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New Micro-Needle Holds the Answer for Painless Medical Injections in Pets and Farm Stock

Once the patented Canadian-developed PKA SoftTouch Micro-Needle becomes commonly used for animal/pet healthcare, veterinarians will no longer need to draw medications into old fashioned syringes from a vial, and more importantly, animals will feel no pain from injections. And, the need for sharps disposal will be completely eliminated.

How can this be true? The Micro-Needle works because of its innovative technology. The needle design is small, functional, invisible and easy-to-use. The tiny needle, which only emerges from its casing when a small plunger is depressed, can penetrate the skin of animals to a depth of between one and two millimeters where there are no nerve endings, and hence, no pain. It is designed to automatically retract inside its chamber, meaning it can neither be re-used nor abused.

PKA Micro-Needle’s inventors see real value in the delivery of insulin into the animal health care market. The numbers bear this out. As with humans, cats and dogs are also experiencing an increase in the onset of diabetes, with a 32 per cent increase in dogs since 2006, and a 16 per cent increase in cats over the same period.

A brief look at the stats tells the tale: One in 200 cats and one in 250 dogs have diabetes and receive an average of two shots a day. In Canada it is estimated there are 74,300 dogs and cats that are diabetic. In the U.S. the total number of cats and dogs with diabetes is estimated at 829,000. 

How could such a tiny needle effectively deliver insulin into an animal? The Micro-Needle reaches into the interstitial fluid between the skin layers, and no further. It is this fluid that then carries the injected medication throughout the animal’s blood stream. As the skin is the largest organ in the body, it rapidly disperses the drug, twice as quickly as a subcutaneous injection does. Preliminary research shows the drug is dispersed twice as quickly over the conventional and painful syringe method. 

 The Micro-Needle is made up of a top cap with a plunger, inner chamber, bottom chamber, spring, needle, safety cap and drug bubble. The device is made of injection-moulded plastic parts; the spring and 31 gauge needle are made of pharmaceutical-grade stainless steel; plastic film is used to encapsulate the drug for injection. 

The Micro-Needle, which is used once and then safely thrown away, is factory-filled with accurate doses clearly marked on a coloured coded label, eliminating the possibility of potentially dangerous dosage errors.

The PKA Micro-Needle can be easily modified to treat larger or smaller animals with different drugs, making it easier for owners to inject the animal. Large animals can be approached without stress and danger to the owner/veterinarian, since they will anticipate no pain simply because there is none. 

 Most importantly for those interested in investing: the insulin injection market for animals in Canada comes with impressive estimates. The Canadian potential annual health market in 2017 is $847 million (U.S.) and is expected to grow to $1.3 billion (U.S.) in 2024. 

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, proprietary device; the PKA SoftTouch Micro-Needle. This revolutionary device will replace the outdated syringe in drug applications for the pharmaceutical, healthcare and veterinary industries by offering pain-free medication and vaccine delivery. Equity in PKA SoftTouch is now available https://www.frontfundr.com/Company/PKA

The PKA Micro-Needle’s Wide Range of Drug Compatibility

By Richard (Dick) Crawford, CEO PKA SoftTouch Inc.

When Dr. Modi and I created the PKA Micro-Needle, we wanted to ensure the device had a wide range of applications, just like the syringe.

Our design achieved this. Our medical device easily accommodates many different kinds of drugs. The most popular drugs that the device could be used for are:

 ·      Insulin

·      Vaccines   

·      Heparin

·      Pain medications

·      Obesity

·      Psoriasis

·      Hepatitis

·      Testing, etc.

Our device encapsulates the drug in a chamber which we will call a “bubble” as it is made of flexible material. The device has a small fixed volume so it can function reliably inside our fixed chamber. Insulin, vaccines and heparin, for example, could easily be accommodated inside the device due to the small quantity required to achieve the therapeutic results in the body.

One may ask how we can accommodate the different dosages in the same fixed volume. Most drugs have a very small amount of “active” ingredient in a media fluid. What we do is vary the small amount of active ingredient in the fixed media to achieve the desired dosage strength. So, for example, for insulin, we can vary the active ingredient to achieve a wide range of dosages from 3 units to 80 units.

Most vaccines are small, single-shot quantities of liquid which are ideal for our medical device. We would mix the proper “active” in the media fluid to fit the fixed volume. For this reason, our device could be easily manufactured in large quantities.

We also ensured that the design of our device could accommodate other specific drug requirements. By way of example, to get rid of warts, a pharmaceutical company wants to inject a drug into the skin and beneath wart roots to kill the wart. With our device, we were able to put a small button on the bottom of the PKA SoftTouch Micro-needle so it would rest between the wart wall and the skin. We made the needle longer so that the needle, when actuated, was right under the center of the roots, to kill the wart.

Other variations include making a larger device for large animals, such as cows, horses, and pigs. Our fixed storage bubble could be made larger; again, we would vary the amount of active ingredient in the media fill to accommodate the larger animal. Depending on the drug, the veterinarian could use two devices to achieve a larger inoculation.

The PKA SoftTouch Micro-Needle medical device was designed to accommodate a wide range of injection applications. Hence, it is indeed a platform technology, which will ensure wide applications.

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, proprietary device; the PKA SoftTouch Micro-Needle. This revolutionary device will replace the outdated syringe in drug applications for the pharmaceutical, healthcare and veterinary industries by offering pain-free medication and vaccine delivery. Equity in PKA SoftTouch is now available https://www.frontfundr.com/Company/PKA

  • Published on April 28, 2020

Help us change medication delivery forever!

Brian McKinley BA CFP Director of Marketing at PKA SoftTouch Corp.

During my travels to Canada’s teaching hospitals, my most shocking revelations were the frequency of needlestick injuries and medication errors among doctors and nurses. Most impacted were the IV therapy teams that were responsible for the majority of sticks necessary to maintain viable medication and fluid delivery sites for patients.  IV Nurses were stressed as they contemplated their risks due to numerous inadvertent needle stick injuries. Coupled with this concern was the quiet and lesser-known tragedy of medication errors that resulted in needless morbidity and mortality in clinical settings across our country.  I can’t imagine the intensity of stress these two issues have caused during the Covid-19 pandemic.

My journey in the healthcare industry gave me an insider view of the challenges in bringing a Canadian medical device to market.  I served as a New Product Manager and Business Manager, to leading firms in the industry such as Johnson & Johnson and Ciba-Geigy. While serving as a Branch Manager and Division Director for Investors Group, I met an entrepreneur and engineer who specialized in medical building construction, Dick Crawford P.Eng, CEO of PKASoftTouch and Crawford Building Consultants.  For several years I followed Dick’s progress to launch an innovative medical device – PKA SoftTouch Microneedle Device. I was impressed with Dick’s energy and determination to solve the issues which I mentioned earlier by bringing to market a painless, more accurate, rapid and safer delivery method than the traditional needle and syringe, featured here: PKA SoftTouch Opportunity

I became so intrigued by the PKA project that I eventually concluded my career in Financial Services to join him in the hope that part of my legacy would be introducing this device to millions of patients and clinicians.  This brings me to the present day, where PKA SoftTouch Corporation has finalized the commercial product design ready for its last clinical validation to seek licensing partners among the pharmaceutical industry. We have contracted with Canada’s leading equity crowd-funding firm to help guide us through this final stage. The rest of the story is here: Click here to invest in a Painless Future! 

Current concerns about the rapid deployment of Covid-19 vaccines have made this story even more poignant today. We are entering a new Normal, where innovation and entrepreneurs in all areas become even more critical, although sources of capital may be scarce.  However, good ideas continue to attract wealth, and difficult times drive innovation. I can imagine a day where your doctor diagnoses you remotely, and your treatment arrives via drone at your doorstep where you can painlessly inject yourself. I hope that you might consider joining us on this quest to change medication delivery forever!

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, proprietary device: the PKA SoftTouch Micro-Needle. This breakthrough technology will replace the outdated syringe in drug applications for the pharmaceutical, healthcare, and veterinary industries by offering pain-free medication and vaccine delivery. Equity in PKA SoftTouch is now available https://www.frontfundr.com/Company/PKA  

Our Personal Motivations

Dick Crawford, CEO and Co-founder

When I first met Dr. Modi I was impressed with his profound ‘out of the box’ inventiveness. He is brilliant. I decided to join him in helping create a company to bring his micro-needle invention to the market. Since then, we have navigated the minefields presented to a new and brilliantly innovative company in the pharmaceutical and regulatory industry.

During the development of bringing our device up to world regulatory standards, I saw its potential to help prevent and control many chronic diseases in the world. The PKA SoftTouch Micro-Needle could increase the inoculation rate in underserved world populations, thus saving lives and improving health. Currently, organizations such as Doctors Without Borders or the Bill & Melinda Gates Foundation send medical professionals into these communities with vials and syringes. 

Given that our device is a single-shot, pre-measured dose, the dispensing of drugs to people in remote regions is made vastly easier — easier to innoculate people and to prevent dosage errors by the colour-coded caps. Further, disposal of the used device would be easier and safer since the device doesn’t require safe needle containment, only common waste.  

In light of recent events, these unique features of our technology could also be critical in providing a single-shot, pre-dosed COVID-19 vaccine in mass quantities, rapidly and to large populations across the globe.  

No needle is seen by the patient (thus eliminating needle phobia) and there is no pain upon injection (children and elderly would be easily inoculated). Sharps disposal is eliminated, and secondary re-use is avoided. The pre-loaded, single shot is dispensed and then thrown in the garbage with no sharps danger to anyone.

Part of my personal motivation was to help people in underserved areas, living in Africa and Asia. It is my personal dream, helped by the power of Dr. Modi’s inventiveness, to see this company succeed and have the micro-needle available on the by 2021.

Dr. Pankaj Modi, Inventor and Co-founder

My name is Dr. Pankaj Modi and I invented the Micro-Needle. I am also a diabetic and have been since I was diagnosed at the age of 16.

I created the Micro-Needle because I was devastated by the way my diabetes restricted my adolescent years, and also by my painful daily injections of insulin. I vowed then to make it my life’s mission to find another way to inject insulin into people like me, making it a painless and easy process. 

Throughout my life, I have studied extensively. I hold an Internal Medicine specialization in endocrinology and pain management, a Ph.D. in biotechnology-biochemistry –photobiology, a BSc in chemical engineering and over 280 patents worldwide. But the MicroNeedle is my first priority. It has the potential to change and save lives in a pain-free, simple manner – particularly in the current global pandemic.

The world needs this device and this PKA team has the right people to make it happen. 

Brian Mckinley, Director of Marketing 

My years working with IV therapists and medical professionals highlighted the need to deal with needle stick injuries and dosage errors.

I’m driven to provide these groups and their patients with a painless, more rapid delivery system that also addresses these two issues.

Larry Smoot, Business Coordinator

While caring for my father over the last six weeks of life, I had to administer his insulin injections. It was a crash course in giving injections with a syringe and vial of insulin. It was an added strain to an already stressful time.

When I learned of the PKA SoftTouch device, I instantly wished it would have been available for my father.

It’s my wish that no other person would have to know the anguish of being the cause of pain to a loved one in such difficult times.  

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, revolutionary and proprietary device; the PKA SoftTouch Micro-Needle. This revolutionary device will replace the ubiquitous syringe in drug applications for the pharmaceutical, health care and veterinary industries by offering precise, pain-free medication and vaccine delivery in a safe and effective manner. Equity in PKA SoftTouch is now available https://www.frontfundr.com/Company/PKA

New (painless) Injection Technology; Low-priced and Incredibly Easy to Use

The purpose of our single-shot, pre-filled, pre-measured device is simple: to deliver a drug to the body of the patient effectively and painlessly. Our revolutionary technology, the PKA SoftTouch Micro-Needle, achieves this with every single application. About the size of a cork, our device, when properly applied to the skin of an animal or human, will result in a 95% to 97% delivery of the drug into the skin. This achieves effective delivery of the drug into the body with every use, which is a Health Canada and USFDA requirement.

Both Canadian and American governments require drug doses to be marked on the device. To enhance identification of the drug and dosage, our caps are colour coded and referenced to the inside of the box lid containing the device.

The device needle being 1.5mm long delivers the drug between the epidermis and dermis, between these skin layers, allowing a patient to painlessly inject almost anywhere there is skin on the body of an animal or human. This exceptional feature of our micro-needle has been tested and proven in two clinical trials; at the University of Guelph on dogs and at St. Joseph Hospital in Toronto on humans.

The device was designed to be used effortlessly in one hand through minimizing the hand operation by a single movement of compressing a spring. The device is incredibly easy to use and was designed to apply the same pressure one would use to operate a syringe. The simplicity of the technology allows patients from the age of 8 to 80 years old to easily administer medications using our device.

Another impressive feature of the PKA SoftTouch Micro-Needle is that it combines a syringe and vial of drug into one device. Since most of the components are made of injection moulded plastic parts, they can be made inexpensively. A few years ago, we costed the pre-filled device to be similar to a dose of drug and syringe on a volume basis. Generally, the cost is $3.00 CAN per device. As such, it is expected that the cost and ease of use coupled with the painless delivery will make the PKA SoftTouch Micro-Needle a replacement for syringes on the injectables market, interrupting the syringe market entirely.

A painless injection will be welcomed by many patients globally and our team are extremely excited to commercialize this innovative and life-changing medical device.

Equity in PKA SoftTouch will be available soon. Sign up to stay in touch with the latest news about this breakthrough technology and the opportunity to purchase shares in our company: http://eepurl.com/gN_u6H

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, revolutionary and proprietary device; the PKA SoftTouch Micro-Needle. This revolutionary device will replace the ubiquitous syringe in drug applications for the pharmaceutical, health care and veterinary industries by offering a precise, pain-free medication delivery in a safe and effective manner.

Injections Made Easy and Pain-free!

Do you have to give yourself, your child, an elderly person, or your pet an injection regularly? Did you ever think that the words ‘easy’ and ‘pain-free’ would ever be associated with needles? 

That day has come with the PKA SoftTouch Micro-Needle. Our small ingenious device, about the size of a thumb, will bring medications like insulin, preloaded and premeasured, to people and animals suffering from chronic conditions like diabetes.

Do you have to give yourself, your child, an elderly person, or your pet an injection regularly? Did you ever think that the words ‘easy’ and ‘pain-free’ would ever be associated with needles? 

That day has come with the PKA SoftTouch Micro-Needle. Our small ingenious device, about the size of a thumb, will bring medications like insulin, preloaded and premeasured, to people and animals suffering from chronic conditions like diabetes.

Incredibly simple to use, it can be hidden in a pocket or purse due to its compact size. In one smooth move, you can inject yourself or an animal by pressing a tiny plunger that releases the micro-needle. The needle retracts after the medication enters the skin and then locks back inside the device so it can’t be used again. It’s these simple design features that will drastically reduce, if not eliminate, accidental needle sticks. 

The micro-needle is so tiny that it goes only as far as the gap between skin layers, where there are no nerve endings but instead fluid, which carries the medication rapidly into your bloodstream. It’s a breakthrough in the world of healthcare delivery and it’s protected by patents in over 21 countries, with more on the way.

No longer will people have to draw medication from a vial into an outdated syringe. No longer will people and animals have to endure the pain of an injection. No longer will people require a sharps disposal in their homes and workplaces – and say goodbye to the high cost of injection pens! Our vision is to change the way millions of people and animals’ function on a daily basis.

 Imagine taking your children for vaccinations and it becomes a tear-free, pain-free experience. Stressful doctor visits can fade from memory. If you’ve taken care of family members at home, then you know the feeling of uneasiness when our loved ones wince as we inject their skin. 

 With approximately 900,000 dogs and cats living with diabetes in homes across North America, pet owners will also appreciate the benefits that a painless injection could provide for them and their furry companions.  Animals feel pain too and once a dog or cat learns that the syringe is associated with pain, they are much harder to catch for their daily injections. 

This applies to large animals too. As our micro-needle does not resemble a syringe, animals such as cows, horses, and pigs will be more approachable for injections. Our technology was designed for safety and ease of use – to be used effortlessly in one hand. Animals won’t need to be restrained as they would for a syringe injection. 

Later this month, PKA SoftTouch Corp. is moving forward with an equity crowdfunding campaign to perform our last clinical trials in both the veterinary and human markets. To learn more, please visit pkasofttouch.com. Watch our video and subscribe for updates about your opportunity to become a shareholder of our company.

No Pain, All Gain

Our skin is composed of two layers, the epidermis, and the dermis.  The dermis contains a further two layers: the papillary and reticular dermis, and beneath this, the subcutaneous tissue composed of fatty tissue and nerves. 

There are three primary methods by which drugs may be injected: subcutaneously, intramuscularly and intradermally. The PKA SoftTouch Micro-Needle targets the skin by intradermal injection:

Let’s Take a Closer Look

Needles on syringes go over 8 millimeters deep into the fatty and muscular subcutaneous tissues and we feel pain because that’s where our nerve endings are. Conventional methods of injecting drugs also provide less direct dispersal as the drug is injected deeper and needs to permeate tissues.

The PKA SoftTouch Micro-Needle is the ONLY patented device that injects the drug directly into the skin layer. The tiny needle enters the skin only 1.5 millimeters, not deep enough to hit the nerve junctions and cause pain.

By targeting the interstitial fluid between the layers of the skin, we have proven that a shallow delivery process enhances the uptake, bioavailability and efficacy of drugs. The shallow injection into the skin allows the drug to enter into the bloodstream through interstitial fluid. It’s this fluid that circulates through the body like a flowing river and disperses the medication rapidly, twice as fast as a subcutaneous injection.

Also, because our device targets the skin layer, drug delivery can take place anywhere on the body rather than the five, often overused, sites of subcutaneous injection (abdomen, front of thighs, upper arms).  With a shallow injection, the pressure required to administer the drug can also be minimal.  

These unique benefits of our technology, coupled with premeasured doses indicated by coloured caps, means the PKA SoftTouch Micro-Needle will have a level of drug dosage accuracy and safety that is currently unavailable on the market.

What does this mean for the users of our device? 

If you’re a diabetic waiting for your insulin to take effect, the wait time could be halved.

In a hospital setting, clinicians could see patients responding to drugs twice as fast. 

This could have a huge impact in the healthcare sector where speed is often a critical factor for a patient’s welfare such as in cases of poisoning on opioids or where a dog has gone into anaphylactic shock.

The device will greatly enhance the quality of life for patients.

Micro-needle Patented Worldwide

In 2007, Dr. Modi and I decided our device was ready to be patented. Our micro-needle had performed incredibly well in recent tests and a patent would grant us a right as the inventor to exclude others from making, selling or using the invention for a period of time. Given the unique features of our technology and the results we were seeing, this was a prudent next step for us.

Gowling WLG, based out of Hamilton, Ontario, is a worldwide patent law company with roots going back to 1887. They have become one of the largest and most respected law firms in Canada and have helped Dr. Modi patent previous inventions. One would be hard-pressed to find a more seasoned firm to help navigate negotiations with the patent examiners of various countries. Proving to be of great value to us, we also discovered their talent in writing a strong patent that would obtain the necessary approvals.

The first item of business was to search for all prior patent science. It was interesting to discover that many earlier patents reviewed over the previous 50 years have tried to enter the skin only. Most were intricate devices that had many parts and were therefore very complicated. Most had complex ways to enter the skin and would be very expensive.

What made our device novel is that we have only nine moving parts to achieve a painless injection into the skin. That is the strength of Dr. Modi’s intellect – to come up with a unique device that can easily and painlessly enter the skin. We drew all the individual parts and gave them to the attorney to draw up in “Patent Configuration.” Extensive discussions took place to describe the function and movement of each component. The material was selected for each piece as we moved through our testing. 

After multiple write-ups, a final draft was completed. We chose to apply to Canada and U.S. patent departments first. Formal submittals were made and it took several years to finalize our efforts with the two countries. Once our claims were found to be sound and we obtained conditional approval, the patents were then publicized to see if any other country could object. In 2009, our claims were approved and we were issued with our first patent in Canada, followed by the U.S. in 2013. This proved that our patents were strong, and we could now proceed with patents in other countries.  

Since then, the PKA SoftTouch Micro-Needle has been granted a total of 21 patents in the following countries: Canada, United States, South Africa, New Zealand, Australia, Japan, India, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom. We also have patents pending in Argentina and Brazil. 

PKA SoftTouch Corp. is a leading-edge research and development company that has created a unique, revolutionary and proprietary device; the PKA SoftTouch Micro-Needle. This revolutionary device will replace the ubiquitous syringe in drug applications for the pharmaceutical, health care and veterinary industries by offering a precise, pain-free medication delivery in a safe and effective manner. 

To learn more, please visit www.pkasofttouch.com. Watch the video and subscribe for updates for the upcoming equity crowdfunding campaign – your opportunity to become a shareholder of our company.