Cluster client PKA Micro-Needle moves into human clinical trials in time for next gen COVID vaccines
Riding high on previous successful equity crowdfunding campaign, PKA SoftTouch set to be a major market disrupter.
A made-in-Canada med-tech development that may solve future iterations of the time-consuming COVID vaccine inoculation process launches its second equity crowdfunding campaign today, slated to fund human clinical trials in early 2022.
Lakefield, ON-based PKA SoftTouch’s patented Micro-needle is set to complete its first of a two-stepped process for animal clinical trials at the University of Guelph, ON. in June. Funding for these trials, always a first step in Health Canada protocols for new medical devices, came from the company’s first successful raise totalling $437,000 in 2020 hosted by leading equity crowdfunding firm FrontFundr, based in Vancouver, BC.
PKA SoftTouch’s CEO, Dick Crawford, P.Eng., says the human trials require a further $1.27 million, which will be raised through both retail and private accredited investors.
“The Micro-needle, once fully commercialized, will provide a painless vaccine delivery system, eliminating the fear of needles, which experts now claim is contributing to vaccine hesitancy.”
A key feature, particularly in a pandemic with variables and mutations is a speedier inoculation process. Micro-needles can arrive at inoculation sites from pharmaceutical companies where they have been pre-filled with the vaccine. This eliminates the need for a medical technician to stop, draw a syringe full of vaccine, or several at a go, before administering it, thus saving valuable time. There is no wastage as all of the vaccine is used.
PKA co-founders Crawford and Dr. Pankaj Modi, a well-known investor, scientist and physician, noted that injectable drugs are central to the global pharmaceutical industry, with a projected value of over $ 1 trillion US by 2027. The medical technology industry alone is projected to surpass revenue of $797 billion US by 2025, with a pre-COVID CAGR of 5.6 from 2020 to 2025.
The device’s hidden tiny needle that goes 1.5 mm into the skin surface, avoiding all nerves, is invisible. The needle only emerges when a plunger is pushed after the device is held against the skin. Previous clinical trials on earlier versions of the device showed that shallow drug delivery improves the body’s medication uptake, because it enters the interstitial fluid, working faster than with a syringe delivery in subcutaneous tissues.
The company’s profit model is based on future licensing deals from pharmaceutical companies who will license the technology and fill each Micro-needle with its vaccine or other drug. The company expects to be profitable by 2023 from licensing arrangements with veterinary pharmaceutical firms, negotiating a deal with a Canadian animal health manufacturer in the third quarter 2022.
“Naturally, they wait to get proof of the device’s viability from the veterinary and then human clinical trials,” says Crawford. “That’s why today’s campaign is so important. The sooner we can get the trials funded, the sooner the device will become part of the COVID solution going forward.”
PKA is perfectly positioned, says Crawford, to take advantage of the second round of vaccines currently under development to address COVID variations. Vaccinologists are quoted as saying even with current vaccines, we are far from having the pandemic beat.
Danny Altmann, an immunologist at the Imperial College London, is quoted as saying “…this virus is going to change and the vaccines we have approved right now are just not going to be as effective as we think they are.”
PKA SoftTouch Corp is currently raising $1.27 million to complete the human trials of their device. Details of the offering can be found in the Offering Memorandum at FrontFundr.com/PKASoftTouch. This communication is for informational purposes only. Canadians can invest from as little as $500.
About PKA SoftTouch Corp
Patient-friendly, thumb-sized, inexpensive, pre-loaded, disposable, easy-to-use and pain-free PKA SoftTouch’s award-winning Micro-Needle technology could be the answer to global-scale vaccine delivery. What’s more, our medical device has high-value applications in multiple medical areas, addressing the increasing global need for humans and animals to administer all types of lifesaving drugs and medications, like insulin, predosed to people and animals suffering from chronic conditions like diabetes.