CE Marking Received for Osprey Medical’s DyeVert Power XT Device

Osprey Medical Inc. has received CE Marking for the DyeVert Power XT 2nd generation device.
 
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 commercialised by GE Healthcare.
 
Osprey Medical President and 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 renowned cardiologist, Dr Briguori; we are confident of a strong launch in Europe through the GE Healthcare sales force 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 this past summer.
 
In addition to the CE Mark approval, recently an important peer reviewed manuscript was 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.
 
Some of the key findings from this paper included: 

Study Design

• Patients studied had heart attacks (STEMI and NSTEMI)
• Three hundred thirty-nine control patients (no-DyeVert) were compared to 112 patients who received DyeVert
• Hydration (IV fluid administration) protocol was the same in both DyeVert and no-DyeVert
• Observed, retrospective, propensity matched study in a single center in Naples, Italy
   

Results

• Thirty-eight percent dye reduction in the DyeVert group compared to the no-DyeVert group
• Fifty-eight percent Acute Kidney Injury reduction in the DyeVert group compared to the no-DyeVert group
• Twenty-five percent reduction in hospital length of stay in the DyeVert group compared to the no-DyeVert group

 
Osprey forged an exclusive agreement with GE Healthcare to distribute its products across Europe, Russia, Middle East, Africa, Central Asia, and Turkey (‘the Region’). Osprey can now provide some guidance on the agreement which is significant to Osprey. Relevantly, the agreement is expected to contribute materially to Osprey’s revenue over the four-year contracted period. Previously, the company’s operations were primarily in the United States with sales outside the United States (OUS) contributing an immaterial amount to group revenues. This agreement represents a significant shift for the company and means that OUS sales will now contribute materially to Osprey’s group revenues and complement the existing growth of sales generated within the United States.
 
Under the contract with GE Healthcare, there are prescribed minimum order quantities increasing each year with further upside when sales exceed these quantities. Conservatively, under the minimum order quantities agreed, the distribution agreement is expected to add +20 percent to Osprey’s total expected revenues in 2021 with this expected to scale in importance each year, reaching +40 percent by the fourth year. Additionally, under the contract, transfer prices for all products are fixed over the four-year period whereby Osprey will experience margin certainty during the contract period.