Voyageur Pharmaceuticals Ltd (TSX-V:VM, OTC:VYYRF) announced that it has commenced human testing of its barium contrast product line, marking a key step toward its anticipated market launch later this year.
Shares of the company surged on the news, adding almost 18% late morning on Monday.
The products being evaluated- SmoothLD, SmoothHD, VisionHD, VisionLD, and VGas – are advanced formulations designed to enhance radiology imaging for gastrointestinal examinations, the company said in a statement.
This follows the completion of testing for the SmoothX product.
The testing is structured in two phases. Phase one, currently underway, will assess the clinical, operational, and patient-centered performance of the products over the first quarter of 2025. Metrics being tested include imaging quality, diagnostic yield, and patient satisfaction.
Any necessary refinements will be made before releasing the products to the Canadian market.
Phase two, scheduled to begin in Q2 2025, will focus on gathering data for US Food and Drug Administration (FDA) licensing.
This phase will emphasize clinical safety, efficacy, pharmacokinetics, and regulatory compliance, enabling the company to expand its reach to international markets.
“We have begun a pivotal milestone after over a year and a half of formulation and development work,” Voyageur Pharmaceuticals CEO Brent Willis said.
“With successful results, we can begin to roll out our full suite of products to the Canadian market to relieve the supply chain constraints and opening the markets to diversification. This product launch will also allow our company to begin penetrating the international markets that accept Health Canada standards.”
- Updated with share price movement -