Osprey Medical Inc. (ASX:OSP) has expanded into the Canadian market with Medical Device License (MDL) approval and an exclusive distribution agreement with GE Healthcare Canada Inc.
Osprey recently received approval from Health Canada for a Medical Device License (MDL) for the DyeVert Systems. This MDL was approved as the DyeVert technology has positive scientific evidence that supports its quality, safety, and efficacy in reducing Contrast Induced Acute Kidney Injury (CI-AKI).
The DyeVert portfolio reduces the amount of contrast dye used in heart imaging procedures and has been proven to reduce CI-AKI by on average 55% without compromising image quality1-8 .
We are thrilled the DyeVert portfolio has received MDL approval from Health Canada,” says Osprey’s President and CEO, Mike McCormick.
“This approval acknowledges the efficacy and safety of our DyeVert technology in improving clinical outcomes by reducing CI-AKI rates in high-risk patients.”
The MDL approval mirrors the FDA approval process in the US and provides Osprey with the opportunity to distribute in Canada with the approval of Health Canada.
Following on from this approval, Osprey has signed an exclusive 4-year distribution agreement with GE Healthcare Canada Inc. for commercialisation of the DyeVert System in Canada.
Luke Chrusciel, Commercial Manager, Pharmaceutical Diagnostics, GE Healthcare Canada Inc commented on the agreement. “GE Healthcare Canada are pleased to be partnering with Osprey Medical to exclusively distribute the DyeVert technology in Canada.” “
The product portfolio has shown great efficacy in improving patient outcomes which continues to be a main focus for us, so this agreement highlights the aligned goals of both GE Healthcare Canada and Osprey Medical.”
This agreement follows the GE Healthcare agreement in Europe, which expanded global commercialisation of Osprey’s product portfolio in Europe, Russia, Middle East, Africa, Central Asia and Turkey.
Osprey has several sales agreements in place including Regional Health Care Group to distribute across Australia and New Zealand and utilises several Independent Sales Agency agreements for distribution across the US.