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Materials
Cytosorbents Corporation, a leader in blood purification technology, has outlined an ambitious growth strategy for 2025, focusing on its innovative DrugSorb-ATR system. This device is designed to remove antithrombotic drugs during surgeries, specifically targeting ticagrelor (Brilinta), apixaban, and rivaroxaban. The goal is to enable patients undergoing cardiothoracic surgeries to avoid delays and reduce the risk of severe bleeding complications associated with these blood thinners.
DrugSorb-ATR leverages Cytosorbents' polymer adsorption technology, similar to its CytoSorb product used in Europe for reducing cytokine storms. CytoSorbents has already received FDA Breakthrough Device Designations for DrugSorb-ATR, indicating its potential to address significant unmet medical needs.
In August 2023, Cytosorbents announced the completion of the pivotal STAR-T trial, a randomized controlled study evaluating DrugSorb-ATR's efficacy in removing ticagrelor during cardiothoracic surgery. This trial is crucial for supporting FDA and Health Canada marketing approvals. Cytosorbents anticipates releasing topline results from this study by the end of 2025, aligning with the expected regulatory decisions from both agencies.
The company submitted a De Novo medical device application to the U.S. FDA in September 2024, which was accepted for substantive review in October. This application aims to secure approval for DrugSorb-ATR to reduce perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft (CABG) surgery. Additionally, a Medical Device License (MDL) application for Health Canada is pending MDSAP certification.
Cytosorbents projects that the total addressable market for DrugSorb-ATR in the U.S. and Canada could exceed $1 billion as the system becomes established and Brilinta transitions to generic status. The company plans a controlled market release at key clinical trial sites once approved, allowing for real-world feedback and refining its commercialization strategy.
The growth strategy includes engaging with key opinion leaders, recruiting essential talent, and conducting market access activities. Visibility and thought leadership are core components, with impactful new data expected at major cardiovascular conferences.
DrugSorb-ATR is designed to integrate with cardiopulmonary bypass circuits during cardiothoracic surgeries. It utilizes a polymer adsorption technology to actively remove ticagrelor from the blood, thereby reducing the risk of major bleeding complications. This capability allows for safer and timelier surgeries, avoiding the need for patients to wait several days for the drug to naturally clear from their system.
Additionally, DrugSorb-ATR has been designated for the removal of direct oral anticoagulants (DOACs) such as apixaban and rivaroxaban, further broadening its potential applications.
Cytosorbents is positioning itself for significant growth with DrugSorb-ATR, leveraging its established foundation of commercial sales and strong regulatory progress. The company expects to manage its core business toward breakeven while advancing its global commercialization strategy. Challenges in certain markets, such as Germany, are being addressed through restructuring and realignment strategies.
Cytosorbents' 2025 growth strategy, centered around DrugSorb-ATR, offers substantial market potential by addressing critical needs in cardiothoracic surgery. As the company awaits regulatory decisions and prepares for a controlled market launch, it is poised to drive significant advancements in patient care and safety while expanding its market presence.
