NuGen would first like to thank our shareholders for their continued support as the Company completed the Qualifying Transaction and achieved its public listing on the TSX Venture Exchange (the “Listing“). The Company is working towards its objectives of becoming the global leader of needle-free injection technology while the Company navigated a longer than expected listing timeline.
Medical injections are a common healthcare procedure and the demand for a needle-free delivery solutions are increasing to improve safety and drug effectiveness, while lowering costs and reducing medical waste of disposable needles. It also helps reduce the fears and anxiety of administering medications and vaccines through hypodermic needles.
2021 was a year of building the necessary infrastructure to position NuGen for success in 2022 and beyond. This included financing, appointing additional management, directors and advisors, securing its manufacturing, building out the supply chain, and advancing distribution and sales agreements while seeking regulatory approval in North America for its needle-free injection system, also known as InsuJet™.
Nugen’s needle-free injection system is the first ever self-administered needle-free injection system approved by Health Canada and gives access to safe, cost-effective drug delivery for the millions of patients who suffer from diabetes or other chronic illnesses.
It is specifically designed for the safety of patients who are required to self-administer their medication as well as health care workers who perform medical injections. The Company’s needle-free injector is not only suitable for administering insulin, vaccines and other treatments for chronic diseases but also for pets requiring medical injections.
- Commenced trading on November 8th, 2021, under the symbol “NGMD” on the TSX Venture Exchange;
- Received a substantial investment from appointed director Michael Wekerle, an investor on the Canadian reality show Dragon’s Den, Ex-Vice Chairman of GMP Securities and one of the key figures in the Rogers Communications takeover of Maclean-Hunter;
- Recruited or renewed its advisory team, including:
- Vincente Fox, former President of Mexico
- Dr. Camillo Riccordi, Head of the Diabetes Research Institute of the University of Miami
- Dr. Richard Gallo, Cardiologist at the Montreal Heart Institute
- Dr. Ronald Denis, Head of General Surgery, Traumatology, Bariatric Surgery at Sacre-Coeur Hospital in Montreal
- Joseph McClendon III (doctorate in neuropsychology), best-selling author, lecturer and one of the most sought-after Ultimate Performance Specialists.
- Announced a CAD$5.8 million, 5-year distribution agreement with Khotwa Medical Co., for its InsuJet™ needle-free injection system, which would be 37% of 2022 sales objectives.
- Received regulatory approval from Health Canada for its needle-free injection system and accessories giving access to safe, virtually pain-free, and cost-effective drug delivery for the millions of patients who suffer from chronic illnesses such as diabetes.
With the funds recently released from escrow of the previously completed CAD$6 million financing in connection with the Listing, the Company is well positioned to execute on its 2022 sales objectives.
Michael Wright, CEO of NuGen states, “We wish to thank our shareholders for their patience while we continued to build a strong foundation for future success. We recognize our public listing is just the beginning of our journey and we are fully committed to executing on our 2022 objectives and positioning NuGen to become the global leader in needle-free injection technology. We are in a market with rapidly growing demands and our technology and capacity will strongly position NuGen to begin gaining market share from the global hypodermic needle market and participate in the newly developed categories in the injection space. We are truly excited about the opportunity to improve the lives of patients with chronic illnesses while creating long term shareholder value for all our stakeholders.”
- Secure additional global distribution and sales agreements with minimum yearly commitments for its needle-free injection device and consumables;
- Supply a minimum 8,000 needle-free injection systems into the global market, generating one-time revenue for the device in addition to the recurring revenue of the consumables over the expected lifetime of a device (~3 to 5 years), both important revenue streams to the Company;
- Submit for regulatory approvals in other key markets with high demand for our product line;
- Continue to monitor the market for potential M&A opportunities in an effort to rapidly grow its sales and position itself as the global leader in needle-free injection technology;
- Continue R&D on our next generation Needle-Free injection technologies;
- Capitalize on the opportunity in the animal market to give pet owners access to safe, fear-free and virtually painless injections for their pets
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, among others. Nugen 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.
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 and it is estimated that 463 million people are living with diabetes all over the world.
According to Diabetes Canada, complications related to diabetes are serious and can be life-threatening. Annually, people living with diabetes account for:
- 30 percent of strokes;
- 40 percent of heart attacks;
- 50 percent of kidney failure requiring dialysis;
- 70 percent of non-traumatic amputations.
Diabetics manage blood sugar levels through daily administration of insulin, often three to four times per day.
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 please visit the Company’s website.
About NuGen Medical Devices:
NuGen is an emerging specialty medical device company focused on developing and commercializing novel drug delivery technologies. NuGen’s principal business is the 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 anemia, neutropenia, autoimmune rheumatoid arthritis, growth and fertility hormone, psoriasis as well as DNA and conventional/pediatric vaccines.
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President and CEO
NuGen Medical Devices Inc.
Investor Relations Contact:
Kin Communications Inc.
Notice Regarding Forward-Looking Information:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of NuGen to be materially different from any future results, performance or achievements expressed or implied by 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. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risks Factors” in the Company’s prospectus dated as of September 29, 2021, which is available for view on SEDAR at www.sedar.com. Forward-looking statements contained herein are made as of the date of this press release and NuGen disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.
NuGen’s operations could be significantly adversely affected by the effects of a wide spread global outbreak of a contagious disease, including the recent outbreak of illness caused by COVID-19. It is not possible to accurately predict the impact COVID-19 will have on operations and the ability of others to meet their obligations, including uncertainties relating to the ultimate geographic spread of the virus, the severity of the disease, the duration of the outbreak, and the length of travel and quarantine restrictions imposed by governments of affected countries. In addition, a significant outbreak of contagious diseases in the human population could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could further affect operations and the ability to finance the Company’s operations.
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