NuGen Medical Devices Receives Health Canada Approval for its Needle-Free Injection System

First self-administered, needle-free injection system approved by Health Canada gives access to safe, painless, cost-effective, and more sustainable drug delivery for chronic illnesses

TORONTO, Ontario – December 9, 2021 – NuGen Medical Devices (TSXV: NGMD) (“NuGen M.D.” or the “Company”) is pleased to announce the Company has received approval from Health Canada for its needle-free injection system and accessories, also known as InsuJet™.

NuGen M.D.’s needle-free injection system is the first ever self-administered needle-free injection system approved by Health Canada and gives access to safe, pain-free, cost-effective drug delivery for the millions of patients who suffer from diabetes, or other chronic illnesses.

Better known as InsuJet™, the needle-free system could also be suitable for vaccination efforts protecting health care workers from the dangers of cross contamination, injuries, and infections.

“This is an important moment for NuGen M.D. and although our device has regulatory approval in over 40 Countries, the Health Canada approval of our needle-free device represents a significant milestone to introducing our devices to the North American market. This approval creates a strong foundation to achieving regulatory approval in both the United States, through the FDA and also Mexico which we expect to be a natural next step for us,” said Michael Wright, CEO of NuGen M.D. “Individuals will now have an option to self-administer without the pain and fear associated with the use of a needle which is especially meaningful for patients requiring daily injections to manage their chronic illnesses. We believe that this could improve the lives of the millions of patients who suffer from diabetes as well as other chronic illnesses by providing them increased access to safe, fear-free drug delivery for the treatment of their disease.”

NuGen M.D.’s needle-free drug delivery system is specifically designed for the safety of healthcare workers who perform medical injections or vaccinations and patients who are required to self-administer their medication. Its needle-free injector is suitable for administering vaccines, insulin, and other treatments for chronic diseases or pets requiring medical injections.

In recent years, diabetes has become one of the leading causes of deaths worldwide. According to the World Health Organization, around 1.5 million people worldwide died due to diabetes in 2019. It is estimated that 463 million people are living with diabetes all over the world. By 2045, projections show this number rising to some 700 million diabetics globally.

According to Diabetes Canada, complications related to diabetes are serious and can be life-threatening. Annually, people living with diabetes account for:

• 30 per cent of strokes;
• 40 per cent of heart attacks;
• 50 per cent of kidney failure requiring dialysis; and,
• 70 per cent of non-traumatic amputations.

Diabetics manage blood sugar levels through daily administration of insulin, often three to four times per day.

The InsuJet™ is currently approved in over 40 countries and is available through distributors in The Netherlands, United Kingdom, Taiwan, Hong Kong, Australia, Kingdom of Saudi Arabia and Jordan amongst others. NuGen M.D. focuses on partnering with distributors that are hyper focused on their respective markets, particularly diabetes and anticipates it will be announcing additional distribution partnerships soon.

About The InsuJet™:

The InsuJet is a revolutionary needle-free drug delivery device, to self-administer medication in a safe, fear free, and virtually pain free manner and is now approved for use in over 40 countries globally. For a tutorial on how to use the InsuJet needle free delivery device, click here:

About NuGen Medical Devices:

NuGen Medical Devices is an emerging specialty medical device company focused on developing and commercializing novel drug delivery technologies. NuGen Medical Devices principal business is the research, development and commercialization of innovative needle-free injection devices and systems for the administration of subcutaneous medication. It is developing products using needle-free drug delivery technology in several important fields including, but not limited to, anaphylaxis, diabetes, severe migraine, erectile dysfunction, chronic anaemia, neutropenia, autoimmune rheumatoid arthritis, growth and fertility hormone, psoriasis as well as DNA and conventional/pediatric vaccines.

Follow NuGen Medical Devices on Social:

Twitter: @NuGenMD

For further information, please contact:

Michael Wright
President and CEO
NuGen Medical Devices Inc.
(514) 992-9484

Investor Relations Contact:
Kin Communications Inc.
(604) 684-6730

Forward-Looking Information: This press release contains forward-looking information based on current expectations. Statements about the date of trading of the Company’s common shares on the Exchange and final regulatory approvals, among others, are forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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