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June 2, 2022

FDA grants 510(k) clearance for Royal Biologics’ MAXX- BMC system

The MAXX-BMC system allows users to prepare an autologous concentrated BMA product with enhanced stem cell concentration.

The US Food and Drug Administration (FDA) has granted 510K clearance for Royal Biologics’ MAXX-BMC bone marrow aspirate concentration system.

The device has been designed for use at point of care setting to provide optimal samples of concentrated bone marrow aspirate (BMA) from a patient to users.

Developed using the company’s patented Lead Screw technology, the MAXX- BMC system allows users to prepare an autologous concentrated BMA product with enhanced stem cell concentration.

The technology allows users to prepare a customised sample at point of care setting for orthopaedic and sports medicine surgical procedures’ use.

Concentrated BMA is a biologic concentrate, which is derived from the patients’ own bone marrow and contains many hematopoietic stem cells and mesenchymal stem cells.

They have shown to be critical during biological processes like tissue regeneration and bone formation.

Royal Biologics said in a statement: “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.

“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.”

The new bone marrow aspirate concentration system is marked as the latest addition to the company’s portfolio of Advanced Cellular Technologies & Enhanced Autologous Healing solutions.

The company noted that the Lead Screw technology will enable clinicians to accurately locate the areas of ‘Buffy Coat’ fraction of bone marrow aspirate, in seconds after concentration.

Furthermore, the system has the capability to provide up to two concentration cycles within eight minutes.

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