What is the Micro-Needle?
Do you hate getting shots because of the pain? An exciting new breakthrough from PKA SoftTouch lets you administer your meds by injection virtually painlessly. The small and inexpensive Micro-Needle is the ONLY device that lets you inject only into the skin layers where there are no nerves and NO PAIN.
History and background
- Research began in October 2005 to design and develop a cost-effective, painless, minimally invasive medical device technology for the treatment of chronic diseases such as diabetes.
- Completed a successful working prototype.
- Achieved successful proof of concepts for US FDA and Health Canada suggested animal/human clinical trials.
- Received North American and International patent protection.
- Founders have over 60 years of combined experience in drug delivery systems.
- Founders have extensive experience in the pharmaceutical industry and with insulin technology.
- Design and develop a cost-effective, non-invasive medical device technology for the treatment of chronic diseases such as diabetes.
- Develop the product for entry into the worldwide insulin market based on PKA SoftTouch experience with insulin.
- Improve the quality of life and enhanced value for patients by painless injections of life saving drugs.
- 'Safety and Efficacy Evaluation of the Micro-needle Insulin Injection of Healthy Dogs', University of Guelph
- Clinical Study to evaluate the performance of the Micro-needle Injection Device in dogs using Atropine, University of Guelph
- Proof of Concept Human Clinical Trial Data in Type-1 Diabetics (St. Joseph Hospital, Diabetes Research Unit, Toronto)
- The device was recently cleared by the US-FDA for large scale human clinical trials related to insulin and/or heparin
- Canadian, South African, New Zealand, Japanese, and Australian patents have been issued.
- U.S. Patent is pending.
- International patents are pending.
- PKA SoftTouch has developed and perfected technology to stabilize insulin at room temperatures. This is exclusive and will be patent protected.