Osprey Medical (ASX:OSP) said it received FDA 510(k) clearance for its DyeVert contrast modulation system, sending shares of the company to a nearly 2-month high.
The DyeVert system automates contrast modulation during manual dye injections, self adjusting for catheter and contrast types without requiring user adjustments, Osprey said.
“With FDA Clearance of our DyeVert System, we will now gain real-world physician use to gauge market acceptance of the product’s additional automation and ease-of-use benefits,” CEO Mike McCormick said in a press release.
A trial of the DyeVert system is underway in Australia and Germany to test the ease of use and capabilities of the system, the company said. It is also developing compatability with contrast monitoring smart syringes, and expects to complete development in mid 2016.
The news has sent Osprey shares up as much as 12% to peak at 55¢ (A 75¢) today. The company’s stock is up 34% this year.
Australian Osprey Medical is developing technologies to protect patients with chronic kidney disease from contrast dye related acute kidney injury. Its primary product is the Avert plus system, designed to reduce and monitor the amount of dye used during heart and peripheral procedures.
Currently the system has limited commercialization in Texas and has full U.S. commercialization slated for later this year.
