HemoClear B.V. today announced it received CE Mark approval for its first-in-class, advanced technology, the HemoClearTM autologous blood filter. HemoClearTM significantly expands the existing and medically preferred therapy options to use patient’s own blood for blood transfusion. With CE Mark approval, HemoClearTM is now available to European hospital systems and the CE quality confirmation initiated numerous low-income country registration procedures. FDA 510(k) clearance in the United States is expected later this year.
In addition of the previously obtained ISO 134385:2016 certification of its quality management system, HemoClear proofed its ability to provide medical devices that consistently meet both customer and applicable regulatory requirements, reviewed audited and approved by international body governing quality in medical device manufacturing.
Anesthesiologist, intensivist and inventor of the HemoClearTM blood filter Dr. Arno Nierich MD, Ph.D., states that “the CE Mark and ISO certification are important milestones for the product HemoClearTM and the global blood transfusion community. The product can now be integrated into autologous blood transfusion therapy options at major hospitals across Europe and because of the certification, in multiple low-income countries”.
HemoClear’s CEO Vincent Franssen emphasizes the advantages the product brings “despite its wide applicability, donor blood transfusion is still associated with high costs, medical complications, longer recovery time and scarcity in low-income countries. Autologous (patient own) blood transfusion addresses these donor blood downsides, HemoClearTM transforms patient shed blood in a simple and fast way into a fresh, safe, cost efficient and high-quality autologous transfusion blood.”
At HemoClear we are on a mission to create innovative medical devices for patients in need. Our pipeline focuses on diseases that are severe or life-threatening and have limited available or affordable treatment options. All devices that we are developing are related to the use of blood and blood components. The sterile HemoClear filter was developed to captures Red Blood Cells (RBC) from patients shed blood and separates them from plasma, with a high degree of specificity. After filtering, the RBCs are re-infused (autologous blood transfusion) and the plasma is disposed. If the plasma contains COVID-19 antibodies, this valuable plasma is used in the treatment of critically ill COVID-19 patients.