US-based orthobiologics company Royal Biologics has received the US Food and Drug Administration (FDA) 510K approval for its MAXX-BMC (Bone Marrow Concentration) system.

MAXX-BMC is a bone marrow aspirate concentration system, designed to provide an optimal sample of concentrated bone marrow aspirate from patients.

Royal Biologics developed the bone marrow aspirate concentration system by combining its patented Lead Screw technology with its Maxx concentration device.

The system allows users to prepare an autologous concentrated bone marrow aspirate in a point of care (PoC) setting, with enhanced stem cell concentration.

Concentrated bone marrow aspirate, which is derived from the patients’ own bone marrow, contains plenty of mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs).

The concentrate is said to be critical in biological processes such as tissue regeneration and bone formation and is used in orthopaedic and sports medicine surgical procedures.

Royal Biologics, in a statement, said: “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 orthopaedic and regenerative medicine industry.”

MAXX-BMC forms the latest addition to the Royal Biologics’ portfolio of advanced cellular technologies and enhanced autologous healing solutions.

Its patented Lead Screw technology will enable clinicians to accurately locate the areas of ‘Buffy Coat’ fraction of bone marrow aspirate, within seconds after concentration.

The system is capable of providing up to two concentration cycles in eight minutes, which is a new standard for delivery time and cellular output, said the company.

Maxx-BMC’s performance, flexibility and customisable outputs make it a distinct versatile system for multiple clinician settings and procedures.

Along with MAXX-BMC, Royal Biologics’ portfolio also includes FIBRINET (Platelet Rich Fibrin Matrix), OSTEO-SPIN, MAXX-Cell (bone marrow harvester), MAXX-PRP (Platelet Rich Plasma) systems.

In September last year, the company secured the US FDA 510K approval for Maxx-PRP, its platelet-rich plasma concentration system.