NuGen Medical Devices Inc. Provides Update on Health Canada License

Rhea-AI Summary

NuGen Medical Devices (TSXV:NGMDF) temporarily halted sales of certain devices in Canada after its Health Canada licence expired due to an untimely certificate renewal. This lapse is not a regulatory suspension or safety issue. A new licence application has been submitted and the company says communications with Health Canada are ongoing; global operations remain unaffected.

Positive

• Submitted a new Health Canada licence application
• Global operations and sales remain unaffected

Negative

• Temporary halt of device sales in Canada
• Regulatory lapse caused by untimely certificate renewal

Toronto, Ontario--(Newsfile Corp. - February 5, 2026) - NuGen Medical Devices Inc. (TSXV: NGMD) ("NuGen" or the "Company") is initiating a temporary halt on its devices in Canada due to the lapse of its license with Health Canada.

The Company's Health Canada Licence became expired due to an untimely certificate renewal. This is not a suspension or cancellation related to regulatory compliance or enforcement action. The temporary status does not constitute a product safety risk. However, to remain compliant with Health Canada medical device regulations, NuGen is currently not selling the affected devices in Canada.

A new licence application has already been submitted, and NuGen has been in active communication with Health Canada throughout the process. NuGen is confident the licence will be renewed soon, and sales will resume once the new licence becomes available. The Company's operations elsewhere in the world remain unaffected. The Company will continue to provide updates when available.

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

LinkedIn: https://www.linkedin.com/company/nugen-medical-devices

Investor Relations: IR@nugenmd.com

For further information, please contact:
Liang Lin, Chief Executive Officer
+ 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/282935

FAQ

Why did NuGen Medical Devices (NGMDF) stop selling devices in Canada on February 5, 2026?

Because the company's Health Canada licence expired due to an untimely renewal, the company paused Canadian sales. According to the company, this pause is administrative, not a regulatory suspension, and is intended to maintain compliance while a renewal application is processed.

Will NuGen (NGMDF) resume Canadian device sales soon after the licence lapse?

The company expects sales to resume once Health Canada renews the licence. According to the company, a new licence application has been submitted and active communication with Health Canada is ongoing to expedite renewal and restore Canadian sales.

Does the Health Canada licence lapse for NuGen (NGMDF) indicate a product safety problem?

No; the company says the lapse is administrative and does not indicate a product safety risk. According to the company, the status is not a suspension or cancellation related to compliance enforcement or safety concerns.

How does the licence lapse affect NuGen's international operations and revenue (NGMDF)?

International operations remain unaffected by the Canadian licence lapse, the company says. According to the company, only Canadian sales of the affected devices are paused while the renewal is processed, leaving other markets operational.

What should investors in NuGen (NGMDF) watch for next regarding the Health Canada licence?

Investors should watch for a confirmed licence renewal and resumption of Canadian sales from the company. According to the company, it will provide updates when available and is actively communicating with Health Canada about the renewal timeline.