CytoSorbents Corporation (NASDAQ: CTSO) has obtained approval of its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA). The conditional approval will allow the company to carry out a controlled pivotal trial on STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) in the US. In addition, the study will support the regulatory clearance of the newly designated DrugSorb-ATR™ Antithrombotic Removal system.
Many high-quality US clinical centers have already demonstrated their interest in participating in the STAR-T trial. The company has done the pre-screening of the clinical centers. However, it can only provide further details on the trial once it has met all the conditions for full IDE approval and within the 45-day timeframe outlined by the FDA.
The IDE Approval is a Step Forward for the Removal of Antithrombotic Drugs
The use of antithrombotic agents such as Ticagrelor while performing cardiac surgery is widespread in the US. Unfortunately, this presents a very high risk of perioperative bleeding likely to result in morbidity, mortality, and added costs. More often than not, there has to be a delay in surgery to allow wearing off the antithrombotic agent’s effects. In emergency surgery, the surgeons have to proceed with the risk of elevated bleeding hanging on their knecks.
However, the STAR-T study will evaluate whether the removal of ticagrelor has the potential of reducing bleeding complications. According to CytoSorbents’ President, Mr. Vincent Cappon, the study’s success will step towards accomplishing their commercializing strategy. It will also demonstrate the full potential clinical and cost-economic benefits of DrugSorb-ATR.
And based on the high level of excitement and engagement, the study will likely complete by 2022. Meanwhile, the Chief Medical Officer of CytoSorbents, Efthymios Deliargyris, acknowledges, “… we will continue to collaborate closely with the FDA to leverage the priority review associated with our ticagrelor removal application in the spirit of the granted Breakthrough Designation.”