NuGen Medical Devices Inc. Provides Update on Health Canada License

Executive Summary

• NuGen Medical Devices Inc. has temporarily halted sales of its devices in Canada because its Health Canada licence expired.
• The lapse is due to a delayed certificate renewal and does not reflect any regulatory enforcement action or product safety issue.
• A new licence application has been submitted; the company expects renewal soon and plans to resume Canadian sales once approved.

Key Details

• The Health Canada licence for NuGen’s devices became expired because the required renewal certificate was not filed on time.
• This expiration triggers a temporary halt of device sales in Canada; no devices are being sold in the Canadian market until the licence is reinstated.
• The company emphasizes that the situation does not constitute a suspension, cancellation, or safety risk related to regulatory compliance or enforcement actions.
• NuGen has already filed an application for a new licence and is maintaining active communication with Health Canada throughout the review process.
• The company is confident that the licence will be renewed shortly, after which Canadian sales are expected to resume.
• Operations and sales in all other regions worldwide remain unaffected by this licensing issue.
• NuGen commits to providing further updates as more information becomes available.

Notable Quotes

• “NuGen is confident the licence will be renewed soon, and sales will resume once the new licence becomes available.” – Liang Lin, Chief Executive Officer.