Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents (NASDAQ: CTSO) reported Q2 2025 financial results showing revenue growth of 9% to $9.6 million compared to Q2 2024, primarily driven by 22% growth in Germany. The company achieved a net income of $1.9 million ($0.03 per share) versus a net loss in Q2 2024, while maintaining a gross margin of 70.9%.

Key developments include an FDA appeal hearing for DrugSorb™-ATR, with a final regulatory decision expected in 2025, and continued work with Health Canada following their Notice of Refusal. The company's cash position stands at $11.7 million as of June 30, 2025. Management expects to approach breakeven operations by the end of 2025 through improved execution and cost control measures.

The company announced an upcoming World Sepsis Day Global Webinar on September 10, 2025, highlighting CytoSorb's role in treating sepsis and septic shock, supported by recent positive clinical studies and meta-analyses showing significant mortality reduction.

CytoSorbents (NASDAQ: CTSO) highlights significant advancements in treating sepsis and septic shock using their CytoSorb® blood purification therapy. Recent studies demonstrate that early and intensive CytoSorb treatment substantially improves patient outcomes. Key findings include 74% 90-day survival rate in COVID-19 patients on CytoSorb and ECMO, and nearly doubled survival rates (70% vs. 37% predicted) in septic shock patients with early treatment.

The first meta-analysis of 744 septic shock patients showed significant improvements in survival, with CytoSorb reducing in-hospital mortality and halving 28-30 day mortality. The therapy works by removing toxic substances from bloodstream, controlling inflammation, and addressing multiple aspects of septic shock, complementing traditional antibiotic treatment.

CytoSorbents (NASDAQ: CTSO), a company specializing in blood purification for intensive care and cardiac surgery, has scheduled its Q2 2025 earnings release for August 7, 2025 after market close.

The company will host a conference call and webcast at 4:30 PM ET on the same day, featuring management presentations and a Q&A session. Participants can join via North American toll-free (1-800-836-8184) or international toll (1-646-357-8785) numbers.

CytoSorbents (NASDAQ: CTSO) provided regulatory updates regarding DrugSorb-ATR, its FDA-designated Breakthrough Device, in both the U.S. and Canada. The FDA has scheduled an appeal hearing for the company's supervisory review, expected to complete by August 2025.

In Canada, Health Canada issued a Notice of Refusal for the Medical Device License application. CytoSorbents plans to file a Level 1 "Request for Reconsideration" by July 25, 2025. DrugSorb-ATR is designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping Brilinta®. The company expects final regulatory decisions from both authorities by year-end 2025.

CytoSorbents (NASDAQ: CTSO) has filed an administrative appeal with the FDA for supervisory review of its DrugSorb-ATR Device De Novo request denial. The appeal was filed on June 18, 2025, following the FDA's denial letter from April 25, 2025. DrugSorb-ATR, a Breakthrough Device Designation recipient, aims to reduce bleeding severity in patients undergoing CABG surgery within two days of stopping Brilinta®.

The administrative appeals process includes a formal hearing with FDA's CDRH upper management, with a decision expected within 60 days of filing. Simultaneously, the company's application with Health Canada remains under advanced review, with a final regulatory decision expected in 2025.

CytoSorbents Corporation (NASDAQ: CTSO), a company specializing in blood purification for critical care and cardiac surgery, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The event will take place in New York on June 4-5, 2025. Management will conduct a presentation on Thursday, June 5, 2025, at 9:20 AM ET and hold one-on-one meetings with investors. The presentation will be available via live webcast and archived for up to 90 days on the company's website under the Investors section.

CytoSorbents Corporation (NASDAQ: CTSO) presented new real-world data at EuroPCR 2025 demonstrating significant benefits of their blood purification technology. The study compared 150 patients from the STAR Registry using CytoSorbents' device to 644 control patients during urgent CABG surgery while on ticagrelor. Key findings showed remarkable reductions in bleeding complications: BARC-4 severe bleeding (10.7% vs 33%, p<0.001), large transfusion events (6% vs 27%, p<0.001), and re-operations for bleeding (4% vs 9.6%, p=0.02). The device showed no adverse events, proving both safe and effective in removing ticagrelor from blood during cardiac surgery. The study included patients from 28 sites across 6 European countries, with comparable baseline characteristics between groups including age, acute coronary syndrome presentation, and perioperative risk.

CytoSorbents (NASDAQ: CTSO) reported its Q1 2025 financial results, showing product revenue of $8.7M, down 3% from Q1 2024. The company posted a net loss of $1.5M ($0.02 per share), improved from $6.1M loss in Q1 2024. Operating loss improved 17% to $3.9M, with gross margin at 71%. The company raised $6.8M through a Rights Offering and ended Q1 with $13.1M in cash. Key developments include expansion into Middle East/Africa with a new Dubai subsidiary and FDA's denial of DrugSorb-ATR De Novo Request, which the company plans to address through formal appeal process. Management remains confident in receiving regulatory decisions for DrugSorb-ATR in both US and Canada during 2025, while focusing on improving German sales performance through commercial team reorganization.

CytoSorbents Corporation (NASDAQ: CTSO) received a denial letter from the FDA on April 25, 2025, regarding its De Novo Request for DrugSorb-ATR, a breakthrough device designed to reduce bleeding severity in coronary artery bypass grafting (CABG) patients who recently stopped taking Brilinta®. The FDA identified remaining deficiencies that need to be addressed before authorization.

The company has met with the FDA and will continue discussions to resolve the issues. If no resolution is reached, CytoSorbents plans to file a formal appeal within 60 days. Despite this setback, the company remains confident in obtaining a final regulatory decision in 2025 for this device, which addresses an unmet medical need affecting tens of thousands of U.S. patients annually.