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PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ: CTSO), a $63 million market cap medical device company known for its blood purification therapies, has received a denial letter from the U.S. Food and Drug Administration (FDA) for its De Novo Request for DrugSorb-ATR. The news has contributed to a nearly 13% decline in the company’s stock price over the past week, according to InvestingPro data. The device, designed to reduce bleeding in patients undergoing coronary artery bypass grafting (CABG) soon after stopping the antiplatelet drug Brilinta®, has not met all the regulatory requirements for commercialization in the United States.
On April 25, 2025, the FDA outlined deficiencies that need resolution before the device can be authorized for market entry. CytoSorbents has engaged in discussions with the FDA to address these issues. If unresolved, the company plans to file a formal appeal within 60 days.
Dr. Phillip Chan, CEO of CytoSorbents, expressed the company’s commitment to making DrugSorb-ATR available, citing the absence of alternative therapies in the U.S. for the large number of patients at risk of life-threatening bleeding post-Brilinta® treatment. The company still anticipates a final regulatory decision within the year.
CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and used in over 70 countries. The technology, based on polymer beads, removes toxic substances from blood and is utilized in various critical care applications. While CytoSorb is not yet approved in the United States, the company has achieved impressive revenue growth of 14.5% over the last twelve months, with a robust gross margin of 70.6%. For deeper insights into CytoSorbents’ financial health and growth prospects, including additional ProTips and comprehensive analysis, visit InvestingPro.
The DrugSorb-ATR system, similar in technology to CytoSorb, aims to reduce perioperative bleeding in patients on antithrombotic drugs and has received FDA Breakthrough Device Designations for removing ticagrelor and direct oral anticoagulants during urgent cardiothoracic procedures. Despite this, the device awaits marketing authorization in the U.S. and Canada.
This news is based on a press release statement from CytoSorbents Corporation.
In other recent news, CytoSorbents Corporation reported its fourth-quarter 2024 earnings, surpassing expectations with a smaller-than-expected earnings per share (EPS) loss of $0.03 compared to the forecasted loss of $0.05. However, the company fell short on revenue, reporting $9.15 million against an anticipated $10.25 million. CytoSorbents also secured $1.7 million through the New Jersey Technology Business Tax Certificate Transfer Program, which will support the launch of DrugSorb™-ATR in the U.S. and Canada and expand manufacturing capabilities. Additionally, the company announced an extension of its Series B Right Warrants expiration to June 10, 2025, allowing more time for warrant holders to exercise their rights. Despite challenges in the German market, CytoSorbents saw a 25% year-over-year increase in product revenue for the quarter, driven by strong international sales. The company aims for near cash flow breakeven by the end of 2025 and is preparing for potential regulatory approvals of DrugSorb™-ATR. CytoSorbents is actively working with the FDA and Health Canada, expecting decisions on DrugSorb™-ATR in 2025. The company continues to focus on strategic initiatives to strengthen its financial position and expand its market presence.
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