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Detailed
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Idea Description
Supplementary Information
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)
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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)
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 / Innovation and adoption
Benefit to NHS:
Integrate primary and secondary care to provide an effective and specialist service within a community setting.
Increase knowledge and awareness of liver disease in primary health care teams and within the general public.
Create an economic model to provide financial information about the long term cost effectiveness of the pathway. The pathway costs are also significantly within the NICE threshold of £20,000 per quality-adjusted life-year (QALY) at £2,138 per QALY for NAFDL and £6,537 per QALY for ALD
The pathway is picking up patients much earlier, with the ultimate aim of halting the condition or dramatically improving patient outcomes compared with current processes which often lead to patients not being identified soon enough.
It has undergone a full health economics evaluation and attracted interest from regional Clinical Commissioning Groups (CCGs) which has recently included the team facilitating the redesign of the liver disease pathway in one locality.
Benefit to WM population:
Promote the Scarred Liver project diagnostic pathway to other East Midlands CCGs and support the development of further commissioning cases where possible.
Adoption
There are 12,000,000 people nationally at risk – the pathway will identify these people if scaled throughout England and Wales. We would like to establish a roadmap to expanding the pathway from a regional to national service
1. Adoption and diffusion of innovation and research
2. Spreading best practice
Current and planned activity: 
Engage with commissioners and providers to facilitate the implementation of the pathway into multiple areas within the East Midlands.
Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
N/A
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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':
Coronary Artery Disease (CAD) is the leading cause of death world-wide. HeartFlow’s non-invasive technology, FFRct, has been found to accurately diagnose patients with suspected CAD, avoid unnecessary invasive procedures, and reduce healthcare costs
Overview of Innovation:
The diagnosis and care of patients with suspected coronary artery disease is significantly improved by the use of HeartFlow's FFRct analysis. Our process starts with data from a standard Coronary Computed Tomography Angiography (CCTA). High-quality (64 slice or greater) CT scanner images are sent to HeartFlow.

HeartFlow then creates a personalized, 3D model of each patient’s arteries. Where computational fluid dynamics are used to evaluate blood flow and assess the impact of blockages in the arteries. With this actionable information, clinicians can determine the right course of action for each patient.

While FFRct is still in an early  stage of adoption, there are now over 150 publications on the technology. Clinical trials have validated both the diagnostic accuracy and clinical utility. Most recently NICE issued guidance on HeartFlow FFRct, stating "The technology is non-invasive and safe, and has a high level for diagnostic accuracy... may avoid the need for invasive coronary angiography... Based on current evidence using HeartFlow can lead to cost savings of £214 per patient."

CT data is securely (Anonymised CCTA data) and seamlessly sent via our “HeartFlow Connect” once installation is approved by the hospital trust. HeartFlow ensures that the scans and FFRct results and analysis models are acceptable to a sites radiologists / radiographers.
 
Whilst this is an emerging diagnostic its well positioned to become an integral part of standard patient care for those who are at risk of CAD. As this is a new technique HeartFlow provides training to radiologists, radiographers, cardiologists and support staff. We work closely with each site to provide support and training to help evaluate the technology and as they begin to incorporate FFRct into their clinical practice. [A high level overview of HeartFlow’s training support can be found in the Adoption guide published by NICE. (see attached)]
 
HeartFlow FFRct users are invited to educational seminars and we are working on establishing a UK users group to help sharing best practice around FFRct’s use.
 
HeartFlow has received CE mark approval for use in UK/Europe.  CCTA image specifications for HeartFlow FFRct analysis; HeartFlow’s CCTA quality requirements are consistent with those of the Royal College of Radiology (RCR), British Society of Cardiovascular Imaging and the Society of Cardiovascular Computed Tomography (SCCT) performance of CCTA guidance document.
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 / Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption
Benefit to NHS:
The use of HeartFlow FFRct can improve patient care, efficiency, and lower medical costs:

Patient Care
  • HeartFlow FFRct provides a physician with both functional and anatomical data, improving diagnostic accuracy, thus reducing invasive procedures and associated complications
  • Improved diagnostic accuracy improves patient care and quality of life
  • Studies suggest that incorporating FFRct lowers patient radiation levels due to decreased angiography
Efficiency
  • Studies indicate that the application of FFRct may result in a reduction of unnecessary angiographies, improved cath lab efficiency, and reduced waiting lists
  • By providing both functional and anatomic data, physicians may be able to reduce the need for and waiting times associated with other diagnostic imaging tests
Cost of Care
  • As demonstrated in the NICE guidance, the use of HeartFlow FFRct can potentially reduce the cost of care. NICE estimates an average savings of £214 per patient. This saving is based on not conducting inappropriate invasive diagnostics.
  • A Japanese study has indicated that the use of the CCTA-FFRct strategy to select patients for Percutaneous Coronary Intervention (PCI) would result in 32 % lower costs and 19 % fewer cardiac events in 1 year compared to the most commonly used CAG-visual strategies. 
 
“The HeartFlow FFRct Analysis provides a definitive understanding of both anatomical and functional findings, without any additional testing or risk for patients. Application of the HeartFlow FFRct Analysis is likely to transform the quality of care we can provide for patients, ensuring the most accurate diagnosis and the best treatment plan, as well reducing the need for invasive coronary angiography – a procedure not without its risks.”
  -  Dr. Joseph Mills, Liverpoool Heart and Chest Hospital
Initial Review Rating
4.60 (1 ratings)
Benefit to WM population:
As stated in the NICE guidance, the adoption of HeartFlow FFRct in the West Midlands region could improve patient care and outcomes while generating significant savings for the region.
 
We are looking for additional adoption sites and would be interested in hearing from West Midlands Trusts that would like to take the lead in establishing our UK user group.  
Current and planned activity: 
HeartFlow is in early conversations with NHS Trusts and commissioners. A handful of early adopting NHS medical centres have begun to provide HeartFlow FFRct for their patients. HeartFlow is engaging with interested physicians at centres with high quality CT capabilities.

UK Sites where Heartflow FFRct is being used:
  • St. Bartholomew’s Hospital (London)
  • Liverpool Heart and Chest
  • Russell Hall Hospital (Dudley, West Midlands)
  • Freeman Hospital (Newcastle)
HeartFlow is in discussion with other UK site about adoption of FFRct.

Planned / required activity
  • We are looking for additional adoption sites and would be interested in hearing from Trusts that would like to take the lead in establishing our UK user group 
  • Whilst we have undertaken worldwide studies we are always interested in ongoing evaluation / validation and collaborative developments technically and with clinical pathway integration.
  • In the future we plan on conducting clinical trials based & focused on specifically the UK population.
What is the intellectual property status of your innovation?:
HeartFlow has established significant intellectual property and has been issued several patents.
HeartFlow received CE IIA mark approval for use in UK/Europe in July 2011. The technology is also ISO 13485 certified.  

Return on Investment
Savings have been demonstrated in clinical trials (PLATFORM), third party health economic modelling (NICE guidance, Int’l Journal of Cariology 183 (2015) 173-7), and real world experience at early adopting centres.
 
NICE recommendations for Heartflow FFRct (February 2017) state:  “Using HeartFlow FFRct may lead to cost savings of £214 per patient. By adopting this technology the NHS in England may save a minimum of £9.1 million (annually) by 2022 by avoiding invasive investigation and treatment.  
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
6-12 mon
Ease of scalability: 
2
Regional Scalability:
Liverpool Heart and Chest has performed more HeartFlow analyses than any other site. They have demonstrated clinical and economic benefits to incorporating HeartFlow FFRct into their practice. The uptake is due in part to to the strong support from their regional CCG.
Measures:
HeartFlow is seeking to achieve the following outcomes:
 - Improved patient care: Reduction in unnecessary invasive angiographies and eventually a reduction in waiting times for those patients that need angiographies
 - Reduction in Healthcare Costs: NICE estimates cost savings of 214 GBP per patient. We are working with existing sites to demonstrate real world outcomes.
 - Quality of Life: HeartFlow's clinical utility trial, PLATFORM, demonstrated an improvement in quality of life when FFRct was incorporated into patient care pathways. It is likely that this is in part due to the avoidance of unnecessary interventions. To date we have not seen any adverse events from avoiding invasive procedures.   
Adoption target:
NICE estimates cost savings of 9.1M GBP annually within five years. To reach this objective approximately 35,000 patients would need to have access to a HeartFlow FFRct analysis. 
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