當地是全球最先進的醫療保健系統之一，現在引進這個迄今應用於 75 個國家近 25 萬次治療的強大的血液淨化技術，用於治療危疾和心臟手術患者新澤西州，普林斯頓, June 26, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO) 是透過其專屬的聚合物吸附技術使用血液淨化在深切治療部和心臟手術治療致命病症的領導者，現宣布CytoSorb®在台灣獲得食品藥物管理署 (TFDA) 的監管批准。獲核准的適應症包括從患者血液循環中藉由體外去除細胞因子（例如細胞激素風暴、敗血症）、膽紅素（例如肝病）和肌紅蛋白（例如創傷）。 心胸外科手術期間停用抗血栓藥物 Brilinta®（替格瑞洛，阿斯特捷利康）和 Xarelto®（利伐沙班，楊森/拜耳）亦獲得批准，目的是減少手術前後出血。CytoSorb 將由 Hemoscien Corporation 分銷至全台灣。 CytoSorbents 國際經銷商銷售副總裁 Bettina Sabisch 女士表示：「我們很高興宣布這個里程碑，彰顯我們 CytoSorb 療法的價值和功效，而這是經歷漫長而複雜的審 ...

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 ...

Product Usage and Development - CytoSorb has been used in over 237,000 human treatments globally for critical illnesses and cardiac surgery [274]. - The company has received FDA Emergency Use Authorization for CytoSorb in critically-ill COVID-19 patients, with over 7,650 treatments conducted to date [274]. - The company is developing multiple product candidates based on its blood purification technology, including DrugSorb-ATR and ContrastSorb [276]. - The company has completed its pivotal STAR-T trial evaluating the DrugSorb-ATR system, which aims to support FDA and Health Canada marketing approval [310]. - The company is now the preferred supplier of hemoadsorption technology to the three largest private hospital chains in Germany, facilitating access to CytoSorb [313]. - CytoSorb has been granted Emergency Use Authorization by the FDA for use in critically ill COVID-19 patients, allowing commercial sales in the U.S. [316]. Financial Performance - Revenue from product sales was approximately $8,990,000 for the three months ended March 31, 2024, an increase of approximately $1,080,000, or 14%, compared to $7,910,000 for the same period in 2023 [319]. - Distributor sales increased approximately $614,000, or 20%, while direct sales increased approximately $466,000, or 10% [319]. - Product gross margins improved to approximately 76% for the three months ended March 31, 2024, compared to 68% for the same period in 2023 [320]. - The company received approximately $880,000 in cash from the approved sale of net operating losses and research and development credits from the State of New Jersey in March 2024 [324]. - As of March 31, 2024, the company's total cash position was approximately $10.1 million, raising substantial doubt about its ability to continue as a going concern [328]. Sales and Marketing - The company entered a global marketing agreement with Fresenius Medical Care, positioning CytoSorb as the featured solution for cytokine, bilirubin, and myoglobin removal [282]. - Expansion of direct sales territories includes the U.K., Ireland, and France, bringing the total to 15 countries direct overall [285]. - The average exchange rate of the Euro to the U.S. dollar was $1.09 for the three months ended March 31, 2024, compared to $1.07 for the same period in 2023, positively impacting product sales by approximately $98,000 [319]. Operational Expenses and Agreements - The company recorded interest expense of approximately $10,700 related to a final fee for Term Loans for the three-month periods ended March 31, 2024, and 2023 [287]. - The company has a lease agreement for a new operating facility with monthly rental payments starting at approximately $111,171 [294]. - The weighted average remaining lease term as of March 31, 2024, was 12.4 years [297]. - The company granted options to purchase 110,000 shares of common stock to Board members, with a fair value of approximately $70,000 [300]. - The company granted 69,750 restricted stock units to employees, with a fair value of approximately $67,000, vesting upon a Change in Control [301]. Clinical Trials and Patient Enrollment - The company anticipates improved conditions for patient enrollment in clinical trials due to the easing of COVID-19 impacts [326].

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 ...