Presentation Executive English Revised

Executive Presentation Mass vaccination using MIT CANADA Needle-Free Jet Injector MED-JET H-III

Presentation Objectives • Presenting MIT CANADA and its founder • Demonstrate the integral factors in the use of the Med-Jet needle-free jet injector • Outlining the inherent advantages in the use of the Med-Jet needle-free jet injector • Conclusion of the presentation

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History of MIT Canada and its founder Our goal is to develop a needle-free drug delivery system using state-of-the-art technology for the Human and Veterinary medicine communities and make the world needle-free.

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MIT Canada founder Karim Menassa • Born in Cairo, Egypt, in 1951. • In 1968, he received his diploma as a designer in precision mechanics. • Immigrated to Canada in 1970 and received his immigration status in 1976. • Designed the first needle-free jet injector for human application in 1978 and continued to improve it until 1984. • Has over 30 years of experience in research, development, and design of medical equipments and devices. 4

MIT Canada: its past,its present and its future • •

Founding of the company « Idée International R&D Inc » in 1984 Filing the patent for its needle-free injector for diabetics during the first year.

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Research and development of its first needle-free jet injector for animal applications; signed a multi-million dollar agreement with US company Pitman & Moore (over $5 million was spent to adapt the injector to the company’s need) – Pitman & Moore invested well over 50 million$ to adapt their hormones to the Lene-Jet of Idee. – The venture aborted in 1993 when Pitman & Moore could not obtain the approval from FDA and thereafter was acquired by Mallinckrodt Pharmaceutical.

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The animal project was revived in 1997. In 2000, the new needlefree injector was conceived with new technological advancements and was given the current name of Agro-Jet, which includes many models. Founding of MIT Canada in 1998 and operations started in 2002.

More than 20 million spent in R & D since 1984

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MIT Canada: its past, its present and its future Publicly traded corporation in development • • • • • • • •

Traded at the Nasdaq stock Exchange (OTCBB - MDLH) 5,000 ft2 of offices and an option of additional 2,500 ft2 An estimated market value from 2002 between $48 and $56 Million dollars evaluated by Wise & Blackman Employs 6 people and has 6 subcontractors/suppliers in Quebec Has the capacity to produce 100 units per month at 95 % Quebec components Applied for a $350,000 PPE loan for the purchasing of 4 injection molding machines 49% Shareholder of a Canadian/Chinese joint venture, located in Jiangsu Province, Taizhou, declared by the Central Government to be « China Medical City » with 8,000 ft2 of operation facilities granted by the local Chinese Government. (see pictures on left)

The only company in the world that can offer NeedleFree injectors for mass inoculations with volume and pressure adjustment suited for the vaccination of Humans and Animals

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MIT Canada: its past, its present (2) and its future •

Honouring a-5 year contract ($6 Million) to supply its Malaysian Distributor with Med-Jet MBX –

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Distributes its human models in 15 countries around the world including Canada Distributes its animal models in 33 countries around the world including Canada –

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More than 1,200 AGRO-JET in use since 2001

Negociating with 2 multinational pharmaceutical companies for exclusive right in the animal market In discussion with a major pharmaceutical company for exclusive right in the human dentistry market Investes annually between $250,000 to $400,000 in R&D Many certifications: – – –

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The Med-Jet MBX is sold in Asia for US$ 8,000

Health Canada certification, European Union certification ISO certification

Sales of over $600 000 this year

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MIT Canada: its past, its present and its future Growing public company Projected: • Will eventually be listed on the AMEX or the NASDAQ. • Will have modern manufacturing facilities in Quebec, USA, Europe, China and Mexico. • Will employ more than 100 people in Quebec alone. • Will be able to manufacture more than 5,000 injectors per month. • To obtain certification from FDA. • To become the world leader of a global market estimated at over 4 billion$ per year. 8

Motivations underlying the use of a needle-free injector

There are multiple

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What is the history behind the needle-free injector?

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By 1866, there already were writings on this subject and even images of injectors. In 1934, the first real needle-free injectors were conceived in the hope of better control of epidemics in Europe and to vaccinate soldiers. – –

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The 1970s saw renewed interest in this technology because of technological advances in: – –

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The Russians were pioneers in this area Unfortunately, those injectors were very inefficient, costly and too heavy Composite materials Drugs with smaller molecular structures

In 1997, under the auspices of the World Health Organization, ANFIM (Association of Needle-Free Injection Manufacturers) was founded. –

MIT CANADA will join this association when FDA approval will be obtained

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Why is its use not widespread today? Because: •

Technology, despite all the efforts that were made, was not yet fully developed in the past – –

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Using too much pressure lead to persistent pain No possibility of intradermal injection

Nobody has really produced a detailed analysis of costs and benefits associated with its use Nothing is really possible without the support of national and global institutions Manufacturers of needle-free injectors, in very small numbers around the world, have little or no capacity for lobbying and marketing The multinational pharmaceutical companies had no interest The health professionals do not yet know the technology Citizens have yet to experience the comfort of vaccination with such injectors 11

What modivating factors could help spread its use? •

The resurgence of infectious and very contagious viruses affecting the world –

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The stronger will of global organizations to eradicate certain endemic diseases (eg: malaria) –

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The One Foundation, Oprah, Bill Clinton, Bill Gates In 2007, the G8 pledged 60 billion to help Africa

The desire to reduce accidents related to the use of syringes with needles The desire to reduce the side effects of drug absorption The desire to make the planet greener (Recycling) –

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3,3 billion people at risk; 247 million cases of malaria in 2007 causing one million deaths

The threat of proliferation of biological weapons by terrorist nations and organizations The expressed wishes to help Africa and other countries in the Third World: – –

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A H1N1, H5N1, SARS, mad cow disease, etc.

Brazil returns 1,400 tons of used syringes to Great Britain

Compassion for humanity, its suffuring and fears, rational or not –

Medical science tries again and again to reduce or control pain at its lowest level

We now realize that everything is connected, the infected animal may, in turn, contaminate humans 12

The main motivation: contamination Contamination is the medical term used to describe the invasion of a living organism by pathogenic micro-organisms – Preventive measures always have their place • Hygiene (washing hands, wearing a mask, wash the infected areas, etc.)

– More extreme measures also become necessary • The slaughter of animals • The isolation or containment of population in restricted zones

– Mass vaccination then takes on all its meaning

(Better safe than sorry) • It should begin at the animal as it may, living or dead, be the main factor for disease transmission • Mass vaccination must be supervised by public health departments

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Possible consequences of contamination •

Any threat of contamination, if not treated promptly, can lead to: – – – –

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Important loss of animal and human life Indescribable Human suffering Staggering costs of hospitalization Incalculable financial losses

Of course, we must first have developed a vaccine and have produced it in large volumes – 95 % of actual drugs can now be administered using needle-free injector • Everything depends on the viscosity of the injection solution

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Thereafter, it is essential to have the means to administer the vaccine quickly and on a large scale 14

Another motivation: Reduce accidents with syringes •

We already know that a factor of the spreading of AIDS (0,3%) and hepatitis B et C (10 %) comes from the use of contaminated needles

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But is it also known that: – 800 000 accidents with needles have been listed in the U.S. alone in 1999 • Approximately 35 à 50 % of these cases affects health workers

– The prevalence rate of accidents is estimated at nearly 5 per 100 000 injections – On average, each case results in direct and indirect costs of over US $2,500

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Further motivation: Elimination of Fear and Pain •

Many people simply hate getting vaccinated –

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This fear leads to the following: – – –

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It is estimated that nearly 10 % of the population has a significant fear of needles Some simply do not get vaccinated and do not go to the dentist The time required to vaccinate frightened people may waste time and therefore money Others, such as diabetics will deliberately skip doses making treatment less effective

The MIT Needle-Free Injector is painless –

The diameter of the jet (gauge) is 10 times smaller (270) than the needle used to vaccinate (27) •

The smallest needle in the world has a gauge of 33

Blood tests could be done without any pain or discomfort to the patient if a tiny injection of 0.03ml of local anesthesia is administered using the MED-JET MBX prior to entering the needle. MIT CANADA has the only needle-free injector in the world that can inject such a small volume (0.02 à 0.3 ml)

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Why choose the needle-free injector today? The technology is ready and available

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Injection accuracy and effectiveness •

Vaccination of a drug, an antibiotic, Botox, etc. must be done in one of the following 4 approaches: – Intradermal (into the skin between the epidermis and dermis) • •

The most difficult to do For tuberculosis, spa treatments

– Subcutaneous (under the skin in the dermis) •

Eg: For diabetics

– Intramuscular (must always check that it has not hit a vein) •

Quite painful

– Intravenous •

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A needle-free injector can be used in the first 3 types of vaccination. –

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The most painful and uncomfortable

Only MIT CANADA MED-JET H-III model is designed for all three 3 types of injection in one

Intradermal vaccination (possibly the most effective for absorption of medication) becomes easy with the MED-JET MBX 18

Injection accuracy and effectiveness •

The effectiveness of injection should take into consideration the following 3 elements: – The injection site – The depth of injection •

In reference to the type of vaccination

– The period of drug absorption •

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This last factor is not really taken into account althought it is probably the most important

The difference between an injection syringue and an injection with the needle-free injector is night and day for the last 2 criteria – With the pressure regulator associated with the needle-free injector, we control the depth of injection – By using a spray, the injected substance is absorbed more quickly in the body •

In doing so, less medication is required and takes effect more quickly

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The (2) MED-JET models for human: Principal features • More than 300 injections per hour • Dose of 0.1 to 1cc (H-III), MBX (0.02 to 0.3cc) • Weight of 0.7 Kg • Accuracy at 99 % for a dose of 1cc • Robust equipment, which can easily last over 10 years • Variable injection pressure for patient comfort • Adapted for receiving syringes and even bags of saline

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The (2) MED-JET models for human: Principal advantages Increase drug absoprtion (Less medication required)

Increased efficiency for intradermal vaccination

Less damage to tissue and less pain

More opportunities in the siting of vaccination

Fast (At least 3 times more vaccine per hour)

Accuracy of injection and reliability ways difficult to achieve using a needle) Does not produce waste

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The AGRO-JET for animal (11 different models) Principal features: – – – – –

Between 600 and 3 000 injections per hour Adjustable & accurate dose (0.1 à 5cc) Light weight between 0.7 Kg to 1.5 Kg Accurary of 99 % 1cc Reliable and durable

Their main advantages: – –

The same as human models There is evidence that the use of needles causes stress to animals, which affects their growth It should be noted that a version of the AGRO-JET was tested for over 2 years by Pitman & Moore who called it powerful and very reliable

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Possible applications for needle-free injector There are many

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Use of needle-free injector for human •

The syringe (with needle) in humans is used for a multitude of applications: – The injection of vaccines, hormones, Botox, insulin, lidocaine, etc. – Blood tests – Intravenous

• Approximately 50 to 55% of these could be done by a needle-free injector because they dont need to pierce a vein – The worldwide annual consumption of syringes is estimated at more 12 billion units

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Use of needle-free injector for human (2) Other applications : • • • • • • •

Hair transplant Palmar and plantar hyperhidrosis (with Botox) Treatment of migraine (with Botox) Injection of collagen Liposuction Local anesthesia A vast majority of medical interventions involving the use of a syringe with needle

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Use of needle-free injector for animal •

The syringe (with needle) in animals is mainly used for: – – – –

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The injection of vaccines The injection of antibiotics The injection of hormones Blood tests

The use of syringes with needles could therefore be abandoned in more than 95 % of situations The same needle is used to vaccinate at least 25 and often more than 100 animals, which can lead to: – – – –

Risk of contamination Abscesses Risk of accidents Fragments of left needle into the body of the animal

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Advantages of needle-free injector

They are astonishing

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Advantages of needle-free injector for human The needle-free injector can: • •

Eliminate a significant number of accidents caused by the use of needles Significantly reduce the doses of vaccines currently used –

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Tests would be desirable although MIT CANADA is satisfied that the report findings would be similar to those obtained from tests done in the animal sector

Reduce stress and pain in humans Reduce the side effects of drugs injected Ensure safe injections in each individual Lessening skin problems in diabetics who need to vaccinate every day

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Advantages of needle-free injector for animal The needle-free injector can: •

Eliminate the accidents leaving needles in animals –

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Substantially reduce the doses of drug injection –

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These animals must pass through a metal detector in order to locate the fragment

Tests done by MIT CANADA with the company Schering-Plough Animal Health showed that the dose of vaccine could be reduced by 5 to 10 times maintaining the same efficiency

Eliminate abscesses caused by needles Eliminate the stress and pain of the animal Ensure equal injections in each animal Only 0.2 % of the animals in the world are vaccinated using a needle-free injector 29

A Cost/Benefits analysis • The Quebec government buys 1,750 MED-JET H-III for 6 million injections – Costs: 10 million – Benefits: 55 million • Less vaccine used • Less effort to vaccinate (1/3 less)

• Other non-financial benefits – A reduction of economic loss due to absenteeism at work • 162 million days of work are lost annually in Canada due to the common cold

– Greater coverage

• People are less afraid to come get vaccinated

– A government initiative very well received by the population – A government initiative very well received by health workers

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MIT CANADA future projects • Obtain FDA approval to open up U.S. market – Botox® Cosmetic awaits only FDA approval to begin advertisement campains for the use of MIT CANADA’s needle-free injector among its users around the world

• The needle-free injector for dentists (2010) • The needle-free injector for diabetics (2010) –

World Health Organization (WHO) estimates that there will be 300 million diabetics worldwide in 2025 • There were already 194 million in 2003 (China alone accounts for over 80 million)

And why not a needle-free injector for each doctor and dentist 31

Conclusion Eliminating needles in human and animal markets makes a world of sense • The technology is available, reliable and economical • The leader of this technology is Canadian

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Are you ready ? Let’s roll up our sleeves For a safer world

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