ZIP!4!WoundU.S. Patent Numbers 7,591,835 & 8,066,735

Hello world !

Today it is 2014 AD - for most of us

But in some parts of the medical world, it is still 3014 BC

Today, “modern” medicine is STILL using the same needle and thread technique to sew up wounds that they were using in Ancient Egypt in 3,000 BC

five THOUSAND years agohttp://en.wikipedia.org/wiki/Suturing

Do you want to be sewn up with 5,000 year-old technology?

With all the spectacular benefits this 5,000 year-old wound-closure technology has to offer?

The spectacular benefits of “modern” (5,000 year-old) wound-closure “technology”

Impressive, isn’t it?

Well, if YOU step into an operating theatre some day that is what is likely to happen to YOU

Like it?

Decorative?

Pretty?

ZIP!4!WoundU.S. Patent Numbers 7,591,835 & 8,066,735

THE ZIP!4!Wound STORY

A medical student at a top university discovered that when the EXACTLY RIGHT 4 CONDITIONS all exist, skin wounds always heal spontaneously

with no scar. He also found that when all four conditions do not exist, a scar always forms.

When the EXACTLY RIGHT 4 CONDITIONS are created by hand (using time-consuming, tedious manual methods) skin wounds always heal with no scar

at all. But the method was too tedious and too time consuming for every-day practical use. It took many years to figure out ZIP!4!Wound as a way to

reliably create EXACTLY THE RIGHT 4 CONDITIONS in a few seconds.

ZIP!4!Wound easily and inexpensively

creates the EXACTLY RIGHT 4 CONDITIONS in seconds

The proof? - Spot the Difference• Ever cut your finger with a razor blade or had an

injection? – No scar, right?

• Ever had an operation or got a wound closed some time after it happened? – Got a nice scar to prove it, right?

How to get a scar1. Ensure cells at the edges of the wound are real dead when the wound

is closed.

2. Ensure that the edges of the skin are dried out and have no working blood supply.

3. Close the edges of the wound long after the wound was made.

4. Join the edges of the wound in a miniature version of the Himalayas. Better still - close the back!! edges of the skin together using staples.

Every time the EXACTLY RIGHT 4 CONDITIONS do NOT exist, a nice scar is ALWAYS left to prove it happened.

The more negative the conditions, the worse the scar.

How to NOT get a scar

Under the EXACTLY RIGHT 4 CONDITIONS, the body – your body - knows perfectly well how to close wounds without a scar. It has proved that to you many times with your own body - just try and find where you got that injection (injection needles are small blades) or where you stabbed yourself in the finger with something. Go on. Try.

ZIP!4!Wound is the only device that creates the EXACTLY RIGHT 4 CONDITIONS

ZIP!4!Wound

The EXACTLY RIGHT 4 CONDITIONS which must exist for the body to close skin wounds

without a scar are:1. Cells at the edges of the wound must be alive and well,

2. AND the closed edges must have a working blood supply,

3. AND freshly cut, bleeding edges of the skin must be closed together within seconds of being cut, (before the edges can dry and die),

4. AND the edges of the wound must be held flat, touching precisely edge-to-edge, neither squashed nor gaping during the time healing is occurring

Every time all 4 of the EXACTLY RIGHT 4 CONDITIONS occur, no scar is ever left to show it ever happened

ZIP!4!WoundThe EXACT RIGHT 4 CONDITIONS were verified by creating them

manually with the following procedure:1. Any deep level repair which would normally be done before suturing the skin should be completed before

using ZIP!4!Wound to close the skin. In surgical situations the dermis must be carefully closed to leave a flat foundation for the epidermis closed by the ZIP!4!Wound. There must be no empty space or non-flat space area underneath ZIP!4!Wound when closed.

2. Clean the wound.

3. Anaesthetize the wound.

4. Trim off the skin at the edges of the wound: – far enough from the edge to cut through live undamaged skin. – Trim so as to leave smooth straight wound edges which can close together in a neat butt (edge-to-edge, no gaps or

excess skin) join when pulled together very evenly.

5. After trimming:– Do not stop bleeding from the wound edges. If necessary, just gently wipe away excess blood.– Do not use any cleaning or other fluids on the wound after trimming the edges because doing so could kill the cells at

the edge.– Do not use a cautery on the wound after trimming. – Do nothing to the wound that could kill the cells at the edge of the wound.

6. Do the following without delay so as not to let clotting occur at the wound edges and so that they edges are still bleeding when they are closed together:

– Apply several large stress-relief stitches well away from the wound edge. • Draw these just tight enough to get the two cut edges to JUST touch one another without bunching up

and without leaving a gap.• Use only enough of these large stress-relief stitches to prevent excessive skin stress or pulling from

tearing out the tiny joining stitches to be applied next.

ZIP!4!WoundThe EXACT RIGHT 4 CONDITIONS were verified by creating them

manually with the following procedure (continued):5. (continued)

– Using the smallest available needle and thread, work from one end of the wound to the other, and:• Apply very small joining (skin edge positioning) stitches close to the edge of the wound so as just to

hold the edges together in a precise edge-to-edge join. Your aim is to reproduce as well as you can the same look you see when you cut a thumb or finger with a razor blade, and when you wipe the blood away you can hardly see the join.

• The little skin edge positioning stiches need to be placed very close together - 2 – 3 mm apart - so that there Is no bowing of the skin edges between places where the stiches are and at the same time the two skin edges are touching along their whole lengths . You are trying to achieve the same effect as if you placed two pieces of paper together edge-to-edge. When you have finished, the two edges of the skin should be:

– touching along whole length of the wound– there should not be any place where the stitches are too tight so that they make the skin bunch

up.– The skin at the two trimmed edges of the wound should be lying completely flat along their

whole length when you are finished. – If a stich is wrong – too loose or too tight – cut if off and replace it. – If you have done a good job there should be little or no bleeding.– Remember always that the razor-blade cut is the Ideal Scene you are working to achieve.

6. Bandage so as to assist the stress relief stiches in relieving stress from the edges of the wound joined with the tiny joining stitches.  You are aiming to prevent shearing or tearing forces from reaching the skin positioning, closing stiches or the edges of the healing wound itself. Non-elastic adhesive bandage can help with this by capturing skin stress either side of the healing wound and transmitting it through the bandage to the other side of the wound and prevent the stress form being transmitted to the healing wound.   

ZIP!4!WoundCreates the EXACTLY RIGHT 4 CONDITIONS needed for scar-free closure to occur.

ZIP!4!Wound 1) makes it easy to accurately trim away the skin from the wound edge to leave fresh, live skin 2) enables the fresh wound to be closed within seconds before cells at the edge can die or lose their blood supply and finally 3) holds the edges in the right position (joined accurately edge to edge like two sheets or paper placed side-by-side) so that scarless healing can occur:

1. Cells at the edges of the wound are alive and well because the dead edges of skin are trimmed away immediately before closing using the built-in ZIP!4!Wound trimming knife guide.

2. The result is that the edges to be closed have an excellent working blood supply with the cells at the edge alive and well.

3. ZIP!4!Wound then enables the trimmed edges of skin to be closed together within seconds of being trimmed back to live skin – just zip it closed.

4. ZIP!4!Wound then holds the edges of the wound together flat, touching precisely edge-to-edge, neither squashed nor gaping, in the exact right position nature needs to perform its scar-less healing magic.

Here’s what an individual (small wound) ZIP!4!Wound looks like before trimming

away excess skin:

Using a ZIP!4!Wound:1. An individual ZIP!4!Wound is taken out of its sterile package and the adhesive

protection peeled off the adhesive on the skin side of the sterile ZIP!4!Wound, which is then adhered to the skin so that the opening in the skin (or the old scar to be removed) is entirely within the opening in the ZIP!4!Wound.

2. An ordinary scalpel is used to trim away all the skin inside the ZIP!4!Wound, using ZIP!4!Wound’s two connecting strips to guide the scalpel so that the skin is trimmed exactly flush to the inner edges of the connecting strips. Trimmed-away skin is discarded.

3. Within seconds of the skin being trimmed, the pommel is used to pull the slider. This pulls the connecting strips together flush with one another, and locks them together similarly to the way a zip-lock bag closes.

4. The action of closing the ZIP!4!Wound brings together the skin edges to which it is attached, so that live cells with a working blood supply are held together flat, touching precisely edge-to-edge, neither squashed nor gaping, in the exact position for scarless healing to occur in the same position your skin is when you cut your finger with a razor blade and you can hardly see the cut when you wipe away the blood.

5. After closing ZIP!4!Wound, it can be protected with a normal bandage to prevent it catching on anything. .

Partly closed ZIP!4!Wound showing the skin opening after trimming away excess skin:

A cross-section through the resulting closed ZIP!4!Wound

The two ZIP!4!Wound connecting strips close together in a neat butt-join – and the two trimmed edges of the skin also close in a neat butt-join, so that:

1. Live cells with

2. A working blood supply

3. Have been quickly closed together within seconds of being trimmed, and the result is that

4. The edges are held together flat, touching precisely edge-to-edge, neither squashed nor gaping, in the exact position for scarless healing to occur. After 7 – 14 days of healing (normallly about 7) the ZIP4Wound is pealed off. Look – no scar!

For more precise trimming, a knife guide can be built into the ZIP!4!Wound and a knife supplied which runs in the guide:

The “competition” - such as it is

ZIP4Wound “competitors”

V-Loc XX• Method is same as suturing

but the thread has opposing V’s to prevent backwards pull therefore eliminates the tying of knots in thread

Medizip / Cloze X• The most similar product to

ZIP4Wound on the market but does not eliminate scarring, only claims to reduce scarring to “cosmetically acceptable” levels

• Does not create the EXACTLY RIGHT 4 CONDITIONS for scar-free wound closure

ZIP4Wound ”Competition”

• There are many other products in the marketplace which distribute tension along the wound but still use outdated suturing methods

• Perform a Google Search on Wound Closure Device – you will see ClozeX and V-Loc dominate the market

• Neither one creates ALL the EXACTLY RIGHT 4 CONDITIONS for scar-free wound closure.

ZIP!4!Wound is the only device on the market which creates the EXACTLY RIGHT 4 CONDITIONS for scar-free closure

• Medizip and ClozeX quote their results are “cosmetically acceptable”.

• But the only acceptable result for a patient is no scarring at all. But that has always seemed to be impossible.

• Suturing methods date from Egyptian days but are still the preferred method even if generic needle and thread brands do cost 2 – 4 Eu each. This BC mindset needs updating both to the public and health care professionals.

• If the public knew ZIP!4!Wound existed and what it achieves, the public would always insist on ZIP4Wound. After all, who really wants a scar?

ZIP!4!Wound is the only device that creates the EXACTLY RIGHT 4 CONDITIONS for scar-free closure

ZIP!4!Wound “Competitors”

• A number of devices exist on the market which are based around some kind of toothed zipper.

• Toothed zipper devices cannot meet the EXACTLY RIGHT 4 CONDITIONS because:– Firstly, the teeth of a zipper cannot be a very precise guide for trimming the skin because they

are uneven and cannot give a firm and precise support for a trimming knife. – Secondly, a zipper is wider from one side to the other when it is open than when it is closed,

because when the zipper is closed the teeth overlap one another. Consequently, supposing that the zipper teeth are used as a trimming guide, then, when the zipper is closed, the skin underneath will be compressed into the reduced space now available under the closed zipper. This violates the 4th condition which is:

• “4. The edges of the wound are held together flat, touching precisely edge-to-edge, neither squashed nor gaping”• A ZIP!4!Wound is designed to be the same width when it is closed as when it is open (when ignoring the space

between the sides of the open ZIP!4!Wound)

– This problem is even worse at the ends of the trimming area where the width of the zipper-closing slider will add to the amount of skin which gets compressed when the zipper is closed.

– If an attempt is made to compensate for this width reduction problem by trimming at the estimated “right” place under the zipper teeth, then there is not much chance of getting it right, so that when the zipper is closed the “edges will touch precisely edge to edge, neither squashed nor gaping.”

ZIP!4!Wound is the only device that creates the EXACTLY RIGHT 4 CONDITIONS for scar-free closure

The Problems with current Zip systems to close wounds

ZIP!4!Wound “Competitors”

Comparison of how well each contender implements the EXACTLY RIGHT 4 CONDITIONS for Scarless Healing

EXACT RIGHT CONDITION

Traditional Suturing

ZIP!4!Wound MediZip ClozeX V-Loc XX

1. Cells at edges are alive and well when closed

2. Wound edge has working blood supply

3. Edges closed within seconds of being cut

4. Edges of wound held flat, edge-to-edge, touching, not squashed or gaping

Provides a good skin trimming guide

ZIP!4!Wound ”Competitors” Patient & Practitioner Experience Features Compared

Benefits/

ClaimsTraditional Suturing

ZIP!4!Wound MediZip ClozeX V-Loc XX

Quicker than stitching Non-Invasive No Scarring Reduced Risk Infection Reduced Wound Pain – Earlier Mobility

MARKETING NOTES

ZIP!4!Wound Variants

• ZIP!4!Wounds would normally be made in different standard lengths to match common lengths of cut.

• ZIP!4!Wounds could also be made in high-margin variants for specialised purposes, for example:

– ZIP!4!Wounds could be made in different colours to match different skin colours.– ZIP!4!Wounds could be made with a variety of curvatures and bends to match

awkward places and cuts which have an angle in them.

• For long cuts such as might occur with open heart surgery, ZIP!4!Wounds can be manufactured on reels with each side of the ZIP!4!Wound on one reel and then cut to length required.

• ZIP!4!Wounds could also be developed and marketed for closing flexible materials edge-to-edge - there is no accurate edge-to-edge closing system for flexible materials:

– Repairing tears in curtains, car seats and the like– Joining sheets of plastic or canvas using tape on the backside or adhesive

ZIP!4!WoundMarketing Facts:• Wound closure is a multi-billion dollar business• There are 95 million Accident & Emergency visits in the US alone

annually of which traumatic lacerations are the third most common problem accounting for 8% or 7.6 million

• There are no animal tissues or anaesthetics involved in ZIP4Wound itself so non US approvals are easy – Class II (low risk)

• Markets:– Human– Military (US military wants to see prototypes)– Veterinary– Flexible material closure markets

ZIP!4!Wound is the only device that creates the EXACTLY RIGHT 4 CONDITIONS for scar-free closure

ZIP!4!Wound Summary• No other product can meet our claims• Unique and simple. • Monopoly of scarless skin closure. • With aggressive marketing sales and distribution, has the

potential to become wound closure market leader.• Very cheap to manufacture (cents).• Inexpensive and easy to bring to the market• Because patients who know about ZIP!4!Wound will insist

it is used, inexpensive publicity can be used to get ZIP!4!Wound accepted in the face of doomed resistance of entrenched competition selling 5,000 year old technology.

ZIP!4!WoundCREATES THE

EXACTLY RIGHT 4 CONDITIONS

NEEDED FOR SCARLESS HEALING

The USA market for ZIP!4!Wound is protected by two USA patents. •U.S. Patent Number 7,591,835, 8,066,735•Other markets do not have patent protection, and therefore must be protected by design patents and approached on a market-capturing basis, to capture the market and establish a dominant position before any other company can do so.

CONTACT INFORMATION

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ZIP!4!Wound Investment Costs – main stages to marketable product

Prototype Development €50,000*

BSI Approval (CE Mark)** €30,000*

FDA approval** €30,000

Testing and reporting €40,000

Marketing €100,000 TOTAL €250,000

* Quotations received

** In the EEC, ZIP!4!Wound comes under Class IIA (the same class as bandages). We have been advised that the FDA will take a similar view.