Toronto - 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.

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.

Contact:

Tony Di Benedetto

Tel: (416) 791-9399

Email: tony@nugenmd.com

(C) 2023 Electronic News Publishing, source ENP Newswire