Syringex Medical, Inc.

PREFERRED BY MORE MEDICAL PROFESSIONALS

Syringex Medical Inc. controls world-wide patent rights to a unique low cost "safety syringe" for the administration of all forms of intramuscular, intravenous and subcutaneous injections.

The syringe has been designed to prevent accidental needle sticks during the injection of medication. The uniqueness of this syringe lies in its simple design whereby the plunger of the syringe locks onto the needle following administration of the injection. The needle is then withdrawn directly from the injection site into the barrel of the syringe to be safely housed within.

Information Profile

Ø The Problem That Started it All

Ø Why Did It Take So Long To Respond To The Problem?

Ø Who Was Responsible For Bringing About Change?

Ø What Is The Cost Of Change?

Ø Competition Comparison

Ø Syringex Safety Syringe

Ø New Products

Ø Where We Are

Ø Quality Assurance

Ø Conclusion

Ø How It Works

Ø Contact Information

Every Year

• 1 million healthcare workers in the U.S. are stuck with hypodermic needles that may be infected with Hepatitis B, Hepatitis C or HIV.
• Over 1000 of them contract serious infections.
• Over 80% of these injuries could be prevented.

• In some countries as many as 90% of the injections given are unsafe.
• 24 million people in developing countries around the world are infected yearly.
• More than 580 million people in the world are chronic carriers of these diseases.
• An estimated 1.3 to 1.6 million die.
• Countless others in the private sector including housekeepers, janitors, and trash handlers are not even counted in these statistics.
• The medical community was aware of this problem for years.
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So why wasn’t a solution put into place ASAP?

• Purchasing decisions were made primarily on cost.
• Purchasing contracts set up with major group purchasing organizations (GPOs) limited the choices.
• Existing syringe manufacturers were reluctant to invest in new designs.
• And, why change? They already controlled the industry.
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Something needed to be done

• Frontline medical professionals were the first to demand safer syringes.
• In April of 1998 the San Francisco Chronicle printed the “Deadly Needle Series”, putting California legislators on notice.
• In September, 1998 Cal/OSHA passed the first legislation mandating the use of safety needle products in California.
• In November of 2000 President Clinton signed the Federal Needlestick Safety and Prevention Act requiring the use of safety devices.

• Purchasing decisions in hospitals are no longer based solely on cost.
• Purchasing agents are now required to listen to needlestick committees comprised of medical professionals; and they want something effective.

• 23 states have passed additional needlestick legislation and 17 states currently have legislation pending.

• Group purchasing organizations have been brought before the US senate for their monopolistic practices.
• Retractable Technologies filed and prevailed in an antitrust suit against Premier, Novation, and Kendall Healthcare.
• The case with the fourth defendant, BD, was settled out of court for $100 million.
• These events are causing the major syringe manufacturers to lose their grip on market domination.
• The stage is set for smaller manufacturers to enter the market.

• Outside the United States markets are beginning their own transition to safety-engineered devices.
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The Cost of Change

• The cost of needlestick injury follow-up in the U.S. per incident is around $3,000.
• Accident follow ups cost the US medical industry $1.2 billion annually.
• Annual treatment for contracted diseases in the US is $1.8 billion.
• A total of $3 billion is spent annually in the US on needlestick injuries.
• This is three times the amount spent on conventional syringes.
• And almost 3 times the cost of converting to safety syringes.

The balance of power is in transition, and the stage is set for the right product to gain more market share than has been achievable in recent history. [Back to Top]

Competition Comparison

There are currently four general types of safety syringes.

· Sheathing tube syringes

· Sliding needle covers

· Hinged needle Covers; and

· Spring retractable syringes

Sheathing Tube Syringes

BD Safety-Lok

Kendall Monoject

• Require two hands to operate.
• Require a second hand moving closer to the needle to activate them.
• Harder to read the scales because of the sheath.
• Many reported problems of being able to reliably engage the safety mechanisms.
• Must retract from the injection site, exposing the needle before actuation.
• Take up more room in expensive sharps containers.
• Use of the BD Safety-lok syringe increased needlesticks at Kaiser Permanente.
• The Kendall syringe requires a second operation in order to lock it in place. The same old problem with a new twist.

Sliding Needle Covers

BD Safety Glide

Kendall Magellan (needle only)

• Require a grip change.
• Safety feature actuation requires a thumb or finger in closer proximity to the needle.

• Must retract from the injection site, exposing the needle before actuation.

• Kaiser’s use of the BD SafetyGlide failed to reduce needle sticks during one year of wide-spread use.

Hinged Needle Covers

BD Eclipse

Terumo Surguard

• Necessitate reaching next to the needle to move the cover out of the way in order to give an injection.
• Require a grip change to operate a safety feature.
• Puts at least one finger in close proximity to the needle after the injection.
• Must retract from the injection site, exposing the needle before actuation.
• Cumbersome to use.
• Flipping motion as the needle snaps into the cover can cause blood splatter.

Spring Retractable Syringes

NMT

Vanishing Point

BD Integra

• Splatter on activation.
• Aerosol residual contents, potentially spreading contagious viruses.
• Difficult to actuate, requiring over 9 lbs of push.
• Actuation can cause movement of the needle resulting in tissue trauma.
• Weak springs don’t always pull the needle out of the patient.
• The needle hanging up in the muscle and skin flips back, splattering the needle’s contents on the operator.
• Viruses can be picked up through contact with the eye, nose, mouth, or skin.

Other disadvantages of the competitors’ safety syringes

• Difficult to learn to use.
• Require extensive training.
• Lack of instructions on the device pouches.
• Lack of confirmation that the safety mechanism is locked.
• Many safety syringes are currently discarded in sharps containers without actuation because they are difficult or cumbersome to activate.
• As a group they give healthcare workers a false sense of security.
• Calling them Safety Syringes is a major misnomer.

The lack of instructions on the pouches is a real problem at hospitals, where medical professionals grab a syringe out of a bulk bin.

Many syringes are packaged in pouches that don’t break open and the operator is required to fumble with the “peel open” corner. This can be a real problem when a syringe is required rapidly in an emergency. [Back to Top]

Syringex Safety Syringe

Advantages of the Syringex Safety Syringe

• No splatter or aerosol.
• Actuation requires just over 1 lb of force.
• No danger of tissue trauma.
• Low cost.
• Fewer needle sticks.
• Simple and intuitive to use.
• Instructions are printed on the rip through pouch.
• The needle is retracted directly from the patient into the barrel of the syringe.
• A “snap feel” confirms actuation of the safety feature.
• The operator can see the needle safely retracted into the barrel.
• Graduation lines are easy to read.
• Hands and fingers stay behind the front of the syringe.
• Lower disposal costs. It doesn’t take up any additional room in sharps containers.

The combined major benefits of the Syringex Safety Syringe are improved ease of operation and safety through simplicity of design and use.

• There was an overwhelming preference for our safety syringe during Syringex Medical’s clinical trials.
• The clinical trial participants stated that they would change to our syringe as soon as it was available.
• Demonstrations to other medical professionals have elicited the same favorable response.
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New products being developed in the near future

• A line of irrigation syringes.
• Additional safety products - IV, catheter, dental syringes, and safety blood draw designs.
• Medical diagnostic tools for physicians.
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Where we are

• Hold 1 US and 11 foreign patents
• Our products pass rigorous testing exceeding all U.S. and international medical standards.
• Received clearance from the Food and Drug Administration June 23, 2003.
• Executed agreement to for an exclusive automated clean room facility in mainland China.
• The manufacturing facility is in production.
• Product for additional hospital trials is finished.
• Can rapidly expand to meet any increase in sales.
• Our cost of manufacturing will allow us to compete with the major companies.
• Understandings in place for all of our anticipated key personnel.
• Marketing plan in place to penetrate the market.
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Quality Assurance

• Quality testing is critical in order to maintain efficacy and reliability.
• Our syringes are manufactured, batch tested to our specifications, packaged, and sterilized in China, then shipped to our U.S. facility.
• We will quarantine all incoming containers until additional batch testing is performed at our facility to verify compliance to our standards.
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IN CONCLUSION

Current solutions are ineffective, expensive and/or difficult to use.

For years the market has been dominated by a few key players. Not because they had a superior product, but because they bought the market through key group purchasing organizations who controlled over 80% of the market.

The market growth, relatively slow in the beginning, is finally speeding up because of public awareness, pressure from medical professionals, and the growing body of legislation. The awareness on the international scene has peaked and massive drives are in progress in countries throughout the world.

I’d like to end on a quote from the Frost & Sullivan June 2003 report on the safety syringe market. “End users are demanding safety devices that are simple to use and require no training. Manufacturers are challenged to develop a low cost, retracting needle syringe design. It would take a technological breakthrough to develop a safety device with comparable costs of conventional devices”.

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Syringex has that technological breakthrough now; and we’re inviting you to participate. The timing could not be better.

Safety Feature Actuation

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Syringex Medical, Inc.	Phone: 253-661-1241
1911 SW Campus Dr. #301	Fax: 253-838-8549
Federal Way, WA 98023	Email: info@syringex.com