What happened
Shares of Cytosorbents Corporation (CTSO +6.14%) jumped 17.3% on Tuesday, spurred higher by news that the Investigational Device Exemption (IDE) request for its DrugSorb-ATR Antithrombotic Removal system has been approved by the U.S. Food and Drug Administration, allowing clinical trials of the device to move forward.
So what
Cytosorbents' DrugSorb-ATR Antithrombotic Removal device just cleared another regulatory hurdle. Exempt from certain other steps that some medical devices must go through, the company can now begin testing the device, which allows patients undergoing heart bypass surgeries to curb the amount of blood-thinning drug ticagrelor in the bloodstream during and after the procedure. The device is to be used in conjunction with Cytosorbents' DrugSorb-ATR, which is a proprietary polymer capable of removing a variety of drugs and chemicals from the bloodstream more effectively than standard filtration technologies such as hemodialysis.
Image source: Getty Images.
Now what
The FDA has not outright approved the DrugSorb-ATR Antithrombotic Removal system. The approval only exempts the device from routine steps typically taken to launch new medical devices.
Still, it's not a surprising turn of events. A little over a year ago the FDA designated the device as a "breakthrough device," unofficially acknowledging there's a medical need for such a solution.
Given the length of the required trial and prospective market size, though -- in addition to the fact that the biotech company has so other products and research and development projects under way -- Tuesday's surge isn't a reason to step in. More than anything, it's a chance for investors not committed to Cytosorbents for the long haul to get out of their position.
