Royal Biologics Announces FDA Approval of the Maxx™ Concentration System
Royal Biologics, an ortho-biologics company focused on Autologous and Live Cellular solutions, has announced FDA 510K approval of their Maxx™-PRP concentration system. Maxx™-PRP is a patented next-generation concentration device that can be used to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma to use point of care for mixing with autograft and/or allograft to improve handling characteristics. Royal’s Maxx™-PRP system 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 within seconds at their fingertips. Multiple formulation options such as Leukocyte Rich (LR-PRP), Leukocyte Poor (LP-PRP) and Platelet Pure Plasma (P-PRP) are easily achieved within minutes. Maxx™-PRP also allows users to perform two concentration cycles in one device, in under 10 minutes. This enhanced novel technology sets a new bar in the orthopedic and regenerative medicine industry for concentration times, customizable formulations and efficiency.
Maxx™-PRP is the latest product launch in Royal Biologics continuous expansion of their Autologous and Live Cellular (ALC) Technology portfolio. Royal Biologics has now launched three novel systems in their ALC portfolio that provide an efficacious and cost-benefit advantage to clinicians and hospital systems.
“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,” says Salvatore Leo Chief Executive officer of Royal Biologics.
Royal Biologics has released a new multimedia video on their website (www.royalbiologics.com) that highlights the functionality of the Maxx™ concentration system. The Maxx™-PRP concentration system and their ALC Technology portfolio will be on display at this year’s upcoming North American Spine Society Meeting (NASS) in Boston from September 29 – Oct 1.
Seen on GlobeNewsWire (Medtech): Article Link