NuGen Medical Devices Announces New Needle-Free Injection System Featuring Internal Cartridge Technology

Rhea-AI Summary

NuGen Medical Devices (TSXV: NGMD) has announced the development of a next-generation needle-free injection system featuring innovative internal cartridge technology. The system, protected under international patent WO2021206553, integrates a sterile internal insulin cartridge into their proprietary autoinjector.

The new design eliminates the need for external connectors and manual filling, offering improved safety and ease of use compared to current systems like InsuJet. Key technical features include an internal cartridge integration, backflow control mechanism, and enhanced usability.

Under CEO Liang Lin's leadership, NuGen plans to begin clinical investigations using their current platform while developing the new system. The company aims to produce working prototypes within six months and begin tooling investment in early 2026.

Positive

• Patent protection secured in EU and China, with pending applications in Canada and US
• Eliminates manual filling steps, reducing contamination and dosing error risks
• Improved safety and usability compared to current needle-free systems
• Parallel development approach allows faster clinical validation

Negative

• Full tooling investment and commercialization not starting until 2026
• Patent approvals still pending in key markets (US and Canada)
• Working prototypes not yet available for demonstration

Toronto, Ontario--(Newsfile Corp. - August 21, 2025) - NuGen Medical Devices Inc. (TSXV: NGMD) ("NuGen" or the "Company"), a leader in needle-free subcutaneous drug-delivery technology, is pleased to announce research and development of a next-generation needle-free injection system, in drug delivery technology. This innovation, protected under international patent WO2021206553 (granted in the EU and China; pending in Canada and the US), introduces a cartridge-based solution that simplifies drug administration and enhances patient safety.

At the heart of this breakthrough is the integration of a sterile internal insulin cartridge into NuGen's proprietary needle-free autoinjector, an innovation conceived by Nicky Canton, the inventor behind the patent. Unlike current systems such as InsuJet, which require external connectors to manually draw insulin into a temporary reservoir, this new design eliminates that step entirely. The result is a safer, more intuitive experience for patients, with reduced risk of dosing errors and contamination.

"This innovation is anticipated to be most welcomed for patients who rely on daily injections," said Liang Lin, CEO of NuGen Medical Devices. "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."

Technical Highlights of the 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, ensuring precise and safe insulin delivery.

• Improved Usability: Simplifies operation for patients and caregivers, reducing training time and improving compliance.

Under Liang Lin's leadership, the Company has expanded its internal R&D, quality, and clinical teams to support this development, with a focus on regulatory compliance and clinical validation.

Future Milestones:

• Clinical Investigations: Since the efficacy of needle-free injections is not affected by this design change, NuGen will begin clinical investigations using its currently approved needle-free platform. This allows parallel development of the new cartridge-based system while generating clinical data for new drug indications.

• Prototype Development: Within six months, NuGen aims to produce working prototypes to showcase the technology and conduct usability studies.

• Tooling Investment: Full tooling investment is expected to commence in early 2026, paving the way for scaled manufacturing and commercialization.

NuGen remains committed to advancing needle-free solutions that emphasize patient comfort, safety, and usability, redefining how medications are delivered across therapeutic areas.

About NuGen Medical Devices

NuGen develops next-generation needle-free devices for subcutaneous drug delivery. Its flagship InsuJet™ system is approved in 42 countries and is designed to improve the lives of millions of people with diabetes worldwide.

Websites: insujet.com | insujet.fr | nugenmd.com

Instagram / X: @NuGenMD | LinkedIn: NuGenMD

Investor Relations: IR@nugenmd.com

For further information, please contact:
Liang Lin, Chief Executive Officer
+1 (833) 285-2666
ir@nugenmd.com

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accept responsibility for the adequacy or accuracy of this release.

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263223

FAQ

What is NuGen Medical's new needle-free injection system technology?

NuGen's new system features an integrated internal insulin cartridge technology that eliminates the need for external connectors and manual filling, making drug administration safer and more intuitive for patients.

When will NuGen's new cartridge-based injection system be available?

NuGen plans to produce working prototypes within 6 months and begin tooling investment in early 2026, with commercialization to follow.

What are the key benefits of NuGen's new needle-free injection system?

The system offers improved safety through reduced contamination risk, eliminates manual filling steps, includes backflow control mechanisms, and provides enhanced usability compared to current systems.

What patents does NuGen have for their new injection system?

The technology is protected under international patent WO2021206553, which has been granted in the EU and China, with pending applications in Canada and the US.

How will NuGen conduct clinical trials for the new injection system?

NuGen will conduct clinical investigations using their currently approved needle-free platform while developing the new cartridge-based system in parallel.