SurGenTec, a leader in orthopedic and spine technology, is excited to announce that its proprietary B-MAN Bone Marrow Aspirate Kit has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The B-MAN Kit revolutionizes bone marrow aspiration by offering a centrifuge-free method for collecting high-quality aspirate with minimal contamination. Featuring an integrated diamond-tip trocar and CELLect filtration technology, it effectively reduces bone spicules and impurities, resulting in purer aspirate with improved cell viability.
Travis Greenhalgh, CEO of SurGenTec, expressed enthusiasm about the new addition to their product line: “Our goal was to develop a minimally invasive device that simplifies the aspiration process while preserving cell quality. The B-MAN Kit maintains native cell structure and reduces manipulation, offering physicians a superior autologous treatment option.”
Unlike traditional methods that rely on multiple steps and centrifuges, potentially compromising cell health, the B-MAN Kit streamlines the process. It enhances marrow contact with a surface area up to three times greater than conventional techniques, improving progenitor cell retrieval and reducing contamination with peripheral blood and bone spicules.
The B-MAN Kit is valuable for various applications, including orthopedic and spinal procedures, as well as regenerative medicine. By utilizing a patient’s own cells, it reduces disease transmission risks compared to allografts or donor products. As the regenerative medicine field advances, the B-MAN Kit provides an effective option for enhancing patient care.
Based in Boca Raton, Florida, SurGenTec is dedicated to developing innovative technologies for orthopedic and neurosurgical treatments. With numerous national GPO agreements and a growing international presence, SurGenTec plans to expand its portfolio with additional product releases throughout 2024 and 2025.