Lindis Blood Care Establishes Scientific Advisory Board of Leading Industry Experts
Hennigsdorf (Berlin), Germany: November 16, 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:
- Neil Blumberg, MD, is Professor of the Department of Pathology and Laboratory Medicine at the University of Rochester Medical Center and Director of the Transfusion Medicine Unit, Blood Bank, and Stem Cell Storage Facility. As an expert in the field of blood transfusion immunology, Dr. Blumberg has worked to enhance the quality, safety and efficiency of transfusion services at Strong Memorial Hospital and across the broader medical community. His long-standing clinical and research foci are immune cytopenias, supportive care for patients with hematologic malignancies and the immunologic sequela of transfusion therapy.
- Ulrich Granzer, PhD, CEO Granzer Regulatory Consultants, Munich, Germany, has been operating a leading consultancy for regulatory affairs and clinical development in Munich since 2002. His background in pharmacy together with his industry experience provide him with an excellent overview of current drug development programs as well as detailed insights into the requirements of key regulatory authorities. He has held global responsibility for regulatory affairs at Bayer AG and BASF Pharma Knoll. He is a founding member & president of the board of the German Association of Regulatory Affairs, DGRA, as well as co-founder of the European Union Regulatory Affairs Group, EURAG, and a member of the Drug Information Association, DIA.
- Professor Hartmut Link, MD, PhD, Professor of Medicine, is Managing Director of Onkodin GmbH, which develops and publishes digitized oncology treatment regimes, he works also in his Private Practice for Internal Medicine, Hematology & Oncology Kaiserslautern he is Member of the Guideline Commission of the German Cancer Society. He has been, for almost two decades, the head physician of the Clinic for Internal Medicine I at the Westpfalz Clinic Kaiserslautern where he specialized in hematology, oncology, stem cell transplantation and diabetology. He has conducted numerous national and international phase II-IV clinical trials.
- Professor Aryeh Shander, MD, FCCM, FCCP, FASA, is Clinical Professor of Anesthesiology, Medicine and Surgery at Icahn School of Medicine at Mount Sinai; Chief of Department of Anesthesiology, Critical Care Medicine, Hyperbaric Medicine and Pain Management at Englewood Hospital and Medical Center; Director of Education for TeamHealth Anesthesia. In addition, he serves as President for the Society for the Advancement of Blood Management (SABM) and is a Fellow of the American College of Critical Care Medicine and the American College of Chest Physicians. Aryeh Shander has also founded and is a member of several committees, in leading positions, such as: National Anemia Action Council (NAAC), the American Society of Critical Care Anesthesiologists (ASCCA), the American Association of Blood Banks (AABB), and the American Society of Anesthesiologists (ASA) where he serves as Chair of Committee on Patient Blood Management.
- Bruce D Spiess, MD, FAHA, is Emeritus Professor of Anesthesiology and Associate Chair for Research at the University of Florida. He was the Vice Chairman of Anesthesiology at Virginia Commonwealth University in Richmond, for over 17 years and, later on, the Chief of Cardiothoracic Anesthesiology at the University of Washington.
- Professor Kai Zacharowski, MD, PhD, ML FRCA, FESAIC; Director of the Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at the University Hospital Frankfurt; Kai Zacharowski is an anesthesiologist, intensive care physician and clinical pharmacologist and former President of the European Society of Anesthesiology and Intensive Care. Focal points of his research are risks in anesthesiology and intensive care medicine, the complex interaction of the immune and coagulation systems, blood poisoning (sepsis) and patient blood management.
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.
Lindis Blood Care GmbH
Dr. Franzpeter Bracht
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