Lindis Blood Care's CATUVAB Device Achieves 100% Tumor Cell Removal in Pivotal Cancer Surgery Study
Key Insights
Lindis Blood Care (search)'s CATUVAB (search) device demonstrated 100% efficacy in removing EpCAM (search)-positive tumor cells from salvaged blood during cancer surgeries in the pivotal REMOVE study with over 135 patients.
The multicenter trial met all primary and secondary endpoints with high statistical significance (p<0.0001) and showed no serious adverse events attributable to the device.
CATUVAB (search)'s trifunctional antibody technology enables safe intraoperative blood salvage across multiple cancer types, potentially reducing reliance on donor blood transfusions in up to 1 million annual cancer surgeries worldwide.
Lindis Blood Care (search) has announced successful results from its pivotal REMOVE study, demonstrating that its CATUVAB (search) device can safely enable intraoperative blood salvage in cancer surgery by completely removing tumor cells from salvaged blood. The confirmatory open-label, multicenter clinical study, published in the Journal of Clinical Anesthesia, enrolled over 135 patients and met all primary and secondary endpoints with high statistical significance.
Complete Tumor Cell Elimination Achieved
In the primary efficacy analysis, CATUVAB (search) demonstrated a 100% (95% CI (95.8%-100%)) rate of sufficient depletion of EpCAM (search)-positive tumor cells (p<0.0001) from intraoperatively salvaged blood after a single intraoperative blood salvage cycle. The study population included patients with a broad range of solid tumors, including bladder, gastric, ovarian, pancreatic, colorectal, lung, and peritoneal cancers.
Of more than 130 patients analyzed, 119 had sufficient blood samples for evaluation, with EpCAM (search)-positive tumor cells detected in 61 cases (51%). Ultimately, 80 patients received retransfusion of their own blood following CATUVAB (search) processing and were included in the safety analysis.
Strong Safety Profile Demonstrated
The safety analysis confirmed that no severe adverse events were attributable to CATUVAB (search). 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.
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. Additionally, proinflammatory cytokines IL-6 and IL-8 (search), present in intraoperative blood due to surgical trauma, were reduced approximately 30-fold and 38-fold, respectively, from reservoir to erythrocyte concentrate.
Revolutionary Technology for Cancer Surgery
CATUVAB (search) works through a purely physical mode of action, using a trifunctional antibody to crosslink EpCAM (search)-positive tumor cells with immune cells into cell aggregates. These aggregates are then removed in two steps during the subsequent process, efficiently removing tumor cells and immune cell aggregates from salvaged intraoperative blood.
"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 (search) reliably removes all tumor cells from salvaged blood, addressing the key barrier that has limited autologous blood transfusion in oncology."
Addressing Critical Medical Need
Each year, up to 1,000,000 cancer surgeries worldwide require donor blood transfusions, which increase the risk of immunosuppression and tumor recurrence. Intraoperative blood salvage can reduce reliance on donor blood by reusing the patient's own blood. However, its use in oncology has been limited due to the risk of reinfusing viable tumor cells.
Professor Patrick Meybohm, MD, FESAIC, Head of the Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine at University Hospital Würzburg, noted that "these promising results have the potential to re-define the intraoperative blood salvage protocols in cancer surgeries. By physically binding tumor cells and removing them through cell aggregate filtration, CATUVAB (search) clears contamination while preserving the quality of the blood."
Regulatory Progress and Future Development
CATUVAB (search) is currently in the late stage of the CE certification process and has been submitted for approval to the US FDA. As an add-on to existing intraoperative blood salvage devices, CATUVAB is designed to ensure high compatibility and seamless integration into established clinical workflows.
"With CATUVAB (search) 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 (search), in a joint statement. "These results strongly validate our Antibody Based Cell Removal-Technology, allowing safe intraoperative blood salvage in cancer surgery."
The study results also support further development beyond oncology, including safer transfusion practices for immunosuppressed patients. Leveraging its Antibody-Based Cell Removal Technology platform, Lindis Blood Care (search) is developing further high-value indications to address critical gaps in transfusion safety across diverse markets.