Sparta’s SBM-01 Biomimetic Implant gets FDA breakthrough device status
Sparta Biomedical said that its SBM-01 Biomimetic Implant has secured a breakthrough device designation from the US Food and Drug Administration for the replacement of damaged knee cartilage, as per an announcement made in March 2021.
SBM-01 Biomimetic Implant is intended to be used in patients with single or multiple chondral or osteochondral defects in the knee.
According to Sparta Biomedical, its minimally invasive treatment mimics the properties of native cartilage and offers a smooth articulating surface.
While stabilizing the subchondral bone, SBM-01 Biomimetic Implant gives support to surrounding cartilage, thereby minimizing further exacerbation of the disease, said Sparta Biomedical.
Dushyanth Surakanti – Co-Founder and CEO of Sparta Biomedical said: “The Breakthrough Device Designation reflects our team’s drive to develop a truly unique solution to address a large clinical need.
“This new treatment option is designed for the hundreds of thousands of patients who experience persistent knee pain and compromised mobility after failing conservative care, but who are too young for a total knee replacement.”