Voyageur Pharmaceuticals Ltd. (TSX-V: VM)(OTC Pink: VYYRF) announced independent laboratory test results confirming that its barium sulfate active pharmaceutical ingredient (API), sourced from the Frances Creek barite property in British Columbia, meets pharmaceutical-grade purity standards. The testing, conducted by SGS Laboratories in Mississauga, Ontario, showed %BaSO4 assay results ranging from 98.1% to 99.4%, surpassing the USP monograph requirement of 97.5%, with an average grade of 98.8%. All samples passed the complete suite of USP monograph tests, including identification, pH, loss on drying, limit of soluble barium salts, acid-soluble substances, sulfides, and microbiological requirements. Elemental impurities testing showed heavy metal levels significantly lower than USP specifications. Additionally, the processed barite achieved 1-micron and 10-micron particle sizes, with excellent flowability, 100% yield, and no discoloration or contamination.
These results were completed as part of the Alberta Innovates AICE-Market Access Program, previously announced on February 5 and March 4, 2025. Voyageur anticipates completing the first stage of this project by manufacturing batches of new product using Frances Creek barium sulfate, then moving to stage two, which unlocks additional non-dilutive funding. The company believes the upcoming patient trial may confirm a path to commercial use of natural barium sulfate API, potentially replacing synthetic products with higher quality, lower cost imaging agents.
Brent Willis, CEO of Voyageur, stated, “These results are promising and represent a major de-risking milestone. We believe we have proven that our natural barite resource delivers high chemical purity, ideal particle size after micronization, and full USP compliance. The upcoming clinical trial in patients is the final bridge to using our Frances Creek API in our Health Canada-approved contrast products.” He added that this brings the company significantly closer to a fully integrated, secure, and cost-effective North American supply chain for barium contrast media.
With this milestone, Voyageur is set to advance to stage two of the Alberta Innovates program, following completion of manufacturing its barium contrast agents for the clinical trial. The trial, designed by Chief Scientific Officer Dr. Iryna Saranchova in accordance with Health Canada standards, will compare the functional effectiveness of Voyageur’s contrasts with current standard-of-care options for gastrointestinal Computed Tomography and fluoroscopic imaging. By evaluating both barium-based and iodinated oral contrasts, the trial is expected to provide a comprehensive assessment of the company’s products’ performance, ensuring results are clinically meaningful and aligned with Health Canada, FDA, and other international regulatory expectations.
Successful study outcomes are expected to validate clinical performance, strengthen regulatory positioning, and accelerate market adoption. Full study completion is targeted for the fourth quarter of 2026. The clinical trial results will also support the company’s FDA licensing applications, beginning in the first quarter of 2026, and contribute to the prefeasibility and final feasibility study for the Frances Creek project, expected by the fourth quarter of 2026.
By developing this domestic resource, Voyageur is building a fully integrated supply chain from quarry to finished contrast media, reducing reliance on imported or synthetic materials while improving cost efficiency and supply reliability for hospitals and patients. The company also announced the issuance of 378,651 Deferred Share Units (DSUs) to directors and a consultant, and 4,300,000 stock options to directors and officers, as well as a proposed issuance of units for debt to an arm's length third party, subject to TSX Venture Exchange approval. For more information, visit https://voyageurpharmaceuticals.ca.
