Toronto, Ontario--(Newsfile Corp. - November 13, 2026) - NuGen Medical Devices Inc. (TSXV: NGMD) ("NuGen" or the "Company"), a developer of needle-free drug delivery technology, provides an update regarding its Canadian medical device licence for the InsuJet needle-free insulin injection system.
Further to the Company's news release dated February 5, 2026, Health Canada has issued a Notice of Refusal in respect of the Company's Class II medical device licence application no. 407982. As previously disclosed, the Company's prior Canadian medical device licence had lapsed and sales in Canada were halted while the new application was under review. Sales and further supply of InsuJet in Canada remain halted.
Health Canada determined that the clinical evidence submitted with the application was insufficient to demonstrate compliance with certain safety and effectiveness requirements under sections 11, 12 and 13 of the Canadian Medical Devices Regulations. The matters identified by Health Canada include the need for additional evidence concerning insulin-specific clinical performance, bioequivalence or alternatively evidence supporting the safety and effectiveness of insulin therapy using the device, longer-term glycemic control and safety endpoints, reliable patient self-administration, and injection performance.
The Notice of Refusal applies to the Canadian application and does not, by itself, amend the regulatory status of InsuJet in jurisdictions outside Canada. NuGen continues to maintain registrations and commercial activities in a number of markets outside Canada, subject in each case to applicable local regulatory requirements.
The Notice of Refusal does not state that InsuJet is unsafe or ineffective. It states that the evidence submitted was insufficient to demonstrate that the requirements applicable to the Canadian application and its proposed use with NovoRapid insulin had been met. Investors should not interpret this distinction as an assurance that a future Canadian application will be approved.
Canadian Market and Existing Users
Based on discussions with the Company's Canadian regulatory representative, the Notice of Refusal does not require a recall of InsuJet devices previously lawfully imported and sold in Canada while the applicable licence was active. The Company has also been advised that existing Canadian users are not required to discontinue use of devices already supplied.
Clinical Evidence and Regulatory Path Forward
NuGen intends to review the Notice of Refusal with its regulatory and clinical advisers and to continue discussions with Health Canada concerning the evidence that may be required for a future submission. Subject to available funding, final protocol design, regulatory feedback and other factors, the Company currently intends to incorporate relevant elements of Health Canada's feedback into clinical evidence-generation activities in connection with its next-generation needle-free injector platform.
Management Comment
"We are disappointed with Health Canada's decision, but the Notice of Refusal provides greater clarity regarding the additional clinical evidence required for a future Canadian application," said Liang Lin, Chief Executive Officer of NuGen. "We intend to consider these requirements as part of our planned clinical program for our next-generation needle-free technology. While sales and further supply in Canada remain halted, we remain committed to working with our regulatory and clinical partners to address Health Canada's requirements and pursue a path back to the Canadian market."
About NuGen Medical Devices
NuGen develops next-generation needle-free devices for subcutaneous drug delivery. Its flagship InsuJet system has been registered in numerous international markets and is designed to provide an alternative to conventional needle-based injections.
Websites: insujet.com | nugenmd.com
Investor Relations: IR@nugenmd.com
For further information, please contact:
Ajay Mishra,
Chief Financial 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/323903
