SurGenTec has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for its B-MAN Bone Marrow Aspirate Kit.
The kit features an integrated filtration system that simplifies the collection of high-quality bone marrow aspirate.
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The B-MAN Kit’s CELLect filtration technology, coupled with a diamond-tip trocar, allows for the collection of bone marrow aspirate without the need for a centrifuge.
This method not only streamlines the process but also ensures the aspirate is of high quality with minimal contaminants.
Traditionally, bone marrow aspiration can be cumbersome, often requiring centrifugation that can harm cell viability.
SurGenTec’s B-MAN Kit addresses this issue by offering a more efficient and less invasive alternative, which is expected to benefit both healthcare providers and patients.
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By GlobalDataThe kit’s design allows for increased contact with bone marrow, enhancing the retrieval of progenitor cells and reducing contamination.
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’s B-MAN Kit provides a safer option for cell-based therapies by using the patient’s own cells, thus reducing the risk of disease transmission associated with donor-derived products.
