CytoSorbents(US:CTSO)2025-06-23 07:47Financial Performance - Q1 2024 product sales reached approximately $9.0 million, a 14% increase from $7.9 million in Q1 2023[12, 20] - Q1 2024 product sales increased 22% sequentially from $7.3 million in Q4 2023[12] - Product gross margins for Q1 2024 were 76%, up 800 basis points from 68% in Q1 2023, excluding a one-time inventory adjustment[12, 20] - Grant revenue was $797,000 in Q1 2024, compared to $1.5 million in Q1 2023, a decrease of 48%[20] - Total revenue for Q1 2024, including product sales and grant income, was $9.8 million, compared to $9.4 million for Q1 2023, a 4% increase[20] Operational Highlights - Cumulative CytoSorb treatments exceeded 237,000 as of March 31, 2024, and are expected to reach a quarter million this year[15] - The company expects to launch the PuriFi hemoperfusion pump in select international countries in Q2 2024[15] - The company is on track to submit marketing applications for the DrugSorb-ATR system to the FDA and Health Canada in Q3 2024[12] DrugSorb-ATR and Regulatory Path - The FDA has granted two Breakthrough Device Designations for DrugSorb-ATR[30] - Regulatory experts recommend FDA submission for DrugSorb-ATR use in CABG surgery under the De Novo pathway[40] - The company is targeting parallel De Novo submission to FDA and Health Canada in Q3 2024, with FDA review potentially taking 6-12 months following submission[39, 40] STAR-T Trial - In the Isolated CABG Per Protocol group, the Severe endpoint showed a WIN Ratio of 1.59 with a p-value of 0.041[32] - Exploratory analysis of Major Bleeding showed a reduction from 22% in the control group to 6% in the DrugSorb group, with p=0.028[34]