Maxx Concentration PRP System Gains FDA 510(k) Approval

Royal Biologics has received FDA approval for its Maxx-PRP concentration system, allowing clinicians to treat conditions in orthopedics, sports medicine, plastic surgery and regenerative medicine.

Maxx-PRP Concentration Device
Maxx-PRP Concentration Device
Courtesy of Royal Biologics

Royal Biologics has received FDA 510(k) approval of its Maxx PRP concentration system. 

Royal Biologics is an ortho-biologics company focused on autologous and live cellular solutions.

Maxx-PRP is a patented device that can be used to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma to use at the point of care for mixing with autograft and/or allograft to improve handling characteristics. It offers "customizable formulations" of platelet-rich plasma, allowing clinicians to treat a variety of conditions in orthopedics, sports medicine, plastic surgery and regenerative medicine.

Maxx-PRP's patented lead screw technology allows users to customize various platelet-rich plasma formulations, such as Leukocyte Rich (LR-PRP), Leukocyte Poor (LP-PRP) and Platelet Pure Plasma (P-PRP). The system also allows users to perform two concentration cycles in one device. 

Maxx-PRP is the latest product launch in Royal Biologics continuous expansion of their Autologous and Live Cellular (ALC) Technology portfolio. 

"We continue to see with science-backed clinical evidence, that the power of our bodies' own cells for fusion and soft tissue solutions is a premier option in orthopedics and regenerative medicine. The Maxx concentration system is another extension of our expanding Platelet and Fibrin Matrix Technologies portfolio. Platelet Rich Fibrin Matrix (PRFM) is developing into a new novel class in orthopedics and Royal Biologics is developing a multidimensional approach with our patented intellectual properties surrounding Platelets and Fibrin. We are now providing optimal cellular solutions, point of care, at a fraction of the cost of other companies' products on the market. Royal's innovative portfolio surrounding Platelet Rich Fibrin Matrices (PRFM) and Autologous based PRP therapies is creating a robust offering of novel solutions and a value-based proposition for the future of orthopedics and regenerative medicine," said Salvatore Leo, CEO of Royal Biologics.


More in News