BUSINESS TARGET 2017

SWISSmediscan INOVATIVE TECHNOLOGY

TIME MAKES A DIFFERENCE What will give SWISSmediscan the edge in today’s market will be its ability to expand in a market that based on effective transformations as to how we view rural medicine and rejuvenate treatments and medical tourisum.

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Businesses

The Zen Beauty rejuvenation center and medical facility

Branded Products

The Zen FDA Approved cellular rejuvenation creams

Rapid IVD Tests

Wholesale IVD rapid tests targeting rural regions and internet sales

Rapid Cancer marker

tests

The development of a IVD cancer test to detect the possibility of cancerous cells

Franchise

Building a franchise system to market and expand SWISSmediscan

The future to controlling contagious diseases is in the ability to detect them before the become life threatening

Shifts in Medical Tourism in Asia

BANGKOK, 1 August 2017: Kasikorn Research Centre estimates income from international patients at private hospitals will generate THB48 to THB49 billion this year, an increase of 3% to 4% year-on-year. The bank think-tank unit said the number of patients from the Middle East has declined steadily, mainly due to a change in healthcare policies in their home countries and an improvement in quality and standards of their public health systems. However, the drop in medical tourists from the Middle East should be compensated by international patients from other regions, in particular Asia such as Cambodia, Laos, Myanmar, Vietnam and Japan. The centre estimates that international patients will help generate some THB48 to THB49 billion in income for the country’s private hospitals in 2017, increasing 3% to 4% year-on-year, against an 8% increase from last year. The number of international medical tourism visits this year should reach 2.4 million with another 900,000 hospital visits by expatriates in Thailand. The centre said: “Despite the promising outlook, Thai medical-service related businesses may face heightened competition from new providers in the domestic market and Asian rivals such as Singapore, Malaysia and South Korea, which are all competing to become the regional leader in medical services.”

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Diagnostics For Developing Countries

IMAGINE FREE RAPID IVD TESTING

By offering free rapid IVD testing for

contagious diseases you would create a rapid screening process that offers a risk free system with high accuracy at a very low cost to local governments with great

sponsorship opportunities for local businesses in rural areas to support their

said regions

RAPID IVD TESTING SAVES LIVES As in most cases time saves money , but in relation to our health it can also save lives. In rural regions IVD in the future will pay a large part in the diagnostics of contagious diseases , TB, detection of cancers, tumors and viruses such as dengue fever and malaria .

In most cases when detected in time the problem is treatable

Improving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the disease. Diagnostic laboratories are often poorly resourced in developing countries, and sparsely distributed. Improved access may be achieved by using tests that do not require laboratory support, including rapid tests for use at the point-of-care.

Despite increased interest, few new in vitro diagnostic (IVD) products reach the majority populations in low income countries. Barriers to uptake include cost and lack of robustness, with reduced test performances due to environmental pressures such as high ambient temperatures or dust. In addition to environmental factors test developers must consider the local epidemiology.

Confounding conditions such as immunosuppression or variations in antigen presentation or genotype can affect test performance. Barriers to product development include access to finance to establish manufacturing capacity and cover the costs of market entry for new devices.

Costs and delays may be inflated by current regulatory preregistration processes to ensure product safety and quality, and more harmonized approaches are needed.

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INTRODUCTION SWISSmediscan offers a platform of Rapid IVD test to developing countries at affordable pricing

Many low income countries with weak and poorly resourced health care systems are burdened with levels of infectious disease detrimental to their socio-economic development. Notwithstanding the recent Ebola pandemic, tuberculosis (TB) and HIV/AIDS remain major public health concerns and are the most frequently recorded cause of adult death in parts of sub-Saharan Africa

[1]. Average life expectancies in sub-Saharan Africa have increased with the rollout of anti-retroviral treatment but remain less than sixty years of age

[2]. Failure to control communicable diseases is in part due to the failure to correctly diagnose and treat infectious cases, when opportunities to prevent onward transmission are missed.

[3]. The World Health Organization (WHO) estimates that only 64%, of new TB cases are detected and notified, suggesting over 3 million cases of this highly contagious disease are missed each year

[4]. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that less than half of people living with HIV in sub-Saharan Africa know their status and that globally 19 million individuals remain unaware

[3]. The situation for children is also critical. Without HIV treatment, it is estimated that half of children living with HIV will die by age two with peak mortality 8–12 weeks after birth

[5]. In 16 countries in sub-Saharan Africa less than half the children born to HIV positive mothers are screened for the virus and in some countries less than one in 10 HIV-exposed children are tested

[3]. Inadequate provision of diagnostic services for infectious diseases is a serious impediment to improving the health of a nation

[6]. Laboratories in developing countries are often sparsely distributed, and access may be limited by economic or geographical factors. Where they do exist clinical laboratories are often under resourced and amenities such as electrical supply and water may be unreliable

[7]. Shortage of skilled technical personnel is also a problem in some countries, particularly in rural areas. Particular diagnostic tests may not be available to the majority population due to their high cost or lack of robustness. In addition, some manufacturers may be reluctant to supply countries if return on their investment is likely to be low or where it may be difficult to establish effective mechanisms for product distribution or technical support

[8]. For some tropical and neglected diseases appropriate tests have not yet been developed

[9]. Weak regulation has also contributed to the sub-optimal provision of diagnostic services and in some countries tests of unknown or dubious quality are sold without hindrance

[10,11].Technological advances and the development of novel devices that can be used outside of the laboratory have the potential to overcome some of the challenges faced by healthcare providers in developing countries

[12]. Rapid tests for use at the point-of-care offer new solutions for detecting communicable disease.

[13]. However, despite increased interest in academic and other circles, few new tests suitable for use in low income countries reach the market place. This article discusses factors

influencing the development of in vitro diagnostic devices for developing countries with special consideration of the major infectious diseases, TB and HIV/AIDS.

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To maintain competitiveness, Thai medical businesses will need to cement their strengths, especially service quality and medical standards, because these are important factors that boost the confidence of international patients. But there is room for expansion. “Thai medical service providers may consider venturing into the general health and wellness business category to capture more international tourists, or older foreign tourists taking long-stay vacations in Thailand.” Medical tourism is a key factor that can boost Thailand’s income, but the Ministry of Tourism and Sports as well as Tourism Authority of Thailand must be more supportive to reach out to new markets. Deputy Prime Minister Thanasak Patimaprakorn said earlier this month that visitors to Thailand from China, Cambodia, Laos, Myanmar and Vietnam who are seeking medical treatment are now allowed to stay for up to 90 days visa-free. The same privilege is also offered to as many as four people accompanying them. Visitors age 50 years or older from 14 countries also can apply for long-stay visas valid for up to 10 years from the current tenure of one year. Permission will initially be extended for five years and an additional five years can be added for people who meet the conditions. The same privilege is also offered to their spouse and children under 20. The 14 eligible nationalities are the United Kingdom, the United States, Germany, Switzerland, Japan, France, Australia, Norway, Sweden, the Netherlands, Italy, Finland, Denmark and Canada. Both measures are designed to support Thailand to become a medical and wellness tourist destination and world-class medical hub which will help boost more revenue and build quality tourism for the kingdom. Kasikorn Research Centre is a subsidiary company of Kasikorn Bank, which conducts tourism and business research mainly on Thailand’s economy including tourism with reliable recommendations and indicators on business prospects.

Diagnostics in the Pipeline

The development, production and marketing of a new in vitro diagnostic device is a complex undertaking, made more challenging if it is intended for use in developing countries. The Pruducts to be marketed by SWISSmediscan have already overcome the majority of these hurdles.

As demonstrated in Figure 1 there are hurdles at all stages of the R&D (Research & Development) pipeline that SWISSmediscan has already overcome.

Although the clinical and humanitarian justification for a new test may be obvious there is often little guidance for test developers regarding the product profile or technical specification. The head start the SWISSmediscan has by already receiving full FDA approval in Thailand (A member of ASEAN) and already manufacturing IDV tests of HIV/AIDS, TB, Dangue Fever, Malaria Drugs of Abuse and the new possibility of a cancer marker test in the pipeline gives SWISSmediscan a massive head start in the market for developing countries.

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Variation in the biology and pathogenesis of infectious diseases necessitates multiple approaches to their detection. For pathogens such as malaria or HIV that circulate in bodily fluids, or those that elicit a characteristic immune response the selection of samples to test is straight forward. For diseases such as TB or leishmaniasis sampling is more problematic as direct detection of the organisms is often difficult, particularly during early stages of the disease when treatment interventions that could prevent further transmission are most effective . Unfortunately tests for immune response to these diseases often lack specificity and cannot differentiate past or latent infection from active disease . One of the challenges shared by all test developers is access to well characterized samples with which to validate their tests. SWISSmediscan has already past this stage .

To address this issue the WHO and some not for profit organizations have established specimen banks where clinical samples are curated and made available to test developers designing tests for developing countries. An example is the tuberculosis specimen bank that is currently managed by the Foundation for Innovative New Diagnostics (FIND) which may be accessed via the website

www.finddiagnostics.org/programs/tb/find_activities/tb_specimen_bank. Characterization of samples from TB patients is particularly problematic. Extra-pulmonary disease and pediatric cases are often difficult to detect and evidence from autopsy studies from settings with a high prevalence of TB suggests undiagnosed extra pulmonary disease may be present in a proportion of the population .

Unlike sputum based tests, those that use blood or urine may detect all forms of the disease and misclassification of samples used in validation studies due to a failure to detect extra-pulmonary disease may lead to inaccurate estimates of test specificity.

There are additional challenges when working with infectious diseases, particularly deadly airborne pathogens such as M. tuberculosis which require microbiological safety level III . The need for specialist handling and infection control facilities increases costs and is a disincentive to working with hazardous pathogens. Once validated in laboratory studies the performance of the device must be determined at sites of intended use. For devices intended for use at the point-of-care studies should take place in the clinic as studies undertaken in a referral or research laboratory may give a false impression of the robustness of the device.

Quality assurance and maintenance of equipment is often difficult to achieve in developing countries, particularly for devices used outside of the laboratory network and at the point-of-care. This may easier for devices that incorporate wireless or mobile phone technology, where information on usage and performance of the device can be collected remotely. However, connectivity (the state of being connected), is in its infancy for in vitro diagnostics and international standards or guidelines have not been implemented.

Where our advantages as opposed to other competitors is our grass roots approach to marketing and distribution. Due to the fact that our products of already passed most of the hurdles mentioned above we can immediately start distribution. Included in the purchase price and consultancy fee for McInnis co-Ltd of Marshall islands the first 12 months of the operations of the company are included in this amount and by utilizing this we will be targeting rural areas in Thailand where we are currently FDA approved . Our plan is to distribute free of charge to areas that cannot afford health care or do not have the facilities to test contagious diseases on site and we will obtain sponsorship from companies in those regions to support the locals by purchasing the IVD tests. This will produce positive feedback by local authorities and support of government departments and possibly NGOs. We will target repetitious for three main contagious diseases being that off Dengue fever and malaria and tuberculosis.

LOGISTICAL CHALLENGES

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Currently the dilemma is when a doctor goes to test a patient in a rual area for Dengue fever. First you must take the blood then have it sent to a lab and some places the local Laboratory or the closest Laboratory is over 100 km away this process alone can take up to 1 to 2 days to get the results. Once the results are confirmed the doctor then must go back to the rual area ,find the patient and in some cases these patients have no records for identification . The then either place the patient into quarantine or begin treatment. In the case of malaria or then we feel that this time can mean the death of a young child. Dengue fever if diagnosed with in the first two days can be treated and basically treatment for this is pure water however past 2 to 3 days dengue fever to come to life-threatening.

Our goal is to have a team visiting rule areas throughout the rainy season which starts in the third month of 2018 and set up appointments and advertise free rapid testing for the above diseases. Our advantages that our IVD testing system gives result in 30 seconds ,if the result is read as positive , then secondary testing can be done with the laboratory ,however treatment can start immediately in order to possibly save a life. It is McInnes co Ltd belief that this kind of advertising will rocket SWISSmediscan to be a known name throughout the country of Thailand in a very short and rapid timeframe . With the above recognition we gain the support of all local business communities NGOs and government departments which gives us a project that we can possibly utilise in other countries based on the data gathered from the Thailand project .

THE MAIN ADVANTAGE

What gives the advantage to SWISSmediscan is the fact that the products already have FDA in Asia and with a proven track record in rual areas which will be generated in the beginning of 2018, the expense in distrubution foreign countries and registering products for distribution will be minimal as independent evaluation of the products won't be required in most cases, not to mention that the products distributed by SWISSmediscan are ISO approved, FDA approved, Moody’s regulated and CE certified. So all the hard work and initial setup including R&D is now complete we can virtually open the doors and go straight into the marketing some regions. The value of this is priceless to a new company entering in the medical field as most companies are destroyed by the cost of R&D research and development before they even open to sell.

SWISSmediscan Advantage

SWISSmediscan Spring 2012

The above is a small summary based on the first module part of our SWISSmediscan project. The above gave you a small inside in relation to IVD testing and why SD has the possibility of a major advantage .

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