EmCyte Corporation issued the following announcement on June 11.
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System. The system's 510(k) number is K183205 and is cleared for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate. Bone marrow's platelet and cell concentrate is the strongest autologous biologic prepared at the point of care. The system's clearance is uniquely powerful in that it does not require bone marrow aspirate to be mixed or diluted with whole blood, a method that reduces cell potency and strength.
The PureBMC® Supraphysiologic Concentrating System is designed for minimally invasive collection and preparation of bone marrow aspirate through centrifugation. The quality of the system's BMC biologic is exemplified in its powerful, yet viable progenitor stem cell milieu combined with platelet growth factors and cell mediators. The system's distinction lies in its ability to remove hemolytic oxidative free hemoglobin from its BMC biologic, a toxic substance that causes oxidative stress, loss of nitric oxide, inflammation, immunosuppression, microcirculatory dysfunction and significant tissue injury. PureBMC® Supraphysiologic is innovative and sets a new safe and powerful standard in BMC biologics.
"The PureBMC® Supraphysiologic Concentrating System is scientifically potent, clinically pure and processes with ease," said Patrick Pennie, President & CEO of EmCyte Corporation. "It was designed to improve the quality of the bone marrow cell concentrate deliverable we offer to our clients. We believe it has surpassed our expectations with its consistent and exceptional performance. Its inspirational to know that our innovative ideas are improving the lives of so many people around the world."
EmCyte Corporation®, headquartered in Fort Myers, Florida, is the world leader in platelet rich plasma and progenitor stem cell biologics. Its PURE™ regenerative product solutions have set a new standard in regenerative deliverables with protocol versatility and outstanding recovery performance. EmCyte products are manufactured in its 30,000 sq ft manufacturing facility equipped with certified clean rooms and state-of-the-art manufacturing equipment. With over 20 years of experience, EmCyte's commitment to innovation has made a clinical difference in countries around the globe. Its team of qualified experts are available to provide advanced training and clinical support. To learn more about EmCyte Corporation®.
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