Prnewswire·2026-01-12 12:00Financial Results - Fourth quarter 2025 revenue is expected to be approximately $9.2 million, consistent with the fourth quarter of 2024 [5] - Full-year 2025 revenue is expected to be approximately $37.0 million, representing a growth of about 4% compared to $35.6 million for full-year 2024 [5] - Fourth quarter gross margin is expected to be in the range of 73% to 75%, an increase from 71% in the fourth quarter of 2024 and 70% in the third quarter of 2025 [5] - Full-year gross margin is expected to be approximately 72%, compared to 71% for full-year 2024 [5] Business Updates - The pivotal STAR-T study results for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, indicating the clinical relevance of the technology [4][5] - A Pre-Submission Meeting with the FDA is scheduled for this month to discuss the upcoming De Novo Application for DrugSorb®-ATR, with a filing expected by the end of Q1 2026 [4][5] - The company has surpassed 300,000 cumulative CytoSorb treatments worldwide, demonstrating the widespread use of its technology in critical care [6] Strategic Initiatives - The company amended its credit agreement to strengthen its balance sheet, adding $2.5 million in cash and extending the interest-only period through December 31, 2026 [5][6] - A strategic workforce and cost reduction program has been implemented, with expectations to achieve cash-flow breakeven (excluding restructuring payments) in the first quarter of 2026 [6] - Management will host in-person investor meetings during the J.P. Morgan Healthcare Conference in San Francisco [6]