The US Food and Drug Administration (FDA) has cleared Biologic Therapies' new Bio-MAC Bone Marrow Aspiration catheter, designed to simplify and safely harvest bone marrow.
The Bio-MAC catheter, which contains growth factors and adult cells, is designed to facilitate physicians to use autologous bone marrow aspirate concentrate (BMAC) in surgical procedures to accelerate healing of bone, tendon, muscle and cartilage injuries.
The Bio-MAC Bone Marrow Aspiration catheter contains eight large, smooth, bevel-edged fenestrations which allow for a gentle aspiration as well as incorporate a proprietary plunger component that when inserted down the catheter creates a void where marrow pools.
Biologic Therapies chief medical director and Bio-MAC catheter co-inventor Wade McKenna said, "The Bio-MAC Bone Marrow Aspiration Catheter makes marrow harvesting much easier for clinicians and increases access of bone marrow aspirate for the patients, while decreasing the complication and pain associated with other current bone marrow harvesting devices."
Biologic Therapies president Steve Bales said the company believes that the Bio-MAC catheter will set a new ‘standard of care’ for bone marrow aspiration and regenerative medicine procedures.
"Point-of-care autologous orthobiologic therapy is now being proven in a number of medical specialties, both human and animal, and we expect the Bio-MAC to be the first in a pipeline of successful products designed to effectively meet the needs of physicians and patients worldwide," Bales added.