NuGen Provides Corporate Update
Toronto, Ontario – August 4th, 2023 – Toronto, Ontario – NuGen Medical Devices Inc. (TSXV: NGMD) (the “Company” or "NuGen") is pleased to provide shareholders the following corporate update.
Corporate mission:
NuGen’s mission is to reduce the daily burden of diabetes care by providing a needle-free insulin injection device and supplies tailored to each diabetic’s personal needs with our InsuJet™ device which is approved for sale as a medical device in 42 countries. It is noteworthy that InsuJet™ is not yet approved for sale in the USA, leaving America as a large untapped market for NuGen to pursue. NuGen anticipates reporting to shareholders in the coming weeks its plans on how it looks to obtain U.S Food and Drug Administration (“FDA”) approval for InsuJet™ along with its plans for distribution in the USA if FDA approval is obtained.
Estimated business margins in excess of 70%:
NuGen has three business verticals that include B2B with estimated margins of 72%, B2C with estimated margins of 76% and a bio similar business vertical where margins are estimated to be 80%+.
B2B business vertical:
Our B2B vertical was the first business silo to launch in Q2 2023 where NuGen has signed distribution agreements with Science-Link Trading SAPI de CV in Mexico, Trustmed SRL in Romania, and Rosheta in Yemen. Sales in each Mexico, Romania and Yemen were announced during Q2 of 2023.
The Company also reported InsuJet™ is registered for supply and distribution through the NHS Drug Tariff with Reliance Medical Ltd. (“Reliance Medical”) which is NuGen’s PL partner and distributor for InsuJet™ in the United Kingdom.
Reliance Medical is a leading trade distributor of high-quality surgical dressings, healthcare products, medical equipment and first aid supplies in the United Kingdom.
The Company further announced on July 25th that it entered into a master sales 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 commencing on June 30, 2023. Sol-M is now the preferred distributor of InsuJet™ in Canada, Brazil, France and Spain. NuGen estimates the value at approximately $204 million dollars with estimated gross margins of 72%.
NuGen is pleased to further report to shareholders that it has sufficient production capacity at its factory in China along with inventory on hand to meet 2024 anticipated product sales demand.
Headquartered in Chicago, Illinois, USA, Sol-M are global leaders in the diabetic industry with offices in Brazil, Polland, Switzerland, the USA, and China.
B2C business vertical:
NuGen engaged Porter Media (“Porter”), a growth marketing team that specializes in scaling online businesses, to develop product awareness and grow sales of NuGen’s needle-free injection device, InsuJet™. Porter was selected based on their demonstrated ability to grow sales from inception to large seven-figure levels.
Porter takes a holistic approach to growing direct-to-consumer brands and blend the art of psychology with the science of data-driven strategies, creating effective paid social advertising campaigns. Their pragmatic approach, deep understanding of consumer behaviour, and profit-first mindset enable them to develop innovative solutions beyond the conventional.
NuGen’s B2C business vertical, with home delivery on a subscription basis as built by Porter is now nearing completion after months of development work. NuGen looks to provide more details surrounding its official launch of our B2C subscription website in mid-September 2023.
Bio similar business vertical:
Utilizing InsuJet’s™ needle-free technology for pain-free drug delivery of other medications offers a 3rd business vertical referred to as ‘bio similar’. InsuJet’s™ patented technology may possibly be used for other medications allowing drug manufacturers an opportunity to differentiate themselves from their competition. Brand name by needle, generic by InsuJet’s™ needle-free technology; an opportunity NuGen is pursuing. An active example is semaglutide. “Would you like your injection by needle pen, or would you select a bio similar that injects needle free using the InsuJet™ needle-free method of drug delivery? This is the alternative that NuGen wants to offer to semaglutide users” said Richard Buzbuzian, CEO of NuGen.
In Q2, 2023 NuGen announced it engaged Basic Pharma Technologies (“Basic Pharma”), a pharmaceutical company located in the Netherlands, to perform an assessment and feasibility study which will include validation testing of semaglutide if administered using NuGen’s needle-free injection device, InsuJet™. Semaglutide is currently administered by a pen-needle method.
Integrity testing of semaglutide being administered via InsuJet™ will be conducted by Basic Pharma over a seven-to-eight-month period comprised of three phases:
Phase 1 will focus on regulatory compliance and literature search, method development literature search, and reference standard research and sourcing.
Phase 2 will focus on the feasibility study method and development.
Phase 3 will focus on the QC method and writing, composing and validating, method and validation protocol writing review and effectiveness, method validation study execution and data review, method validation report writing and effectiveness and sample measurement and reporting of sample measurement.
The conclusion of Phase 3 will determine a Go/No-Go outcome which will be reported to shareholders. This bio similar opportunity represents NuGen’s third business vertical. NuGen anticipates reporting the outcome to shareholders in late Q4 2023 and into Q1 2024.
Basic Pharma is an advanced, independent pharmaceutical company primarily engaged in the development, licensing, manufacture and commercialization of pharmaceutical and biopharmaceutical products. Basic Pharma is a full-service package for the Pharmaceutical, Biotech and Medical Device industry.
For more information, visit www.basicpharma.nl
Clinical evidence and efficacy of InsuJet™:
Clinical evidence of InsuJet™ is supported by four peer-reviewed clinical studies published in academic journals from 2011 to 2016. The efficacy of InsuJet™ shows improved insulin uptake of upwards of 40%. Clinical studies, certificates, and InsuJet™ reports are found at: https://www.insujet.com/pages/partners.
This news release does not constitute an offer to sell or a solicitation of an offer to sell any securities in the United States. The securities of NuGen have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
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
Richard Buzbuzian
President CEO
(647) 501-3290
To arrange a media interview with NuGen, please contact:
Morna Gorman
(416) 553-1732
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.
