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A Non-Invasive GLUCOse MONitoring device for diabetics based on Stimulated Raman Spectroscopy in a quick, cheap and painless method.

Periodic Reporting for period 1 - NiGlucoMon (A Non-Invasive GLUCOse MONitoring device for diabetics based on Stimulated Raman Spectroscopy in a quick, cheap and painless method.)

Reporting period: 2014-10-01 to 2015-03-31

"‘’NiGlucoMon’’ incorporates excellence in science, people and resources, and is aligned with our research and development activities in optical systems, sensors and biotechnologies, specifically Medical Devices. The results of this project will help us to develop a leading position in the valuable area of medical diagnostic devices for diabetics (market size in revenue > €8 Billion/year) and allow us to leverage private finance and venture capital for our highly disruptive innovations. Most importantly our innovations can help over 387 million diabetics throughout Europe and elsewhere, by improving their quality of life, while significantly reducing health care costs and potentially saving lives.

""It is a fact that diabetes not only has strong adverse effects on people's health (over 1.5 million deaths per year) but also presents a large - and at least partly avoidable - economic burden (nearly €300 Billion Euro worldwide/annum).
For both rich and poor countries, this means that better prevention and management of diabetes has the potential to not only bring good health and save lives but also economic gains.""

In NiGlucoMon we built the first Proof of Concept to measure blood glucose within 10 seconds using a system that requires no calibration. Employing a technique called Stimulated Raman Scattering NiGlucoMon uses customized lasers to stimulate the Raman Effect allowing us to achieve 10000 times amplification of the Raman signal from glucose. Further our designs for the final system will allow us to penetrate tissue more easily, detect blood vessels and cause no damage or pain to the patient.

Our initial application will be to measure blood glucose non-invasively in diabetic patients at Points of Care (in hospitals and clinics) and build a business which will manufacture and sell 3.4 million devices each year generating over €550 million revenue per annum. Our product will address long standing problems among many diabetic patients who must measure their blood sugar (glucose) levels many times each day in order to manage their illness effectively. The problem with monitoring blood glucose levels with invasive devices (the standard today) is that it is painful, inconvenient, expensive and there is a risk of infection.

During NiGlucoMon we carried out investigations into the funding requirements and opportunities for our business. We analysed the industry, the market and customer requirements to determine the minimum viable product which will allow us a successful and efficient entry into the market. These investigations have resulted in a comprehensive business plan which maps out the critical funding, product development, clinical trials and industrialization paths.

NiGlucoMon is the basis for a platform of non-invasive blood compound testing devices to be used at Points Of Care starting with glucose which accounts for nearly 90% of the entire POC diagnostic market and expanding to more than 80 other compounds including lactate, potassium, phosphorus, magnesium, haemoglobin and insulin in the future.
During NiGlucoMon we carried out a technical feasibility study, including;

- Building a proof of concept system to assess the risk and prove the feasibility of our proposed diagnostic technique for non-invasive glucose measurement. Having previously modelled our process mathematically in this project we built the experimental test setup to carry out the Proof Of Concept (POC),
- We detemined that no correction factors were required for our mathematical model.
- We defined the exact specifications for the laser system required for the final product.

We also carried out the commercial feasibility study and wrote a business plan covering among other things;
- the identification of suitable laser manufacturers as the laser specifications require custom made semi-conductor lasers, housings and optics.
- preparations for Phase 2, including funding requirements and opportunities, product design & development, performance verification, product testing, development of pilot lines, validation for market readiness, investment readiness, maturity for market take-up, identifying the key people needed and IP issues.
- the plan for clinical validation, including the identification of the clinical partner network.

The main technical results achieved so far were;
1. We were able to confirm the feasibility of our proposed SRS technique and most importantly we can do so without exceeding skin safety requirements for the laser powers needed.
2. Using our NiGlucoMon proof of concept we were able to measure glucose concentrations that compared well with our theoretical model. No correction factors were needed.
3. Laser specifications can be changed in order to increase system performance and lower costs.

The main business results were;
1. We have started co-operations with 2 laser manufacturers for the design and development of the lasers we will need for our product prototypes and final products.
2. With the assistance of our business coach we have developed a funding strategy which will help us bridge the gap between Phase 1 ‘’Feasibility’’ and Phase 3 ‘’Commercialization’’.
3. A short business plan and Pitch deck were created and first discussions with potential investors have taken place.
4. We have aligned clinical partners to carry out validation of our product prototype and a project (to start in 2016) for the validation studies is being worked on.
Today we have taken our first successful step in testing the feasibility of our technology. In the coming year we will build and test our first product prototype. The final result will be a new business (called Trigona Medical) set up to manufacture and sell a non-invasive blood glucose monitoring devices and ultimately a medical diagnostic platform which can revolutionize Point of Care testing. The major impact will be to our customers who could be a spouse, son or daughter; most likely everybody will know one or more of our customers personally. They could be a Type 1 diabetic, a diabetes care giver, a nurse, a doctor or any of the 500 million people involved in the treatment of Diabetes Mellitus. Our customers want us to help simplify their lives and at the same time empower them to take charge of their health and happiness.

Customers will buy from us because our product;
1 is the only non-invasive solution in the marketplace,
2 is 100% discrete,
3 requires no expensive disposables,
4 can be operated in either single or continuous measurement mode,
5 causes no pain (injury phobia)
6 has no needles (for those patients with needle phobia)
7 draws no blood ( blood/injury/needle phobia)
8 is accurate, convenient, safe and great value
9 fulfills a basic need for many diabetics and medical professionals

Deep down anyone who has to injury themselves or others to give treatment desires another “better” solution. It is a basic need in parents for their children, care providers for their patients and nearly everyone when it comes to inflicting pain on themselves or on others; do no harm!

In a recent study of medical professionals, up to 35% of the participants stated that pain is the main reason people with diabetes refrain from regular blood glucose testing.

In building a business like Trigona Medical we are bringing together highly skilled people to work together and will work together with our partners to achieve our goals. Today we are working with a core team of 5 people and 6 European partners, in the future we plan to build a business with 60 employees, working with 30 partners worldwide making 3.4 million products each year and generating over 550 million Euro revenue per annum.

From a socio-economic perspective the global diabetes population will rise to 590 million by 2035, a 55% increase and a huge global burden for healthcare services. The greatest risk from diabetes is the variety of complications it causes, which continuously increase the cost of medical care. In 2013, global expenditure on diabetes care was around 300 billion Euros, which accounts for 11.6% of all human medical expenses, and it ranks as one of the top five diseases in the medical expense budgets for all countries. However, these huge medical expenses are primarily attributed to improper glycemic control by diabetic patients, which leads to complications. To effectively avoid the occurrence of complications, health care authorities around the world are working continuously to advocate the strengthening of health education for patients with diabetes, so as to improve the effectiveness of glycemic control by diabetes patients. This effort also spurs the continuous increase in the demand for improved blood glucose monitoring products.
Assisted daily blood glucose monitoring
Statistics from the IDF
Increasing global burden of diabetes