SurGenTec’s FDA clearance for B-MAN Bone Marrow Aspirate Kit

SurGenTec 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, using 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.

“We are excited to add this unique device to our product portfolio,” says Travis Greenhalgh, CEO of SurGenTec. “Our aim was to create a minimally invasive solution that simplifies the aspiration process while optimizing cell quality. The B-MAN Kit preserves native cell structure and facilitates the extraction of healthier cells by reducing the manipulation that takes place, providing physicians with a robust autologous option for patient treatment.”

Traditional bone marrow aspiration techniques often involve multiple steps and the use of centrifuges, which can negatively impact cell health. The B-MAN Kit streamlines this process by promoting ease of use and efficiency while accessing bone marrow.

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. This innovative design positions the B-MAN Kit as a powerful tool for healthcare providers seeking to treat their patients.

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.

SurGenTec is a privately owned medical device company based in Boca Raton, Florida, specializing in unique technologies for orthopedic and neurosurgical spine treatments. They are committed to providing minimally invasive treatment options that prioritize patient safety. SurGenTec has secured numerous national GPO agreements throughout the United States and has entered the international market. SurGenTec will continue to develop its portfolio through its in-house engineering incubator, with more product releases throughout 2024 and into 2025.