CytoSorbents Advancing DrugSorb-ATR Through FDA Challenges
CytoSorbents Engages with FDA for DrugSorb-ATR
CytoSorbents Corporation (NASDAQ: CTSO), a notable player in the field of blood purification therapies aimed at treating life-threatening conditions, has shared an important update regarding its DrugSorb™-ATR device. This device, recognized by the FDA as a Breakthrough Device, is designed to mitigate bleeding complications in patients undergoing coronary artery bypass grafting (CABG) after ceasing the use of the blood thinner Brilinta® (ticagrelor).
Regulatory Developments with the FDA
In a recent communication from the U.S. Food and Drug Administration (FDA), CytoSorbents received a denial letter concerning their De Novo Request for DrugSorb-ATR. This letter pointed out specific deficiencies that must be addressed in order for the device to be authorized for commercialization in the U.S. In response, CytoSorbents has initiated discussions with the FDA, aiming to resolve these outstanding issues. If resolution is not achieved through dialogue, the team plans to formally appeal the FDA's decision within a 60-day timeframe.
Commitment to Patient Safety
Dr. Phillip Chan, the Chief Executive Officer of CytoSorbents, expressed the company's resolution to bring DrugSorb-ATR to market. He emphasized that preventing severe bleeding in CABG patients remains a critical medical objective, particularly in light of the absence of comparable therapies in the United States. With thousands of patients at risk each year, CytoSorbents is hopeful of a timely regulatory resolution and anticipates receiving a final decision in the near future.
About CytoSorbents Corporation
CytoSorbents Corporation is at the forefront of developing innovative blood purification technologies. Their proprietary devices utilize biocompatible and highly porous polymer beads, which effectively remove harmful substances from blood and other fluids through pore capture and surface adsorption. These technologies can be integrated with standard hospital blood pumps such as dialysis and extracorporeal membrane oxygenation (ECMO), providing significant therapeutic benefits.
Diverse Applications of CytoSorbents Technology
CytoSorbents has developed applications aimed at addressing pressing medical needs, such as removing blood thinners during cardiothoracic surgery and reducing inflammatory agents in severe illnesses. These technologies are critical for managing conditions like sepsis, trauma, and acute liver failures, where traditional treatment options are often limited or ineffective.
Expanding Global Footprint
CytoSorbents' flagship product, CytoSorb, is now recognized across over 70 countries and has been utilized in more than 270,000 procedures globally. This device has achieved European Union approval and has undergone subsequent expansions for various clinical applications, including the removal of bilirubin and myoglobin in severe conditions. While CytoSorb is currently not yet authorized in the United States, the company is actively pursuing regulatory pathways to bring their innovations to American patients.
Future Growth and Product Innovation
The company is continually advancing its product line, including the investigational DrugSorb-ATR system, which aims to minimize perioperative bleeding linked to blood-thinning medications. CytoSorbents has earned FDA Breakthrough Device Designations for multiple indications, demonstrating its commitment to developing effective solutions for high-risk surgical patients.
Frequently Asked Questions
What is DrugSorb™-ATR?
DrugSorb-ATR is a medical device designed to reduce bleeding severity in patients who have recently stopped using the blood thinner Brilinta® during coronary artery bypass surgery.
What recent updates has CytoSorbents provided?
CytoSorbents announced their engagement with the FDA following a denial letter related to the regulatory approval of DrugSorb-ATR, addressing specific deficiencies outlined by the agency.
How does CytoSorbents' technology work?
CytoSorbents' blood purification technology employs polymer beads that filter toxic substances from blood, effectively improving patient outcomes in various critical conditions.
Is CytoSorb authorized in the United States?
No, CytoSorb is not currently authorized for use in the United States; however, the company is working on securing FDA approval.
What types of medical conditions do CytoSorbents' products target?
The products are aimed at treating conditions such as severe bleeding, inflammatory diseases, and toxic agents resulting from various critical illnesses.
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