Voyageur Completes Human Testing of Barium Contrast Products and Prepares for Canadian Market Launch

April 1, 2025 (Source) — Voyageur Pharmaceuticals Ltd. (TSX.V:VM) (OTC Pink:VYYRF) (“Voyageur” or the “Company“) is pleased to announce the successful completion of a key phase in human testing of its Health Canada-licensed barium contrast media product suite. This milestone paves the way for Voyageur’s upcoming product launch across the Candain market.

A total of 24 test subjects participated in the phase one program, which involved oral administration of Voyageurs contrast agents, followed by diagnostic imaging procedures. Four of Voyageur’s licensed barium contrast media products (SmoothLD®, SmoothHD®, VisionHD®, and VisionLD®) were used in these evaluations. The images generated are currently undergoing final analysis by Voyageurs team of radiology experts and its Scientific Advisory Board, who are assessing both quantitative and qualitative imaging performance, including diagnostic clarity and overall image quality.

Final performance review is expected to be completed within 30 days. Following this, Voyageur will begin market testing and initial commercial sales in Canada. Discussions are also underway with international distribution partners in jurisdictions that recognize Health Canada licensed medical products.

Upon Canadian market entry, Voyageur will initiate phase two testing to support FDA licensing under the 505(2)(b) pathway. This next phase will generate clinical and operational data focused on key performance indicators, including safety, efficacy, pharmacokinetic, pharmacodynamics, regulatory compliance and market readiness.  

Voyageur’s proprietary contrast media formulations are engineered to deliver superior image clarity for gastrointestinal radiographic procedures across adult and pediatric populations. The Company’s focus on innovation, image quality and patient safety positions it as a key player in the evolving global contrast media market.

Diagnostic centres interested in integrating Voyageur’s next generation barium contrast media products into their imaging programs are encouraged to contact Ethan Mohan at [email protected].

About Voyageur Pharmaceuticals Ltd.

Voyageur, a Canadian public company trading under the symbol VM on the TSXV, is in development of barium and iodine Active Pharmaceutical Ingredients (API) that offer high-performance and cost-effective imaging contrast agents. With a strategic focus on vertically integrating the barium and iodine contrast markets, Voyageur aims to become a key player by producing its own barium and iodine. In addition, Voyageur is pursuing the development of new endo fullerene drugs.

Voyageur’s business plan is set to generate cash flow by partnering with established third-party GMP pharmaceutical manufacturers in Canada thereby ensuring the validation of its products by regulatory agencies worldwide. As Voyageur solidifies its presence in the market, it plans to transition into a high-margin domestic manufacturer of radiology drugs.

Voyageur is committed to sustainability and environmental stewardship. Voyageur envisions a future where reducing carbon emissions is the norm, and to achieve this, it will build state-of-the-art carbon-capture infrastructure utilising the Rain Cage EDEN^TM system. By investing in carbon capture energy sources and sustainable manufacturing practices, Voyageur aims to generate revenue from carbon captured “advanced carbon production”. Voyageur’s unwavering commitment to the environment sets it apart as a pioneer in the industry.

At the core of its operations, Voyageur owns a 100% interest in the Frances Creek barium sulphate (barite) project. Currently, the worlds pharmaceutical barium sulphate is almost entirely synthetically produced resulting in a less effective imaging quality product. Voyageur’s Frances Creek resource boasts a rare and exceptional grade mineral suitable for the pharmaceutical marketplace that Voyageur believes will replace the current synthetic products with higher quality imaging products.

Voyageur’s ambitious vision is to become the first vertically integrated company in the radiology contrast media drug market. By controlling all primary input costs, from the sourcing of raw materials to final production, Voyageur believes it can ensure quality and cost efficiency. With its approach, it embodies the motto of “From the Earth to the Bottle,” highlighting Voyageur’s commitment to responsible sourcing and manufacturing practices.

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Cautionary Statement Regarding “Forward-Looking” Information

This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to: the successful completion of clinical testing; Canadian, FDA and other regulatory approvals; and the effectiveness, efficiency and market acceptance of the five barium contrast drugs and one gas agent. All statements included herein, other than statements of historical fact, are forward-looking information and such information involves various risks and uncertainties. There can be no assurance that such information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such information. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR+ website at www.sedarplus.ca. Voyageur does not undertake to update any forward-looking information except in accordance with applicable securities laws.