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New tissue implant could benefit athletes sidelined with common shoulder injury
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This common shoulder injury could heal faster, thanks to the first implant that recreates a crucial tissue structure
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DURHAM, N.C., March 17, 2021 /PRNewswire/ Sparta Biomedical Inc., a developer of orthopedic solutions, today announced that its SBM-01 Biomimetic Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee.
The Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatments for debilitating conditions. The Program provides patients and health care providers timely access to these medical devices by assisting sponsors in their development, assessment, and review, consistent with the FDA s mission to protect and promote public health.
Sparta Biopharma Announces US Commercial Availability of BioEnthesis™ for Rotator Cuff Repair
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DURHAM, N.C. and MADISON, N.J., March 9, 2021 /PRNewswire/ Sparta Biopharma, Inc., a privately-held company, developing osteobiologics for sports medicine announces the availability of BioEnthesis
TM, the first-of-its-kind allograft that has both mineralized and demineralized layers which provide the requisite properties for healing and repair within the rotator cuff. According to the Healthcare Cost and Utilization Project, there are more than 4.5 million physician visits per year for rotator cuff pain and dysfunction.
Osteobiologics have been used successfully over the last several decades. These allografts have facilitated the formation of functional bone tissue and the healing of bone. In that time, hundreds of allograft compositions and forms have served patients across multiple orthopedic ailments. However, their pote