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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.

3
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.
• 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.
• The animal project was revived in 1997. In 2000, the new needle-
free 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 5


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 Needle-


Free 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 ($6 Million) to supply its
Malaysian Distributor with Med-Jet MBX
– The Med-Jet MBX is sold in Asia for US$ 8,000
• Distributes its human models in 15 countries around
the world including Canada
• Distributes its animal models in 33 countries around
the world including Canada
– 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:
– Health Canada certification,
– European Union certification
– ISO certification
• Sales of over $600 000 this year

7
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.

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Motivations underlying the use of a
needle-free injector

There are multiple

9
What is the history behind the
needle-free injector?

• 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.
– The Russians were pioneers in this area
– Unfortunately, those injectors were very inefficient,
costly and too heavy
• The 1970s saw renewed interest in this technology
because of technological advances in:
– 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
– 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
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What modivating factors could help
spread its use?

• The resurgence of infectious and very contagious viruses affecting


the world
– A H1N1, H5N1, SARS, mad cow disease, etc.
• The stronger will of global organizations to eradicate certain
endemic diseases (eg: malaria)
– 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:
– 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)
– 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
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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:
– 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

• Thereafter, it is essential to have the


means to administer the vaccine quickly
and on a large scale

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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

• 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
– It is estimated that nearly 10 % of the population has a significant fear
of needles
• This fear leads to the following:
– 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
• The most painful and uncomfortable
• A needle-free injector can be used in the first 3 types
of vaccination.
– 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
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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
• 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 Increased efficiency for
(Less medication required) intradermal vaccination

Less damage to tissue


More opportunities in the and less pain
siting of vaccination

Accuracy of injection and reliability Fast (At least 3 times more


ways difficult to achieve using a needle) vaccine per hour)
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Does not produce waste
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:
– 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
– 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
– These animals must pass through a metal
detector in order to locate the fragment
• Substantially reduce the doses of drug
injection
– 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

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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
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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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