Toronto, Ontario--(Newsfile Corp. - March 25, 2026) - NuGen Medical Devices Inc. (TSXV: NGMD) ("NuGen"), a leader in needle-free drug delivery, today announced the filing of a new patent covering a Ready-to-Fill (RTF) COP/COC injection nozzle designed specifically for pharmaceutical needle-free applications. The nozzle, which is the subject of a newly filed patent application, represents a novel pharmaceutical packaging component that enables needle-free injection using established aseptic fill-finish processes, analogous to prefilled syringes but without a needle.

The COP/COC nozzle architecture that is the subject of a newly filed patent application is optimized for high-pressure jet injection, combining dimensional stability, material consistency, and compatibility with pharmaceutical requirements. This enables scalable manufacturing of needle-free, prefilled drug delivery systems without reliance on traditional needles.

The newly filed patent application underpins the Company's Prefilled Nozzle (PFN) platform, designed as an integrated drug-device system, combining a prefilled nozzle with a reusable auto-injector. Following aseptic filling, the nozzle functions as the primary drug container and is supplied ready for use, eliminating manual drug transfer steps at the point of care.

Drug administration is enabled through a reusable auto-injector designed to accommodate multiple prefilled nozzle formats, including 0.5 mL and 1.0 mL long nozzles. Upon insertion, the injector automatically adapts to the nozzle configuration and delivers the full prefilled dose in a single activation. This auto-dosing capability allows pharmaceutical partners to support multiple dose presentations using one injector platform, while providing patients with a simple and consistent injection experience.

"According to Business Wire^[1], the global prefilled syringe market is experiencing rapid growth, with most industry analyses projecting between 9% and 12% over the next several years, driven by self-administration and biologic therapies," said Nicky Canton, COO of NuGen. "With this development, NuGen is extending its needle-free technology creating new opportunities for patient-centric differentiation."

To support scalable pharmaceutical manufacturing, NuGen is collaborating with Gerresheimer Medical Plastics, a global leader in Ready-to-Fill primary packaging solutions. Leveraging Gerresheimer's fully automated production lines and RTF expertise, the Prefilled Nozzle is being developed in a nesting configuration aligned with existing prefilled syringe formats, minimizing changes to established aseptic filling processes.

Benefits for Pharmaceutical Partners

• Achieve ESG targets through reusable auto-injector design;
• Less drug waste and higher dosing accuracy through low dead volume;
• Fast injection time (<1 second), including for high-viscosity formulations;
• Reduced risk of chemical interactions due to the absence of a needle lumen; and
• Enhanced safety profile by eliminating the risk of needle stick injuries.

Key Milestones Achieved

• Development of a Prefilled Nozzle prototype targeting complex biologics, including GLP-1s, growth hormones, biosimilars, and monoclonal antibodies; and
• Patent filed covering core aspects of the Prefilled Nozzle platform.

What's Next

• Samples qualified for pre-clinical testing by the end of 2026; and
• Introduction of a fixed-dose auto-injector supporting 0.5 mL and 1.0 mL long RTF nozzles, with automatic dosing across the 0-1 mL volume range in 2027.

"This patent reinforces our momentum and positions NuGen for the next phase of growth as we continue to scale our technology and global distribution footprint," said Liang Lin, CEO of NuGen.

About NuGen

NuGen is a leading developer of needle-free devices to administer therapeutics subcutaneously. The Company is marketing and selling its current InsuJet™ needle-free injection system designed to improve the lives of people with Diabetes. InsuJet™ is approved for sale in 42 countries around the world.

For further information, please visit:

Websites: www.insujet.com, and www.nugenmd.com
LinkedIn: https://www.linkedin.com/company/nugen-medical-devices/

Notice Regarding Forward-Looking Information:

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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.

^[1] Business Wire, https://www.businesswire.com/news/home/20241014504897/en/Prefilled-Syringes-Research-Report-2024-2030-Global-Market-to-Reach-%2413.3-Billion-Driven-by-Increasing-Adoption-of-Self-administration-of-Medications-and-Expansion-in-Home-Healthcare---ResearchAndMarkets.com

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