Sam Brusco, Associate Editor06.01.22
Royal Biologics, a company specializing in advanced cellular technologies and enhanced autologous healing, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the MAXX-BMC system. The company also began commercial launch in the U.S.
MAXX-BMC is a bone marrow aspirate concentration system that can be used at the point of care to collect optimal samples of concentrated bone marrow aspirate. The company’s technology lets users develop a customized sample for orthopedic and sports medicine surgical procedures.
Bone marrow concentrate is used in orthopedics as a complement to facilitate mature bone growth. Bone marrow aspirate is a rich source of cells, cytokines, and growth factors, and concentrating the aspirate helps harness the growth factors for bone growth and soft tissue regeneration.
The MAXX-BMC system’s “Lead Screw” tech helps pinpoint the “Buffy Coat” fraction—the growth factor layer—of bone marrow aspirate in seconds after concentration. Two concentration cycles can be provided in eight minutes.
"We are thrilled with the announcement of the FDA's 510(k) regulatory clearance of our MAXX-BMC system,” Royal Biologics told the press. “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."
MAXX-BMC is a bone marrow aspirate concentration system that can be used at the point of care to collect optimal samples of concentrated bone marrow aspirate. The company’s technology lets users develop a customized sample for orthopedic and sports medicine surgical procedures.
Bone marrow concentrate is used in orthopedics as a complement to facilitate mature bone growth. Bone marrow aspirate is a rich source of cells, cytokines, and growth factors, and concentrating the aspirate helps harness the growth factors for bone growth and soft tissue regeneration.
The MAXX-BMC system’s “Lead Screw” tech helps pinpoint the “Buffy Coat” fraction—the growth factor layer—of bone marrow aspirate in seconds after concentration. Two concentration cycles can be provided in eight minutes.
"We are thrilled with the announcement of the FDA's 510(k) regulatory clearance of our MAXX-BMC system,” Royal Biologics told the press. “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."