Pharma Focus Asia
Eppendorf Bioprocess Solutions

EmCyte Announces FDA 510(k) Clearance for its PurePRP® Supraphysiologic Concentrating System

Wednesday, February 26, 2020

EmCyte, the world leader in platelet rich plasma and progenitor stem cell biologics, announces its FDA 510(k) clearance for its PurePRP® Supraphysiologic Concentrating System for platelet rich plasma. The system's 510(k) number is BK190317 and is cleared to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. This clearance completes EmCyte's PURE Supraphysiologic product portfolio allowing practitioners to now use the most advanced in autologous biologic concentrating systems.

The PurePRP® Supraphysiologic Concentrating System is designed to use a single device to prepare PurePRP®. This innovation has been anticipated by practitioners as it shortens preparation time, improves product quality and enhances versatility. Physicians can be more efficient without compromising quality or effectiveness. Autologous regenerative medicine is fast becoming a standard of care and using the right biologic is vitally important to how patients respond. PurePRP® is advanced clinical PRP and the new standard in platelet biologics. Its cell composition is powerful, viable and friendly to the local tissue environment making it an effective and well tolerated treatment application for patients.

"The PurePRP® Supraphysiologic Concentrating System is the next step in clinical excellence," says Patrick Pennie, President & CEO of EmCyte Corporation. "We believe we've hit the mark on this innovation after improving the clinical experience for both the practitioner and patient."

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