Research & Development
EmCyte awarded US FDA 510(k) clearance for PureBMC Supraphysiologic Concentrating System to improve quality of bone marrow cell concentrate
12 June 2019 -

Stem cell biologics company EmCyte reported on Tuesday the receipt of US FDA 510(k) clearance for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate setting a new safe standard in BMC biologics.

EmCyte said PureBMC Supraphysiologic Concentrating System's clearance is powerful as it does not require bone marrow aspirate to be mixed or diluted with whole blood, a method that reduces cell potency and strength. Bone marrow's platelet and cell concentrate is the strongest autologous biologic prepared at the point of care.

According to the company, the PureBMC Supraphysiologic Concentrating System is designed for minimally invasive collection and preparation of bone marrow aspirate through centrifugation. Its BMC biologic quality is exemplified in its powerful, yet viable progenitor stem cell milieu combined with platelet growth factors and cell mediators.

The PureBMC Supraphysiologic Concentrating System can remove hemolytic oxidative free hemoglobin from its BMC biologic, a toxic substance that causes oxidative stress, loss of nitric oxide, inflammation, immunosuppression, microcirculatory dysfunction as well as significant tissue injury, concluded the company.

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