SurGenTec received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate kit. The Boca Raton, Florida-based company says its B-MAN kit offers a cutting-edge approach to bone marrow aspiration. It utilizes a centrifuge-free method to collect high-quality aspirate with minimal contaminants. The kit’s integrated, diamond-tip trocar works simultaneously with CELLect filtration technology. This effectively reduces spicules and other impurities, resulting in refined aspirate with enhanced cell viability.
Related: FDA clears AISAP’s AI-powered Cardio platform
According to a news release, traditional bone marrow aspiration techniques often involve multiple steps and the use of centrifuges. This can negatively impact cell health. B-MAN streamlines the process by promoting ease of use and efficiency when accessing bone marrow.
The kit maximizes marrow contact with a surface area up to three times greater than conventional methods. This enhances the retrieval of progenitor cells while reducing contamination with peripheral blood and bone spicules.
“We are excited to add this unique device to our product portfolio,” said 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.”
