Artcline GmbH

100 patients already enrolled: ARTCLINE reports rapid progress in multicenter clinical study on immune support in septic shock (ReActIF-ICE) ReActIF-ICE study evaluating ARTICE® procedure for treatment of septic shock via improvement of immune function at 20 leading intensive care centers in Germany Recruitment for the randomized, controlled multicenter study expected to complete by the end of 2025 Broad market launch of ARTICE® therapy planned for the second half of 2026 Rostock, Germany, July 28, 2025 – ARTCLINE, a biomedical company focused on the development of novel immune cell therapies for the treatment of septic shock, today announced that 100 patients (of a total 142 planned) have been enrolled in the randomized, controlled clinical study, ReActIF-ICE (NCT05442710). The study aims to validate the clinical benefit of ARTCLINE's proprietary extracorporeal ARTICE® therapy. This novel treatment approach uses immune cells from healthy donors to relieve and regenerate the dysfunctional immune system of patients with septic shock. The purified granulocyte concentrates are administered as a directed manufacturing process under a manufacturing authorization in accordance with GMP guidelines. Dr. Jens Altrichter, Managing Director and Founder of ARTCLINE GmbH, commented: “We are very pleased to see that recruitment is progressing as quickly as planned. This is a great sign, confirming that our ARTICE® therapy has broad interest among intensive care unit clinicians. We are convinced that ARTICE® has the potential to significantly improve treatment outcomes for patients with septic shock and addresses the major unmet medical need for this often-fatal condition. As all components of the therapy have already received regulatory approval for general use in Germany, we are preparing for a broad market launch in the second half of 2026.” “This study will provide us with valuable understanding about the targeted treatment of dysregulated immune systems in patients suffering from septic shock. Extracorporeal immune cell therapy is proving to be a viable option in clinical practice, appears to be medically useful and potentially provides a much-needed treatment for severe cases of septic shock. We look forward to announcing the study results, which we expect to offer important insights into the stabilization and survival of patients with this life-threatening condition,” said Prof. Martin Sauer, M.D., Chief Physician, Department of Intensive Care and Emergency Medicine, Magdeburg Hospital (Germany). The ReActIF-ICE study is a multicenter, randomized, controlled validation study enrolling 142 patients with septic shock. The study’s primary endpoint is the safety and tolerability of ARTICE® therapy, assessed based on the occurrence of new serious adverse events (SAEs) up to day 28. Secondary endpoints include all-cause mortality at day 28, day 90 and until hospital discharge, as well as daily changes in SOFA (Sequential Organ Failure Assessment) score. The control group will be treated with the current standard of care, while the treatment group will receive up to 6 ARTICE® immune cell treatments within 9 days, in addition to standard of care. The study is currently being conducted at 20 leading intensive care centers in Germany and is expected to be fully recruited by the end of 2025. GMP manufacturing authorization and CE marking have already been obtained for all components of the ARTICE® procedure (donor immune cells, devices and treatment kit). Based on the experience that will be gained in routine clinical practice in this study, ARTCLINE is preparing for a broad market launch in the second half of 2026.
About septic shock The mortality rate for sepsis remains alarmingly high despite continuous research and development by the medical and scientific communities. According to the WHO, sepsis affects 48 million people a year, including 20 million children under 5 years of age. About 20% of global deaths are due to sepsis. The impairment of the immune system plays a crucial role in the progression of sepsis. Thanks to modern intensive care options, patients usually survive the first phase of septic shock. However, many then die subsequently because of immune dysfunction from secondary infections and/or organ failure. About ARTCLINE GmbH ARTCLINE GmbH is developing innovative therapeutic approaches for intensive care medicine. The company focuses on a novel, immune cell-based extracorporeal therapy for the treatment of septic shock – one of the major challenges for global health systems. The ARTICE® therapy, developed in collaboration between immunologists and dialysis specialists, uses allogeneic immune cells from healthy donors to temporarily support key functions of the patient's dysregulated immune system and help restore its activity. For more information, please visit www.artcline.de, follow us on LinkedIn or contact us at info@artcline.de.   Contact:
ARTCLINE GmbH
Dirk Hessel, Managing Director
dirk.hessel@artcline.de
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Eva Bauer / Julia von Hummel
Phone: +49-89-210228-0
artcline@mc-services.eu