Cytosorbents Corp. (CTSO) stock prices surged by 17.41% as of the market closing on July 6th, 2021, bringing the price per share up to USD$8.63 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock dip by 7.76%, bringing it down to USD$7.96.
FDA Approval of IDE Application
July 6th, 2021 saw the company announce the full approval of its Investigational Device Exemption application to support FDA regulatory clearance to conduct the STAR-T trial in the U.S. The Safe and Timely Antithrombotic Removal – Ticagrelor is a double blind, randomized, controlled trial that is being performed under the recent FDA Breakthrough Designation. The Designation was granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during critical cardiothoracic surgery using the company’s proprietary adsorption technology.
STAR-T Trial
STAR-T will enroll a maximum of 120 patients across 20 U.S clinical sites, with enrollment expected for the summer of 2021. The study’s primary endpoint will evaluate the reduction in risk of peri-operative bleeding complications arising from the use of DrugSorb-ATR in patients with ticagrelor who undergo cardiothoracic surgery, as compared to standard of care alone.
Additional Details
The trial will also facilitate the evaluation of the reduction in ticagrelor blood levels and various additional outcomes to encapsulate the comprehensive potential clinical and cost-economic benefits of the treatment. The company forecasts a completion in 2022 based on the promising activity exhibited by participating sites. CTSO plans to continue its collaboration with the FDA to leverage the priority review stemming from the granting of a Breakthrough Designation for its ticagrelor removal application.
Scope of DrugSorb-ATR
A very high risk of perioperative bleeding makes the conducting of cardiac surgery on patients that are on antithrombotic agents a major issue across all U.S cardiac surgery centers. This issue results in morbidity, mortality, as well as higher costs, thus proving a major problem for patient management by cardiac surgeons around the world. Currently, surgery needs to be delayed until the effects of antithrombotic agents wear off or, in cases of extreme urgency, surgery is conducted regardless of the elevated bleeding risk.
Future Outlook for CTSO
Armed with the approval and support of the FDA for its flagship treatment, CTSO is poised to push for the commercialization and proliferation of DrugSorb-ATR. Investors are hopeful that the company will be able to leverage its resources to accelerate the development of the treatment, resulting in substantial and sustained increases in shareholder value.
