NuGen Signs $204M Distribution Agreement With Global Leader in the Diabetic Industry

Toronto, Ontario–(Newsfile Corp. – July 25, 2023) – NuGen Medical Devices Inc. (TSXV: NGMD) (the “Company” or “NuGen“) is pleased to announce it has entered into a distribution agreement for its needle-free InsuJet™ medical device and consumables with Sol-Millennium Medical Inc. (“Sol-M“) of Chicago, Illinois USA, for a term of five years which NuGen estimates the value at approximately $204 million dollars with estimated gross margins of 72%.

Sol-M is now the preferred distributor of InsuJet™ in Canada, Brazil, France and Spain where Sol-M has an extensive existing business footprint in the safety syringe and the diabetic supply business and where InsuJet™ is approved for sale as a medical device. Sol-M will be required to fulfill minimum yearly purchases to maintain its five-year distribution rights which NuGen estimates to be approximately $132 million dollars.

“Today’s announcement of our $204 million, 5-year distribution agreement with Sol-M at 72% gross margins represents the beginning of the global rollout of our B2B business. InsuJet™ is approved for sale as a medical device in 42 countries and our agreement with Sol-M represents only 4 countries where we are approved for sale as a medical device,” commented Richard Buzbuzian, CEO. “This agreement offers investors great leverage to the diabetic healthcare space. With anticipation, we look forward to reporting to shareholders additional wins in Q3.”

Headquartered in Chicago, Illinois, USA, Sol-M are global leaders in the diabetic industry with five offices around the world.

“During the COVID-19 pandemic, we sold over 2 billion safety syringes annually, so it is fair to say we know our market well. At Sol-M, we believe InsuJet™ is a game changer for how insulin soon will be administered by diabetics around the world,” commented Liang Lin CEO at Sol-M. “Needle or no needle? How would you prefer to take your insulin? It’s a simple question and we believe almost any diabetic would reply ‘needle free please’. We are delighted to be working with Richard and the NuGen team in what is truly a global disruptive opportunity for diabetics to become needle free in their treatment of their diabetes. InsuJet™ is the needle-free solution for millions of diabetics who suffer daily with their injections.”

National country-wide rollout of InsuJet™ in each of Canada, Spain, France and Brazil will occur in Q1 of 2024.

In Canada, Spain, France and Brazil, InsuJet™ will be available for purchase in all major pharmacies, grocery stores, hospitals, diabetic clinics and offices of endocrinologists and diabetic nurse practitioners.

The combined diabetic population of these four counties is estimated at 8,803,807 people.1

The total addressable market of these four countries is estimated to be $7.923 Billion based upon a $900 lifetime value2 of InsuJet™ and an aggregate diabetic population as described below.

Market Statistics3:

Canadian Market:

Population: 38,781,291
Diabetes prevalence: 7.7%
Estimated insulin users: 865,986

Spanish Market:

Population: 47,519,628
Diabetes prevalence: 10.3%
Estimated insulin users: 1,419,411

French Market:

Population: 64,756,584
Diabetes prevalence: 5.3%
Estimated insulin users 995,309

Brazilian Market:

Population: 216,422,446
Diabetes prevalence: 8.8%
Estimated insulin users: 5,523,101

Share consolidation

Until the Company makes an application to uplist to a senior stock exchange, a share consolidation is not expected to occur before this time, if at all.

About Sol-M

Headquartered in Chicago, Illinois, USA, Sol-M are global leaders in the healthcare industry with five offices around the world. Sol-M is a high-growth global medical device company committed to improving the safety and well-being of healthcare workers and their patients with the design and development of innovative safety-engineered medical devices. Sol-M is one of the world’s largest designers and distributors of needles, syringes and diabetic supplies, offering a broad portfolio of patented products with global brand recognition such as Sol-Care for safety sharps, Sol-M for conventional medical devices and Sol-Guard for immunization products.

Website: www.solm.com

About NuGen

NuGen is a specialty medical device Company that is marketing and selling its next-generation InsuJet™ needle-free injection system designed to improve the lives of millions of diabetics. InsuJet™ is approved for sale in 42 countries around the world.

For further information, please visit:

Websites: www.insujet.com and www.nugenmd.com

Instagram: @NuGenMD

Twitter: @NuGenMD

LinkedIn: https://www.linkedin.com/company/nugenmd/

For further information, please contact:

Tony Di Benedetto
Executive Chairman
(416) 791-9399
tony@nugenmd.com

Richard Buzbuzian
President & CEO
(647) 501-3290
richard@nugenmd.com

To arrange a media interview with Nugen Medical Devices, please contact:

Morna Gorman
(416) 553-1732
morna@nugenmd.com

Notice Regarding Forward-Looking Information:

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

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. 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.

Notice Regarding Future Oriented Financial Information and Financial Outlooks

To the extent any forward-looking information in this presentation constitutes “future-oriented financial information” or “financial outlooks” within the meaning of applicable securities laws, such information is being provided to demonstrate the impact to the Company with potential market penetration and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such future-oriented financial information and financial outlooks. Future-oriented financial information and financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to the risks set out above. The Company’s actual financial position and results of operations may differ materially from management’s current expectations. Such information is presented for illustrative purposes only and may not be an indication of the Company’s actual financial position or results of operations.

The forward-looking information contained herein was prepared by the management of the Company based on information available at the time this press release was prepared. Unless otherwise stated, information in this press release is current as of July 25, 2023.

This press release may contain certain financial performance measures that are not recognized or defined under International Financial Reporting Standards (“IFRS“), which measures are “Non-GAAP Measures”. As a result, this data may not be comparable to data presented by other companies. The Company believes that any Non-GAAP Measures included in this presentation are useful indicators of performance and are specifically used by management to assess the current and future performance of the Company. Non-GAAP Measures should be considered together with other financial information prepared in accordance with IFRS to enable readers to evaluate the Company’s performance and prospects in a manner similar to the Company’s management. Accordingly, any Non-GAAP Measures are intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS.

Any third-party information contained herein has not been independently verified. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information. The Company disclaims and excludes all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way out of or in connection with the information in this press release, its accuracy, completeness or by reason of reliance by any person on any of it.


1 Source: Population by Country (2023) – Worldometer (worldometers.info), Countries ranked by Diabetes prevalence (% of population ages 20 to 79) (indexmundi.com) and Estimate-of-Insulin-Use-in-Type-2-Diabetes.pdf (haiweb.org).

2 For each InsuJet ™ device sold, the lifetime value per unit including consumables to be purchased over the span of approximately 3.5 years is approximately $900.

3 Source: See footnote No. 1.

/NOT FOR DISTRIBUTION IN THE UNITED STATES./

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