EQS-News: Lindis Blood Care to Present Top Line Results from Clinical Certification Study REMOVE with CATUVAB® at NATA24 Annual Symposium

Lindis Blood Care to Present Top Line Results from Clinical Certification Study REMOVE with CATUVAB^® at NATA24 Annual Symposium

Hennigsdorf, Germany – 11 April, 2024.

Lindis Blood Care, a company aiming to set a new standard for blood management during cancer surgeries with its medical device CATUVAB^®, today announces that top line results of its certification study REMOVE assessing the Company’s medical device for the removal of tumor cells from intraoperative blood during high-blood loss surgeries will be presented at the NATA24 Annual Symposium. The symposium will take place in Bologna, Italy between April 18 – 20, 2024. CATUVAB^® aims to ensure that cancer patients receive their own blood, minimizing the risks associated with allogenic (donor) blood transfusions.

The data will be presented during the Hot Topics session:

Title: Safety of intraoperative blood salvage in cancer surgery – first results of the REMOVE Study

Presenter: Prof. Dr. med. Patrick Meybohm, Head of the Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine at the University Hospital Würzburg.

Time: April 19, 2024 – 12:00-1:00 pm CEST

Prof. Dr. med. Patrick Meybohm will present the first safety and efficacy results from the REMOVE study evaluating CATUVAB^®, a medical device that aggregates tumor cells and lymphocytes and removes those cell complexes in a standard intraoperative blood salvage (IBS) device procedure. Following the positive study outcome, CATUVAB^® is aimed for approval in the EU and US in accordance with Medical Device Regulations. The device would then be the first approved medical device for safe own blood transfusions avoiding the well-known disadvantages of allogenic blood donations in cancer patients as e.g., immunosuppression, potentially increased tumor recurrence rates and an increased number of operation wound infections.

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About REMOVE:

REMOVE, a confirmation open-label multicenter clinical study, enrolled more than 130 patients being one of the largest studies assessing a medical device for the removal of tumor cells in an intraoperative blood salvage (IBS) procedure. CATUVAB^® is designed to reliably remove cells from EpCAM (epithelial cell adhesion molecule)-positive tumors from patient blood during cancer surgeries. EpCAM is a tumor marker that can be found on almost all common carcinomas such as ovarian-, colon-, gastric-, prostate, lung and bladder cancer. By removing these tumor cells, it is possible to safely return the patient’s own blood during high blood loss surgery, thereby avoiding the various risks associated with donor blood including infection with untested viruses, immunosuppression, transfusion related lung injury and increasing wound infections. The procedure was applied extracorporally during oncological surgery, and the treated intraoperative blood was then re-transfused back to the patient as an erythrocyte concentrate.

About NATA and NATA24 Annual Symposium:

NATA, the Network for the Advancement of Patient Blood Management, Hemostasis and Thrombosis, is a global independent medical association dedicated to advancement and promotion of best clinical practice in the management of anemia and iron deficiency, critical bleeding, and thrombosis.

Founded in 1998, NATA (formerly the Network for the Advancement of Transfusion Alternatives) provides a unique multidisciplinary forum for dialogue between hematologists, transfusion medicine specialists, anesthesiologists, intensive care and emergency physicians, surgeons, perfusionists, nurses, biomedical scientists, and other healthcare professionals.

The NATA24 Annual Symposium is one of the Networks Educational activities. It attracts a wide international and multidisciplinary audience of on average 600 delegates from more than 40 countries. The scientific program covers a wide range of topics related to anemia, patient blood management (PBM), critical bleeding and thrombosis. NATA partners with other organizations, institutions, and renowned experts to offer knowledge and expertise in the latest science and practice.

About Lindis Blood Care:

Lindis Blood Care is a medical technology company developing the medical device CATUVAB^®. CATUVAB^® is used to remove EpCAM-positive tumor cells from surgical blood with the use of IBS (intraoperative blood salvage) technology, which is generally used today to re-transfuse surgical shed blood in non-oncological procedures.

During cancer surgeries, donor blood is typically used when large volume blood loss occurs. This is the case for around half a million oncological procedures worldwide, each year. However, the transfusion of donor blood can result in numerous serious side effects including immunosuppression of the recipient and increased tumor recurrence rates. Such side effects could be reduced in the future with the use of CATUVAB^® and the potential re-transfusion of the patient's own blood. In cancer surgeries, the collection and return of surgical blood during an operation (autologous blood transfusion) with the help of IBS devices, which is standard procedure for many other surgeries, cannot be applied, since cancer cells are often released into the patient’s blood during the surgery. In this case the patient’s blood must not be re-transfused due to the possibility of metastasis. This is where CATUVAB^® comes in. It consists of a trifunctional antibody and filter that enables tumor cells to be removed reliably from surgical blood using the standard IBS procedure, as shown in the REMOVE certification study. The product and process can be integrated easily into everyday clinical practice and can become part of contemporary "patient blood management".

Lindis Blood Care’s success has been facilitated 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.

www.lindis-bloodcare.com