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Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
A community based pathway to detect asymptomatic chronic liver disease at a critical stage at which it can be halted or reversed. At risk patients are proactively identified and the use of a non-invasive diagnostic test (Fibroscan®) is utilised.
Overview of Innovation:
Liver disease constitutes the third commonest cause of premature death in the UK (ONS 2010) and the death rate is continuing to rise (Williams et al 2014). This is despite the fact that the majority of liver disease results from lifestyle related risk factors including excess alcohol use, obesity (and related type 2 diabetes) and intravenous drug use. Liver disease develops over several decades due to a persistent insult causing low grade cellular injury and inflammation, resulting in the gradual development of advanced liver scarring and subsequently irreversible cirrhosis. Therefore, if the disease is detected early there are opportunities to reverse or halt this process.

However, current strategies to identify liver disease within the community are inadequate resulting in approximately 50% of patients with cirrhosis being diagnosed when they present to hospital with end-stage liver disease where subsequent prognosis is poor (Ratib et al 2014). In primary care, liver function tests (LFTs) are the main diagnostic test used to identify patients but these are inadequate. Many patients with elevated liver enzymes have no significant evidence of disease, and normal LFTs do not rule out the possibility of cirrhosis. However, there is the potential to use newer non-invasive tests to detect early stages of liver disease by targeting those patients with established risk factors.

NIHR Nottingham Digestive Diseases Biomedical Research Unit, Nottingham University Hospitals Trust and local GPs have collaborated on a pilot study within four suburban GP practices.  This study evaluated the feasibility of implementing a new diagnotic pathway and using a new non-invasive imaging test called a Fibroscan, to detect liver disease within the adult community.

Out of a patient population of 20,368 adult patients, 2,022 were identified to be at risk due to hazardous alcohol use or having a diagnosis of type 2 diabetes. Nine hundred and nineteen patients accepted an invitation to attend their GP practice for a Fibroscan. A significant proportion of patients who had a Fibroscan have liver scan results compatible with liver scarring (25.6%) and 26 new cases of cirrhosis were identified. Importantly, 68.3% of the patients with an abnormal Fibroscan, and 73.1% of patients diagnosed with cirrhosis, had normal LFTs and would not have been detected through normal standard of care.

 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
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Innovation 'Elevator Pitch':
LiverMultiScan is an FDA 510(k) cleared and CE marked MRI technology that provides a quantitative assessment of liver health, including fibroinflammatory disease, steatosis and iron, all in a non-contrast 5 minute scan.
Overview of Innovation:
Perspectum Diagnostics is a medical imaging company with an ISO 13485 compliant CoreLab. The company has developed novel imaging technology, LiverMultiScan, an MRI-based non-invasive tool that has attained CE-marking and FDA 510(k) clearance to aid the diagnosis of patients with chronic liver disease.
LiverMultiScan (and LiverMultiScan Discover for clinical trial use) can characterise liver tissue in three ways, providing accurate measurements of liver fat, hepatic iron content and fibro-inflammatory disease, using the proprietary Liver Inflammation and Fibrosis (LIF) score. The LIF score has been shown to stratify NAFLD and NASH patients (Pavlides, 2015), correlate with histological markers of inflammation and fibrosis (Banerjee, 2014), and most importantly, is the first imaging test to predict liver-related clinical outcomes (Pavlides, 2016). It is the only liver imaging technology included in the UK Biobank study, with 100,000 scans to be performed in the coming years (Kelly, 2015).
Available as a Quantitative Analysis Service (QAS), LiverMultiScan has been cleared as an imaging tool to aid the diagnosis of early liver disease. It offers a standardised and high-quality method for supporting Gastroenterology/Hepatology and Radiology departments in diagnosis and monitoring of the liver in clinical settings and studies, and has potential to streamline clinical management by compressing the diagnostic pathway. Perspectum is also supporting multiple international clinical trials with LiverMultiScan Discover.
  • Banerjee et al. (2014) Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 60:69-77.
  • Kelly et al. (2015) Predicted prevalence of NAFLD and NASH in a large population using non-invasive multiparametric MRI. AASLD 2015. Abstract ID: 931.
  • Pavlides et al. (2015) Multi-parametric magnetic resonance can accurately assess NAFLD histological disease severity; comparison with transient elastography. AASLD 2015. Abstract ID: 2190.
  • Pavlides et al. (2016) Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 64:308-315.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wealth creation / Clinical trials and evidence / Digital health / Patient and medicines safety
Benefit to NHS:
The utility of LiverMultiScan for assessing fibroinflammatory disease, steatosis and predicting clinical outcomes means it is well-positioned to reduce (and potentially remove) the need to perform invasive liver biopsies. It also facilitates longitudinal monitoring, which is near impossible with current sampling technology.
According to a recent NIHR HTA report, the cost of a liver biopsy is £956, but this can increase significantly with complications (clinically significant bleeding in 1.1 – 1.6%). For healthcare providers, liver biopsies are unappealing because of the attendant risk, financial cost, lack of reliability (as sampling only 0.002% of the liver volume), and uncertainty in interpretation. Nevertheless, primarily because there has not been a viable alternative, it is estimated that 650,000 liver biopsies are performed annually worldwide. 
There are substantial costs associated with managing patients with NAFLD, in particular for those patients progressing to NASH who are at significant risk of cirrhosis, HCC and liver failure. Although pharmacologic options are limited, there are numerous clinical trials ongoing.
Available treatment options increase (e.g., diet, surgery), outcomes improve and healthcare costs decrease the earlier those with, or at risk of, more advanced disease are identified. When combined with the rising incidence of NAFLD and NASH, the availability of a non-invasive test for accurately assessing fibroinflammatory disease, steatosis and predicting clinical outcomes, is vital.
A recent health economic study (submitted for publication) from the University of Birmingham concluded that LiverMultiScan is cost effective either as an adjunct to or replacement of Fibroscan in the diagnostic pathway of NAFLD. In addition, the utility of LiverMultiScan in reducing the proportion of patients with suspected NAFLD undergoing hospital consultations and/or liver biopsies is currently being evaluated in a large Europe-wide multicentre clinical trial (including the UK).
LiverMultiScan could allow:
  • A faster throughput and diagnostic analysis than conventional sampling – reducing patient lists and identifying those that need and do not need clinical intervention.
  • Regular monitoring of patients without painful invasive and potentially dangerous biopsies.
  • A less traumatic assessment of liver disease in children.
  • Assessment of liver health in other diseases (e.g., viral hepatitis, alcoholic liver disease)
Initial Review Rating
5.00 (2 ratings)
Benefit to WM population:
Liver disease is the fifth ‘big killer’ in England and Wales, after heart, cancer, stroke and respiratory disease (http://www.britishlivertrust.org.uk/about-us/media-centre/facts-about-liver-disease), with twice as many people dying from liver disease now compared to 1991.
In a European study, the healthcare costs for patients with NAFLD were 26% higher than for those without the disease (Baumeister, 2008). In the US, the direct costs of cirrhosis and chronic liver disease were estimated to by $2.5 billion, whereas indirect costs were estimated to be $10.6 billion (Ruhl, 2008).
Identifying those with, or at risk of, more advanced liver disease earlier increases treatment options available, reduces healthcare costs and improves outcomes. Benefitting both the NHS and wider West Midlands community.
This diagnostic test could also be used to aid the diagnosis and monitoring of liver disease in children, with a European clinical trial underway.
 
  • Baumeister et al. (2008) Impact of fatty liver disease on health care utilization and costs in a general population: A 5-year observation. Gastroenterology. 134:85.
  • Ruhl et al. (2008) Costs of digestive disease. In The Burden of Digestive Disease in the United States. NIH Publication. pp 137-143.
Current and planned activity: 
LiverMultiScan currently in use at University Hospitals in Birmingham, Edinburgh, Oxford Southampton & Kings College London (KCL). Discussions with other NHS sites

Recent completion of large Innovate UK funded 2.5 year study at University Hospitals Birmingham & Edinburgh to develop & validate against liver biopsy

KCL is UK site for large EU multi-centre clinical trial to evaluate cost-effectiveness of LiverMultiScan in primary care pathway.

Patient study - 100 patients with history of liver disease receive LiverMultiScan, nearing completion with extremely +ve feedback

LiverMultiScan is only liver imaging technology in UK Biobank - 100,000 subjects to be imaged

Planned activity
West Midlands location of choice as:
  • Build on relationship with University of Birmingham following 2.5 yr study
  • West Midland’s considerable expertise in liver disease
  • Large patient cohort and trials infrastructure
  • Involve Children’s Hospital in study
  • Dr Banerjee, founder & CEO, visiting Hon. Consultant Hepatologist at UHB
What is the intellectual property status of your innovation?:
Perspectum holds or exclusively licenses 7 patent applications in the UK and other territories. To date, one has been granted in the UK (GB2497668).
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
A medical screening technology based on a mathematical model of the autonomic nervous system & physiological systems which has significant potential to improve the cost-effectiveness of primary care
Overview of Innovation:
Strannik technology is based upon a mathematical model of the autonomic nervous system and physiological systems. It meets the key aims and objectives of the EC’s Human Brain Project: (i) to identify what the brain does and how it does it, (ii) to develop a new generation of cognitively-based screening technology, (iii) to understand and adapt with therapeutic effect the multi-level nature of brain function.  This is quite without precedent in modern medicine. The Strannik technology comprises Strannik Virtual Scanning (SVS) and Strannik Light Therapy (SLT). 
The technique can be viewed in a demonstration video at the following link: www.montaguehealthcare.co.uk/presentation.php
SVS is a screening technology which has an unprecedented ability to determine the health of the patient i.e. it is able to determine 5-15 pathologies in each of the 30 main organs (including medical conditions for which the current tests are poor or for which there is currently an unmet clinical need), to differentiate between and quantify the extent of the genotype and phenotype in each pathology, and to determine the earliest onset of each pathology from its presymptomatic origins. The technique adopts a methodology more advanced than is currently used in most diagnostic technologies. It is non-invasive and more safe than contemporary diagnostic tests. The results are available in circa 20 minutes at a cost which is estimated to be 5-10 times lower than contemporary diagnostic tests. It presents the opportunity to screen the entire UK population once (or twice) each year for less than £5BN (est £3-4BN) and to reduce the cost of healthcare by an estimated £20BN pa.
(See Operating Manual: www.montaguehealthcare.co.uk/OperatingManual.pdf)
The basic methodology, and the scope of this technology, is outlined in a series of 60 peer-reviewed medical papers.
(uk.linkedin.com/pub/graham-ewing/44/386/214)
 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Clinical trials and evidence / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Strannik Virtual Scanning is able to determine all common pathologies in a single test of 20 minutes duration. In-market surveillance has indicated that SVS appears to be circa 2-23% more precise than contemporary methods of diagnosis. A recent non-clinical study in Spain (10/16) illustrated that the technology was able to determine all known medical conditions in the cohort of (20) patients.
 
Using the data derived from this cognitive, computer-based, test the technique determines the precise parameters of Strannik Light Therapy -which acts upon autonomic dysfunction, and (across a wide range of medical indications) appears to be typically 83-96% effective. This compares with the 50% effectiveness of drugs and also that the effectiveness of many drugs declines over a period.
 
Benefits:
 
  • reduce the flow of patients into the healthcare system;
  • reduce the cost and complexity of training the GP
  • improve the ability of the GP to identify complex medical conditions, reduce the need for repeat consultations, and/or avoid doctor errors
  • reduce the need for histopathology samples (nurses, rubber gloves, sampling tubes, transport costs, histopathology lab costs)
  • reduce expenditure in secondary care i.e. for highly expensive scans and tests;
  • provide health reports and increase the ability for patients to have a clear understanding of their health and assume responsibility for their health i.e. change the focus of medicine  from treating the symptoms to prevention
  • regularly screen the health of the most at-risk patients thereby reducing the need for A&E services
  • improve the accuracy of drug prescribing thereby avoiding mis-prescribing of drugs
  • reduce the need for drugs
  • reduce the overall cost of healthcare by an estimated £20BN pa
“I have to hand it to you. You have correctly and in precise detail identified the five or six major items which are known to be of concern to me”. Dr John Doran, Medical Director, Nottingham’s Queens Medical Center, November 2003.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Support patients to obtain an early diagnosis to seek timely treatment.
Current and planned activity: 
Mimix Montague Healthcare is actively seeking NHS partnerships to move forward Strannik Technology. Evaluation and trials have been conducted in other countries (Russia and Spain) and a collaboration within the UK is currently being sought.
 
  • Procurement / Adoption of Strannick Technology within NHS Trusts
  • Evaluation / Validation / Clinical Trial - Need to gain additional validation seeking a trial centre.
  • Project Assistance required - The Company’s development project is interested in locating possible clinical / academic collaborators.
What is the intellectual property status of your innovation?:
software/copyright
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
3 years +
Ease of scalability: 
Simple
Regional Scalability:
The technology is immediately scaleable. In theory, and as an indication of scaleability, we could train 1000 practitioners to use Strannik technology within 4 weeks. 
Measures:
Strannik Virtual Scanning is unique for a number of very good reasons e.g. (i) that it can determine pathological onset from its presymptomatic origins, (ii) it can determine the full spectrum of pathologies in all organs and not just a single biomarker, (iii) it can determine genotype and phenotype, and (iv) it can determine many conditions where there is currently an unmet clinical need.  Further studies are required to illustrate how such a sophisticated technology will complement the current range of biomarker tests which are generally used in clinical practice. The technique is non-invasive and has a base cost of circa £15/test thereby addressing safety and cost.  The procedure is entirely non-invasive which significantly enhances the patient experience, often experienced as 'a pleasure'.  
Strannik Light Therapy is based upon an understanding of how the brain regulates the autonomic nervous system.  A comparison of Strannik Light Therapy with contemporary methods of treating patients is likely to enhance the patient experience, result in significantly reduced side-effects, and will be at very much lower cost.
Success will be measured by reduced number of patient consultations, lower cost of diagnosing and treating patients. 
Adoption target:
Our aim is to secure the introduction of Strannik technology to every primary care practice
Rejection Reason:
Dear Mr Ewing Thank you very much for your submission to the Meridian Innovation Health Exchange. I can confirm that we have now reviewed your submission and i regret to inform you that we have not been able to identify any clinical champions for this project. While I appreciate that Strannick are looking for support on the evaluation/evidence side, feedback from clinical / academic colleagues has not been positive and therefore we have done everything possible to engage but the appetite isn't there unfortunately. Given that our network is not focussed in exploring this area at this time we will therefore close your idea leaving it visible to our Meridian users. We wish you luck with your innovation. Regards The Meridian Team
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Innovation 'Elevator Pitch':
BVI technology is an innovative and easy to use, mHealth service to determine the percentage and distribution of visceral fat using a mobile device (tablet) or a smart phone. 
Overview of Innovation:
The Body Volume Indicator (BVI) is a new measurement for healthcare and obesity. After eight years of successful and innovative validation from scientific collaborators around the world, BVI is now undergoing final testing prior to a full launch later in 2017.

Using 3D technology, BVI calculates risk factors associated with a person's body shape, by measuring weight and body fat distribution, with particular focus on the abdomen; the area associated with the greatest risk.

BVI is designed to be a long-term addition to the Body Mass Index (BMI); the current recognised standard for measurement of obesity. The intention is for the Body Volume Indicator to become a Body Volume Index by 2020, by which time sufficient data will have been collected globally. Using smartphone technology, BVI data can now be collected anywhere with web or internet access.

Body Volume, as an indicator of health, offers a potential long-term solution as a measure of individual health risk. 

BVI was developed in the West Midlands and collaborators have included Heartlands Hospital, Aston University, Mayo Clinic and the Medical Research Council. The application was patented in the US in 2012 and throughout Europe in 2015.


 
Current Status
In 2012 Select Research obtained exclusive use of the largest and most comprehensive collection of Body Composition Data (BCD) of visceral fat data from MRI scans in the world. This has been used to develop an App which will be used to scan/photograph lightly clothed patients and then comparing their BCD database to predict their body fat and visceral fat.
 
Further research and development is being undertaken with our current BVI (Body Volume Index) tool, to provide additional evidence and to validate the efficacy, and appropriateness of this BVI application in real-life environments. Through a ‘real-life’ project work with WMAHSN will provide clinical validation for the underpinning methodology, thus making potential users (Clinicians, patients & public) aware of the benefits (social and economic) of utilising the service.
 
Thus our current BVI application is to be incorporated into the existing patient pathways currently used by Health Exchange Health Trainers in the West Midlands.
 
NB: The application has been patented in the US in 2012 and throughout Europe in 2015 and covers all measurements of part body volume for healthcare from a 3D scan. Body fat is a part volume of the human body.

Please assist us with our 5 min Survey http://BVISurvey.SSIsurveys.com​ 
Stage of Development:
Evaluation stage - Representative model or prototype system developed and can be effectively evaluated
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Visceral fat is body fat stored within the abdominal cavity around a number of important internal organs such as the liver, pancreas, and intestines often referred to as 'active fat'. This type of fat plays a potentially dangerous role in affecting how our hormones function.

Higher amounts of visceral fat are associated with increased risks of a number of health problems.  NHS healthcare costs attributed to obesity are £5.1b p.a. and set to rise by £7.1b by 2030; The cost to the UK economy is £27b p.a. Benefits through effective intervention based on accurate visceral body fat determinations are complex but undoubtedly would lead to a reduction in the burden of obesity (diabetes, heart disease, stroke, and certain cancers), by a reduction in years lost to premature mortality and disability (DALY). NICE suggests reducing obesity of 1% would save the “NHS and local authorities around £97 million per year.” Diabetes costs the NHS over £1.5m an hour or 10% of the NHS budget for England and Wales. 

The lifetime benefits of weight loss - direct £297 and indirect £2068 estimates based on 50% compliance and 25% success.  A saving to the NHS of between £1.2m and £6.9m, and the economy of between £135m and £1620m.

Select’s BVI tool App predicts the early identification body and visceral fat & estimates via a quick, simple and non-invasive scan which provides an insight and benchmark for clinicians and their patients; just by taking two photographs of a patient. 

Therefore BVI significantly contributes to the monitoring, intervention and control processes for clinicians and other health professional to apply, so that they can tackle and halt the potential for escalation into Diabetes and CHD etc.


Particular value for patients will be that they can monitor their own progress and to improvement at home. Through recognition of the scale of their own obesity and particularly any high levels of visceral fat. The early identification of visceral fat, through this simple, quick and accurate method of measuring obesity will thus take a large step towards achieving considerable saving to the NHS and the UK economy.

The proposal for delivery of BVI is under discussion with BVI data (including BMI, Waist Circumference, and Waist to Hip Ratio automatically) stored for tracking purposes on patient records via the N3 spine. Automatic data collection through BVI of current methods saves time, money and provides new informative data on body composition for future research.
Online Discussion Rating
5.50 (2 ratings)
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Clinical Outcomes & Economic
In the West Midlands 65.7 per cent of people are carrying excess weight, along with 65.6 per cent of people in the East Midlands. Obesity costs the UK economy exceed £3 billion per year. In Birmingham, over 25% of the population are obese - the third highest rate in the UK. The high prevalence of obesity in adults within England show that national averages of over 40% of males overweight and more than 20% obese in the 16-75 year age range, while in women the averages are lower for the overweight classification but higher for obesity.
 
Nationally GPs make 97,000 annual referrals to weight watching programmes (WWP) and costs will reach £15.6m p.a. in 2017. A saving of £48.5 per patient might be made using the BVI App. With as low as 10% uptake, £0.5m could be saved, rising to £2.8m with a 60% uptake. Better management of weight issues with patients will have significant cost savings within the West Midlands.
 
This tool will support early detection of visceral fat and therefore allow a much more preventative and timely approach to supporting West Midlands Patients to make positive lifestyle change.
 
Environmental
The BVI App offers considerable environmental benefits in reducing the number of visits (road trips) to a surgery and specialist clinics. It will also allow people within remote and rural locations to engage in such activities.
 
Research
Additional R&D is being undertaken with the WMAHSN, to further ‘validate’ the efficacy, appropriateness and validity of the BVI application in real-life environments using the BVI App, which is being incorporated into the existing patient pathways.
 
Commercially
The adoption of this technology within the West Midlands and UK will also allow our company to grow and develop, not only with increasing its functions and capabilities but also in marketing this to a worldwide healthcare organisations and individuals as obesity is a major developed countries epidemic. 
 
There is also interest from other commercial organisations involved in weight management and associated healthcare which will further extent this products role and integration with people taking charge of their well being.

Trials
The BVI tool will be tested in 3 locations in the West Midlands with patients and GP Practices in Birmingham, Dudley and Solihull. Analysis of weight loss achieved over a period will be monitored.

Please assist us with our 5 min Survey http://BVISurvey.SSIsurveys.com​ 
Current and planned activity: 
Current BVI application is undergoing R&D and incorporation into existing patient pathways within the West Midlands via;
  • Patient Engagement - Face to face consultation, scanning of approximately 1000+ patients
  • Clinical Benefits - Analysis and monitoring of weight loss achieved over a defined period. Developing delivery protocols
  • Dissemination - Facilitation of BVI tool awareness raising sessions with Key Public Health and NHS Management, Clinical Teams and frontline staff
  • Training - BVI tool training to specialist clinical teams (Primary & Acute), ensuring correct use of the tool and providing feedback for use with patients
  • Data analysis – Verification/validation of App algorithms
  • Data gathering - Provision of clinically requested data – Core data profiling to gauge health outcomes and patient benefits. Establishing minimum data requirements
Required
  • Evaluation & Trials - Seeking trial interests
  • Adoption – Looking for discussions with CCG’s, Healthcare and Council Health Prevention teams   
What is the intellectual property status of your innovation?:
BVI has both BVI Patents and Trademarks approved.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
6-12 mon
Ease of scalability: 
Simple
Regional Scalability:
We have not as yet implemented at scale within the WM region or elsewhere. The BVI product will be launched in the US market in March 2017 and Select Research Ltd are currently in discussions with Health Exchange and NHS Heartlands Hospital (who are collaborators on BVI development) for a possible follow on wider trial across the region for 2017.
Measures:
When the BVI app has been fully completed in terms of it’s scalability for widespread use, the trial results have been published and the launch takes place in April 2017, the success criteria will be determined by the number of users and the take up when the product is available and being used by customers.
 
Development is currently ongoing with scaling of the technical infrastructure for release on all accepted and recognised technical platforms (e.g. Google Play. App Store) in late April 2017. The success criteria will then become easily measurable by virtue of the volume of downloads achieved after launch.
Adoption target:
These will be dependent upon the outcome of the discussions with NHS Heartlands Hospital and Health Exchange as to a future extended trial.
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