EQS-News: Lindis Blood Care GmbH / Key word(s): Personnel
Lindis Blood Care Establishes Scientific Advisory Board of Leading Industry Experts
Hennigsdorf, Germany – 16 November, 2022.
Lindis Blood Care, a company aiming to set a new standard for blood management during cancer surgeries with its medical device CATUVAB®, is pleased to announce the formation of its Scientific Advisory Board (“SAB”) comprising world-leading experts and key opinion leaders in the field of perioperative patient care, de-risking operative interventions, blood management and regulatory affairs. The SAB will serve as a strategic resource to Lindis Blood Care as the Company finalizes its current clinical program with lead product candidate CATUVAB® and guide the Company through the CE certification and FDA market application process.
“Attracting such a distinguished group of leading regulatory, anesthesiology and hematology experts highlights the importance and strength of our approach to fill the urgent need for an effective and easy-to-implement method to remove tumor cells from patient blood during cancer surgery that can avoid the risks associated with allogeneic red blood cell transfusions and decrease the use of donor blood,” said Dr. Franzpeter Bracht, co-founder and Managing Director of Lindis Blood Care. “We are advancing towards exciting milestones with our clinical study nearing completion. Our preparations are in the final steps for market entry in our key markets Europe and the US to ensure EU Medical Device Regulation and FDA conformity and, thus, timely approval. In addition, for the launch of CATUVAB®; we have established our own manufacture at the Company's headquarters to produce so far up to 10,000 kits per year. As we progress, the scientific expertise and in-depth knowledge of the SAB will be invaluable in supporting and guiding us towards our goal of making the benefits of autologous (patient’s own) blood transfusions [more easily] available to cancer patients.”
“Blood transfusions can have a major impact on patient outcomes. They are essentially comparable to mini-transplantations in that the patients receive cells from someone else and are therefore associated with risks such as immune-suppression, congestive heart failure, allergic reactions, potentially increased tumor recurrence rates and decreased life expectancy. The usage of intraoperative blood salvage, IBS, with which blood lost during surgery is recovered and re-transfused, has become an established practice to circumvent these negative side effects. However, IBS in cancer surgery is generally refrained from due to the high risk of metastasis from tumor cells being released into the blood during the procedure” Prof. Kai Zacharowski member of the newly formed SAB of Lindis Blood Care, explained. “Lindis Blood Care’s approach has the potential to become a game changer in blood management during cancer surgery by providing a reliable and easy to implement method to avoid this risk. I welcome the opportunity to collaborate with the LBC team to bring this new approach to this patient group.”
CATUVAB® is a novel approach designed to be a safe and cost-effective way to reliably remove tumor cells from autologous blood. Its mechanism of action is physical and does not involve pharmacological, immunological, or metabolic action, reducing to a minimum any secondary effects in the body. The approach can easily be integrated into existing clinical practice and represents a cost-effective method compared to fully burdened allogeneic blood transfusions and the treatment-related costs due to severe side effects associated with such transfusions.
The Company's approach has already shown proof of concept both in vitro and in an initial clinical study. The data showed that no tumor cells could be detected in the surgical blood treated with CATUVAB®. A confirmatory multicenter clinical study was initiated in February 2021 with the objective to achieve European CE certification by the end of 2023.
Composition of the Lindis Blood Care Scientific Advisory Board:
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 including Cancer Stem Cells from surgical blood and is thus designed to enable the use of Intraoperative Blood Salvage (IBS), which is already applied broadly in non-oncological surgeries, in the re-transfusion of blood shed during tumor surgery.
During cancer surgery, donor blood is typically used when large volume blood loss occurs. However, the transfusion of donor blood can result in numerous serious side effects and increased tumor recurrence rates. In the future, such side effects could be reduced by re-transfusing the patient’s own blood after treatment with CATUVAB®. In cancer surgery, the collection and return of intraoperative blood during an operation with the help of IBS devices, which is standard procedure for many other surgeries, cannot be applied routinely, since tumor 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 risk of metastasis. This issue is what CATUVAB® addresses. CATUVAB® consists of a trifunctional antibody and a filter that enables tumor cells to be removed reliably from surgical blood using standard IBS procedure. The product and process can be integrated easily into everyday clinical practice and become part of standard patient blood management.
16.11.2022 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.