Nugen introduces needle-free injection system

Executive Summary

• Nugen Medical Devices Inc. announced the development of a next-generation needle-free injection system featuring an internal cartridge technology, protected under international patent WO2021206553.
• The new design integrates a sterile internal insulin cartridge directly into the autoinjector, eliminating the need for external connectors and manual filling steps required by current systems like InsuJet.
• The company plans to begin clinical investigations using its currently approved platform to generate data for new indications while developing prototypes, with full tooling investment expected in early 2026.

Key Details

• Patent Protection: The innovation is protected under international patent WO2021206553, granted in the European Union and China, and pending in Canada and the United States.
• Technical Innovation:
  • Internal Cartridge Integration: Removes the need for external adaptors and manual filling, streamlining the injection process.
  • Backflow Control Mechanism: Addresses high-pressure backflow challenges unique to jet injection to ensure precise and safe insulin delivery.
  • Improved Usability: Simplifies operation for patients and caregivers, reducing training time and improving compliance.
• Competitive Advantage: The design aims to rival the convenience of pen-based injectors without the use of a needle, offering a safer experience with reduced risk of dosing errors and contamination.
• Organizational Changes: The company has expanded its internal R&D, quality, and clinical teams to support regulatory compliance and clinical validation.
• Clinical Strategy: Clinical investigations will begin using the currently approved needle-free platform to generate clinical data for new drug indications, allowing for parallel development of the new cartridge-based system.
• Development Timeline:
  • Prototypes: Working prototypes are targeted for production within six months for usability studies.
  • Manufacturing: Full tooling investment is expected to commence in early 2026 to pave the way for scaled manufacturing and commercialization.

Notable Quotes

• "This innovation is anticipated to be most welcomed for patients who rely on daily injections. By embedding a prefilled cartridge directly into our needle-free platform, this will become a solution that rivals the convenience of pen-based injectors, without the needle." — Liang Lin, Chief Executive Officer