Brainomix e-ASPECTS Stroke Imaging (#1990)

Idea Description
Supplementary Information
Detailed Submission Data
Innovation 'Elevator Pitch':
e-ASPECTS automates medical imaging analysis, providing confident decisions in the treatment pathway for acute stroke patients.  e-ASPECTS automatically implements the clinical scoring methodology, Alberta Stroke Programme Early CT.
Overview of Innovation:
Brainomix’s ground-breaking technology, e-ASPECTS, circumnavigates the time lag to treatment by automatically implementing the Alberta Stroke Programme Early CT Score (ASPECTS) scoring system on brain images from acute ischemic stroke patients, to identify and quantify signs of early ischemic stroke damage and provide an assessment to support treatment decisions.

Innovation of Brainomix e-ASPECTS Stroke Imaging
The key thing to note that is that the solution is highly innovative and first to market of its kind with no comparable solution available. Our co-founders include Professor Alastair Buchan, dean of medicine at Oxford University and the inventor of the ASPECTS score, and practicing clinician Professor Iris Grunwald, interventional Neuroradiologist at Southend Hospital and one of the first physicians to be successfully performing thrombectomies in the UK. 
  • e-ASPECTS is a decision support tool that automates the clinically validates ASPECT method scoring of CT scans, providing a fast, standardized result
  • e-ASPECTS is the only decision support tool for scoring non-contrast CT scans of stroke patients using the ASPECT method - a well established stroke scoring system
  • It is CE marked and has been validated to perform as well as expert Neuroradiologists in performing ASPECTS on hyper-acute stroke patient scans
  • Multiple randomized multicentre clinical trials have demonstrated (as recently as last year) that endovascular treatment is effective, and it is set to become the future standard of stroke care (in conjunction with existing thrombolysis treatments).
  • International guidelines for the selection of patients for this treatment include the ASPECTS score for identifying ischaemic core on non-contrast CT scans
 Health Economics
·         Reduced length of stay – baseline 0.04 days per patient
·         Identifies the correct treatment option for stroke patients and speeds up
          treatment times
·         Reduced decision making time for stroke patient – baseline 15 minutes per
·         Increased uptake of thrombectomy - baseline x 1.1 (i.e. 10% increase)
·         Cost savings - projected cost saving for a 15 minute time reduction in
          decision making is £40 of consultant time, plus £21 from reduced length of
          stay, leading to a total of £61 saving per patient. If thrombolysis uptake is               also increased by 20%, the total saving rises to £150 per patient.

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)
Similar Content3
Overview summary:
SMARTChip is a purine biosensor which uses a finger-prick sample of blood to detect ischaemic brain events that occur during a stroke. It’s been developed to address the need for a rapid diagnostic test to help decision making in early stages of a stroke.

SMARTChip was created by Prof Nick Dale of the University of Warwick and developed in a NIHR i4i research study carried out at UHCW NHS Foundation Trust under vascular surgeon Prof Chris Imray in collaboration with stroke physician Prof Christine Roffe of UHNM NHS Trust.
Challenge identified and actions taken :
Currently, patients suspected of a stroke are taken to A&E to have a CT scan as confirmation before given thrombolysis treatment; however, the length of time it takes to recognise stroke symptoms is critical as delay in treatment leads to increased damage to the brain. Furthermore, there are no diagnostic tests to help clinicians and paramedics to identify stroke, resulting in high levels of misdiagnosis and delays in treatment.

SMARTChip was created to reduce delays by diagnosing stroke faster and better informing clinical decision making.

Research proved that, at the onset of a stroke, the brain releases a detectable quantity of purines into the blood. Purines are produced and released by cells undergoing the oxidative stress that occurs during a stroke. SMARTChip measures these purines to detect and diagnose symptoms of a stroke faster, improving patient outcomes and saving the NHS time and money.

There were many practical challenges to overcome with the first proof-of-concept device developed (SMARTCap) including difficulty experienced by nurses accurately and rapidly collecting and measuring blood samples in test tubes. This led to modification of the design and the development of SMARTChip. SMARTChip only requires a finger-prick sample of blood thereby simplifying, miniaturising and speeding up the technology.
Impacts / outcomes: 

There are several positive outcomes from the SMARTChip project:
  • The study provided an excellent example of partnership working across academia, industry and the NHS.
  • The SMARTChip study has been featured in the national media with articles in The Guardian and the National Institute for Health Research Website.
  • The time it takes for SMARTChip to make a measurement is approximately 3-5 minutes.
  • SMARTChip will be used in conjunction with the existing assessment procedures such as FAST (Face, Arms, Speech, Time) and ROSIER (Rule Out Stroke in the Emergency Room) to aid clinicians to diagnose stroke more rapidly.
  • SMARTChip is also expected to help by triaging patients and directing them to the most appropriate clinical unit.
  • SMARTChip may also be able to detect a number of other injuries including traumatic brain injury (TBI), heart attack and foetal hypoxia.
  • SMARTChip has the potential to improve patient outcomes but also can save major cost to the NHS.
  • SMARTCHIP won the MidTECH Award for Best NHS-Developed Medical Technology Innovation at the WMHASN Awards 2018.
Which local or national clinical or policy priorities does this innovation address:
National Clinical Priority: One of the key priorities of the Stroke Association and the NHS RightCare Pathway is for stroke to have a more rapid diagnosis and treatment, from a 999 call through to optimal treatment. Every year, around 110,000 people in England have a stroke, and it is the third largest cause of death, after heart disease and cancer. Earlier diagnosis of stroke can better inform clinicians, meaning that treatment can be administered earlier. This leads to fewer complications later, as every minute that a major stroke is untreated, the brain loses some 1.9 million neurons, 14 billion synapses and 7.5 miles of myelinated fibres.
Supporting quote for the innovation from key stakeholders:
Quotes from Nicholas Dale, founder of Sarissa Biomedical Ltd:
“In 10 years’ time, I’d hope that SMARTChip will be in the defibrillator boxes that enable the public to treat cardiac arrest…upgraded with Sarissa’s SMARTChip, they should become multifunctional, enabling the public to contact the health service with more complete information.

“Sarissa has developed a world beating technology that will improve the lives of stroke victims and save the NHS money. Our ambition is to create jobs and economic wealth, we see the development of our production capability as being a key factor in transforming Sarissa from an R&D company into a high value IVD manufacturer and look forward to working with Aston University to deliver our ambition.”

Quote from Norman Phillips, Patient representative:
“Having had a stroke in 2003 at the age of 55 and being treated under the then current practice I was left with hemiplegia on the left side.

“After being discharged I took an interest in stroke treatment and research serving on many bodies and taking part in research in all areas.

“During the time since my stroke I have seen the introduction of the FAST campaign and fast tracking of patients to acute stroke units where diagnosing can be carried out, but, as we know, “time is brains.” The use of thrombolysis is governed by time so speed is of the essence.

“The introduction of SMARTChip will greatly reduce the time element and mean that treatment can begin sooner. Its use would also reduce the number of false diagnoses that turn out not to be a stroke.

“In my mind, and that of other stroke survivors and medical professionals that I have spoken to, this is a major breakthrough in the early diagnosis of the onset of a stroke.”
Plans for the future:
Further research studies using SMARTChip in an emergency setting will provide evidence for it to be implemented as an early diagnosis indicator of strokes. A planned study in an ambulance setting will also allow the device to be used and tested on patients with a suspected stroke before they arrive at A&E, again saving critical time in diagnosis and treatment.

Sarissa is now working on developing SMARTChip to support wider diagnosis and treatment of Ischemic Vascular Disease (IVD), with further trials planned for traumatic brain injury, heat attack, foetal hypoxia, limb ischaemia, peripheral artery disease and neurological disorders such as epilepsy.

In the longer term, a ‘wellness’ test is planned to screen people most at risk of a stroke and prevent them occurring.
Tips for adoption:
Final research and testing is reaching its conclusion, with an SBRI funded paramedic led trial of SMARTChip in the North West, North East and West Midlands NHS ambulance trusts and led by Dr Chris Price (Newcastle). SMARTChip is expected to achieve CE marking in 2020 with the product being available commercially by the start of 2021.
Contact for further information:
If you would like more information on the SMARTChip please contact:

Further information on Sarissa Biomedical Ltd and SMARTChip is available via the following links:
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Innovation 'Elevator Pitch':
Tipsim® is a completely new product producing long lasting improvements in sensorimotor abilities of the hand in rehabilitation after brain damage, such as stroke, craniocerebral trauma or other neuro diseases e.g. Complex Regional Pain Syndrome.
Overview of Innovation:
Tip-stimulation with Tipstim® facilitates long-lasting therapy procedures. By sensory stimulation of the finger tips, Tipstim® drives plasticity processes in cerebral areas involved in the activation of the hand and fingers. Specially designed stimulation patterns – developed over many years of research & trials at the Institute for Neuroinformatics at the Ruhr University Bochum – are generated by a small, portable electronic pulse generator and applied directly to the finger tips via a completely new and highly-sophisticated therapy glove. The Tipstim glove® is the first product of its kind to utilise a new advanced medically approved conductive and biocompatible textile.
The therapy is completely painless, without side-effects and very easy to apply. The patient simply pulls over the glove, connects it to the pulse generator and starts the therapy session once a day for 1 hour. The therapy does not demand any special attention from the patient. Due to the small size of the pulse generator, the therapy can easily be integrated into everyday life and home. In principle, therapy can be applied everywhere, even when out walking.

 The proven efficiency of Tipstim® results from stimulation pattern specially designed for most effective enforcement of neuroplasticity processes. Clinical studies show that these special patterns produce cerebral changes which lead to persistent improvement of a patient’s sensorimotor abilities. This especially true with sensory and proprioceptive deficits which have shown a greater recovery than with standard rehabilitation therapy alone
Studies have shown that sensory stimulation drives plastic processes in the brain areas activated by the stimulation. This induces reorganisation in and around those brain areas that became dysfunctional by stroke or other brain injuries. This reorganization facilitates reactivation of cortical tissue that has preserved some functionality. The resulting remodelling of cortical circuits then mediates functional recovery.
Tipstim® is a clinically tested and CE approved product. The efficacy & safety of Tipstim® therapy has been proven in rigorous clinical trials.
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 / Wellness and prevention of illness / Education, training and future workforce / Wealth creation / Clinical trials and evidence / Person centred care
Benefit to NHS:
Stroke is the UK’s third biggest killer.
First-time incidence of stroke occurs almost 17 million times a year worldwide; one every two seconds. Stroke is one of the largest causes of disability – half of all stroke survivors have a disability.
In the UK there are 152,000 recorded incidences of stroke a year and currently over 1.2 million stroke survivors. The economic costs of stroke in the UK from a societal perspective totals around £9 billion a year (Source: State of the Nation Stroke statistics - January 2016). The average cost of care (acute & rehabilitation) per stroke patient is currently £23,315 (National Audit Office. Progress in improving stroke care..., (February 2010). NAO Report (HC 291 2009-2010))
Over a third of stroke survivors in the UK are dependent on others.
Tipstim® is a completely new product to improve sensorimotor abilities of the hand in rehabilitation after brain damage, such as stroke, craniocerebral trauma and other neurological diseases such as Complex Regional Pain Syndrome.
Tipstim® comprises a small, battery powered electronic pulse generator unit and a close fitting glove that delivers the neurostimulation at the finger tips. Due to the compact size of the pulse generator, the therapy can easily be integrated into everyday life. In principle, therapy can be delivered everywhere, even during walking or when reading or watching television.
Clinical trials have demonstrated that the stimulation provided by Tipstim®  demonstrates a persistant reactivation of affected brain areas responsible to sensory and motor control of the hand and fingers. Moreover, balancing processes in adjacent non-affected brain areas are promoted.
The result is a substantially improved sense of touch as well as an improved mobility of the concerned hand.
The sensory & functional improvements resulting from Tipstim® neurostimulation have been demonstrated to last longer than for traditional therapy alone.
The Tipstim® is self contained and can easily be used by the patient in their own home. This reduces the frequency of hospital / clinic visits, frees up therapist time and would enable more patients to be treated than is currently possible.
Furthermore, the sensory and functional improvements resulting from the Tipstim® therapy will increase the patient’s ability to carry out task of daily living and will therefore increase their independence, thus reducing the need for additional care and support – with resultant manpower and monetary savings.
Initial Review Rating
5.00 (2 ratings)
Benefit to WM population:
The West Midlands has the highest mortality for stroke in England in people over 65.
The region’s ethnic diversity and socioeconomic status also reflects in a higher than average incidence of strokes as people of black and South Asian origin are at double the risk of stroke as are those living in the most economically deprived areas of the UK (West Midlands has 28.1% of its population in the most deprived national quintile)
These statistics demonstrate that the demand for stroke rehabilitation services will be higher than the national average and therefore the opportunity to make a significant impact will be greater for therapies such as Tipstim®.
The region also has the lowest percentage of patients returning to their usual place of residence, and this is statistically significantly lower than the England average. Improved  independence and post stroke rehabilitation would help to address this and enable people to return to their own homes and live independently.
Current and planned activity: 
We are currently undertaking a pilot multicentre clinical trial of Tipstim® at the Countess of Chester NHS Foundation Trust, Chester.
We would welcome the opportunity to engage with the West Midland’s Stroke rehabilitation communities to raise awareness of our Tipstim®.
In addition, we wish to explore support for business model development and delivery strategies for NHS adoption and or private procurement.

We are also very interested in conducting a cost benefits analysis health economics study of therapeutic intervention with Tipstim®.
What is the intellectual property status of your innovation?:
Tipstim® is protected via granted patents and registered design rights held by the parent company.
Return on Investment (£ Value): 
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Regional Scalability:
Please describe how the innovation could be scaled across the WM region. Have you implemented at scale in any other regions?
What outcomes are you hoping to achieve and what are the measures that you will use to gauge the success of the innovation and how will these assessments be made? Please ensure that you have quality, safety, cost and people measures.
Adoption target:
What are the targets for adoption across the WM and what are the minimum viability levels?
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Innovation 'Elevator Pitch':
Electronic wound imaging, assessment & information management system.  An enabling technology to support objective wound assessment, monitoring & evidence-based treatment for patients with chronic & acute wounds such as diabetic foot ulcers.
Overview of Innovation:
Silhouette is an easy-to-use wound imaging, 3D measurement & documentation system providing accurate wound information at the point of care to support effective clinical management of patients. Silhouette wound informatics are available as a wound assessment PDF report and on a secure web-enabled database and for easy access and sharing across the entire care team. 

The wound images and wound healing progress charts are highly visual and provide immediate and clear indication of a patient's response to treatment.

This award-winning system includes an imaging 3D camera that precisely and consistently measures the area, depth & volume of wounds to track and report healing progress. Silhouette enables wound assessment activity and wound outcomes to be monitored, providing wound information that is available instantly to key stakeholders, integrated with your EMR system. Silhouette is proven in both clinical research & clinical practice.

Silhouette supports pro-active management of wound-related risk & improves communication, helping practitioners to be more productive & effective in their delivery of wound care. Silhouette is suitable for all settings, including acute out-patient clinics, community-based care, home health & telehealth wound care.

The Silhouette system is made up of three main parts – a point of care wound camera, smart software for measuring wounds, & a wound information database:
  • The SilhouetteStar® specialized camera (pictured right) captures the wound image;
  • SilhouetteConnect® software for accurate 3D measurements of the wound based on the data acquired by SilhouetteStar (see below), together with healing progress charts & electronic wound assessment summary reports. 
  • SilhouetteCentral®, a secure Internet-accessible database that stores & consolidates the information obtained from the organisation’s SilhouetteStar + SilhouetteConnect devices, including integration with the EMR.
Unlike non-3D and traditional methods, which are imprecise & unreliable, Silhouette provides meaningful information for better clinical decisions. It is also extremely easy to use & is ready to integrate with EMR systems. Silhouette was first established in clinical research, which requires rigorous source documentation, & is now available for widespread use in clinical practice.

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 / Digital health / Person centred care
Benefit to NHS:
Silhouette is an enabling technology to support safe, cost-effective care for patients with chronic and acute wounds such as diabetic foot ulcers, pressure ulcers and leg ulcers and complex wounds.

Currently, the burden of wound care on the NHS is estimated at £3billion per annum, with unacceptable variances reported in practice standards and outcomes achieved so that thousands of patients are not receiving the standard of care that should be possible.

Silhouette technology transforms how wound status is assessed, documented and reported. Better quality of wound information available in a connected and interoperable system means that clinicians are better supported for effective and timely clinical decisions and actions. Silhouette facilitates data sharing across an entire care pathway to reduce the risks of fragmented care across silos.

Silhouette equips, empowers and enables healthcare professionals and patients to collaborate for best practice to achieve optimal wound outcomes. 

There is significant potential for the NHS to drive for cost savings, greater efficiencies and clinical effectiveness with the adoption of the Silhouette wound informatics solution.
Online Discussion Rating
5.00 (2 ratings)
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
As well as assuring patients of best practice and quality of care, patients can actively engage in their care plan and outcomes due to the highly visual nature of Silhouette wound healing data and charts displayed on the software screens.

The benefits of rapid and effective wound healing for the patient should not be underestimated. The psychological consequences of living with a chronic wound are well documented. Upton and Hender (2012) suggest that patients with chronic wounds may experience negative emotions such as:
  • Stress
  • Concern about physical symptoms
  • Lack of self-worth
  • Despair
See featured Silhouette Patient Story which demonstrate the power of Silhouette informatics in motivating a patient with a debilitating pressure ulcer to recovery.
Current and planned activity: 
Entec Health is an appointed distributor to ARANZ Medical for the Silhouette solution in the UK. Our partnering goals are to inform & engage NHS stakeholders on the advantages of adopting digital wound assessment & wound informatics to address the “best practice, clinical excellence & cost-effectiveness gap” in wound management. Entec has supported 5 field Silhouette evaluations in acute & community care with considerable investment of time, expertise & resource. Entec has successfully established early adopters of Silhouette across the NHS:  
Clinical Practice: King’s College Hospital London Diabetic Foot Clinic, North Bristol Trust Enablement Centre
Clinical Research: 10 NHS centres of excellence in diabetes foot care are currently using Silhouette in a multi-centre clinical trial sponsored by EdixoMed  
Planned activity: A Diabetes Foot Pathway demonstrator project supported by EMAHSN to be announced & 2 further Silhouette collaborations are in progress, information to follow.
What is the intellectual property status of your innovation?:
Product family: Silhouette Mobile, Silhouette Connect
US patent: 8,755,053
Chinese patent: ZL 200680037626.3 

Product family: Silhouette Star, Silhouette Connect
US patents: 9,179,844, 8,755,053, D662,122
Chinese patent: ZL 200680037626.3
Other patent(s) pending

Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.

Health information protocols and privacy:  Silhouette supports a variety of protocols and functionality, including:
·         HL7 patient demographic information exchange or transfer
·         DICOM image transfer
·         DICOM Encapsulated PDF report creation and transfer
Silhouette is designed to support HIPAA and HITECH compliance.
Return on Investment (£ Value): 
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Regulatory Approvals:
Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.
Commercial information:
The Silhouette wound imaging, assessment and information management system is a proven, established in-market solution used across world-wide markets. The Silhouette solution is supporting wound outcomes documentation, reporting and informatics for effective and efficient wound care service delivery. Silhouette is enabling transformation of wound care pathways in acute, community and integrated care settings. Early market for Silhouette is the US with UK, Europe and Asia as emerging markets.  
Investment activity:
Entec Health, as an appointed distributor of Silhouette in the UK,  has invested considerable time, effort and funds to introduce the Silhouette to the NHS/UK market since 2011. ARANZ Medical, the developer and manufacturer of Silhouette has invested signficant funds, effort and expertise in R&D and bringing the Silhouette solution to the global market.

There is continued investment in partnering with the NHS and UK healthcare provider market by Entec Health. ARANZ Medical has a commitment to on-going investment in R&D for Silhouette to ensure that the solution meets the future needs of healthcare professionals.
Regional Scalability:
The Silhouette solution is highly and easily scalable across the West Midlands region for transformation of wound care services within the NHS sector. Silhouette can help to address delivery of greater clinical effectiveness and productivity in managing patients with chronic and acute wounds, including Diabetic Foot ulcers, Pressure Ulcers, Leg Ulcers and complex wounds. Silhouette is an enterprise system designed to be interoperable and connected within the NHS/Provider IT infrastructure to enable support of multi-disciplinary care of patients across a diverse range of care settings. Silhouette can be incorporated into telehealth/teleconsultation models of service delivery to support new models of care that improve patient experience, outcomes and cost-effectiveness. 
The target outcomes of adoption of the Silhouette solution for the Healthcare Provider Organisation are:
Quality outcomes/measure
Organisation will demonstrate objective, evidenced-based practice to support timely and appropriate treatment planning and care for delivery of optimal wound outcomes.
Measure: Silhouette wound informatics available; quantifies and reports wound healing outcomes for individual patient, patient-population, clinical pathway and treatment type. 
Safety outcomes/measure
Organisation will have consistent standard of wound care practice and transparency on wound care outcomes to demonstrate accountable care provision to the required safety standards.
Measure: Silhouette wound informatics available; including digital wound images, wound healing data/charts and wound assessment reports available electronically for audit and management reporting.
Cost outcomes/measure
Organisation will have wound care outcomes data available to support assessment of cost-effectiveness of wound care treatments, service delivery and wound outcomes by treatment type.
Measure: Silhouette wound outcomes and assessment activity data available; to feed into cost-planning and cost-assessment of wound care service.
People outcomes/measure
Organisation will be supported to ensure high levels of staff and patient satisfaction of wound care services through equipping and empowering with quality clinical information on wound progress. The objective wound outcomes data generated with Silhouette will enable joint, evidence-based conversations on care plan and treatment goals with patients and the multi-disciplinary care team.  
Measure: Silhouette patient and population-level reporting available; combined with patient/staff surveys before and after deployment of Silhouette.
Adoption target:
Over next 2 years, we would like to aim to partner with 6 NHS Trusts/other healthcare providers in the West Midlands region for adoption of Silhouette.
Investment sought:
The Silhouette enterprise system is a modular system and investment level is dependent on scope of deployment. An enterprise level Silhouette system based on 5 Silhouette assessment devices and SilhouetteCentral database package starts from £45,000 (net, excluding VAT) for a capital purchase plan. Data integration, IT services, project management and annual software maintenance/support fees are additional costs, dependent on requirements. Silhouette pricing can be offered as an annual subscription model or a capital purchase model to suit different budgetary requirements. 
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