STOCK TITAN

NuGen Files Patent for Ready-to-Fill COP/COC Needle-Free Injection Nozzle, Advancing Prefilled Nozzle Technology

(Moderate)
(Very Positive)
Tags

NuGen Medical Devices (OTC:NGMDF) filed a patent application for a Ready-to-Fill COP/COC needle-free injection nozzle that integrates with a reusable auto-injector as a Prefilled Nozzle (PFN) platform. The nozzle targets high-pressure jet injection, 0.5 mL and 1.0 mL formats, and is developed with Gerresheimer to fit existing aseptic fill-finish lines.

Key near-term milestones include sample qualification for preclinical testing by end-2026 and a fixed-dose auto-injector launch planned for 2027.

Loading...
Loading translation...

Positive

  • Patent application filed for the Ready-to-Fill COP/COC nozzle
  • Partnership with Gerresheimer for scalable RTF manufacturing
  • Supports 0.5 mL and 1.0 mL prefilled nozzle formats
  • Samples qualified for pre-clinical testing targeted by end-2026
  • Auto-injector launch planned with automatic dosing in 2027

Negative

  • Patent status is applied-for, not granted
  • Commercial platform not available until planned 2027 launch

News Market Reaction – NGMDF

+4.62%
+4.62% Session close to close

In the Mar 26 session, NGMDF gained 4.62%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

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/

For information, please contact:
Ajay Mishra
Investor Relations:
+ 1-833-867-5557
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.


[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

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289939

FAQ

What did NuGen (NGMDF) patent on March 25, 2026?

NuGen filed a patent application for a Ready-to-Fill COP/COC needle-free injection nozzle. According to the company, the patent covers a Prefilled Nozzle platform designed for aseptic fill-finish and high-pressure jet injection.

How does NuGen's Prefilled Nozzle (PFN) work with an auto-injector (NGMDF)?

The PFN is a prefilled primary container that mates with a reusable auto-injector for single-activation dosing. According to the company, the injector auto-adapts to 0.5 mL and 1.0 mL long nozzle formats and delivers the full prefilled dose.

What manufacturing partner is NuGen using for the RTF nozzle (NGMDF)?

NuGen is collaborating with Gerresheimer for Ready-to-Fill production and automated lines. According to the company, this aligns the PFN with existing prefilled syringe filling processes to minimize aseptic line changes.

When will NuGen (NGMDF) have samples ready for preclinical testing?

Samples are targeted to be qualified for pre-clinical testing by the end of 2026. According to the company, qualification is a near-term milestone ahead of 2027 auto-injector introduction.

What nozzle volumes will NuGen's PFN support for NGMDF products?

The PFN platform supports 0.5 mL and 1.0 mL long ready-to-fill nozzle formats. According to the company, the reusable injector accommodates multiple prefilled nozzle formats across the 0–1 mL range.

What are the expected patient and manufacturing benefits of NuGen's PFN (NGMDF)?

Benefits include lower dead volume, fast injection time (<1 second), and elimination of needle-stick risk. According to the company, PFN also aims to support ESG goals via a reusable injector and reduce drug waste.