Osprey Medical, Inc. (ASX:OSP) has received critical European CE Marking approval for its 2ndgeneration DyeVert Power XT device.
President and CEO, Mike McCormick, said the CE Marking approval for its DyeVert Power XT device means the product can now be marketed and sold across Europe.
Mr McCormick said Europe is a core market for Osprey and a significant player in the global power injector market. The DyeVert Power XT device is expected to form a core product in the portfolio that is being commercialised by GE Healthcare.
“We are delighted to have received CE Mark approval for our Power XT device. The CE Mark is a very significant achievement as it ultimately enables Osprey to target the full coronary angiography market as our portfolio is now compatible with both automatic and manual injection methods,” he said.
“The approval was a critical building block in our European roll-out and the timing is perfect, following the strategic alliance formed with GE Healthcare in July.
“With the CE Mark ensuring a comprehensive product range, plus a recently published paper by renowned cardiologist, Dr Briguori, we are confident of a strong launch in Europe through the GE Healthcare sales force later this year.”
Mr McCormick said the main feature of the device is its compatibility with automated power injectors, thus complementing the Company’s existing DyeVert EZ product which is compatible with manual injection.
“The regulatory clearance marks a critical evolution in Osprey’s DyeVert technology, as the company now has full coverage of the coronary angiography market in Europe.
This marks another key milestone in the company’s European strategy following the exclusive distribution agreement with GE Healthcare announced on 30 July 2020,” Mr McCormick said
In addition to the CE Mark approval, an important peer reviewed manuscript was recently published by Dr Carlo Briguori, a key opinion leading heart physician in Italy. This study further validates the effectiveness of Osprey’s DyeVert technology at improving patient outcomes and lowering hospital cost. This important publication will form a key part of Osprey’s European sales strategy with GE Healthcare.