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Subtractiv Therapeutx’s Immunopheresis® therapy, including the LW-02 blood-filtering immunotherapy device, has not been approved by the US Food and Drug Administration and is an investigational therapy in all of Subtractiv Therapeutx’s ongoing clinical research studies. LW-02 blood-filtering immunotherapy device has been granted European CE Mark Certification for use in adults with advanced, refractory, triple-negative breast cancer in Europe.