PRINCETON, N.J., June 24, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSo ...

Core Viewpoint - CytoSorbents Corporation reported its financial results for Q1 2025, highlighting strong revenue growth in the EU despite temporary disruptions in Germany, and ongoing efforts to advance its product pipeline, particularly DrugSorb™-ATR, which aims to address life-threatening bleeding in cardiac surgery patients [1][4][5]. Financial Results - Product revenue for Q1 2025 was $8.7 million, a decrease of 3% from $9.0 million in Q1 2024, remaining flat on a constant currency basis [8]. - Gross margin decreased to 71% from 77% in Q1 2024 [8]. - Operating loss improved by 17% to $3.9 million compared to $4.7 million in Q1 2024, reflecting a 12% reduction in operating expenses [8]. - Net loss was $1.5 million or $0.02 per share, compared to a net loss of $6.1 million or $0.11 per share in Q1 2024 [8]. - Adjusted net loss was $3.7 million or $0.06 per share, compared to an adjusted net loss of $3.7 million or $0.07 per share in Q1 2024 [8]. - Adjusted EBITDA loss improved by 17% to $2.7 million compared to a loss of $3.3 million in Q1 2024 [8]. - Total cash, cash equivalents, and restricted cash increased to $13.1 million at March 31, 2025, from $9.8 million as of December 31, 2024 [8]. Business Highlights - The company is focused on bringing DrugSorb™-ATR to the North American market, addressing the unmet need for reducing life-threatening bleeding in patients on Brilinta® during CABG surgery [5][6]. - The FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, but the company plans to resolve the outstanding items through a formal appeal process, expecting a final regulatory decision in 2025 [6][7]. - Real-world adoption of DrugSorb-ATR is increasing, with more heart centers incorporating the technology into standard care based on evidence from the international STAR Registry [7]. - The company completed a shareholder rights offering, raising $6.8 million, which increased liquidity and allowed for the release of $5.0 million of restricted cash [9]. Operational Developments - CytoSorbents opened a new regional sales subsidiary in Dubai, UAE, expanding its global footprint into the Middle East and Africa [9]. - The company appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR [9].

Core Viewpoint - CytoSorbents Corporation has successfully converted its Net Operating Loss (NOL) and R&D tax credits into $1.7 million in cash through the New Jersey Technology Business Tax Certificate Transfer Program, which will bolster its cash reserves and support ongoing growth initiatives [1][2]. Group 1: Financial Impact - The company received $1.7 million in cash proceeds from the sale of its 2023 and amended 2022 NOL and R&D tax credits [1][2]. - This funding is aimed at strengthening cash reserves and supporting strategic initiatives, including the launch of DrugSorb™-ATR in the U.S. and Canada and scaling up manufacturing at its new Princeton facility [2]. Group 2: Tax Credit Program - The New Jersey Technology Business Tax Certificate Transfer Program allows approved technology and biotechnology businesses with NOLs to sell their unused NOLs and R&D tax credits for at least 80% of their value to profitable corporate taxpayers in New Jersey [3]. - The program enables companies to convert tax losses and credits into cash for various expenditures, enhancing their financial flexibility [3]. Group 3: Legislative Context - New Jersey enacted tax reform legislation on July 3, 2023, allowing taxpayers to immediately deduct R&D expenditures retroactively from January 1, 2022, which increased the NOL available for sale in the NJEDA Program for CytoSorbents [4]. Group 4: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5]. - The company's lead product, CytoSorb®, is approved in the EU and has been used in over 270,000 devices globally, with applications in critical illnesses such as sepsis and liver failure [6]. - CytoSorbents is also developing DrugSorb™-ATR, an investigational device aimed at reducing perioperative bleeding in high-risk surgeries [7].

Company Appointment - CytoSorbents Corporation announced the appointment of Melanie Grossman as Vice President and Corporate Controller, bringing over 25 years of finance and accounting experience in publicly-traded companies [1][2] - The Chief Financial Officer, Peter J. Mariani, highlighted Ms. Grossman's expertise in financial operations, planning, analysis, and regulatory compliance as beneficial for the company's growth and efficiency [2] Inducement Grants - The Compensation committee approved inducement awards for Ms. Grossman under Nasdaq Listing Rule 5635(c)(4), with terms subject to applicable award agreements and vesting conditions [3] Company Overview - CytoSorbents is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4] - The proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various critical illnesses such as sepsis and liver failure [4] Product Development - The lead product, CytoSorb®, is approved in the EU and used in over 70 countries, with more than 270,000 devices utilized to date [6] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients, although it is not yet approved in the U.S. [6] Future Products - CytoSorbents is developing DrugSorb™-ATR, an investigational device aimed at reducing perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [7] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR, which is currently under substantive review [7] Intellectual Property - The company holds numerous patents and trademarks for its blood purification technologies, with multiple products under development [8]

Core Insights - CytoSorbents Corporation has appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR in the U.S. and Canada, anticipating marketing approval [1][2] - DrugSorb-ATR is positioned to address perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta® [2][3] - The company expects regulatory decisions from the U.S. FDA and Health Canada regarding DrugSorb-ATR in 2025, with the device currently classified as investigational [3][8] Company Overview - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [5][6] - The company's proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including cardiothoracic surgery [5][6] - CytoSorbents' lead product, CytoSorb®, is already approved in the European Union and has been used in over 70 countries, with more than 250,000 devices utilized to date [7] Product Development - DrugSorb-ATR is an investigational device designed to reduce perioperative bleeding severity in high-risk surgeries due to blood thinners, having received two FDA Breakthrough Device Designations [8] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR in September 2024, which is currently under substantive review [8] - CytoSorbents has a range of products under development based on its blood purification technology, protected by numerous patents [9]

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]