markers of metabolism. By 2009, technical improvements researched in the Department of Bioengineering had made the system suitable for routine clinical use. The system has reduced morbidity and mortality by alerting the surgical team to otherwise undetected ischaemia. It has been used by an international consortium of clinical centres to help decide treatment in approximately 100 patients with brain injury. More recently it was adopted by a Portsmouth hospital to monitor cancer patients undergoing reconstruction of the face and jaw; the biosensor detected a failure of perfusion in transplanted tissue in two of the first ten patients, prompting the surgical team to remove otherwise undetected blood clots that could have led to death from septicaemia.
Professor Norman Williams and colleagues, based at Queen Mary, developed innovative surgical procedures for patients with anorectal diseases to preserve function, reduce morbidity, eliminate the need for a permanent stoma and reduce its complications. They tested these in clinical trials and showed them to be effective and improve quality of life. The APPEAR procedure (designed to preserve continence in patients who would otherwise require a permanent stoma) is now used internationally and electrically stimulated gracilis muscle (ESGN) is well established as a treatment for end-stage faecal incontinence (FI). The team has harnessed the science of neuromodulation to provide minimally invasive methods of treating FI and developed robust processes for technological development, training and dissemination. Two patents have been filed for innovative surgical instruments and these have been developed commercially.
For stroke patients and any patient undergoing surgery the time period from diagnosis to treatment is a major factor in clinical outcomes. Research carried out at the University of Warwick has led to the development of sensors that can be used to measure, in whole unprocessed blood, diagnostically useful analytes that can be used to select the best therapeutic treatments. Point-of- care diagnosis and prompt referral to an appropriate care pathway, facilitated by the use of biosensors, will result in efficiency savings for healthcare professionals and the NHS in the long- term, and will also improve patient outcomes. To commercialize these biosensors, Sarissa Biomedical Ltd was founded in 2002, as a UK-based spinout from the University of Warwick. Sarissa sells, around the world, microelectrode biosensors fabricated by a unique enzyme deposition technology protected by patents filed in 2004 and 2008 by the University of Warwick. The diagnostic sensors are based on technology that incorporates Ruthenium Purple and use a sol-gel coating to entrap enzymes on a microelectrode. Sarissa is pursuing human trials of its biosensors as diagnostic tools in two main areas: stroke, and trauma with associated sepsis.
Misconnection errors involve the administration of drugs via the wrong route. For example, the injection of a toxic drug into the spine which should only be injected into a vein. Following a death in 2001 and 13 others in the UK over the previous 15 years, work began to find an engineered solution to misconnection errors. R.Lawton, at the University of Leeds (UoL), evaluated the usability and acceptability and explored the implementation of these different engineered solutions. This research was the basis for the UK National Patient Safety Agency policy and was used by companies to inform the design of these new devices. Ultimately, this research has led to the production of safer devices that are now being purchased by NHS Trusts to reduce patient risk.
Research undertaken with the Newcastle Hospitals Transplant Unit led to the approval of two new transplant processes and resulted in the expansion of the kidney donor pool.