Lindis Blood Care
Lindis Blood Care, a company aiming to set a new standard for blood management during cancer surgeries with its medical device CATUVAB, announced today 'excellent' top-line results from the REMOVE certification study, a confirmatory open-label, multicentre clinical study, that enrolled more than 130 patients to assess CATUVAB for use during intraoperative blood salvage (IBS) procedures in cancer surgeries.
Data showed that CATUVAB was safe and effective, meeting all primary and secondary endpoints. The data were presented during the NATA24 Annual Symposium in Bologna on April 19, 2024. Detailed results of this study will be submitted for publication to an international peer-reviewed journal.
The study reported on 119 evaluable patients, of which 61 had tumour cells in the intraoperative blood and 80 received a retransfusion of their own blood after the CATUVAB procedure. To determine efficacy, the primary endpoint analysis investigated the presence of tumour cells in intraoperative blood and their removal in the erythrocyte concentrate (EC).
In all 61 patients where tumor cells were found in the blood salvaged, tumour cells were reliably removed and the primary endpoint was met with a high statistical significance. The secondary endpoints, which covered safety criteria, e.g. reduction of cytokines which are found in intraoperative blood due to the trauma of surgery, were also met with high statistical significance.
“We are extremely pleased with the outcome of the REMOVE clinical trial, where CATUVAB demonstrated its capability to reliably remove cancer cells from salvaged blood during high blood loss surgeries. The presented results cement CATUVAB’s promising position as the first medical device designed for this procedure and could redefine the protocols of intraoperative blood salvage in cancer surgeries. Engineered for easy integration within the existing hospital routines, CATUVAB offers a cost-efficient solution, addressing the current limitations and transforming patient blood management practices. We are now preparing for market authorisation in both Europe and the US," said Dr. Franzpeter Bracht, founder and Managing Director of Lindis Blood Care.
Professor Patrick Meybohm, MD FESAIC, Head of the Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine at the University Hospital Würzburg added: “These outstanding results confirm what we saw during the PILOT study. The synergy between the powerful trifunctional antibody (catumaxomab) and leukocyte depletion filter allows CATUVAB to efficiently bind to and remove tumour cells from intraoperative blood via the general tumour marker EpCAM, eliminating the risk of transfusing blood products with metastasizing capabilities back to patients.”
Professor Kai Zacharowski, MD PhD ML FRCA FESAIC Director of the Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy at the University Hospital Frankfurt said: “CATUVAB has the potential to significantly improve blood management during cancer surgeries. Enabling autologous blood transfusions for these patients avoids the risks associated with allogeneic blood donations, such as immunosuppression, potentially increased tumour recurrence rates and an increased number of operation wound infections. Such a procedure would be a real innovation in an area, we have not seen significant technology advances for many years.”
REMOVE was one of the largest studies to date assessing a medical device for the removal of tumor cells from intraoperative blood during high blood loss cancer surgeries according to Lindis Blood Care. CATUVAB is designed to reliably remove cells from EpCAM (epithelial cell adhesion molecule)-positive tumours from the blood of cancer patients. EpCAM is a tumor marker that can be found on almost all common carcinomas such as ovarian, colon, gastric, prostate, lung and bladder cancer.
