NuGen M.D. Receives Additional Health Canada Approval for Insulin Specific Needle-Free Injection System
TORONTO, Ontario – July 21, 2022 – NuGen Medical Devices Inc. (TSXV: NGMD) (“NuGen” or the “Company”), a leader in needle-free drug delivery, is pleased to announce that its needle-free injection system and accessories, also known as InsuJet™, has been approved by Health Canada specifically for the needle-free delivery of insulin.
While NuGen previously announced on December 9, 2021, that its needle-free injection system had received general use approval from Health Canada, the insulin specific approval is the first ever* insulin specific needle-free system approved by Health Canada to sell into the healthcare system and its end users. Additionally, this approval may also aid in the process of obtaining coverage for the system by certain health care insurance providers in Canada.
“This is another important milestone in paving the way for diabetics in Canada to be able to easily acquire and use our needle-free injection device to deliver pain-free and fear-free insulin,” said Michael Wright, CEO of NuGen. “Our device was specifically developed for the benefit of patients that need to self-inject themselves in order to manage their chronic illnesses and offers variable dosing of insulin units which is required for diabetics that must self-inject multiple times throughout the day. This additional Health Canada approval brings more clarity to the intended use of the device and will further support our marketing initiatives to the diabetic community. Our goal is to have our technologies accessible not only to the diabetic community, but to give all patients that are currently burdened with injecting themselves with a needle the option of using a needle-free device.”
Currently, in Canada alone, there are more than 5.7 million people living with diabetes, representing 14% of the population according to Diabetes Canada.
Diabetes can also cause other health complications and disabilities, and is the leading cause of blindness, end stage renal disease (ESRD), and non-traumatic amputation in Canadian adults. According to the International Diabetes Federation (IDF), one person dies due to complications related to diabetes every 5 seconds, making it one of the leading causes of death worldwide.
In both type 1 and type 2 diabetes, the pancreas is unable to make the insulin the body needs to control the amount of sugar in the blood. Type 1 diabetics, and some type 2 diabetics, need multiple daily injections of insulin to keep their blood sugar levels steady.
For many patients living with diabetes, daily injections with traditional hypodermic needles cause stress, risk of injury, or risk of cross-contamination. NuGen’s InsuJet™ device provides a safe, effective, low-cost, and sustainable alternative to traditional injection methods. The needle-free injection system is safe for use by both medical professionals and by patients in their homes, and can be safely used 5,000 times without the risk of needle-stick injury or cross-contamination.
The InsuJet™ is currently approved in over 40 countries and is available through distributors in The Netherlands, United Kingdom, Taiwan, Hong Kong, Australia, Brazil and many Middle Eastern countries, amongst others.
*To the best of the Company’s knowledge, no other needle-free injection system has received Health Canada approval specifically for insulin, making Nugen the first-ever self-administered insulin specific needle-free injection system approved by Health Canada.
About NuGen Medical Devices
NuGen is an emerging specialty medical device company developing the next generation of needle-free technologies and other innovative medical delivery products. The company’s products, which include the InsuJet™ and PetJet™ needle-free injection systems, are designed to improve the lives of millions of people and animals. NuGen continues to receive approval in numerous countries, including Canada. NuGen’s products are designed for use in several important fields including, but not limited to, diabetes, veterinary medicine, and vaccines.
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This news release contains forward-looking information which is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ from those projected in the forward-looking statements. Forward looking statements in this press release include the Company’s 2022 objectives of securing additional distribution and sales agreements, making submissions for regulatory approvals and capitalizing on additional market opportunities. These forward-looking statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The forward-looking information contained herein is given as of the date hereof and the Company assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.