SurGenTec, a medical device company focused on orthopaedic and spine technology, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its proprietary B-MAN Bone Marrow Aspirate Kit.
The B-MAN Kit, with integrated filtration, presents a method for bone marrow aspiration that eliminates the need for a centrifuge. This ensures an aspirate with minimal contamination.
Its diamond-tip trocar, paired with CELLect filtration technology, reduces bone spicules and other impurities to produce a refined aspirate with improved cell viability.
According to SurGenTec, traditional bone marrow aspiration methods often involve multiple steps and the use of centrifuges, which can negatively affect cell health.
The B-MAN Kit simplifies this process by making it easier and more efficient to access bone marrow.
Featuring a surface area up to three times larger than conventional methods, the kit improves the retrieval of progenitor cells while minimising contamination from peripheral blood and bone spicules.
Additionally, its design aids healthcare providers in optimising patient treatment and enhancing patient care in the expanding regenerative medicine market sector.
SurGenTec CEO Travis Greenhalgh said: “We are excited to add this unique device to our product portfolio.
“Our aim was to create a minimally invasive solution that simplifies the aspiration process while optimising 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.”
SurGenTec, headquartered in Boca Raton, Florida, specialises in orthopaedic technologies and neurosurgical spine treatments. Its minimally invasive solutions focus on patient safety.
The medical device firm has secured several national group purchasing organisation (GPO) agreements throughout the US and has entered the international market.
The company plans to further develop its product portfolio through its in-house engineering incubator, with several new releases anticipated throughout 2024 and into 2025.
In March 2024, SurGenTec obtained FDA 510(k) clearance for OsteoFlo HydroPutty Synthetic Bone Graft.
