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CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR
Prnewswire· 2025-06-24 11:00
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 ...
CytoSorbents(CTSO) - 2024 Q3 - Earnings Call Presentation
2025-06-23 07:46
The Emergence of CytoSorbents Corporation Nasdaq: CTSO Q3 2024 Earnings Conference Call November 7, 2024 DrugSorb-ATR is an investigational device currently under U.S. FDA and Health Canada review. It is not yet approved or cleared in any country. Conference Call Participants Moderator: Adanna Alexander, PhD ICR Healthcare Efthymios "Makis" Deliargyris MD, FACC, FESC, FSCAI Chief Medical Officer Christopher Cramer, MS, MBA Senior VP Business Development 2 Phillip Chan, MD, PhD Chief Executive Officer Vincen ...
CytoSorbents(CTSO) - 2025 Q1 - Earnings Call Presentation
2025-06-23 07:46
CytoSorbents Corporation Nasdaq: CTSO Q1 2025 Financial Results and Recent Business Highlights Conference Call May 14, 2025 Conference Call Participants Phillip Chan, MD, PhD Chief Executive Officer Moderator: Adanna Alexander, PhD VP Investor Relations, ICR Healthcare Efthymios "Makis" Deliargyris MD, FACC, FESC, FSCAI Chief Medical Officer Peter J. Mariani, CPA Chief Financial Officer 2 Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries ...
CytoSorbents Extends Expiration Date of Outstanding Series B Right Warrants
Prnewswire· 2025-04-04 11:00
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]