process and function

New safe and cost-effective approach for blood management in cancer surgery for EpCAM positive cancers that can be easily integrated into hospital routines

The primary operating priciple of CATUVAB® is based on the physical removal of aggregates consisting of leucocytes and EpCAM-positive tumor cells from collected blood by centrifugation and filtration.

Filtration will be done by a leukocyte depletion filter (LDF) included in the CATUVAB® kit, after most relevant parts of the leukocytes/monocytes/tumor cell complexes have been removed prior by centrifugation during IBS procedure.

The tumor cell depleted erythrocyte concentrate can be retransfused to the patient.

The formation of the cell aggregates is mediated by the trifunctional antibody, which is a component of the medical device CATUVAB®.


Lindis Blood Care
has started the development of CATUVAB® by generating in vitro data regarding the ability of CATUVAB® to remove EpCAM positive tumor cells from blood, including cancer stem cells

Proof of Principle demonstrated in an in vitro study

Study completed in 2019

Study design:
Blood drawn from volunteers was spiked with tumor cells, samples then treated with CATUVAB® and a standard IBS device
Samples then screened for tumor cells and residual antibody in the final erythrocyte concentrate (EC) after leukocyte depletion filtration

Results summary:
Also at a very low antibody concentration no residual tumor cells were detected in the final erythrocyte concentrate


Lindis Blood Care performed successfully an Exploratory Study, („Pilot Study“) at a German University. In this study the CATUVAB® procedure was used to treat intraoperative blood from 15 Patients during an oncological surgery. To demonstrate the efficacy of CATUVAB®, potentially remaining tumor cells as well as antibodies were assessed with very sensitive detection methods in the erythrocyte concentrates (EC), besides other safety parameters.

Based on convincing data from the PILOT STUDY published by Winter et al., BMC Anesthesiol, 2021, LBC`s Confirmatory Study REMOVE was started.

Ex vivo Pilot Study: CATUVAB® shown to be safe and effective

Study completed in 2020

Study design:
15 volunteers from surgeries of different EpCAM positive carcinomas,
Parameters measured in the intraoperative blood and ECs:

-EpCAM positive tumor cells

-Safety parameters

-Study was successfully completed

-No residual EpCAM positive Tumor Cells were found after use of CATUVAB®.

Results demonstrate the efficacy and safety of CATUVAB®

Winter et al., BMC Anesthesiol, 2021


Lindis Bloode Care has started the multi center, clinical confirmatory study REMOVE.

REMOVE is designed for cancer patients with human epithelial cell adhesion molecule (EpCAM)-positive tumor indications (such as lung-, gastric-, pancreas-, colon-, endometriosis-, ovarian and bladder cancer) and expected high blood loss during surgery.

Our device CATUVAB® will be used to remove cancer cells including cancer stem cells from extracorporal blood during tumor surgery by intraoperative blood salvage (IBS) and additional filtration (Leukocyte Depletion Filter included in the CATUVAB® kit). This procedure enables the retransfusion of autologous erythrocyte concentrate to the patient.

Confirmatory study REMOVE to achieve CE certification

Study started in December 2020, multi center
Up to 110 patients treated with CATUVAB® shall be included

Study design:
– Study design is identical to Pilot Study except retransfusion of EC
was added.
– Confirmatory study

Primary endpoint:
– Demonstrate depletion of EpCAM-positive tumor cells

REMOVE is designed to enable CE Certification of CATUVAB®