Primary endpoint met, demonstrating depletion of EpCAM (epithelial cell adhesion molecule)-positive cancer cells from intraoperatively salvaged blood (p<0,0001)
All safety endpoints, including residual antibody and cytokine amounts in erythrocyte concentrates (EC) were met with high statistical significance, and no serious adverse events were attributable to CATUVAB®
Broad applicability demonstrated across multiple tumor types and surgical procedures
Study results support further development beyond oncology, including safer transfusion practices for immunosuppressed patients
HENNIGSDORF, DE / ACCESS Newswire / September 15, 2025 / Lindis Blood Care, a MedTech company committed to setting new standards in transfusion safety with its Antibody-Based Cell Removal Technology (ABCR-T), today announced the final results from its pivotal REMOVE study, published in the peer-reviewed Journal of Clinical Anesthesia . The study evaluated CATUVAB ® , the company's lead device, developed to enable safe intraoperative blood salvage (IBS) in high-blood-loss cancer surgeries. The device works by using a trifunctional antibody, which links immune and tumor cells into aggregates. These aggregates will be removed in two steps during the subsequent process. Together, these mechanisms efficiently remove tumor cells and immune cell aggregates from salvaged intraoperative blood, helping to reduce the risk of retransfusing blood products with metastatic potential.
The confirmatory open-label, multicenter clinical study enrolled over 135 patients and met all primary and secondary endpoints with high statistical significance. In the primary efficacy analysis, CATUVAB ® demonstrated a 100% (95% CI (95.8%-100%)) rate of sufficient depletion of EpCAM-positive tumor cells ( p <0.0001) from intraoperatively salvaged blood after a single IBS cycle.
Notably, analyses showed that, in 89% of the analyzed erythrocyte concentrate samples, antibody levels were below the limit of quantification. In the remaining cases, levels were well under the predefined safety threshold. In addition, proinflammatory cytokines IL-6 and IL-8, present in intraoperative blood due to surgical trauma, were reduced approximately 30-fold and 38-fold, respectively, from reservoir to EC.
The safety analysis confirmed that no severe adverse events were attributable to CATUVAB ® . The few events observed (3.8% of patients) were deemed unrelated or most likely related to anesthesia or surgery rather than to CATUVAB ® . Device-related technical issues were rare (2.2%), with no associated serious health consequences.
"For the first time, we have clear clinical evidence that intraoperative blood salvage can be made safe for cancer surgery," said Professor Kai Zacharowski , MD, PhD, ML, FRCA, FESAIC, Director of the Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy at University Hospital Frankfurt. "CATUVAB ® reliably removes all tumor cells from salvaged blood, addressing the key barrier that has limited autologous blood transfusion in oncology."
"These promising results have the potential to re-define the intraoperative blood salvage protocols in cancer surgeries," added Professor Patrick Meybohm , MD, FESAIC, Head of the Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine at University Hospital Würzburg. "By physically binding tumor cells and removing them through cell aggregate filtration, CATUVAB ® clears contamination while preserving the quality of the blood. Since this process is straightforward and reproducible, it offers a reliable solution for routine clinical use."
The REMOVE study population included patients with a broad range of solid tumors, including bladder, gastric, ovarian, pancreatic, colorectal, lung, and peritoneal cancers, underscoring CATUVAB ® 's broad applicability across cancer surgeries. Of more than the 130 patients analyzed, 119 had sufficient blood samples for evaluation, with EpCAM-positive tumor cells detected in 61 cases (51%). Ultimately, 80 patients received retransfusion of their own blood following CATUVAB ® processing and were included in the safety analysis.
"With CATUVAB ® in the late stage of the CE certification process, we are looking forward to a timely launch," said Dr. Horst Lindhofer and Dr. Franzpeter Bracht,founders and Managing Directors of Lindis Blood Care , in a joint statement."These results strongly validate our Antibody Based Cell Removal-Technology, allowing safe intraoperative blood salvage in cancer surgery. The convincing results of the REMOVE study warrant further development of this technology to investigate its wider potential in transfusion medicine."
To access the full publication, "Removal of EpCAM-positive tumor cells during intraoperative blood salvage - A pivotal multicenter clinical study (REMOVE)" , please visit Journal of Clinical Anesthesia - ScienceDirect
###
About CATUVAB ® in cancer surgery:
CATUVAB ® is the first device developed to enable safe intraoperative blood salvage (IBS) in cancer surgery, allowing patients to receive their own blood without the risk of reintroducing tumor cells.
Each year, up to 1,000,000 cancer surgeries worldwide require donor blood transfusions, which increase the risk of immunosuppression and tumor recurrence. IBS can reduce reliance on donor blood by reusing the patient's own blood. However, its use in oncology is limited due to the risk of reinfusing viable tumor cells.
CATUVAB ® overcomes these hurdles through a purely physical mode of action, using a trifunctional antibody to crosslink EpCAM-positive tumor cells with immune cells into cell aggregates. These cell aggregates are then removed.
CATUVAB ® demonstrated strong efficacy and safety in the pivotal REMOVE trial. It is expected to offer a cost-effective alternative to allogeneic transfusions by lowering both direct blood procurement costs and the downstream expenses associated with managing possible severe side effects from donor blood.
As an add-on to existing IBS devices, CATUVAB ® is designed to ensure high compatibility and seamless integration into established clinical workflows, supporting modern patient blood management.
Watch the video for further insights into CATUVAB ® and the study results: https://www.lindis-bloodcare.com/catuvab-video/
About Lindis Blood Care:
Founded in 2018 and headquartered in Hennigsdorf, Germany, Lindis Blood Care GmbH is a MedTech company committed to setting new standards in transfusion safety and blood management with its proprietary Antibody-Based Cell Removal Technology (ABCR-T).
The company's lead product, CATUVAB ® , is clinically proven to remove EpCAM-positive tumor cells, enabling safe autologous blood reinfusion in high-risk settings. EpCAM is a tumor marker found on almost all common carcinomas and has been shown to be expressed on both cancer cells and cancer stem cells.
In the pivotal REMOVE study, CATUVAB ® has demonstrated safety, efficacy, and feasibility, reliably removing cancer cells from salvaged blood during oncologic surgery. CATUVAB ® is now in the final stages of the EU CE certification process and, in parallel, has been submitted for approval to the US FDA.
Leveraging its ABCR-T platform, Lindis Blood Care is developing further high-value indications beyond oncology. Applying the same proven technology to make donor blood safer for immunosuppressed patients, the company is unlocking a broad pipeline of opportunities to address critical gaps in transfusion safety across diverse, high-growth markets. Lindis Blood Care's success has been supported by funding from High-Tech Gründerfonds and Brandenburg Kapital, the venture capital arm of the investment bank of the State of Brandenburg, as well as several private investors.
CONTACT | FOR MEDIA REQUESTS |
SOURCE: Lindis Blood Care GmbH
View the original press release on ACCESS Newswire
