German medical technology company Lindis Blood Care has announced that the last patient participating in its trial of the removal of tumour cells from surgical shed blood has completed the trial with top-line results expected in early 2024.

The study, entitled the Remove study, is investigating the company’s Catuvab device, designed to remove cancerous cells from a patient’s blood whilst undergoing cancer-related surgery.

The company has said that its confirmational open-label multicenter clinical study was able to enrol 130 patients and is one of the largest studies of its kind examining the use of a medical device for the removal of tumour cells in an intraoperative blood salvage (IBS) procedure.

Catuvab is intended to be used in surgeries involving epithelial cell adhesion molecule-positive tumours, a tumour marker that can be found in many of the most common carcinomas, including ovarian, colon, gastric and prostate cancer. The benefit of the IBS procedure is to allow the patient to receive their blood back as part of a high-risk cancer surgery, significantly reducing risk to the patient as opposed to relying on donor blood.

Lindis Blood Care co-founder Franzpeter Bracht commented: “We are pleased to announce the completion of our confirmatory study, which represents an important milestone towards certification of our device and brings us one step closer to making Catuvab and autologous blood transfusion available to cancer patients.”

The Remove trial is intended to form the basis of Lindis Blood Care’s bid to achieve a European CE mark for its device, as well as in hopes of achieving full clearance from the US Food and Drug Administration (FDA)

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By GlobalData

It follows after a competing US company, Illinois-based Ecomed Solutions, launched their own surgical blood management device in 2019, similarly intended to collect a patient’s lost blood during surgery and return it to their body in a process known as cell salvage.

Lindis Blood Care co-founder Horst Lindhofer said: “Blood is a precious and scarce resource. Being able to use a cancer patient’s own blood in the operation room by avoiding the risk of metastases from remaining tumour cells would be a much-needed transformation in the patient blood management landscape.”

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