- Osprey Medical (OSP) receives medical device licence (MDL) approval to expand its DyeVert Plus EZ and DyeVert Power XT systems into Canada’s health care market
- The technologies help physicians minimise dye usage and monitor dye dosages in heart imaging procedures in patients with poor kidney function
- Following MDL approval, Osprey has penned an exclusive four-year distribution deal with GE Healthcare Canada to commercialise its products
- The Canadian expansion follows OSP’s recent distribution deal with GE Healthcare in Europe
- Osprey shares have closed at 1.5 cents on July 20, 2021
Osprey Medical (OSP) has been granted approval for a Canadian medical device licence (MDL) to expand its trademarked DyeVert Plus EZ and DyeVert Power XT systems into Canada’s health care market.
Based in the US state of Minnesota and Melbourne, Australia, Osprey’s technologies are designed to help physicians minimise dye usage and monitor dye dosages in heart imaging procedures in patients with poor kidney function.
The company received the green light from Canada Health on the basis of “positive scientific evidence” supporting the technology’s quality, safety and efficacy in reducing contrast-induced acute kidney injury (CI-AKI).
Specifically, the company said its DyeVert portfolio was proven to reduce CI-AKI incidence by an average of 55 per cent without compromising image quality.
Osprey President and CEO Mike McCormick said the company was thrilled to receive the go-ahead.
“This approval acknowledges the efficacy and safety of our DyeVert technology in improving clinical outcomes by reducing CI-AKI rates in high-risk patients,” he said.
Following the MDL approval, Osprey has also signed an exclusive four-year distribution deal with GE Healthcare Canada to commercialise its system.
GE’s commercial manager of pharmaceutical diagnostics Luke Chrusciel commented on the partnership.
“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,” he said.
The latest deal follows Osprey’s earlier agreement with GE in Europe, which expanded its commercial portfolio across the continent, Russia, Central Asia, Turkey and the Middle East.
OSP has several sales deals in place, including that with Regional Health Care Group, to distribute its products across Australia and New Zealand.
The company uses independent sales agencies to distribute in the US.
Osprey Medical shares closed at 1.5 cents on July 20, 2021.