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CytoSorbents Secures $20 Million Credit Facility
Newsfilter· 2024-07-02 11:00
Core Viewpoint - CytoSorbents Corporation has secured a $20 million credit facility to enhance its financial position and support the commercialization of its products, particularly DrugSorb™-ATR, which targets a significant unmet medical need in cardiac surgery [2][4]. Financial Overview - The new credit facility includes an initial term of three years and provides up to $20 million in total term loan capital, with an initial tranche of $15 million [3]. - The facility aims to provide non-dilutive working capital to support the ongoing global CytoSorb® franchise, which generated $32.2 million in trailing 12-month sales as of March 31, 2024 [2]. Product Development and Market Potential - DrugSorb™-ATR, an investigational device, has received FDA Breakthrough Device Designations and aims to reduce serious bleeding complications in patients undergoing coronary artery bypass graft (CABG) surgery [4][8]. - The potential addressable market for DrugSorb-ATR in the U.S. and Canada is estimated to exceed $0.5 billion if approved [4]. Strategic Partnerships - Avenue Capital Group is the financial partner for this credit facility, indicating confidence in CytoSorbents' growth and product development strategies [4][5]. - The partnership is expected to support the international growth of CytoSorb® and other products, particularly in the U.S. and Canadian markets [4]. Technology and Innovation - CytoSorbents' purification technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood, addressing critical medical needs in intensive care and cardiac surgery [6][9]. - The company has received approximately $50 million in non-dilutive funding from various U.S. government agencies to support its innovative technologies [9].
CytoSorbents Secures $20 Million Credit Facility
GlobeNewswire News Room· 2024-07-02 11:00
Company Overview - CytoSorbents Corporation is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technology [14][15] - The company's lead product, CytoSorb®, is an extracorporeal cytokine adsorber approved in the European Union and distributed in 75 countries [15] - CytoSorbents has received significant funding, approximately $50 million, from various U.S. government agencies for its purification technologies [10] Financial Partnership - On June 28, 2024, CytoSorbents entered into a $20 million credit facility with Avenue Capital Group to strengthen its financial position and support ongoing initiatives [14] - The credit agreement includes an initial term of three years, providing up to $20 million in total term loan capital, with an initial tranche of $15 million [3] - Proceeds from the facility will support the global CytoSorb® franchise, planned marketing applications for DrugSorb-ATR, and refinancing of existing debt [14] Product Development - DrugSorb-ATR, an investigational device, aims to reduce serious bleeding complications in patients undergoing coronary artery bypass graft surgery while on the blood-thinning drug Brilinta® [1][5] - The company plans to submit marketing applications for DrugSorb-ATR to the U.S. FDA and Health Canada this summer, with a potential addressable market exceeding $0.5 billion if approved [1] - The DrugSorb-ATR has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants during cardiothoracic procedures [5] Market Potential - The anticipated launch of DrugSorb-ATR in the U.S. could significantly impact the market, addressing a major unmet medical need related to bleeding risks in patients on anticoagulants [1][4] - CytoSorbents generated $32.2 million in trailing 12-month sales as of March 31, 2024, indicating a strong market presence [14]
CytoSorbents 公司宣布 CytoSorb® 獲得台灣監管部門批准
GlobeNewswire Inc.· 2024-06-25 23:00
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 ...
CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan
Newsfilter· 2024-06-24 11:00
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].
CytoSorbents Announces the Launch and Immediate Availability of the PuriFi™ Blood Pump in the European Union
Newsfilter· 2024-06-13 11:00
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® ...
CytoSorbents to Host its 2024 Virtual Annual Stockholders Meeting
Newsfilter· 2024-06-05 11:00
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 to Host its 2024 Virtual Annual Stockholders Meeting
GlobeNewswire News Room· 2024-06-05 11:00
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 ...
CytoSorbents STAR Registry Data on Patients on Ticagrelor Undergoing CABG Surgery with CytoSorb Presented at EuroPCR 2024. Named Top Five Finalist for Best Scientific Abstract
Newsfilter· 2024-06-04 11:00
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 ...
CytoSorbents(CTSO) - 2024 Q1 - Earnings Call Transcript
2024-05-10 03:01
Cytosorbents Corporation (NASDAQ:CTSO) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Eric Ribner - Investor Relations Phil Chan - Chief Executive Officer Vincent Capponi - President and Chief Operating Officer Kathleen Bloch - Chief Financial Officer Makis Deliargyris - Chief Medical Officer Christian Steiner - Executive Vice President, Sales and Marketing Christopher Cramer - Senior Vice President, Business Development Conference Call Participants Yuan Zhi - B. Riley Securiti ...
CytoSorbents(CTSO) - 2024 Q1 - Quarterly Results
2024-05-09 21:23
· 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 ...