Cytomedix (OTC:CMXI) received FDA clearance for its Angel concentrated platelet rich plasma system, a whole blood separation system designed to produce consistently high platelet yields.
Angel PRP, the only PRP system with adjustable settings to customize plasma formulations, can prepare plasma from whole blood samples either at the patient’s point-of-care or in a clinical setting, according to the company’s website.
"We are pleased to reach this important regulatory milestone that will broaden utilization of the Angel cPRP System in a range of orthopedic procedures," CEO Martin Rosendale said in prepared remarks. "This is a significant market opportunity for Cytomedix as Angel cPRP will be positioned as a ‘best in class’ device that offers important competitive advantages including high platelet concentration capacity, efficient reduction of inflammatory cells, and an automated, closed system for all surgical settings."
The research shows approximately 400,000 spinal fusion procedures are performed each year in the U.S. Concentrated PRP produced from blood and bone marrow might be used in up to 90% during spinal fusion procedures, according to the press release.
The company said the launch of Angel PRP could help them advance the market in personalized regenerative medicine and bone grafting as well.