Medical Device Regulatory Approval

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CytoSorbents(CTSO) - 2024 Q2 - Earnings Call Presentation
2025-06-23 07:47
Financial Performance - Total revenue in Q2 2024 increased by 5% to $9.9 million compared to $9.4 million in Q2 2023[10, 20] - Product sales in Q2 2024 increased by 10% to $8.8 million compared to $8.1 million in Q2 2023[10, 20] - Operating loss in Q2 2024 decreased by 48% to $3.4 million from $6.6 million[10] - For the first half of 2024, total revenue increased by 4% to $19.7 million compared to $18.9 million in the first half of 2023[21] - Product sales for the first half of 2024 increased by 12% to approximately $17.8 million compared to $16.0 million in the same period last year[21] - The company's cash balance at the end of Q2 2024 was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash[10] Operational Highlights - Over a quarter million CytoSorb devices have been cumulatively delivered to date[10] - The company completed additional cutbacks, expected to save an additional $5 million in expenses going forward, and decreased the workforce by 17% over the past 5 months[10] - The company secured an additional $20 million credit facility with Avenue Capital Group[10] Regulatory and Clinical Developments - The company is on track to submit marketing applications for the investigational DrugSorb-ATR system to FDA as a De Novo application and Health Canada in Q3 2024[15] - Data from the STAR Registry was presented at EuroPCR 2024 and was selected as a top 5 finalist in the best scientific abstract competition[15] - Real-world data from the STAR Registry showed a 44% lower rate of severe bleeding (UDPB 3) with CytoSorb compared with the E-CABG Registry when TLD is less than 24 hours, and an 80% lower rate when TLD is between 24-72 hours[37]