SurGenTec Receives FDA Clearance for B-MAN Bone Marrow Aspirate Kit with Integrated Filtration
August 23 2024 - 10:30AM
Business Wire
SurGenTec, an innovative medical device company specializing in
orthopedic and spine technology, is thrilled to 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.
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the full release here:
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(Graphic: SurGenTec)
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.
“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.”
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.
For more information about the B-MAN Bone Marrow Aspirate Kit
and SurGenTec's innovative solutions, please visit
www.surgentec.com.
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