What is the PKA SoftTouch Path to Profit?

We are now raising a third round of capital to perform human clinical trials and secure licenses with pharmaceutical companies who will then manufacture and sell our device in the human medical market.  By investing, you will receive shares and become a co-owner of PKA SoftTouch, and have the potential to profit from the sale of each and every device. 

Clinical Trials

Proof of Concept clinical trials completed & data generated.

PHASE I: Animal Trial
PAHSE II: Human Trial

License with Pharmaceutical Company

Pharmaceutical company receive clinical trial data then fill device with drug they produce.

Drug Company
(Distributes Micro-
Needle to market)

Large-scale licensee manufacturers, prefills & sells device.

PKA manufactures & pre-fills device & small-scale licensee sells

Profit for Shareholders

Royalties from each sale.

Manufacturing Profit & Royalties from each sale.

REVENUE STREAMS

PKA SoftTouch Corp. follows a licensing model for revenue generation, a standard scenario in the pharmaceutical industry. Revenue streams could be derived from two sources; royalties and a manufacturing profit.

ROYALTIES

  • PKA contracts with a pharmaceutical company to license its technology. The drug company will fill the Micro-Needle with their drug and utilize its sales, distribution and marketing channels to bring the pre-filed device to market.
  • The licensing agreement will generate initial revenue through front-end and milestone payments, followed by ongoing royalties, thus creating a constant revenue stream.

MANUFACTURING PROFIT

  • Small to medium-sized drug companies may only want to market and distribute the pre-filled device, and accordingly, a licensee will supply the drug to PKA who will fill the device in PKA’s manufacturing plant (to be built in Peterborough ON, or at a third-party manufacturer)
  • PKA would enjoy an additional revenue stream from the filling operation i.e. manufacturing profit.

KEY MILESTONES ACCOMPLISHED TO DATE

  • Welcomed an initial $1.37M through 47 investors, who showed full confidence in the device and business model to fund the preliminary concept and research phase.
  • Followed by another $437k from 312 investors via FrontFundr raise Round I to fund product development, patent protection, licensing and veterinary clinical trials.
  • As of 6 September 2021, $750k has been raised from a total of 400 investors in our FrontFundr raise Round II!

PATH TO SUCCESS — Market Opportunities

PKA has established a 3-phase process to successful roll-out.

PHASE 1:
Launch into Veterinary Injection Drug Market — North America

Next steps:

  • Completion of Proof of Concept Clinical Trials at the University of Guelph — May, 2021
  • Negotiate a deal with a major Canadian animal health manufacturer for a licensing agreement — Sept, 2022
  • Develop additional animal health markets — 2023
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PHASE 2:
Launch into Human Diabetes Market — North America

Next steps:

  • Conduct Proof of Concept Clinical Trials in Newmarket, Ontario, Canada — Aug, 2022
  • Develop a licensing agreement with a major global insulin manufacturer — Sept, 2023
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PHASE 3:
Accelerate growth by diversifying into other Human Injection Drug Markets.

Next steps:

  • Develop licensing agreements with major global drug manufacturers, with a focus on:– COVID-19/other vaccines
    – Heparin
    – Tuberculosis screening
    – Naloxone (anti-opioid treatment)
    – Narcotics for pain management
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GO-TO-MARKET STRATEGY & EXECUTION

Strategy

Our primary strategy to access the market is to sell licences to pharmaceutical companies who, due to regulations, will assume responsibility for manufacturing, pre-filling and selling the device.

For this reason, they:

  • 1. want proof that the device works, and
  • 2. that their drug is compatible with the device.

Clinical trials will provide proof the device works.

(Two previous clinical trials returned positive results. Trials for the GEN VI device are now required because Health Canada only accepts trials conducted on the device going to market.)

Pharmaceutical companies then provide us with a small amount of drug to test for compatibility.

(Typically either 60-90 days or 12-18 months.)

Execution

We have been in discussions with:

  • Seven major pharmaceutical companies,
  • Six medium-sized pharmaceutical companies, and
  • 10+ smaller pharmaceutical companies & clinics.

All parties are interested in securing a licence based on existing clinical data and the potential for increased market share and high cost-savings. 

Once we present clinical data to them, an agreement to licence will be executed, subject to compatibility testing*.   In addition, once early adopters commercialize the device, we expect to attract further interest at a rapid rate.

*This is common practice in the pharmaceutical industry and is a process we have spent 15 years preparing for.

GLOBAL PATENTS

A key component for financial success and stability is the protection of our technology. Patentability also plays a vital role in a medical device company’s shareholder value.

We have protected our intellectual property in 23 countries: Canada, United States, India, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, Japan, New Zealand, South Africa, Brazil and Australia. Patents are still pending in Argentina.

For further details on this investment offering and how to invest, please click below.

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If you have additional questions, please contacts us.