EmCyte Announces FDA 510(k) Clearance for its Progenikine® Concentrating System for Adipose

FORT MYERS, Fla., Dec. 3, 2019 /PRNewswire/ -- EmCyte, the world leader in platelet rich plasma and progenitor stem cell biologics, announces its FDA 510(k) clearance for its Progenikine® Concentrating System for adipose lipoplasty. The system’s 510(k) is cleared for all medical procedures involving the harvesting and transferring of autologous adipose tissue. The system’s 510(k) number is K191564.

The Progenikine® Concentrating System is designed for pure extraction and centrifugal preparation of adipose concentrate at the point of care. It is uniquely equipped with innovation that permits the full and complete removal of oil contaminants and effluent residuals while securing a robustly concentrated adipose treatment sample. This allows the powerful regenerative bioactive substances to work on transferred tissue without hindering influences. Patients will benefit from another PURE autologous biologic that is both richly effective and gentle to the local tissue environment.

“We’re excited about the vast benefits of the Progenikine® Concentrating System,” says Patrick Pennie, President & CEO of EmCyte Corporation. “It’s a powerful biologic with a wide application base allowing it to be a viable choice for a multitude of procedures. Progenikine® has taken its place on the stage of regenerative biologics and provides practitioners with a superior option for adipose concentrate.”

The Progenikine® procedures include Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

About Emcyte Corporation:
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 square foot 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, and its team of qualified experts are available to provide advanced training and clinical support. To learn more about EmCyte Corporation®, visit https://www.emcyte.com.

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SOURCE EmCyte Corporation