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Idea Description
Supplementary Information
Detailed Submission Data
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)
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Innovation 'Elevator Pitch':
Woundex is a innovative breakthrough discovery, the only product in the world which efficiently works on all types skin ulcerations, and is one of the best treatments available.
Overview of Innovation:
Diabetic foot problems, such as ulcerations, infections, and gangrene, are the most common cause of hospitalization among diabetic patients. Routine ulcer care, treatment of infections, amputations, and hospitalizations cost billions of pounds every year and place a tremendous burden on the health care system.
 
This therapy will help save the psychological distress people go through when they have amputations. This treatment will reduce the monetary burden on the national health care system. It has shown good results, even on the severe cases of ulcerations.

It has no side reactions. This product can be used in all types of skin ulcerations , open wounds, burns, gangrene  and diabetic ulcers. Patients would be saved from having an amputation.
This product on application helps increase blood circulation around the wound area .It also increases and promotes tissue growth this in turn helps to heal the wound speedily.

 if it is cut, however, in some people with diabetes the skin on the feet does not heal so well and is prone to developing ulcer. This can be even after a mild injury such as stepping on a small stone in your bare feet.
There is reduced sensation of the skin on your feet. Your nerves may not work as well as normal because even a slightly high blood sugar level can, overtime damage some of your nerves. This is a complication of diabetes called peripheral neuropathy of diabetes.
Diabetic ulcers can lead to gangrene , amputation making the patient immobile.
This causes great psychological distress for the patient.
 
Diabetic foot ulcer places a big budgetary burden on the healthcare authorities. Along with treatment of foot ulcers, amputation  the cost are substantial.
The healthcare authorities have to employ multidisciplinary foot care services led by healthcare professionals, and this consist of specialists with skills in the following areas: Diabetology, Podiatry, Diabetes specialist nursing, Orthopaedic surgery, Biomechanics and orthoses, Interventional radiology, Casting and Wound care-putting an even greater financial strain on the heathcare provider.
 
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: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Clinical trials and evidence / Innovation and adoption / Person centred care
Benefit to NHS:
Diabetes ulcer and amputations cost £1 in every £150 spent in the NHS budget. Around 15 % of all diabetes patients will suffer from diabetic ulcer and at a advanced stage amputations have to be carried out.  There are currently 150 amputations performed every week in the UK.  Patients who  have diabetic ulcers are given antibiotics as treatment to control the ulcer. These are given over many years. As you may be aware of there is a big problem of antibiotic resistance.
There will be big benefit to the NHS if they use this treatment.
Benefit to WM population:
This Treatment will benefit the WM population in big way and will eleviate the suffering diabetic ulcer patients go through.
Current and planned activity: 
The medicine is a phyto chemical spirit based solution and has to be imported from India. This medicines ingredients can only be grown in India. At the present time this product is being licenced in India
What is the intellectual property status of your innovation?:
At this stage no status
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Neurocare’s™ muscle stimulation  therapy is safe, comfortable, non-invasive and clinically proven to accelerate  wound healing and musculoskeletal  rehabilitation which enables major treatment  cost reduction with  significant increases in HRQoL.
Overview of Innovation:
Neurocare™are seeking to promote the adoption in the UK of their muscle stimulation device and its comprehensive treatment protocols .
 
Neuromuscular electronic stimulation therapy is well established in many countries in the world particularly in the U.S.A. and with six FDA indications has a strong clinical trial evidence base in most of its  applications.  The Canadian and American Health Authorities have recommended its use in healing pressure ulcers as did the EPUAP/NPUAP collaboration in work published in 2009.
 
Patient compliance is potentially a challenge particularly where adherence to a treatment programme over a period of time is necessary. Many muscle stimulation devices can be painful  when set at voltages required to achieve a therapeutic level of muscle recruitment.
 
The Neurocare™ device has a unique electronic configuration which features AC output and allows very high voltage for full muscle recruitment at very low amperage for pain free comfortable therapy. Whether treatment occurs in clinic or in the home the objective is to recruit the patient as an enthusiastic active participant in their own programme of therapy.
 
The Neurocare™ device functions by introducing an electrical signal into the motor nerve of the muscle causing a muscle contraction which replicates exercise whilst activating the peripheral arterial and vascular systems which are essential to moving freshly oxygenated blood through the wound site.
 
Each treatment lasts between 30 to 45 minutes and may be administered once or twice daily as necessary at a cost of approximately £2 per treatment.
 
As an option remote web-based management incorporating a “virtual clinic” allows home self-treatment without the presence of healthcare professionals facilitating much more intensive therapy than periodic clinic/outpatient visits allow. This has potential for substantial cost reductions and significant acceleration of healing wounds or musculoskeletal rehabilitation with consequent improvement in HRQoL and timescales reduction.
 
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 / Wealth creation / Clinical trials and evidence / Innovation and adoption
Benefit to NHS:
As an adjunct therapy, NMES devices have been shown in clinical studies to reduce healing timescales compared with existing treatment pathways.  This is true of wound healing and musculoskeletal rehabilitation in general.
 
The Neurocare™  device is  simple,safe, non-invasive and comfortable. It is suitable for use in hospitals, clinics and the home and can be self-administered which permits both logistically and financially very much more intensive therapy than could be achieved with multiple visits to a clinic for outpatient treatment.
 
With the addition of the web-based management system the patient and Healthcare Professional can maintain constant contact for monitoring and management of the patient’s progress thus minimising the frequency of outpatient visits.
 
As an example diabetic ulcers are known to be slow healing. Six months plus  would be typical and many endure well in excess of one year. An adjunct therapy which can reduce  healing timescales by 25%+ and in many cases avoid patient episodes such as  revascularisation and amputation clearly reduces costs and radically improves the outcome for patients.
 
Many of the documents attached evidence the potential improvements accessible with this therapy which is very versatile and will bring more effective resource utilisation, cost reduction and improved patient outcomes across its very broad range of applications.
 
Web-enabled home self treatment accords well with NHS strategic priorities which stress the objective of bringing treatment closer to the patient and highlight the increasing importance of improving the patient experience.
 
Once established as a cost effective way of achieving wound healing the concept of using web-enabled treatment would be extended on a broad front. With NMES an extensive range of medical conditions can be treated remotely. The use of the Internet and the “Virtual Clinic” staffed by multi disciplinary experts allows scarce expert resources to be active over very large patient populations whilst simultaneously permits the patient to remain under the general care of their GP Practice.
Initial Review Rating
3.80 (3 ratings)
Benefit to WM population:
A healthy population is likely to be more productive than an unhealthy one and increasing productivity creates increasing wealth per capita. Healthcare delivered in the most productive way means that for each resource unit consumed more units of healthcare can be delivered.
 
Incremental productivity gains are largely driven by innovation but if maximum value is to be gained  proven innovation must be rapidly adopted and diffused.
 
Today’s aging population is increasingly frail and high quality care is increasingly expensive . Expectations will not be met if innovation driven productivity improvement stalls.
 
In a definitive NHS Document entitled ”Innovation Health and Wealth” published in Dec 2011, Innovation is defined as “An idea service or product new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied”. To this end the document recommends inter alia that the NHS should strive  to embrace innovation and become an early adopter, should make full  and early use of digital technologies and increasingly shift focus  toward early diagnosis and prevention,
 
The innovation proposed in this document accords well with these aspirations in that we are proposing the widespread adoption and diffusion of a clinically proven but as yet sparsely adopted medical technology supported by a state of art web-based management system.
 
Healing diabetic ulcers with home self-treatment has been chosen to illustrate the potential of web enabled management of NMES therapy  in this document but the same principles may be applied wherever this form of therapy has proven efficacy.
 
Effective prevention is difficult to prove clinically but several trials have shown that pressure ulcers can be prevented using NMES and the restoration of muscle strength and balance may extend self sufficient independence and thus delay nursing home and/or inpatient costs.
 
The way is open for CCGs to finance adoption trials at relatively low cost and risk pending widespread diffusion.
 
Current and planned activity: 
We are working with
1). Prof. Michael Edmonds at the Diabetic Foot Clinic - Kings College London.
2). Mr. David Russell at the Limb Salvage Clinic - Leeds NHS Trust
3). Prof. Ian Chetter - Vascular Surgeon at Hull NHS Trust

preparing an application for RfPB.

We also recently participated with other NHS hospitals & their Test Beds applications. We are continuing work with the Leeds Academic Health Network.
 
We are currently also working with four further AHSNs; East Midlands, West Midlands, West of England, Yorkshire and Humber.
  • Evaluation / Validation / Clinical Trial - Need to gain additional validation of system within the UK – Thus seeking a trial centre.
    Leading to:
  • Procurement / Adoption - Require addition assistance and validation to support UK sales and marketing to UK treatment centres within Acute and Primary sectors
What is the intellectual property status of your innovation?:
The device IP belongs to Neurocare Europe Limited under license from Neurocare  Inc USA.  
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Solesee is a foot inspection mirror designed for people with diabetes to help them see the whole of the bottom of their feet to check for cuts, grazes, dry skin & blisters. Solesee makes this much easier to achieve and encourages daily use.
Overview of Innovation:
The Solesee Foot Inspection Mirror has been specifically designed for people with diabetes to help them to see the whole of the bottom of their feet. With diabetes, people should be checking their feet every day for cuts, grazes, dry skin, blisters, changes to the colour and general condition, etc. Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in the feet.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition. In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

Having a product like Solesee makes checking feet much easier to achieve and encourages daily use thereby helping to prevent problems occuring in the first place.  Solesee was developed, using input from both podiatrists and diabetes patients, as a result of hearing about the lack of anything simple and easy to use to check the soles of your feet every day. The key elements to Solesee are:
  • A large shatterproof mirror;
  • The mirror is set at the perfect angle to allow users to see the whole of the sole of their foot when in a seated position;
  • It folds into an iPad sized folder for easy carrying and storage
  • ​It has been designed and manufactured in the UK
  • It is design protected
A big part of what Solesee aims to do is educate people about making foot checks as regular a part of the morning and evening routine as cleaning your teeth. Part of this is consumer education through general awareness building, but it is also through getting the professional clinicians involved as they are the people who probably have most influence over the patients that they are seeing.

The National Diabetes Foot Co-ordinator for Scotland sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during & after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.Taking ownership of their condition if you will. Wider clinical take-up and patient awareness is our key aim.
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 / Person centred care
Benefit to NHS:
Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in their feet. As a result they are not able to feel if they have cut or damage to their feet in any way e.g.a stone in a shoe, a blister, a cut, a scold from hot bath water or burn from a radiator or open fire.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition.In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

There are also other, hidden costs, that could manifest themselves in a wider health issue to the patient. Being incapacitated with a foot ulcer can lead to a lack of exercise, low morale, lack of social interaction (due to being housebound) and potentially a poor diet as a result. There is also the mental strain of not being able to get out and about. This can be multiplied when you consider the impact of having an amputation.

From general research and discussions with people who have diabetes, there appears to be a lack of understand about how diabetes really affects your feet. A number of people we spoke to indicated a degree of knowledge, but said they were 'happy to wait until a problem occurred' before really taking it seriously.  Other people had little idea why they should check their feet or even what to look for on their feet if they did check them.

Using Solesee to increase awareness and education, about how serious this condition is, leads to a greater chance that ulcers will not develop in the first place.  Even if a cut or ulcer did occur, the chances of getting it treated at an early enough stage are greatly increased if people are making ther own regular foot checks, especially if encouraged by professionals. A product like Solesee makes checking feet much easier and encourages daily use thereby helping to prevent problems occuring in the first place. Compare using Solesee to using a toothbrush. 30 years ago cleaning your teeth once a day was probably the norm.  Now people clean their teeth twice a day without thinking - and few people die from getting a cavity!
Initial Review Rating
2.60 (1 ratings)
Benefit to WM population:
The aim is to get every clinician, that deals with foot care related issues and education, using Solesee as part of their normal clinical practice.  Whenever a patient presents for an annual foot check or prior to/during treatment for any foot disorder, the clinician should use Solesee to show them what the sole of their foot looks like.  This can be a 'before' and 'after' treatment scenario, so the patients can see what the clinician has done.  It would also be useful for patients to know what signs of irregularity or infection they should be looking out for, if they need to change their dressings between appointments.

It can also be an means to educate patients what their feet should look and what they should be looking for prior to any issues occurring in the first place.  If there are indications that problems could occur, such as the start of dry skin or calluses, then the clinician can clearly highlight this to the patient with some advice about what they should do. 

In all the above cases the clinician should be able to recommend that the patient starts to make regular checks using a mirror, like Solesee, so they get used to seeing the bottom of their feet and what issues to be aware of and look out for.

In this way the level of education about foot related issues for people with diabetes will be raised.  The potential problems, and what that really means to the patient can be discussed in detail, and the frequency of diabetic foot related problems reduced in and around the clinics where it is practiced.

Birmingham has one of the highest incidences of diabetes in the country (according to a recent BBC Panorama programme) and as such has a lot to gain from better educating the patients about the potential foot related problems.  The cost of giving one Solesee 10,000 clinicians or patients is the equivalent to the cost of 56 individual ulcers being treated.  We would like to think that, out of 10,000 people using Solesee, that we could reduce the incidence of diabetes related ulcers by at least 56 patients!

All the above doesn't take into account the longer term benefits to the region. Reducing the incidence in ulcers will reduce days lost to sickness in industry, as well as the the other 'hidden' costs assocuated with someone who is incapacitated through not being able to walk or work.  This includes mental health related issues.
Current and planned activity: 
I have been speaking to Duncan Stang (the National Diabetes Foot Co-ordinator for Scotland) who sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during and after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.  Taking ownership of their condition if you will.  I am in contact with Dr Jane McAdam (Head of prosthetics and podiatry at Salford University) and I am also trying to speak to Dr Paul Chadwick from Salford Royal Hospital NHS Fundation.

However I need to try and get a better access to the wider NHS and the clinicians who deal with diabetes patients on a regular basis e.g. GP's diabetes nurses, etc as well as the NHS podiatrists.  Getting professionals to use and recommend Solesee will help increase the awareness of the foot issues related to diabetes and hopefully increase the daily foot checks of patients. 
What is the intellectual property status of your innovation?:
Solesee is design protected and the brand name is a registered trade mark.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
Scalability is simple as it is a self contained product.  Our only challenge would be to fund product production should there be a very large upswing in demand.  However this could be managed if we have POs from recognised organisations or bodies such as the NHS.
Measures:
The aim is to see a reduction in the number (percentage) of people that present themselves with a reoccurrance of a diabetic foot ulcer.  By taking a more proactive approach to daily footcare the chances of an ulcer reoccurring are significantly reduced.

To measure this, we would need a clinic to a group of patients who have previously had a diabetic foot ulcer that has been successfully treated.  They would then be split into two groups - those who are given a Solesee and shown how to use it and those that are told to check their feet but not given a Solesee to use.  The condition of their feet would be checked at the usual regular intervals over the course of a 6 month period to assess the condition of their feet.  The expected result is that group using the Solesee would see a lower reoccurance rate compared to those that were not given a Solesee to use.

We would also assess usability and product quality issues looking at both groups using more qualitative techniques.  We would want to assess how people found using Solesee on a daily basis and also what the people, who were not given a Solesee to use, did instead.

Using the approximate costs to treat an ulcer that have already been stated (to treat a foot ulcer on the NHS is about £5,000) we would look at developing a commercial case for that clinic based on the number of patients that have a diabetic foot condition, using the data produced from the trial.  This should give a firm commercial argument for investing in Solesee mirrors and prescribing them to pateints with diabetes and at a high risk of developing a foot ulcer.
Adoption target:
This is difficult to gauge as the number of people with diabetic foot conditions will vary from clinic to clinic.  To be able to price Solesee at a level that the NHS would feel is suitable, then there would need to be economies of scale as far as production is concerned.  This would mean a minimum order of about 1,000 units.
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