Core Viewpoint - CytoSorbents Corporation has received regulatory approval for its CytoSorb therapy in Taiwan, which is aimed at treating critical illnesses by removing harmful substances from the blood, highlighting the therapy's efficacy and the company's commitment to expanding its market presence [1][6]. Group 1: Company Overview - CytoSorbents Corporation (NASDAQ:CTSO) specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery [6][10]. - The company’s flagship product, CytoSorb, is an extracorporeal cytokine adsorber that has been approved in the European Union and is distributed in 75 countries [1][10]. - CytoSorbents has received approximately $50 million in funding from various U.S. government agencies, indicating strong institutional support for its technologies [3]. Group 2: Product and Technology - CytoSorb is designed to reduce cytokine storms and is effective in treating conditions such as sepsis, acute respiratory distress syndrome, and liver diseases [1][6]. - The device has been used in over 237,000 cases globally as of March 31, 2024, demonstrating its widespread application and acceptance in critical care [1]. - The technology is based on biocompatible polymer beads that remove toxic substances from blood through pore capture and surface adsorption [3]. Group 3: Market and Collaboration - Hemoscien Corporation will distribute CytoSorb in Taiwan, leveraging its established customer relationships in the region [1][6]. - Taiwan's healthcare system, which serves approximately 24 million inhabitants, is recognized for its advanced medical standards and technology, making it a promising market for CytoSorb [8]. - The partnership aims to address the critical need for effective therapies in Taiwan, where sepsis is a significant health issue with an estimated 150,000 new cases annually and a mortality rate of up to 30% [8][9].

The PuriFi peristaltic blood pump features a number of differentiating innovations that separate it from other standard hemoperfusion pumps including a pre-assembled adult and pediatric blood line kit, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen graphical user interface with a step-by-step user-friendly set-up guide, optional blood warming, and a rapid 10-minute set-up time. Together, these unique features enable an easy and rapid way to administer CytoSorbents' leading CytoSorb® ...

PRINCETON, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that it will host its 2024 Virtual Annual Stockholders Meeting tomorrow, June 6, 2024 at 10 AM EDT. CytoSorbents Corporation Virtual Annual Stockholder Meeting When: Thursday, June 6, 2024, at 10:00 ΑΜ EDT Webcast: www.virtualshareholdermeeting.com/CTSO2024 Kathleen Bloch, CFO 30 ...

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death ca ...

PRINCETON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the recent data presentation entitled "Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry," at the international EuroPCR 2024 conference in Paris, Fr ...

Financial Data and Key Metrics Changes - Product sales for Q1 2024 were approximately $9 million, a 14% increase from $7.9 million in Q1 2023 and a 22% increase from $7.3 million in Q4 2023 [7][20] - Total revenue for Q1 2024, including product sales and grant revenue, was approximately $9.8 million compared to $9.4 million in 2023 [7] - Product gross margin improved to 76% in Q1 2024, an increase of 800 basis points from 68% in Q1 2023, excluding a one-time inventory adjustment [7][20] Business Line Data and Key Metrics Changes - Core non-COVID-19 product sales showed a year-over-year growth of 10% for the trailing 12 months ending March 31, 2024 [8] - The company delivered over 237,000 devices cumulatively and expects to reach a quarter million devices this year [5] Market Data and Key Metrics Changes - The company is seeing strong customer responses to new data published on CytoSorb across various applications, indicating a growing market potential [6] - The post-COVID market remains challenging, but improvements are noted, particularly in direct sales in Europe and distributor countries [8][80] Company Strategy and Development Direction - The company plans to submit marketing applications for the investigational DrugSorb-ATR system to the FDA and Health Canada in Q3 2024 [5][15] - The launch of the PuriFi hemoperfusion pump is expected to drive sales in regions with less established dialysis infrastructure, enhancing the treatment of patients with CytoSorb [21][81] - The company aims to strengthen its balance sheet and reduce operating expenses through tight control over working capital [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential driven by demographic trends and the increasing use of blood thinners globally [51] - The company anticipates continued growth in product sales and gross margins, supported by new clinical data and strategic partnerships [51] Other Important Information - The company has $10.1 million in cash as of March 31, 2024, which is expected to fund operations into Q4 2024 [26] - The STAR-T trial results were presented at a major cardiothoracic surgery conference, highlighting the efficacy of the DrugSorb-ATR device [5][47] Q&A Session Summary Question: What were the pushes and pulls that helped achieve the $9 million in product sales? - Management highlighted stabilization in the Central European market and strong initiatives to address new customer groups and expand indications [37][80] Question: What is the expected impact of the PuriFi system? - The PuriFi pump is intended to build an infrastructure for blood purification in areas lacking strong dialysis support, driving more sales of CytoSorb [81] Question: Are the FDA and Health Canada approvals independent? - Yes, the approvals are independent, and submissions will be structured differently as required by each regulatory body [40][62] Question: What is the addressable market for DrugSorb-ATR? - The addressable market is estimated at $325 million, with a 10-to-1 split favoring the U.S. market over Canada [68] Question: What is the outlook for grant income for the rest of the year? - Grant income is expected to remain similar to Q1 levels, but the company is applying for new grants to potentially increase this income [65]

· Product Sales up a robust 14% over prior year, and a significant 22% sequentially · Enhanced profitability with gross margins that surged an absolute 8% to reach 76%, reflecting stronger operational ef iciencies · STAR-T data presented at AATS support a favorable benefit-to-risk profile of DrugSorb-ATR in coronary artery bypass graft (CABG) patients · On track for U.S. Food and Drug Administration (FDA) De Novo and Health Canada submissions for DrugSorb®-ATR in Q3 2024 Additionally, we expect to take deli ...

Table of Contents SECURITIES AND EXCHANGE COMMISSION FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 (Exact name of registrant as specified in its charter) Delaware 98-0373793 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) | --- | -- ...

PRINCETON, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today announced that it will host a virtual Key Opinion Leader and Analyst-Investor Day on Monday, May 6, 2024 from 11:30 AM to 1:30 PM ET. To register, click here. The program will cover the significant challenge of severe perioperative blee ...

PRINCETON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today announced that topline results from its pivotal U.S. and Canadian Safe and Timely Antithrombotic Removal of Ticagrelor (STAR-T) randomized controlled trial will be featured as a late-breaking clinical trial presentation at the 104th A ...