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PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ:CTSO), a medical device company with a market capitalization of $81 million and impressive YTD returns of 42%, announced today that the U.S. Food and Drug Administration has scheduled an appeal hearing for the company’s DrugSorb-ATR device, following the FDA’s earlier denial of its De Novo marketing application. According to InvestingPro data, the company has shown strong momentum with a 57% price return over the past year.
The hearing, confirmed on June 27, is part of CytoSorbents’ supervisory review process under 21 CFR 10.75 and is expected to conclude by the end of August 2025. The company is seeking approval for its blood purification device designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting surgery within two days of stopping the blood thinner Brilinta. While the company maintains a healthy current ratio of 2.61, InvestingPro analysis indicates the company is currently burning through cash, with negative EBITDA of $14.5 million in the last twelve months.
In a separate development, Health Canada issued a Notice of Refusal for the company’s Medical Device License application on June 26, citing non-compliance with certain regulations. CytoSorbents plans to file a Request for Reconsideration with Health Canada by July 25.
"We believe DrugSorb-ATR addresses a critical and growing need in cardiac surgery," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, in the company’s press release statement. The device has previously received FDA Breakthrough Device Designation.
The DrugSorb-ATR system uses polymer technology to remove blood thinners during surgery. CytoSorbents’ flagship product, CytoSorb, is already approved in the European Union and distributed in over 70 countries, though not yet approved in the United States.
The company expects final regulatory decisions from both the FDA and Health Canada by the end of 2025. DrugSorb-ATR is not currently authorized for commercialization in the U.S. or Canada.
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 has filed an appeal with the FDA after the agency denied its DrugSorb-ATR device application. The company is seeking a supervisory review to address the deficiencies identified by the FDA.
Meanwhile, CytoSorbents’ Series B Right Warrants expired without value due to the common stock price failing to meet the required threshold. At the company’s 2025 Annual Meeting of Stockholders, five directors were elected, and the appointment of WithumSmith+Brown, PC as the independent registered public accounting firm was ratified. In other developments, CytoSorbents presented significant findings at the EuroPCR 2025 conference, demonstrating that the CytoSorb® device significantly reduced severe bleeding complications in coronary artery bypass grafting surgery. The company also noted that its DrugSorb-ATR application with Health Canada remains under review, with a decision expected in 2025.
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