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PRINCETON, N.J. - CytoSorbents Corporation (NASDAQ:CTSO), a medical device company with a market capitalization of $67.78 million and year-to-date returns of 18.68%, announced Wednesday that the U.S. Food and Drug Administration has upheld its previous denial of the company’s De Novo application for its DrugSorb-ATR device, while finding no issues with the device’s safety. According to InvestingPro analysis, the company’s current valuation appears fair based on comprehensive Fair Value calculations.
The FDA’s appeal decision, received on August 14, maintained the April 25 denial of market authorization for the blood purification device, citing the need for additional information to support the company’s desired label indication. However, the agency proactively proposed a potential path forward for market authorization of the FDA-designated Breakthrough Device. Despite regulatory challenges, InvestingPro data shows the company maintains strong liquidity with a current ratio of 2.34, indicating sufficient resources to pursue regulatory approvals.
CytoSorbents is continuing discussions with the FDA to clarify this proposal. The company also has the option to file another appeal with the Director of the FDA’s Center for Devices and Radiologic Health within 30 days, which it is currently evaluating.
"Although we are disappointed that the denial decision was upheld, we believe significant progress has been made with the resolution of the majority of outstanding issues previously raised by the FDA," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, in a press release statement.
The DrugSorb-ATR device is designed to remove blood thinners during and after cardiac surgery to reduce bleeding risk. It specifically targets ticagrelor removal in patients requiring urgent coronary artery bypass graft surgery while on the medication.
The company is also pursuing approval in Canada, where Health Canada issued a Notice of Refusal for its Medical Device License application in June. CytoSorbents has filed a "Request for Reconsideration" with Health Canada, which will proceed following completion of the FDA review process.
CytoSorbents’ lead product, CytoSorb, is already approved in the European Union and distributed in over 70 countries worldwide, with nearly 300,000 devices used to date. The company has demonstrated solid commercial traction with revenue growth of 20.18% over the last twelve months. For deeper insights into CytoSorbents’ financial health, growth prospects, and additional ProTips, investors can access the comprehensive research report available on InvestingPro.
In other recent news, CytoSorbents Corp reported its Q2 2025 earnings, which revealed a revenue of $9.6 million. This figure fell short of the forecasted $10.25 million. Additionally, the company’s earnings per share (EPS) showed a loss of $0.05, slightly exceeding the anticipated loss of $0.04. These financial results have drawn attention from investors due to the revenue miss. The earnings announcement was followed by a 1% decline in aftermarket trading, indicating investor concern. There were no reported mergers or acquisitions involving CytoSorbents during this period. Analyst firms have not provided any recent upgrades or downgrades for the company. These developments reflect the current financial standing and investor sentiment surrounding CytoSorbents.
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