Mr. Liang Lin reports

NUGEN FILES PATENT FOR READY-TO-FILL COP/COC NEEDLE-FREE INJECTION NOZZLE, ADVANCING PREFILLED NOZZLE TECHNOLOGY

Nugen Medical Devices Inc. has filed a new patent covering a ready-to-fill 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 platform, designed as an integrated drug device system, combining a prefilled nozzle with a reusable autoinjector. 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 autoinjector designed to accommodate multiple prefilled nozzle formats, including 0.5-millilitre- and 1.0-millilitre-long nozzles. Upon insertion, the injector automatically adapts to the nozzle configuration and delivers the full prefilled dose in a single activation. This autodosing 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, the global prefilled syringe market is experiencing rapid growth, with most industry analyses projecting between 9 per cent and 12 per cent over the next several years, driven by self-administration and biologic therapies," said Nicky Canton, chief operating officer 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 environmental, social and governance targets through reusable autoinjector design;
• Less drug waste and higher dosing accuracy through low dead volume;
• Fast injection time, 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 is next:

• Samples qualified for preclinical testing by the end of 2026; and
• Introduction of a fixed-dose autoinjector supporting 0.5-millilitre- and 1.0-millilitre-long RTF nozzles, with automatic dosing across the zero- to one-millilitre 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, chief executive officer of Nugen.

About Nugen Medical Devices Inc.

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.

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