The Osprey Medical Inc (ASX: OSP) share price is today surging higher after it was announced that the company has received European CE Marking approval for its core European product.
At the time of writing, the Osprey Medical share price is up 8.57% to 3.8 cents.
What Osprey Medical does
Osprey Medical aims to make heart imaging procedures safer for patients with poor kidney function. The company's core technologies originated from research conducted by Dr David Kaye at Melbourne's Baker Institute. Its proprietary dye reduction and monitoring technologies are designed to help physicians minimise dye usage and monitor the dose levels of dye real time throughout the procedure.
Osprey's flagship product is its DyeVert system. The company recently announced a strategic alliance with US giant GE Healthcare to distribute the product.
What does the approval mean?
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. The 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 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," he added.
Clinical and operations update
In addition to the CE market approval, an important peer-reviewed manuscript was published by Dr Carlo Briguori. This study further validates the effectiveness of Osprey's DyeVert technology at improving patient outcomes and lowering hospital cost.
The Osprey Medical share price was also driven higher following an update on the partnership with GE Healthcare. Osprey has confirmed the agreement is expected to contribute materially to Osprey's revenue over the 4-year contracted period. The deal also aids increased diversification for the company as it adds to the company's sales outside the US. Under the agreement, Osprey's products will be distributed across Europe, Russia, the Middle East, Africa, Central Asia and Turkey.
The Osprey Medical share price has been on a tear since the announcement of its agreement with GE Healthcare and is currently up 280% since its lows in late July. However, the company is still suffering at the hands of COVID-19 and seeing material declines in sales revenues. Despite this, Osprey is still poised for growth, as the deal is forecast to add 40% in revenue by 2024.