SurGenTec’s B-MAN Bone Marrow Aspiration Kit Wins FDA Nod

SurGenTec has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its B-MAN bone marrow aspiration kit.
 
The B-MAN Kit uses a centrifuge-free method to collect high-quality aspirate with minimal contaminants. An integrated, diamond-tip trocar works with the company’s CELLect filtration technology, which the company said reduces bone spicules and other impurities. This products refined aspirate with enhanced cell viability.
 
The Kit aims to improve on traditional bone marrow aspirate techniques, which often involve multiple steps and using cartridges. This can negatively impact cell health.
 
Bone marrow aspirate is used in many surgical applications, including orthopedic procedures, spinal interventions, and regenerative medicine. Using a patient’s own cells greatly lowers risk of disease transmission compared to those derived from allografts or donors.
 
SurGenTec believes the B-MAN Kit can be a valuable option for physicians looking to enhance patient care.
 
“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.”
 
In March, the company earned an FDA nod for its OsteoFlo HydroPutty synthetic bone graft.