- Osprey Medical (OSP) has received CE Marking approval for its second-generation DyeVert Power XT device
- This approval means the product can now be marketed and sold across Europe, which aligns with the company’s strategy
- The original DyeVert System reduces the amount of dye used during medical imaging without compromising image quality, while the latest feature is compatible with automated power injectors
- Monitoring the amount of dye used is important in reducing a patient’s risk for dye-related kidney damage
- A recently published study by Dr Carlo Briguori found a 38 per cent dye reduction in patients who received DyeVert compared to the no-DyeVert group
- Company shares are up 8.57 per cent and trading for 3.8 cents
Osprey Medical (OSP) has received CE Marking approval for its second-generation DyeVert Power XT device.
This approval means the product can now be marketed and sold across Europe, which strongly aligns with Osprey’s strategy to target the continent — a major player in the global power injector market.
“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 method,” President and CEO Mike McCormick said.
The original DyeVert System reduces the amount of dye (or contrast) while maintaining image quality in a self-adjusting, easy-to-use design that monitors dye usage.
Monitoring the usage is critical, as the amount of dye used during medical imaging procedures increases the patient’s risk for dye-related kidney damage. This damage is known as contrast-induced acute kidney injury (CI-AKI).
The main feature of the new device is its compatibility with automated power injectors.
This marks another important milestone in Osprey’s European strategy following the four-year distribution agreement with GE Healthcare, which was announced last month.
The exclusive deal means GE Healthcare can distribute Osprey’s products across Europe, Russia, the Middle East, Africa, Central Asia and Turkey.
“With the CE Mark ensuring a comprehensive product range, plus a recently published paper by renowned cardiologist, Dr [Carlo] Briguori we are confident of a strong launch in Europe through the GE Healthcare salesforce later this year,” Mike stated.
Dr Carlo Briguori recently published a peer-reviewed study which trialled 339 patients who hadn’t received DyeVert compared to 112 patients who did receive DyeVert.
The study found a 38 per cent dye reduction in the DyeVert group compared to the no-DyeVert group, as well as 58 per cent acute kidney injury reduction in the DyeVert group compared to the no-DyeVert group.
This publication forms a key part of Osprey’s European sales strategy with GE Healthcare.
Company shares are up 8.57 per cent and trading for 3.8 cents each at 11:41 am AEST.