Creation
Draft
Initial
Detailed
Accepted
Adoption
Idea Description
Supplementary Information
Detailed Submission Data
Innovation 'Elevator Pitch':
Levo® Therapy System is an innovative sound based therapy designed for use during sleep. The system creates and delivers a personalised sound therapy that uses the brain’s natural plasticity to reduce symptoms and provide relief long term.
Overview of Innovation:
Tinnitus is a conscious awareness of a sound in the ears or head that is not due to an external noise. Every individual has their own very personal tinnitus tone. It can be a high or low frequency sound and its volume can vary over time. An estimated seven million people in the UK have experienced tinnitus at one time or another.

People living with tinnitus report that their condition limits their social life, their relationships and their opportunity to work (source: British Tinnitus Association patient website https://www.tinnitus.org.uk/).

Levo® Therapy System for Tinnitus is an FDA cleared and CE approved sound-based therapy which works with the brain’s natural plasticity to help the brain to get used to, or habituate, to the tinnitus sound within the hearing centre of the brain.

Levo® is specifically designed to be used during sleep when our brains are more prone to be responsive to sound therapies that strive to change brain activity patterns. The system enables patients to map their specific tinnitus sound, or ‘sound print’, to create a personalised sound therapy.

The personalised therapy sound is presented to the patient while they are asleep via an iPod device using a tailor-made proprietary ear phone system which is designed to be slept in (Levo® will switch itself off automatically during the night once the correct dosage has been applied). This stimulates the hearing centre of the brain with the goal to encourage habituation to the tinnitus sound and reduce the perceptual loudness / annoyance of the tinnitus signal. Improvements in tinnitus symptoms are tracked over time, which is motivating for the patient and provides useful guidance for the clinician.

The Tinnitus Clinic is suitable for patients with atonal or tonal tinnitus, or a mix of frequencies from less than 200Hz right through to beyond 10,000Kz. Levo® System therapy is a prescriptive approach which requires a single course of treatment over a period of 30-60 days. Patients self-administer Levo® therapy during their night time sleep cycle and can carry on their normal daily life without disruption, including wearing hearing aids for hearing loss during the day if required. Attendance at a clinic for follow up visits is usually one or two visits only.
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
Innovation 'Elevator Pitch':
A holistic tinnitus treatment app designed by audiology and ENT specialists that will provide patients with tinnitus education, self-help therapeutic exercises, psychoacoustically tailored sound therapy and efficacy outcome measurements.
Overview of Innovation:
Tinnitus is the involuntary perception of sound, that is localised to within the ears/head, and has been reported to affect 10-15% of the global adult population. 
 
The vast majority of cases are induced by hearing loss. Hearing loss casues changes in neuronal activity patterns within the central auditory system and occur as a result of organic mammalian hearing loss.   However, sudden onset hearing loss cuased by loud noise exposure or some damage to the auditory cortex can also result in tinnitus.

In a significant number of individuals (0.5-1.5%) this can have a severe impact on quality of life due to resultant secondary symptoms such as anxiety; external sound sensitivity; insomnia.

Currently tinnitus is treated by helping the patient to habituate to the noise; so that the perception becomes filtered from conscious awareness much in the same way as the majority of body noises are (i.e. respiration etc.).  Techniques like educational counselling, relaxation, meditation, cognitive behavioural therapy (CBT) and sound therapy are all employed to provide ad hoc control over patient emotional reactivity and perceptual awareness in order to act as a catalyst to the habituation process. 

These complex therapeutic techniques require significant clinical time, resource and expertise in order to be efficacious.  
 
The Tinnitus Clinic Ltd. proposes to design a treatment app to prototype stage for tinnitus. This app will combine a number of evidence based interventions that can be delivered to the patient via one platform in a remote fashion. 
 
There will be both pro bono and chargeable features. 

Users will be able to grade their tinnitus severity via validated questionnaires and access education tools relating to tinnitus aetiology, the progression of the condition and self help techniques.  

Patients will also be able to determine the pitch of their tinnitus and basic hearing acuity in order to provide guidance with respect to basic sound therapy options. 
 
Chargeable services such as spoken word relaxation/mindfullness meditation exercises, CBT techniques and non-bespoke sound therapy options could be available for a monthly fee.   

A more sophisticated array of bespoke sound therapy techniques will also be available but would require the patients to attend a tinnitus clinic in order to undergo testing and calibration of the treatment signal.  Fit for purpose ear/head phones would be provided to enable signal delivery during the day or whilst the patient sleeps. 
 
 
Stage of Development:
Ideas stage - Early concept and ideas stage
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Education, training and future workforce / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
Use of this innovation would reduce appointments taken with GPs and unnecessary visits to audiologiy departments. As both an education and treatment tool the medtech app could treat the majority of people who suffer from mild or moderate tinnitus and need basic support and reassurance. 
Online Discussion Rating
6.00 (1 ratings)
Initial Review Rating
3.40 (1 ratings)
Benefit to WM population:
10% of adults in the west Midlans have tinnitus, and of those around 90% will have mild to moderate tinnitus which does not need treating formally. 
Current and planned activity: 
We have no current activity with NHS for treating patients. However, we do provide training and education on tinnitus to GPs. 
What is the intellectual property status of your innovation?:
Not yet patented .
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Simple
Regional Scalability:
As this is a digital technology, scaling up geographically is a straightforward process.
Measures:
Quality measures: functionality; ease of use;  all information, diagnosis and treatment functions to be evidence based; Tinnitus Functionality Index scores reduced over 3 months of use of app; 
Safety Measures: No adverse events reported at prototype stage or in the ongoing development; 
Cost: Within budget for the prototype with full budget developed for stage 2 (development, marketability and implementation)
People: Quality of life improves using TFI as measure (see quality)
Adoption target:
The protoype would be tested in  a West Midlands population . We would seek to establish an NHS partner to test this at Primary Care level in the later stages of development . 
Read more
Hide details
Innovation 'Elevator Pitch':
SaccScan - a tool for rapid, accurate & affordable diagnosis & clinical management of major psychiatric disorders. Identifies eye movement abnormalities to objectively diagnose illnesses such as schizophrenia, bipolar disorder & severe depression
Overview of Innovation:
The Diagnostic Problem
Delivering an accurate and timely diagnosis remains one of the most pressing challenges of modern psychiatry. 1 in 4 adults suffer from mental ill health during their lifetime but around 50% of cases are misdiagnosed. There are still no objective diagnostic tests to validate the decision. Diagnosis and clinical management are based solely on the patient’s history, symptoms, and behaviour. Treatments are available that allow patients to resume normal functioning in society but clinicians struggle to make accurate diagnosis, match therapy to condition and provide timely care.
 
It is common in psychiatry to find that symptoms are insufficient to give a clear diagnosis and a lengthy consultation period of several years may be necessary. Delays in receiving a diagnosis can significantly impede delivery of the most effective treatment plan, exposing the patient to risk of further deterioration in well-being, reduction in quality of life leading to job loss, family breakdown, and self-harming.
 
Ultimately the wider economy shoulders the burden from loss of economic output, commitment of healthcare resources, and out-of-pocket expenses incurred by patients and their families.
 
SaccScan is a novel eye movement test, designed as an assistive point-of-care tool for diagnosis and clinical management of psychiatric disorders.
 
Using high specification eye tracking technology, and access to a proprietary clinical reference database, the diagnostic tool utilises eye-movement abnormalities as objective clinical diagnostic biomarkers for illnesses such as schizophrenia, bipolar disorder and severe depression. The test can be completed within 30 minutes in a standard consulting room. A shorter version of the test is being developed for use in primary care settings to assist with differential diagnosis of psychosis from mood disorders, better informing referral of serious mental illnesses to secondary care services.
 
SaccScan not only reduces the overall cost of managing psychiatric illness but will improve patient outcome.



A Step Change for Psychiatry
SaccScan has been demonstrated to detect schizophrenia with better than 95% accuracy (> 90% sensitivity & specificity) and has been extended with the same precision to bipolar disorder and major depression illnesses. No brain imaging, serology or DNA test approaches this level of performance (sensitivity, specificity and repeatability).
Stage of Development:
Close to market - Prototype near completion and final form may require additional validation/evaluation and all CE marking and regulatory requirements are in place
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Wealth creation / Clinical trials and evidence / Digital health / Person centred care
Benefit to NHS:
Initial Review Rating
4.60 (1 ratings)
Benefit to WM population:
The benefits of early intervention
It is widely accepted that early intervention in psychosis services not only produces better outcomes but is also cost effective.
 
Primary care - nearly 500,000 people are on GP registers for a serious mental illness. (Care Quality Commission (June 2015), Right here, right now)
 
The demographic inequalities in the prevalence and risks associated with mental health problems are reflected in treatment. People who are white British, female or in mid-life are more likely to receive treatment, while people in black ethnic groups have particularly low treatment rates. People with low incomes are more likely to have requested but not received mental health treatment.
Current and planned activity: 
Current
Research and clinical validation towards CE marking through NHS Grampian, Lothian, Tayside, Glasgow & Greater Clyde with Scottish Borders and clinics in Peterhead & Fraserburgh added in April 2017 targeting >1,000 patients & controls.
 
SBRI contract to survey 50 GP surgeries as part to scope introduction of test in primary care

Planned
  • Seeking trial sites in the WM region to pilot the test in clinical settings to support CE marking
  • Ongoing refinement of the value proposition for clinical adoption and to support service user involvement by NHS e.g. final design of diagnostic report template
  • Dr M. Kumar (Consultant Psychiatrist) and ward staff at the Sth Staffs & Shropshire NHS Foundation Trust, has expressed interest in becoming a lead pilot site in WM region for clinical validation studies.
  • Wish to develop projects with MoD on PTSD using SaccScan technology. Require funding to set up St George’s Hospital as field trial site in collaboration with Clinical Trial Unit at Keele University
What is the intellectual property status of your innovation?:
Currently developing technical file for CE mark class I submission.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Simple
Read more
Hide details
Innovation 'Elevator Pitch':
NATROX® Oxygen Wound Therapy is a medical device designed to heal complex non-healing wounds to improve healing outcomes and quality of life, optimise clinical and economic resources, and reduce diabetic foot related amputation rates.
Overview of Innovation:
NATROX® Oxygen Wound Therapy is a portable, lightweight and easy to use patient-friendly device, designed to topically deliver continuous pure humidified oxygen to the wound bed. The device was developed in order to help improve healing outcomes in wounds which traditionally remain static due to wound hypoxia (oxygen starvation), a common symptom of diabetic and vascular issues.

The NATROX® system is comprised of an Oxygen Generator, 2 rechargeable batteries and a single-use disposable Oxygen Delivery System.  The therapy is designed to be used 24/7 and as an adjunct to standard of care, such as absorbent wound dressings, with an average therapy length of 12 weeks. The product is supported by a growing portfolio of clinical evidence, including RCT-level data, which has demonstrated a significant increase in the healing rates of complex and non-healing wounds, compared to standard of care alone (90% healing with NATROX®  vs 30% for 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 / Innovation and adoption / Person centred care
Benefit to NHS:
It has been shown that over £5.3bn is spent by the NHS each year on the management of 2.2m wounds. The management of non-healing wounds accounts for a significant amount of NHS resources (approx. £3.1bn per year) and is increasing due to an ageing population and higher rates of diabetes and diabetic foot ulceration.  NATROX® therapy is designed to positively impact healing rates and thereby optimise both clinical and economic resources used on non-healing wounds, in turn helping clinicians and financial decision-makers to access and treat a greater number of patients.

Furthermore, it is well documented that patient quality of life is negatively impacted by having a wound, and especially a non-healing wound, with increases in social isolation and depression across this patient population. NATROX® therapy focuses on healing wounds which are unable to heal with standard treatments alone, as these treatments are unable to address the underlying causes of non-healing wounds, such as oxygen starvation (hypoxia). The therapy system therefore focuses on providing pure humidified oxygen to hypoxic wounds, whilst being comfortable, quiet, lightweight and easy-to-use for the patient, allowing normal mobility without any negative impact from the device.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Increases in diabetes rates across the UK has in turn led to an increase in prevalence rates for diabetic foot disease and associated ulcers.  Furthermore, latest health economic evidence (e.g. Guest et al 2015 & 2017) has shown that non-healing wounds account for approximnately 57% of wounds at any time are deemed non-healing, which has a direct impact clinically, financially and to the patient experience.  Both minor and major amputation rates are increasing as a result due to the complexity of many diabetic foot ulcers, which has a significant impact on the health and wellbeing of these patients, with increased patient mortality following amputations of around 50% within 2 years.

Like many areas, the West Midlands is experiencing increased amputation rates, as a result of rising diabetes and diabetic foot ulcer prevalence.  This has a significant impact on the local health economy in the West Midlands area, especially in higher population bases such as city areas and surrounds.  Therefore, the adoption of NATROX® therapy across the West Midlands area could have a significant effect on helping to reduce non-healing levels within the diabetic foot ulcer population, and therefore positively impact the well documented clinical and economic cost that the burden of non-healing wounds brings with it.  

A resulting increased resource utilisation would allow a wider focus on the growing population of diabetic foot ulcer patients, improving clinical and economic output across local vascular, podiatry and wound management services.   
Current and planned activity: 
Inotec AMD is currently engaged with a variety of clinicians and decision-makers across the UK.  There are a number of local product evaluations active or soon to start, which will aim to demonstrate product afficacy in order to facilitate adoption of the technology locally and nationally.  in addition, a large NHS funded UK-based RCT is underway, which is due to report later in 2018.

Furthermore, the product is being reviewed both clinically and evidentially on a national level in both Scotland and Wales, where we are about to start a national clinical evaluation in Wales across both Welsh Podiatry and Tissue Viability networks, whilst in Scotland NATROX® therapy is being formally assessed by Health Improvement Scotland and the Scottish Health Technologies Group, in order to gain an official recommendation. 
What is the intellectual property status of your innovation?:
The intellectual property surrounding NATROX® therapy is owned by Inotec AMD Ltd.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
NATROX® Oxygen Wound Therapy is not yet adopted at scale within the UK, but is undergoing product evaluations with a view to contract listings and wider adoption.  A programme of marketing and events is planned to support the wider awareness and adoption of the technology.
Measures:
Further clinical efficacy demonstrated through local and national product evaluations, health efficiency data supported by the NATROX® Health Efficiency Model utilising local clinical data and outcomes, patient quality of life data from local and national product evaluations, and usability info from clinical usage.
Adoption target:
Availability of NATROX® Oxygen Wound Therapy on podiatry, vascular and tissue viability product formularies and listings in hospitals across WM region, for use on all clinically relevant non-healing and complex wounds. 
Read more
Hide details
6
1
Votes
-99999

Created by

Share and Follow