Royal Biologics Announces FDA 510K Approval and U.S. Commercial Launch of the MAXX™-BMC Bone Marrow Aspirate Concentration System

HACKENSACK, N.J., June 1, 2022 (Newswire.com) - Royal Biologics (Hackensack, NJ), a company specializing in Advanced Cellular Technologies & Enhanced Autologous Healing, announces today the FDA 510K regulatory clearance and U.S. commercial launch of the MAXX™-BMC system. MAXX™-BMC is a bone marrow aspirate concentration system that provides users an optimal sample of concentrated bone marrow aspirate, from a patient, point of care. Royal's patented "Lead Screw" technology in their Maxx™ concentration device allows users to develop a customized sample point of care for use during orthopedic and sports medicine surgical procedures. MAXX™-BMC is the latest addition featured in Royal Biologics' industry-leading portfolio of Advanced Cellular Technologies & Enhanced Autologous Healing solutions.

Bone Marrow Concentrate is widely used and recognized in orthopedics as a complement to help facilitate mature bone growth. Bone marrow aspirate is a rich source of cells, cytokines,  and growth factors. Concentrating bone marrow aspirate accelerates the ability to harness these viable growth factors that are needed for bone growth and soft tissue regeneration. 

Maxx™-BMC's patented Lead Screw technology allows clinicians to pinpoint precise and accurate areas of the "Buffy Coat" fraction (growth factor layer) of bone marrow aspirate in a matter of seconds post concentration. Maxx™-BMC provides up to two concentration cycles in eight minutes, which sets a new industry standard for delivery time and cellular output. Maxx™-BMC's performance, flexibility and customizable outputs make it a unique versatile system for multiple clinician settings and procedures. 

"We are thrilled with the announcement of the FDA's 510K regulatory clearance of our MAXX™-BMC system. Maxx™-BMC's patented Lead Screw technology provides users the most flexible and versatile bone marrow aspirate concentration system on the market. The addition of MAXX™-BMC to our growing Enhanced Autologous Healing portfolio now puts Royal Biologics in the position as a go-to provider for autologous, advanced cellular therapies. Royal Biologics now has the most expansive portfolio of disposable enhanced autologous healing and advanced cellular products in the orthopedic and regenerative medicine industry. Our goal is to harness the power and ability of the patients own cells to help treat a wide variety of specialties at a fraction of the cost of other expensive bone graft substitutes and allogenic options on the market."

Royal Biologics Enhanced Autologous Healing and Advanced Cellular Portfolio is comprised of five unique systems. FIBRINET™ (Platelet Rich Fibrin Matrix), OSTEO™-SPIN, MAXX™-Cell (bone marrow harvester), MAXX™-PRP (Platelet Rich Plasma), and MAXX™-BMC.(Bone Marrow Aspirate Concentrate) Royal Biologics works with health systems to provide a matrix suite of products that provide clinicians with a wide variety of advanced cellular options, through their one time use disposable portfolio.

Royal Biologics will be attending the upcoming 22^nd Annual International Society for the Advancement of Spine (ISASS) conference at the Atlantis Resort, in the Bahamas June 1-4. Royal Biologics will be displaying their Enhanced Healing and Advanced Cellular Technologies Portfolio at booth #103. 

MAXX™-BMC is now available for U.S. Distribution. For partnership opportunities, please contact [email protected]

To learn more about Royal Biologics and their unique portfolio, please visit www.royalbiologics.com.

Source: Royal Biologics