27 August 2007
The SIME Health Project
– A Internet based Health Profile and Early Warning Service

SUMMARY

.The aim is to bring a product and a service to the market, where all individuals will be offered compilation of a life long health profile and early warning for  diseases of the following types: Rheumatism, Cardiovascular diseases, Metabolic disorder, Diabetes 2, Glandular diseases, Infection diseases, Lung diseases and Cancer diseases.

The service is designed for all persons, both healthy and sick ones. The product is planned, brought to the marked, within three/four years from the start of the project, January 2007. A prototype of the instrument is ready to use. The necessary sample size is 50 micro litres.   The service provides with technologically advanced means for individuals to take care of their own health. It also gives for health care providers decision support and assistance for their patients to detect diseases or symptoms of the above types of diseases. By using this service the early warning may significantly improve the chances of health recovery for the patient. This service will be offered world-wide. It may be expected that the early detection of illnesses will be received positively all over the world. It is well known that the earlier these diseases are detected the simpler and less invasive treatments are needed. Therefore, we may expect that this service may reduce the pressure on hospitals all over the world.

SIME [1] Service
The client purchases a SIME measurement instrument. The SIME measurement instrument has been clinically tested to give sufficiently detailed information of the biochemical components in blood, saliva and urine. The client carries out the measurement of blood and/or saliva and/or urine. These measurements are sent to a central Internet based server, which carries out an intensive analysis of the measurements in the light of a clinically tested database and the database of historical values. When the client purchases the instrument, the client will be asked to take a measurement in the morning once a week over the first ten weeks. Each time during the ten weeks the client measures twice. Thus at the end of a ten week period the client is expected to have taken 10*3*2=60 measurements. This will establish the personal safety baseline to the SIME service, because these measurements are sufficient in identifying the basic health parameters and their daily variation. In the morning the body has established an individual stabled biochemical baseline, and thus the chemical components are relatively constant, when measured. After this introductory measurement period, we know the chemical ‘fingerprint’ of the person. When a client has taken measurements, which have been sent to the server, the client will, within a minute or so, receive a health profile, which shows the values of basic health parameters and how they are related/compared to a normal population. Furthermore, optionally, the client may receive graphs of the historical values and a table showing the numerical values of the graph. If some special features have been detected, a significant trend or a critical pattern, the client may be asked to take measurements more frequently than has been done in the past. If a significant change towards one of the above types of diseases has been detected, an early warning is issued, and the expert knowledge report is sent to the health care provider.

Internet Based Service
At the Internet server there are two databases. There is one database that has been developed through clinical studies. It is planned that each of the above type of diseases is studied by 6 months clinical studies. Senior Consultant Mr. Ivan Brandslund, Head at Clinical Biochemical Department, Vejle Amtssygehus, Denmark, has accepted to host the first clinical analysis, where Diabetes 2 will be in focus. The other database is the historical measurements of clients. This database respects the EU and US laws about personal identity/integrity protection.  This database is used to assist in the evaluation of an incoming measurement, both in analysing the trend and also to estimate future developments. In case of an early warning it is used to estimate the expected outbreak of the disease. The server works out a health report to the client, and an expert medical report, which is designed for the health care provider. A health care provider can upload, following hospital standards, laboratory data, which can be included in the analysis of the client.

Health Care Provider
Normally there will be associated a health care provider, medical doctor, who will receive the report from the Internet based server. In countries, where there is not a family doctor for each family, it may be expected that a SIME instrument is bought without associating a health care provider to the instrument. When a SIME instrument is bought in the European Union, there will normally be associated a health care provider to the instrument. The service to the health care provider is according to an agreement. It may be agreed that the health care provider for instance receives report twice a year; if an early warning is issued; or according to an agreement with the client.

Technology
The SIME service is based on combining four modern high technological fields:

·        Chemometric and Neural Network Methods
Award winning algorithms are used in the development of the service. They are the key elements in this service. The algorithms that have been developed can create insight in a ‘data world’, which is described by numerous data. The algorithms can detect the smallest changes in blood/saliva/urine, which the person is not able to sense. The Neural Nets, based on the Intellix Software, are used to create expert knowledge systems, which reflect the procedures and knowledge of the medical experts within the eight disease areas mentioned above. These algorithms are especially efficient in finding patterns, which can be related to these diseases.

·        Internet/mobile phones
The technology offers now standards/tools such that solutions can be delivered as required by clients, health care providers and hospitals. It does not provide with any technological problems to serve millions of clients world-wide each day.

·        The Biomedical Sciences
Today these eight types of diseases are very well understood. The markers for these diseases in blood, saliva and urine are well known. This makes the suggested service a natural business opportunity.

·        The measurement technology
The plan is to aim at first using the NIR (Near Infra Red) measurement technology. It has proven efficient in detecting chemical components in liquids. Research projects have been carried out, which document the efficiency of this technology in measuring blood. Chemometec A/S, Allerød, has applied for a patent on a measurement instrument (20´15´10 cm), which can be used in the present service. While their instrument is being prepared for the market, they will lend us an industrial NIR measurement instrument, which we can use in our clinical studies. But it is being planned to contact other producers of measurement instruments, which could be used. Most instruments, which could be used at the present service, can be made cheap, if they are produced in sufficiently large numbers.

Phases of development of the service
It is estimated that it will take four years to develop the SIME service. It consists of five phases:

Phase 1. Period one year
It will take around one year to establish ‘the proof of businesses’. Two clinical analyses are expected to be carried out, covering two of the above type of diseases. The first one is at Vejle Amtssygehus, where at focus will be Diabetes 2.
 
Phase 2. One year
The service routines, which are necessary for the SIME service, are developed. This includes both running the Internet server and chemometric/ Neural Nets algorithms. Two more clinical studies, six months each are completed. Chemometec is expected to have their NIR instrument ready for the market.

Phase 3. One year
The service is planned to be tested at 10 family doctors in Denmark. The service algorithms of the SIME service will be tested. Two more clinical studies are carried out.

Phase 4. One year
A SIME service will be announced. Two more clinical studies are carried out. It is expected that most of the eight types of diseases are being covered by the SIME service. The SIME service/instrument might need an approval by EU in terms of CE labels.

Phase 5
An approval/marketing of this service internationally, especially in USA, Japan, China and the Arabic countries, will be initiated. Mass production of a SIME instrument is initiated. Clinical trials may be needed in each of these countries.

Market
The plan is that the service will be advertised publicly for each of the eight types of diseases, which have been verified by the clinical experts. In the beginning it is expected that the customers are family doctors, health centres, old people’s homes, schools, companies, ships, sport clubs and similar ones, where many people are being served by one instrument. It may be expected that pension companies, life insurance, workers union and similar ones may be interested in this service, partly because of their possible financial savings and partly because of the service that may be offered to the members. After four years it is expected that the measurement unit is produced in so many copies that the cost of the unit can be included in the subscriber cost of the service. In that case the families and individuals may be expected to be the primary customers. It means that everybody with access to the Internet may be interested in this service. This places no limitations on the possible size of the market. There is no doubt of that the market for medical home devices is large. The EU commission expects yearly increase in the market of medical devices of 5%-8% yearly. This increase is expected to continue in foreseeable future. The industrial countries are becoming richer by each year, and the health of individuals is coming into focus more and more. Our product is unique in the sense that extensive analysis is carried out each time a set of measurements are carried out. The person receives a health profile, which the modern technology can read from the three types of bodily liquids. There is potentially great need for a product, which gives the individual possibility to supervise his or hers own health without straining the health care system of the country. Especially housewives can be influenced to obtain this instrument and take care of that family members are measured regularly in order to secure the health of all family members. There are huge market needs for the service of early warning of the diseases treated here. Especially USA and Japan can be expected to be a big market for this service. The health data service is an area, which is almost untouched to day. Therefore, the market opportunities are enormous. There are more than 500.000 practicing doctors in the world (more than 3000 in Denmark), who may be expected to be interested in this service. Thus, we are convinced of that the market will receive well this product.

For more information please contact us.