Core European Product DyeVert Power XT Receives CE Mark

Approval of DyeVert Power XT (for automatic injection) means the full coronary angiography market is now available to Osprey’s DyeVert franchise Device is expected to be a core product in the product portfolio being commercialized by GE Healthcare Publication of clinical literature supporting effectiveness of Osprey DyeVert technology by renowned cardiologist in Europe (Dr Briguori) Update on GE Healthcare Strategic Alliance

Summation

  • 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.
  • 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.

Core European Product, DyeVert Power XT has received the CE Mark. The news was announced today by Osprey Medical, Inc.

The CE Marking approval for its DyeVert Power XT device means the product can now be marketed and sold across Europe. Europe is a core market for Osprey and a significant player in the global power injector market. Our DyeVert Power XT device is expected to form a core product in the portfolio that is being commercialized by GE Healthcare.

Osprey Medical President & CEO, Mike McCormick, commented:

“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.

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 the renowned cardiologist, Dr. Briguori; we are confident of a strong launch in Europe through the GE Healthcare salesforce later this year”

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.

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