NuGen Medical Devices Advances Needle-Free Drug Delivery with Dual Patent Filings for Enhanced Injection Technology
核心洞察
NuGen Medical Devices (搜索) filed two strategic patents advancing needle-free drug delivery technology, including a dual spring system for optimized pressure profiles and a ready-to-fill COP/COC injection nozzle for pharmaceutical applications.
Ex-vivo testing demonstrated that NuGen's needle-free injections achieved delivery depths comparable to conventional needle-based injections in human tissue samples, validating clinical performance potential.
The company's Prefilled Nozzle platform, developed in collaboration with Gerresheimer Medical Plastics (搜索), targets the rapidly growing prefilled syringe market projected to grow 9-12% annually.
NuGen Medical Devices (搜索) Inc. has filed two significant patents that advance needle-free drug delivery technology, positioning the company to address key challenges in pharmaceutical injection systems while expanding its intellectual property portfolio. The Toronto-based company announced the filing of patents covering dual spring technology for enhanced pressure control and a ready-to-fill injection nozzle designed for pharmaceutical manufacturing.
Dual Spring Technology Addresses Injection Performance Challenge
The first patent application (Reference No. P105204NL) covers a fluid injection technology designed to optimize pressure profiles in needle-free drug delivery systems. Traditional needle-free injectors rely on a single actuator to generate injection pressure, limiting manufacturers' ability to fine-tune injection profiles and forcing them to choose between higher pressure for performance or lower pressure for comfort.
NuGen's patent-pending design introduces a second actuator, enabling more precise pressure curve shaping. This dual-phase approach delivers a strong initial "piercing phase" for consistent skin penetration, followed by a gentler "delivery phase" to reduce discomfort and tissue trauma. The technology is intended to support a broader range of patients and injection scenarios without requiring multiple device variants.
Clinical Validation Through Ex-Vivo Testing
NuGen recently completed ex-vivo testing in partnership with Crux Product Design Ltd (搜索)., evaluating injection performance in human tissue samples. Imaging analysis using μCT showed that the company's needle-free injections achieved delivery depths comparable to conventional needle-based injections, within a range consistent with clinically relevant subcutaneous drug delivery.
"These validation results are an important milestone," said Nicky Canton, Chief Operating Officer of NuGen Medical Devices (搜索). "They demonstrate that our advanced pressure-profile technology can deliver clinically meaningful performance in human tissue, giving us strong confidence as we advance our next-generation platforms."
Ready-to-Fill Nozzle Technology for Pharmaceutical Integration
The second patent covers a Ready-to-Fill (RTF) COP/COC injection nozzle designed specifically for pharmaceutical needle-free applications. The nozzle represents a novel pharmaceutical packaging component that enables needle-free injection using established aseptic fill-finish processes, analogous to prefilled syringes but without needles.
The COP/COC nozzle architecture 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.
Prefilled Nozzle Platform Development
The patent underpins NuGen'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.
Strategic Partnership and Market Positioning
To support scalable pharmaceutical manufacturing, NuGen is collaborating with Gerresheimer Medical Plastics (搜索), 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.
"According to Business Wire, 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 Canton. "With this development, NuGen is extending its needle-free technology creating new opportunities for patient-centric differentiation."
Platform Integration and Applications
The new dual spring technology is expected to play a central role across NuGen's upcoming product pipeline, including the InsuJet (搜索) V6 platform designed to improve usability and clinical performance, a refill platform aimed at simplifying daily use through cartridge-based delivery, and the prefilled nozzle platform supporting pharmaceutical partnerships and biologic drug delivery.
The company has developed a Prefilled Nozzle prototype targeting complex biologics, including GLP-1s, growth hormones (搜索), biosimilars (搜索), and monoclonal antibodies (搜索). Benefits for pharmaceutical partners include achieving ESG targets through reusable auto-injector design, less drug waste and higher dosing accuracy through low dead volume, fast injection time under one 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 needle stick injury risk.
Development Timeline and Strategic Vision
NuGen plans to have samples qualified for pre-clinical testing by the end of 2026 and introduce 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. The innovation builds on NuGen's broader strategy to evolve from a device-focused company into an integrated drug-delivery platform provider.
NuGen's flagship InsuJet (搜索) system is currently approved in 42 countries and designed to improve the lives of millions of people with diabetes (搜索) worldwide. The patent filings expand the company's intellectual property portfolio and reinforce its long-term competitive positioning in the needle-free drug delivery market.