Florida-based SurGenTec receives US FDA clearance for B-MAN bone marrow aspirate kit

SurGenTec, a Florida-based medical device company specializing in orthopedic and spine technology, announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary B-MAN Bone Marrow Aspirate Kit.

The B-MAN Kit introduces a cutting-edge approach to bone marrow aspiration, utilizing a centrifuge-free method for the collection of high-quality aspirate with minimal contaminants. Its integrated diamond-tip trocar works simultaneously with CELLect filtration technology, which effectively reduces bone spicules and other impurities, resulting in refined aspirate with enhanced cell viability.

The B-MAN Kit can streamline a multi-step, centrifuge-relying process by promoting ease of use and efficiency while accessing bone marrow, also potentially avoiding negative impact on cell health. By maximizing marrow contact with a surface area up to three times greater than conventional methods, the B-MAN Kit enhances the retrieval of progenitor cells while reducing contamination with peripheral blood and bone spicules. Bone marrow aspirate plays a critical role in various surgical applications, including orthopedic procedures, spinal interventions, and regenerative medicine. Utilizing a patient’s own cells significantly lowers the risk of disease transmission compared to products derived from allografts or donors. As the regenerative medicine market sector continues to evolve and grow, the B-MAN Kit offers a valuable option for physicians aiming to enhance patient care.