The new device is an upgrade which can now be marketed and sold across the company’s core market
Osprey Medical has received European regulatory approval for its second generation DyeVert Power XT device.
The CE Marking means the product can now be marketed and sold across Europe, a core market for Osprey and a significant player in the global power injector market.
The stock was up almost 12 per cent to 3.9c late on Thursday morning.
The company expects the DyeVert Power XT device to form a core product in the portfolio that is being commercialised by GE Healthcare, following the exclusive distribution agreement announced on July 30.
Osprey Medical’s products are designed to make heart imaging procedures safer for patients with poor kidney function. The amount of dye injected into patients having angiographic imaging procedures increases the patient’s risk for dye-related kidney damage known as Contrast-Induced Acute Kidney Injury (CI-AKI).
The company’s proprietary dye reduction and monitoring technologies are designed to help physicians minimize dye usage and monitor the dose of dye real time throughout the procedure.
The new device is an upgrade because it’s compatible with automated dye injectors.
The CE Mark ultimately enables Osprey to target the full coronary angiography market as our portfolio is now compatible with both automatic and manual injection methods, said Osprey Medical president and CEO Mike McCormick.
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.
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