Osprey Medical (ASX:OSP) announced that it received CE Mark approval in Europe for its DyeVert Power XT second-generation device.
Upon yesterday’s announcement of the regulatory milestone, shares of OSP jumped up nearly 8.6%. However, today, they are trading down -5.3% at 4¢ per share in mid-afternoon trading.
Approval allows Osprey to market and sell its DyeVert Power XT device, which is designed to reduce contrast while maintaining image quality in a self-adjusting, easy-to-use design that monitors dye usage, according to a news release.
Last month, GE Healthcare (NYSE:GE) announced that it will exclusively distribute the DyeVert portfolio, which aligns with GE’s iodinated X-ray contrast media to offer a technology platform to address acute kidney injury (AKI) following interventional coronary angiograms in patients with chronic kidney disease (CKD).
“We are delighted to have received CE Mark approval for our Power XT device,” Osprey president & CEO Mike McCormick said in the release. “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. 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.”