Core Viewpoint - CytoSorbents Corporation has filed a request for supervisory review with the FDA regarding the De Novo Denial Letter for its DrugSorb-ATR Device, which aims to reduce bleeding severity in CABG surgery patients on Brilinta® [1][2][7] Group 1: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5] - The company's proprietary technologies utilize biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including sepsis and organ failure [5][6] - CytoSorbents' lead product, CytoSorb®, is CE Marked in the EU and has been used over 270,000 times globally [6] Group 2: Regulatory Developments - The FDA issued a De Novo Denial Letter on April 25, 2025, citing deficiencies that must be resolved before the DrugSorb-ATR can be authorized for U.S. commercialization [2][7] - The company has engaged with the FDA to clarify these deficiencies and believes that the supervisory review process will effectively address the concerns [2][4] - The appeals process typically results in a final decision approximately 60 days after filing, with the company optimistic about receiving a regulatory decision in 2025 [3][7] Group 3: Market Context - DrugSorb-ATR is designed to mitigate perioperative bleeding in patients undergoing high-risk surgeries while on antithrombotic medications [7] - The application for DrugSorb-ATR is also under advanced review by Health Canada, with the agency committed to issuing a decision despite current delays [4][7]

Financial Performance - Total revenue for 2023 was $36.3 million, a 5% increase compared to $34.7 million in 2022[39] - CytoSorb product sales were $31.0 million in 2023, a 9% increase from $28.6 million in 2022[39] - Q4 2023 total revenue decreased by 8% to $8.7 million compared to $9.4 million in Q4 2022[42] - Q4 2023 CytoSorb sales decreased slightly by 1% to $7.3 million compared to $7.4 million in Q4 2022[42] - The company has $15.6 million in cash as of December 31, 2023, which is expected to fund operations into the fourth quarter of 2024[43] Operational Highlights - Over 228,000 cumulative CytoSorb treatments have been delivered as of the end of 2023, a 17% increase from the end of 2022[9] - International Direct sales experienced strong growth of 27% to $6 million (19% product sales)[23] - The company expects to launch its new PuriFi pump later this year, following the expiration of the distribution agreement with Nikkiso Europe GmbH in September 2023[12] DrugSorb-ATR and STAR-T Trial - The pivotal STAR-T RCT was selected for a Breakout Presentation at the American Association of Thoracic Surgery (AATS) Annual Meeting[13, 17] - The company plans to submit for regulatory approval of DrugSorb-ATR to the U S FDA and Health Canada in the second half of 2024[13, 17] - The initial U S & Canada Total Addressable Market for Brilinta removal is estimated at $325 million, with a potential of $650 million[18, 19] Product Pipeline and Expansion - The company has received ~$50 million in grants, contracts, and other non-dilutive funds since 2003 for its technology[24] - VetResQ, bringing CytoSorb to veterinary medicine, had a limited but successful launch in 2023, with plans for an integrated all-in-one solution in 2024[33] - HemoDefend-BGA aims to create "universal plasma" and has received over $17 million in funding from the U S Department of Defense[37]

Financial Performance - CytoSorbents' product revenue in Q3 2024 reached $8.6 million, showing an 11% year-over-year growth[16] - The company's operating expenses decreased by 25% year-over-year in Q3 2024[16,51] - The operating loss was reduced by 40% year-over-year[16,51] - Cash burn was reduced to $2.7 million in Q3 2024, down from $5 million in Q2 2024[16,54] - As of September 30, 2024, the company had $12.2 million in cash, including $6.5 million of restricted cash and $5.7 million in unrestricted cash[57] DrugSorb-ATR Regulatory and Clinical Updates - DrugSorb-ATR, an investigational device, has been submitted to the FDA and Health Canada, with regulatory decisions expected in 2025[12,21] - The company submitted a De Novo medical device marketing application to the FDA on September 27, 2024, which was accepted in October 2024[22] - In isolated CABG patients, the intraoperative use of DrugSorb-ATR was associated with reduced bleeding severity[20] - Real-world evidence from an additional 102 CABG patients on Brilinta suggests that the guideline-recommended washout period of a minimum of 72 hours may be substantially shortened with CytoSorb and DrugSorb-ATR[23] Market Opportunity - The company estimates an initial market opportunity of over $300 million for Ticagrelor removal in CABG in the U S and Canada[31]

Financial Performance - Q1 2025 product sales were $8.7 million, a 3% year-over-year decrease, but flat on a constant currency basis[18] - Product gross margin was 71% in Q1 2025, consistent with the average from 2024[18] - Total operating expenses decreased by 12% year-over-year, from $11.5 million to $10.1 million[50] - Net loss improved by 17% year-over-year, from $6.1 million ($0.11/share) to $1.5 million ($0.02/share)[50] DrugSorb-ATR Regulatory Update - The company submitted a De Novo submission to the FDA and a Medical Device License application to Health Canada, but received a denial letter from the FDA on April 25, 2025[36] - The company plans to file a formal appeal within 60 days of the FDA letter[36] - Health Canada submission is in advanced review, with a decision expected in 2025[36] DrugSorb-ATR Market Opportunity - DrugSorb-ATR addresses a $300+ million initial market opportunity, which could exceed $1 billion as Brilinta becomes generic and DrugSorb-ATR expands to additional indications[33] CytoSorb Core Business - Core product sales reached a record $35.6 million in 2024[14] - The company aims to return Germany to growth in the second half of 2025 after flat sales for two consecutive years[18] - The company is managing its total core business toward near breakeven in the second half of 2025[18] Balance Sheet - The company received $6.8 million from a successful Rights Offering[51] - The company released $5.0 million of restricted cash[51] - The company had $13.1 million in cash, cash equivalents, and restricted cash at March 31, 2025[51]

Core Viewpoint - CytoSorbents Corporation has extended the expiration date of its Series B Right Warrants from April 10, 2025, to June 10, 2025, allowing more time for warrant holders to exercise their rights [1] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4] - The company’s proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids [4] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and distributed in over 70 countries, with more than 250,000 devices used cumulatively [5] Product and Technology Details - CytoSorb® is designed for applications such as removing blood thinners during cardiothoracic surgery and inflammatory agents in critical illnesses like sepsis and liver failure [4] - The company is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [6] - CytoSorbents holds numerous patents and trademarks for its blood purification technologies, with several products under development [7] Financial and Investment Information - The Series B Right Warrants can be exercised at a price equal to 90% of the 5-day volume weighted average price of the common stock, with a minimum price of $2.00 and a maximum of $4.00 [2] - Approximately 4.8 million shares of common stock are reserved for the exercise of the Series B Right Warrants, which will expire worthless if not exercised [3]