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PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ:CTSO), a $79 million market cap medical device company with a 15% year-over-year revenue growth, filed a request for supervisory review with the U.S. Food and Drug Administration on June 18 regarding the agency’s April 25 denial of its DrugSorb-ATR device, the company announced Tuesday. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 2.61, though it faces near-term cash burn challenges.
The blood purification device is designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting surgery shortly after stopping the blood thinner Brilinta. The device previously received FDA Breakthrough Device Designation. With a robust gross profit margin of 69%, the company demonstrates strong operational efficiency in its existing product lines.
According to the company, the administrative appeals process will allow CytoSorbents to engage directly with senior FDA leadership and includes a formal hearing, with a final decision typically issued approximately 60 days after filing.
"The appeals process allows us to work more directly and effectively with senior FDA leadership connecting them with the Company’s leading external experts, including cardiac surgeons," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.
The FDA’s denial letter identified deficiencies that must be addressed before the device can be authorized for U.S. commercialization. After consulting with regulatory advisors, the company determined an administrative appeal was the best path forward.
CytoSorbents also noted that its DrugSorb-ATR application with Health Canada remains under review, with a decision expected in 2025 despite regulatory backlogs.
The company’s primary product, CytoSorb, is already CE Marked in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used to date.
This article is based on a press release statement from CytoSorbents Corporation.
In other recent news, CytoSorbents Corporation reported its first-quarter 2025 financial results, revealing a larger-than-expected loss in earnings per share (EPS) and a revenue shortfall. The company’s EPS was -$0.06, missing the forecast of -$0.05, while revenue fell to $8.7 million, below the expected $10.82 million. Additionally, CytoSorbents announced that its Series B Right Warrants expired without value due to the stock price not meeting the required threshold. Meanwhile, at the company’s 2025 Annual Meeting of Stockholders, stockholders elected five directors and approved executive compensation and the appointment of WithumSmith+Brown, PC as the independent registered public accounting firm for the fiscal year. In other developments, CytoSorbents presented findings at the EuroPCR 2025 conference showing that its CytoSorb® device significantly reduced severe bleeding complications in coronary artery bypass grafting (CABG) patients. The study highlighted the device’s effectiveness and safety, with no reported device-related adverse events. These updates reflect ongoing challenges and progress as CytoSorbents navigates its financial and operational landscape.
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