expanding the mining operation and product manufacture.
Voyageur has finished its initial test batch of barium contrast media in collaboration with its production partner, Alberta Veterinary Laboratories / Solvet. Voyageur is now evaluating this initial batch clinically to assure its quality and functionality. Voyageur’s aim is to finish testing and commercialize the product in Canada by February, followed by a marketing effort aimed at the Canadian radiology market.
Voyageur’s short-term aim is to build a portfolio of computed tomography products, with SmoothX barium contrast serving as the main offering. The FDA and Voyageur are presently collaborating to develop a novel regulatory approach for device registration. Voyageur plans to submit its device application shortly after the FDA approves the revised rules. On reaching every single milestone, Voyageur will keep the public informed of FDA progress.
Voyageur intends to enter the US market following the conclusion of FDA device licensing in 2022. Simultaneously, Voyageur is working on a drug dossier for overseas markets including the European Union, United Kingdom, and Japan that regulate barium sulfate as a medicine. Voyageur’s goal is to gain regulatory files for SmoothX in the UK, EU, and Japan by the end of 2022 or early 2023, as well as to begin worldwide market penetration. Simultaneously, Voyageur is conducting several batch tests on its product to ensure that it complies with FDA and EU regulatory criteria for licensing requirements. This work is closely linked to the FDA and EU regulatory approval processes.
